Richard "RJ" Kedziora | Co-Founder, Estenda Solutions | Digital Health Solutions, Bettering Lives, & People-First Cultures

8 Mar · The Leading Difference

00:33:41

Richard "RJ" Kedziora, co-founder of Estenda Solutions, dives into the inspiring world of digital health solutions, where innovative minds are not just developing technology, but also saving and improving lives. RJ shares his journey from early software development days to creating impactful healthcare technologies, highlighting the importance of understanding patient and provider needs. With a focus on people and process management, RJ's story is a testament to the power of technology in making a tangible difference in healthcare through human compassion and the drive to better lives.

Guest links: https://www.linkedin.com/in/rjkedziora/ | https://estenda.com/

Charity supported: Save the Children

Interested in being a guest on the show or have feedback to share? Email us at [email protected].

PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium

EPISODE TRANSCRIPT

Episode 025 - Richard "RJ" Kedziora

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

[00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to welcome as my guest today, Richard "RJ" Kedziora, co-founder of Estenda Solutions, focusing on people and process management which also provides strategic technical direction, guidance, and innovative insights, creating digital health solutions that improve patient outcomes, reduce costs, increase efficiencies, and improve patient provider satisfaction. RJ received an MBA from Westchester University and a BS in Computer Science from Duquesne University, where he received the excellence in computer science award. RJ is a frequent podcast guest, has spoken at numerous technology and healthcare conferences, and has coauthored articles in technology and peer reviewed clinical journals.

[00:01:37] Welcome to the Leading Difference, RJ. And RJ, I would love if you would start by telling us just a little bit about yourself and your background.

[00:01:46] RJ Kedziora: Yeah, Lindsey, thanks for having me. It's a pleasure. I look forward to our conversation. My background is through software development. Graduated with a computer science degree back in, in the early nineties before web and mobile and internet. So crazy days. And came up through those software development racks. Started out programming, got into requirements analysis, understanding what a solution is about, project management, general management. And then in 2003, with a good friend, we were working with together at a large consulting company in the pharmaceutical space, we went off and started our own company called as Estenda Solutions and remain there today. We just hit our 20th anniversary, which is always crazy when I can talk about decades, but it has definitely been an interesting journey. So my day to day is, I think of it as a digital solution architect. So helping a mix of large companies and small companies, startups develop tools, technologies, algorithms, better ways of looking and dealing, handling data, to make a difference in the lives of people.

[00:02:56] Lindsey Dinneen: Wonderful. That's incredible. So 20 years. Congratulations. That's no small task. . So I commend you for that. That's really exciting. I. Yeah. So how did the idea to start your own company come into being? Did you identify a gap basically in the market?

[00:03:15] RJ Kedziora: It's something probably even early on as I was graduating from college, always in, in the back of my mind to make a difference, to go off and try something new and really drive what I wanted to do. Even before starting my own company, as I worked in various different roles, I'd be hired by a company, I'd come in with a defined role, and then I'd always just find a niche. They'd be like, "okay, where does this company need help? Where can I make the biggest impact?"

[00:03:40] And that's how I went from software development into like more of the analysis and project management , 'cause I quickly realized software development, developing a digital product, it, you know, technology is important and you have to understand how to program and how to test, but it's very much about the people, the process, understanding what they're going through, and realizing those things. It was sort of a natural evolution of like, "okay, I need to strike off on my own and really drive projects and things like that with my talents and capabilities and now our team's talents and capabilities."

[00:04:17] We were fortunate in those early stages to have a Congressional grant for the development of a diabetes disease management application for military healthcare. That's how we got our start. So we worked with people like Walter Reed Army Medical Center, the Boston VA, the Indian Health Services, which is responsible for the Native American population here in the United States. Still working with 'em 20 years later, which is crazy that we have 20 year clients-- bunch of other clients that we've been working with, 10, 11, 12 years a across the board. So, it's been enjoyable from that perspective.

[00:04:53] And I always talk about, I've developed accounting systems, I've developed inventory management systems. And even a railroad car scheduling system, it's like, "Hey, great. We need to get that railroad from here to here. It's important!" You know, it's essential and the economy's important. But healthcare, there's that sense of giving back, of making a difference.

[00:05:16] Lindsey Dinneen: Yes. Absolutely. Yeah, I, that is one of the things that I really enjoy about being in this industry is you're right all of those things matter that you could do with your skills, because obviously you have those skills and can use them in all sorts of capacities but in healthcare and med tech, it's this really great extra layer of feeling like you really are able to impact people's lives directly. And it, it just, it has a different sort of feel to it.

[00:05:46] RJ Kedziora: Yeah. And our projects are typically on the R&D side, work, working with the R&Ds, working with academic medical centers, work with PhDs, with doctors, where they'll have an idea. It's like, okay, here's a different way of treating a patient with diabetes. A different way of looking at the data that you can collect around diabetes or other chronic conditions. I, I wear the Aura ring. It's there's a lot of data that's available there now. And so as we develop those solutions, it's one thing for us and the doctors, the PhDs, the corporations we work with to say, "okay, yes, this really works." But they, you know, they have to go to clinical trial. They have to go and do, they work in the real world. So we also have a couple PhDs on staff to help drive those discussions and do the planning around those clinical trials.

[00:06:34] And ultimately, in certain situations, things then have to go to the FDA to be approved and validated. These days, there's a new terminology called digital therapeutics that we're getting heavily involved with. It's a relatively new term, probably 2017, 2018 that came around. And if there's probably 300,000 digital health applications out there. Systems, you know, some of which we've helped create over the years. But there isn't extensive clinical evidence that they work. There's some, but not extensive, and I think of it as the difference between, supplements and prescribed medications. And so there's lots of supplements out there. You can go to your CVS, your Rite Aid and pick them off the shelf, and there's some evidence they might work, but the evidence isn't exactly clear.

[00:07:25] But then you go to prescribed medications, go through a very extensive, rigorous process of development of clinical trials, and then the FDA or other global regulatory bodies look at these and say, "okay, yes, this does make a difference." And that's the idea of digital therapeutics today is there are lots of digital health applications out there, but now people are taking these digital therapeutic applications: evidence-based, clinically validated, approved by regulatory bodies that can be prescribed by your doctor, by your provider. And more importantly than reimbursed by the insurance company. So making a difference.

[00:08:05] You know, and we talk about health, healthcare, and being able to make a difference. There's not enough healthcare professionals out there, particularly in mental health. There's a mental health crisis in the United States. We just can't train enough people fast enough. Digital health is a way to approach that, to scale, to increase access and equity to these systems, to the care and treatment people deserve, and so that's the idea of digital therapeutics. They can get out there, provide this treatment, share the information with your provider, and make a difference.

[00:08:38] Lindsey Dinneen: Yeah, absolutely. So what does it look like when somebody comes to you and says, "Hey, I have this idea for this app, for this software, whatever." And then how does it work when they start approaching you, and this is a brand new, never before , you know, project and you step alongside them. How does that work?

[00:09:00] RJ Kedziora: Yeah, it is. It is a great question. And we work with a mix of Fortune 50 clients, so big customers, global customers, lots of people, processes, technology. We do happen to be ISO 1345 certified, which quite simply means we have a, well-developed quality management process of how we do software development, very template driven, process driven. It's like, here's how we're going to do it, and then we demonstrate that we do it. We get audited regularly by external third parties, by our clients.

[00:09:32] But then we also work with startups who, in some cases don't really understand software and don't understand regulations and what's required to create one of those digital therapeutic applications. So when a customer does come to us in the, in those early stages, it's very exploratory. It starts out with prototyping understanding the problem in the domain space. One of the things that differentiates Estenda from a lot of other companies is we are going to provide the entire development team, software developers, QA from the ground up, educational training, medication training. So if you're working in diabetes or congestive heart failure or lupus, multiple sclerosis, the better the entire team can understand the condition, have empathy for the patient, can understand the provider, the care professional's journey about what they're dealing with and how they can care and treat that patient, the better off they're gonna be.

[00:10:27] So it's those early stages of experimenting and playing and we start with, you know, black and white wire frame diagrams and really get those going and gradually build them up. And I think about it as you, you have a problem and you want to get across town as fast as you can from one end to the other, and you can walk. Great. Okay. But it's not very fast. Okay? I have this idea for a car. I can get across town really fast, but it's gonna take a long time to build that car and realize value. So, let's first build a skateboard. Very simple, can do it very quickly, provide value, get feedback, from the stakeholders, from the customers, from the patients, from the doctors, the nurses, whoever we're developing that application for.

[00:11:15] And so you figure out the unknowns, you know, so what, aren't we sure? What areas are showing promise? So we build that skateboard and then it becomes a scooter with a handlebar, you know, okay, I'm getting across town faster. It's not the ultimate goal. But I can get there. And then you can build a simple motor on it,, and then you build a body around it and you progress gradually until you get to that car. But along the way, you're adding value very quickly, which is important.

[00:11:47] Lindsey Dinneen: Absolutely. Yeah, that sounds like a really good process to work through. And I love your illustration. That's such a great way of capturing the essence of the process and the way that you go through all of that. So, I'm curious, have you always had an interest in and passion for computers, technology, software development, or is this something that evolved over time?

[00:12:08] RJ Kedziora: Yeah, I was very fortunate. My parents were able to buy an IBM PC Junior when I was in probably seventh grade in the mid eighties. I went to a local parochial school. They had a computer lab, you know, as one computer in the classroom. But, for the eighties, that was phenomenal. And so I knew going into college that I wanted to do software development. A good friend had a Commodore 64, which is typically a gaming, and so I'd be over there and it's like, "okay, games are fun, but what can we make the computer do?" You know? So I was very early driven by what can I do and the possibilities of digital everything.

[00:12:49] College, I really thought I was gonna go and get the PhD in artificial intelligence. Very much enamored with that idea. Ultimately as I got ready to graduate, I got offered a job and was like, huh, money and so that, that turned my, you know, immediate trajectory there. You know, I did start working in programming kind of thing, but always followed AI and things and applied those ideas and principles and what AI is, has evolved a lot over the years. We've developed some AI systems in the past, but you know, now when you look at them, they're really like rules engines, and think things of that nature. And they were considered AI at the time, but nowadays it's like, "okay, that really wasn't AI."

[00:13:36] But you know, the idea is, and the principals were there, and one of my senior thesis projects was genetic algorithms and how do you apply the idea of genetic algorithms to solving computer problems? And that was at the early stages of the internet kind of thing, just as a browser were coming out. So that made research interesting 'cause you could even at that early stage reach out globally to people and seek ideas and thoughts and stuff like that which led me down that road. But fast forward 30 years now and AI is everywhere. It's all that, that the media can talk about these days. Rightfully so.

[00:14:15] Lindsey Dinneen: Yeah, and actually that brings up a great question that I had for you, because I did notice on your LinkedIn, you do share a lot of articles about AI, and you're obviously very involved in that. How have those tools helped your work or how has it changed your work or whatnot? How do you feel about all of that?

[00:14:33]

[00:14:33] RJ Kedziora: It really comes down to data. That's the core of AI. In the past and today, you need data to be able to train the AI systems to do what they're capable of. And it's interesting, our journey as Estenda is, as I've been reflecting on it was one of data scarcity. You know, 20 years ago, getting data was the difficult challenge. In diabetes, it was typically finger sticks, and people would, you know, do it a couple times a day and EMRs were there. They existed. We were lucky working with government organizations that had them, the military, the VA had them. Now it's, you know, fast forward 20 years later, there's an overwhelming amount of data. So early on it was like, how do you make decisions with limited data? Now it's like, okay, how do you use all of this data and pick out the important, salient things to be able to make decisions on and drive recommendations,

[00:15:29] And the same thing is true with AI today. As you're developing a system, you need a robust set of data to train the AI systems. The broader data that you have, the better off you're gonna be. Day-to-day. I think today, generative AI, you know, the Chat GPTs, the Bards, what everybody's really, the media is talking about are amazing. You need to know and understand how to use these tools today. And it's not so much where they are today because there are challenges, there are problems, you know, they make up stuff. It's called hallucinations. And so you do have to fact check what they do. It was interesting is I was sharing, we do a monthly all staff meeting kind of thing, and I was sharing my experience with chat GBT and one of the people on the call sort of googled, like, tell me about Estenda. And it made him the president of the organization kind of thing. It was like, he's a great guy, does amazing work us, he's not the person. And it was just one of the odds of that, in that moment, kind thing. It was like, yeah, that's not true.

[00:16:34] Lindsey Dinneen: Right.

[00:16:34] RJ Kedziora: So you do have to fact check it. But that's today and where we are. And so imagine where we're gonna be 10 years down the road. And Bill Gates said a long time ago, "Humanity overestimate what technology will be capable of in, in the 18 months, two years, underestimate where it's gonna be in 10 years." And I think about Estenda, if the iPhone didn't exist, Facebook didn't, Instagram, Twitter, X, none of these things existed when we started, and here we are a short 20 years later and the world's changing. In terms of AI now it's really an efficiency thing. And it's like, "okay, I need to do some blog posts." And yeah, I can sit there and come up with the blog, post ideas, but it's like "Hey, ChatGPT, gimme 10 ideas for blog posts," you know, and I might not like four of 'em. Okay, "gimme four more." I don't like this. "Gimme four more."

[00:17:29] You know, and it's just, it's an efficiency thing. Even in healthcare, that's what we're seeing. So there are, a lot of, I think it's over 400 now, approved, FDA approved AI algorithms very much in the idea in the area of radiology and looking at images. That's by far the biggest use of . Today, if you have those images, you can train systems to recognize certain things, you know, whether it's breast cancer or diabetic retinopathy. You can train systems to recognize what you need to see in those images instead of a person looking at them all the time. So, again, you can scale much more effectively, which is nice. But in, in healthcare it's very much, it's that efficiency question.

[00:18:09] Lindsey Dinneen: Yeah.

[00:18:10] RJ Kedziora: It's like, okay, I know how to write a prior off letter for this patient, but that takes time. So have ChatGPT write the prior off letter. And then you as the physician, the trained professional, have to look at that and evaluate. And you can't just send it off. You do have to look at it, but you know, EMRs, there's a plethora of data in the EMR. Let the AI systems...

[00:18:35] Lindsey Dinneen: Yeah.

[00:18:35] RJ Kedziora: ...you know, surface what is important, is a challenge. EMRs is a general idea, are very much around capturing data for billing, not the best, usable experience. If you can use AI that's just listening in the room to then document that encounter, that provider's now not heads down on the computer typing, trying to make sure they get everything in and not looking at the patient and not paying attention to the patient.

[00:19:02] Lindsey Dinneen: Right.

[00:19:03] RJ Kedziora: It can reverse this kind of thing. It's like, okay, the doctor can now pay attention to the patient and look at that person and really understand their situation better and pick up on those cues of just their body language kind of thing, and not have to worry about typing away at the computer. And then there's a lot of duplication in clinical records. So it's like, let the AI systems get rid of that duplication, make it better. And then just, you know, enhance. And I saw an article, I think I posted about it, the idea of collaborative intelligence, but a lot of people are asking is, AI going to replace Doctors, software programmers, software developers, insert profession X, is AI gonna replace it? And then people are like, "AI is not quite there. AI makes mistakes. It has biases. AI Hallucinates."

[00:19:50] I love my doctor, but my father has said over the years, " the doctor that graduates last in his medical school, what do they call him? Doctor!" You know, they're human. That, and that's what it amounts to. It's, they provide a great service, but they're human too. And they might not recognize everything. And so if we work collaboratively with the AI to balance that out we can improve overall care and treatment. So.

[00:20:18] Lindsey Dinneen: Yeah, so a lot of potential for it, and I love your idea of using it for some of those more tedious, time consuming tasks and just giving you your first draft because it's not, like you said, it's not gonna replace the human. Let's look through this. But it can help. And if you're using it appropriately, there's a lot of good uses for it too. So, yeah. So, you know, there's a couple of things that I noticed from your LinkedIn profile I'd love to chat with you about. One of the things that stood out to me was in your headline, you mentioned Chief People Officer as being most important. So I would love if you would speak a little bit to that and why you feel that way.

[00:21:00] RJ Kedziora: I can do a lot, but I can't do everything. So I, the people that work for us are very important. I can make an impact. A team can make a much bigger impact. A company can make an even a bigger impact. So that is, that's why they are important. I talk about family first a lot. And, we provide fully paid healthcare benefits for you and your family. You want to have that sense of safety, want people to feel that they can take risks, and do their best work kind of thing. And the better they feel, that emotional safety, that the better off we're gonna be as an organization. They'll be able to provide more value to that customer, be more productive, 'cause ultimately that's what it amounts to is we need to get software out the door. We have customers and clients that have needs and demands and we have to meet those, but you know, you have to balance that with life. So.

[00:22:02] Lindsey Dinneen: Yeah, absolutely. And I love the emphasis on people first, and I'm, I'm wondering if that's something that, is that an ethos that developed over time for you as well as how did your leadership skills evolve? Because going from starting a business to then and then growing it, I mean, it's a whole thing. So, yeah, I'd love to hear a little bit about that.

[00:22:24] RJ Kedziora: Yeah, it definitely has grown and evolved o, over the years. It there, there's this concept of being a 10x software developer, one person making the impact of 10 people. And that's somewhat of a myth, but there are people that are more productive than others. And the idea of empathy and understanding that other person's perspective and experience is what's driving to that next level to become that 10x developer. You're not developing for yourself. You're developing for the end user, but we embody it in, we have a professional development process, and the idea of helping others is embedded in that.

[00:23:01] You'll see that we do one-on-ones, not as great, as frequently, as I would like. But we try and do those. But as part of our structured plan, we do a self-assessment and we ask everybody that question, "how have you helped other people?" as part of the goal process, "how are you helping others?" But even as you're developing in that day to day when you're writing code, "how is it helping you in the future understand what you're doing? How does it help the tester better test that software? How does it help the support person provide better support?"

[00:23:37] So it's really thinking about how you're helping others along the way. And ultimately the whole company is driven by that of working in healthcare. But it starts at that bottom of every person. It's like, "how, what you're doing, helping the next thing?" So we try and constantly reemphasize that when we can.

[00:23:54] Lindsey Dinneen: Yeah, that's a great approach. And so, and because that is so much the heart of your company and your people, I'm curious if there's any particular moment that stands out to you as you've gone along this journey, that kind of really reinforced, yes, this is why I am here doing this work. Is there anything that, or a series of moments, just things that really stand out as being a very sure "yes, this is correct" for you?

[00:24:20] I

[00:24:21] RJ Kedziora: Yeah. It, I would say it's more a series of moments, because as we've developed software and then it's used by the care providers or patients, we've constantly over the years, hear those anecdotal stories of "Hey, I was using your software, what you developed for us, and found this and helped this patient." There's a series of those, but then it even goes up, it bubbles up that we do those clinical trials and we've done five year NIH funded National Institutes of Health funded RO one study. So it's like a five year study to then demonstrate that the software we produced does make an impact kind of thing.

[00:25:00] But even more importantly, as we're part of that process, we've had several customers put our names, our developers' names on patents, or as those articles have gone to clinical journals, peer review journals that our software developers and QA, other staff have been authors on those. That, that's just rewarding where, okay, yes, we are helping people, but then our customers are also recognizing how much of a part of this journey we are. You know, if you really know what you wanna do and have it, here's my 10 requirements kind of thing. We're probably not the company for you. Let's explore and create something together.

[00:25:38] Lindsey Dinneen: That's really cool. So it's always a collaboration it sounds like with your clients. It's not just a one way or the other, them dictating to you or you dictating to them. It's this, let's figure out the best way for us to work together.

[00:25:50] RJ Kedziora: Yeah, it says how do we add value? How are we, you know, we want to contribute.

[00:25:56] Lindsey Dinneen: Yeah. That's amazing. Yeah. So, one other kind of random question. Based on your LinkedIn profile, when's your next triathlon?

[00:26:04] RJ Kedziora: How much time do you have?

[00:26:06] Lindsey Dinneen: Yeah.

[00:26:06] RJ Kedziora: I, yeah, that's a whole 'nother podcast.

[00:26:08] Lindsey Dinneen: Yeah, sure.

[00:26:09] RJ Kedziora: I think I'm, I think I'm, I think I'm done for this year. I live in the Philadelphia area, the temperature's getting, yeah, temperature's getting a little colder and that type of thing. But, you know, take a little rest for a month or two before I get back into training. And, but there are definitely ones I do every year. There's one escape from Cape May, Cape May, New Jersey. You jump off the back of a boat, the ferry, into the ocean and swim to shore. I did escape from Alcatraz two years ago, which is interesting because they take you out in a boat, in, into the. And jump off the boat from Alcatraz and swim to shore. Always interesting kind of thing to, to do those, but it's very much-- it's interesting because my day-to-day at Estenda, my own company, and how I get involved in projects is 'cause I enjoy the challenge of it.

[00:27:00] And in triathlon, yes, there, there's a definitely a physical aspect of training and, but it is also very mental to, and that's really what I think drives me in the sport of triathlon. It's like, "okay, I need to get up at 4:30 and go jump on the pool and swim for 45 minutes and then hop on a bike" time and time again. And I thoroughly enjoy it. But yeah, it is that mental challenge. I've done just pure marathons in the past and it's like, "okay, get to the next telephone pole. Get to that next half pot." It's that mental, keep pushing kind of thing is drives me.

[00:27:34] Lindsey Dinneen: That's incredible. It just reminds me-- tangent very quickly-- it reminds me, I remember I was running a 10k with my husband and I'm not a runner, I don't claim to be, but I was doing this challenge for myself, and I just remember we, we were getting close and I was so exhausted and, you know, kind of miserable at that point. And he was like, "it's all downhill from here. It's all downhill." And I was like, "it's literally sloping up!"

[00:28:00] RJ Kedziora: Yeah, but it's, you know, it's like, yes, for me, try, it's hard. It's difficult kind of thing. but I'm also good enough that I'm not out there it's like, for a a marathon, I can-- in the past it was like 3:20 for a marathon.

[00:28:16] Lindsey Dinneen: Wow.

[00:28:17] RJ Kedziora: But there are people out there that are five hours, six hours. I think that is so much harder, so much dedication for that individual to be out there for five hours. It's kudos to you for being out there for, you know, it's like, yeah. I'm not saying I, I have an easy time of it by any means, but I'm not out there for five hours and they did it. So I just, I'm astounded by those people and they're not on the couch. And I know I, I look to have a long lifespan and a long healthspan. I want to hit a hundred years, but with a good quality of life. And I have a couple friends that are in, still out doing that 5k at 70 years old, and they're like, "I won my age group! I was the only one in my age group..." but you weren't on the couch! Like you did it! And that's motivation to, to keep going out there as well. So hopefully I'll be that person.

[00:29:10] Lindsey Dinneen: I love it. That's brilliant. Excellent. So, pivoting just for fun, but imagine you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why?

[00:29:29] RJ Kedziora: Oh wow. It would probably be about health.

[00:29:34] Lindsey Dinneen: Okay.

[00:29:35] RJ Kedziora: Which, which combines sort of everything I do. The triathlon, the training, the fact that I'm in software development in the health field. It brings all of those things together. And just a lot of people don't know what they don't know. And so if I could impart that knowledge on more and more people, I think that would make an impact that would make a difference. So yes, I could teach a software development course on cybersecurity. Interesting.. I could teach one on AI. Yes, interesting. But if it, if you really just focused around the idea of eating better, moving. You don't have to do a triathlon, you don't have to do a 5k. And it's like park a little further away from the supermarket and walk. You're gonna be better off, have that longer lifespan, longer health span. So yeah, it's, if I have that million dollars and it is probably health in in general, which encompasses a lot. But yeah, it would be health.

[00:30:37] Lindsey Dinneen: Yeah, absolutely. Yeah. And then, how would you like to be remembered after you leave this world?

[00:30:44] RJ Kedziora: Huh. Wow. Then I've made an impact and I've made a difference in, in some small way. I don't have to win the lottery, I don't have to be the billionaire kind of thing, but that, that I've made a small impact and, the lives of the people around me and hopefully a bigger audience through the work that I've done, that our company's done. And yeah, I've made a small difference and made a few people laugh.

[00:31:12] Lindsey Dinneen: Yeah. Yeah. I mean, I've already laughed today. So , you're succeeding. Excellent. And then final question, what is one thing that makes you smile every time you see or think about it.

[00:31:26] RJ Kedziora: Family, I, that's, you know, wife. I have two daughters, 24 and 21, doing very well. Yeah, any chance I get to see them? Family.

[00:31:36] Lindsey Dinneen: Yeah.

[00:31:36] RJ Kedziora: And oldest of six. So you get to see them and their family kind of thing. Family's important, yeah. Yeah.

[00:31:43] Lindsey Dinneen: Yeah. And you've mentioned that several times: family first and people first. So it's a running theme. . That's great. RJ, this has been so much fun. I really appreciate your time today and just thank you so much for joining us. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. So, thank you so much for picking that, that organization to support and we just wish you continued success as you work to change lives for a better world.

[00:32:24] RJ Kedziora: Thank you very much. This was a great interview. Thank you.

[00:32:27] Lindsey Dinneen: Excellent, excellent, and thank you so much to our listeners for tuning in and if your feeling is inspired as I am right now, I'd love if you'd share this with a friend or two and we will catch you next time.

[00:32:38] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

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Ashley Mooneyham & Jennie Lynch | Co-Founders, Momease | Bridging Science, Motherhood, & Femtech
6 Eyl· The Leading Difference
Ashley Mooneyham and Jennie Lynch are the co-founders of Momease. Ashley, a PhD-trained scientist and melanoma survivor, shares her journey from cancer biology research to developing an innovative breast pump solution inspired by her own motherhood challenges. Jennie, a serial nonprofit entrepreneur, discusses her transition to the MedTech industry and the importance of supporting new mothers. Together, they highlight their mission to create a pumping bra with warmth and massage, aiming to improve the breastfeeding experience for women. Their story is one of passion, innovation, and dedication to advancing women's health.
Guest links: https://www.momeasesolutions.com/ | www.linkedin.com/company/momeasesolutions/ | www.instagram.com/momease_solutions/ | https://www.facebook.com/MomeaseSolutionsInc/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 038 - Ashley Mooneyham & Jennie Lynch
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guests today. They are Ashley Mooneyham and Jennie Lynch. Ashley is the CEO and co founder of Momease with experience as a mother and as a PhD trained scientist to lead research and development. Jennie is the president and co founder of Momease. She is a serial entrepreneur in the nonprofit space with customer base experience leading operations.
Well, thank you so much for being here, Ashley and Jennie. I'm so excited to speak with both of you today.
[00:01:33] Ashley Mooneyham: Thank you.
[00:01:34] Jennie Lynch: Yeah, thank you for having us.
[00:01:35] Lindsey Dinneen: Yeah, absolutely. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and maybe what led you to MedTech. Ashley, do you want to start us off and we'll go from there?
[00:01:48] Ashley Mooneyham: Yeah, sure. So my background is in kind of your traditional laboratory research science. I did choose to pursue a PhD in cancer biology, and that was motivated both by my own personal experiences as a melanoma survivor, as well as, of course, knowing so many people who suffer from cancer and are impacted by cancer. I really wanted to make a difference there. And I very much intentionally chose a laboratory for my thesis work that focused on ovarian cancer research because I've always been really passionate about how scientific discovery can impact human health. And of course, as we're all aware, women's health kind of lags behind. So we need more women in science to be asking those questions and pursuing those answers when it comes to translating scientific discovery into impacting women clinical outcomes.
And I really enjoyed my thesis work, but I felt far from making that clinical impact. I was doing the traditional bench work, working with mice in the basement of my university, and I just wanted to get a bit closer to the action. So after my PhD, I became a medical writer at Superior Medical Experts, which is a Minnesota small business focused on medical writing and research support. And I actually was quickly promoted to their Director of Grants, where I helped small businesses in the medical device industry pursue federal grant funding to de risk their medical innovation. So I got to learn a lot of varieties of discipline within scientific medical device and technology innovation, and got really excited at helping them secure funding to see their idea come to life. And I've actually worked with a few companies that since working with them have made it to clinical use of their innovative technology, which was super rewarding.
Then in April 2021, I had my daughter, she's 3 years old now. And I kind of naively thought it would be easy to go back to work after that experience. But a huge pain point in my going back to work was. trying to maintain my breast milk supply for her via the breast pump. So that kind of leads into the origins of Momease solutions, but I'll save that for after Jennie gets a chance to introduce herself as well.
[00:04:12] Lindsey Dinneen: Amazing. Thank you. Jennie?
[00:04:15] Jennie Lynch: Yeah, so my background is I'm a serial non profit entrepreneur. So I founded two Minnesota based non profits focused on child development and family well being. So mostly doing the business operations and development for those two non profit organizations. The first one is Monarch Montessori School, a traditional children's house Montessori that's really rooted in the literature that supports best pedagogies for optimal child development, as well as Kaleidoscope Learning. That's my second non profit, which is a family community and resource center, just a one stop shop for families to be able to get all the best practices associated with raising their children ages birth to six years old.
I frequently work with the population that is going to be Momease solutions' customer base. So I love working with mothers, women who are pregnant or newly postpartum and are going through the very wonderful, but very precarious kind of transition into motherhood. So that's kind of where my background is. I do not have a medtech background. But I'm somebody who's really passionate about looking at the literature when it's related to child development. So what is the optimal strategy in order to really nurture a person's early development related to cognitive, physical, social, emotional development. I originally got connected with Ashley through Mutual Business Connections and I instantly loved the idea. I saw how it would be used by the women who I currently work with and just really recognized that it was a really special product. So I officially joined the team in 2023.
[00:06:05] Lindsey Dinneen: Wow. Nice. Well, congrats. How exciting. Yeah. So I love it. So would you mind telling us a little bit more about Momease and just maybe the origin story.
[00:06:19] Ashley Mooneyham: So yeah. So like I said, I had my daughter in April of 2021. I was able to nurse her without issue for eight weeks during my maternity leave and I was so excited about that because the American Academy of Pediatrics, the World Health Organization, they all recommend exclusive breast milk nutrition through six months of age. To Jennie's point to try to promote the health of our next generation with cognitive ability and various health indications that research shows are improved with that breast milk nutrition. And I really wanted that for my daughter if I could achieve it. I was grateful to not have issues nursing, but when I went back to work, I thought kind of naively that I would be able to use the breast pump to continue to feed her breast milk, even though I was remote and away.
And unfortunately, that was not the case, which is a super common issue with women. I had to pump three or four sessions to get one bottle for my daughter, so I was really working overtime, trying to do enough breast pump sessions to maintain my breast milk supply. And I was sitting at the breast pump for far too long, usually 20 to 30 minutes a session, increasing the suction power to a level that caused discomfort just in my attempt to provide my daughter with the nutrition I felt that she needed. And I was really frustrated by that because I knew, based on my successful nursing journey, that I did provide enough breast milk for her. I simply wasn't able to collect it. So the issue was with the collection mechanism.
And with my background in science, I immediately sought answers. How can I improve this experience, just for me personally, on the onset. And I did find academic studies that showed if you apply a warm compress while using a breast pump, you get more milk in less time. If you use a hand massage technique while using a breast pump, you get more milk in less time. And anecdotally, that was true. If I applied a warm compress, if I put pressure on my breasts while using a suction based breast pump, it worked. And that made sense to me because a nursing infant is doing a lot more than sucking breast milk. They're also using the warmth of their mouths and the pressure of their jaw and hands in a combination to efficiently nurse. So adding these elements back in made perfect sense.
The issue is it's not convenient. Using a breast pump is already not convenient and having all of these extra tasks while using a breast pump certainly wasn't convenient. So I literally went to Google and looked for a product that could warm and massage the breasts while I was using a breast pump in order to maintain these improved results. And I didn't find one. And I was really shocked by that. I was like, "How could this not exist when there is evidence that it works?" And I'm having personal anecdotal experience that it works. I was so disappointed.
And I sat with that disappointment for a couple of months and then realized, "Well, it doesn't exist because people like me just sit disappointed." You kind of have to get up and get going to solve the problems, especially that you see personally. And the whole first year of business before we had a lot of funding in the door, I made sure to broadly collect women's experiences with the breast pump, and I learned really quickly that I was not alone.
Our first customer discovery survey received 1, 200 responses in 24 hours, which is incredible and unexpected. I just put it out over my personal Facebook to start and it got picked up and got a lot of responses. And that alone, I think, really speaks to how passionate women are about wanting a solution and how desperate they are for wanting a solution. And every day that keeps Jennie and I going. Every day that we pitch this, every day that we talk about this, more and more women say how much this is needed and how much they're rooting for us. And that, that's our big motivation.
[00:10:22] Lindsey Dinneen: Yeah. Wow. That is incredible. Thank you for sharing that story. And even the, I love the personal connection, but then the fact that just within 24 hours, like you said, of your own personal network, you've got this amazing response of all these women saying, "Yes, I am in the same boat or I've experienced this. Please help." I love that. So then Jennie, you're coming into this from your business development, business strategy background. And I'm wondering, how have you been able to to bring Momease along as it continues to grow and opportunities continue to come for it. And then what are you excited about as we go towards the future?
[00:11:06] Jennie Lynch: Yeah. So that's a really good question. Momease is pre launch. So, I'm continuously just having conversations with mothers, continue to get that feedback, that customer discovery. Again, being pre launched most of my focus at the moment is long term business development strategies. So just thinking about those things ahead of time, but also just day to day operational things. I'm definitely excited as we move towards launch of the product. I think that I would love to see this product in people's hands. We're currently prototyping. So just seeing women use it, as well as getting their initial feedback is something I'm just very excited about.
[00:11:46] Lindsey Dinneen: Amazing. So in this pre launch stage, I know you have a bazillion things going on, I'm sure, and there's lots to think about and a lot of exciting things happening, but what's the next step for you at this point? You have some funding, it sounds like, but now what's coming up, the very next thing?
[00:12:08] Ashley Mooneyham: Yeah. So I don't know that we've said explicitly, but just in case anyone isn't aware, we are trying to create a pumping bra with built in warmth and massage. So that's the product that we're seeking to create. And we did receive funding last year from the National Institutes of Health to pursue this, which is really exciting. So the National Institute of Child Health and Human Development awarded us a Phase I grant to do the prototyping that we're currently underway with and achieve our proof of concept ahead of validating it and then launching the product.
So right now we're definitely in that proof of concept prototyping phase. We have seen promising early results that we were hoping to see. And now it's a matter of kind of fine tuning the product at this early stage so that when it hits the market it's more than functional, it's convenient to use. We want this to be very clear that it is a product with integrity that was also designed by a mother for mothers, designed by women for women. I think that is something that this market is looking for, and women's products are booming right now. So I feel like this is right place, right time for us to enter and hit that inflection point.
[00:13:25] Lindsey Dinneen: Absolutely. Well, congratulations on all of the success so far. I know it's not been an easy road. I'm sure there have been lots of late nights and stressful days, but you're doing it. So that's amazing. And thank you for bringing this to market because it's so needed. And I'm curious, is your goal to be able to provide this directly to consumers? Are you hoping to have an intermediary? What are your thoughts with that? Because I'm sure some people are so excited to go, "When is this going to be real?"
[00:13:59] Ashley Mooneyham: That's such a good question.
[00:14:00] Jennie Lynch: Yeah, absolutely. So we have two ways we would love to enter the market. The first one is traditional business to consumer channels, so sales directly through our website, maybe at brick and mortar stores, big box stores, boutiques, being listed on online retailer websites. Just the traditional ways you can get a consumer good into your hands. The second channel is more business to business. We would love to sell directly to NICU units. We have heard from NICU units or individuals who work in NICU units that this is something that would be really beneficial, as well as we would love to reach out to breast pump manufacturers who might be interested in bundling our product with their breast pumps to have that kit mothers can buy right away that will have a synergistic effect right from the get go. So those are two go to market strategies.
[00:14:56] Lindsey Dinneen: Amazing. Well, that is very exciting. So as you've been going on this journey, and I'm sure you've had amazing days. I'm sure you've had some discouraging days. Are there any moments that stand out to you as really clarifying to you that you are in the right place at the right time doing what you are meant to do?
[00:15:18] Ashley Mooneyham: Yeah, absolutely. I think one that I already mentioned was that first customer discovery survey. That's one of the first things I did after formally launching this business. And it's been a through line ever since. It's a touch point that we can constantly go back to that validates why we're doing what we're doing and that it's worth pursuing.
And then shortly after that, I did start participating in pitch competitions where I was able to present this idea more widely. And the first competition that we ever entered was the HyVee Opportunity Summit, which was hosted at US Bank Stadium. And we were selected as, I think, a top nine finalist to pitch from over 900 applicants. And during that pitch contest, we took home grand prize. So out of the top nine, we got the number one prize slot. And I distinctly remember getting down from that stage so shocked that we were able to secure the grand prize our first pitch competition, but feeling so proud that what we're trying to do resonated and literally women came up to us with tears in their eyes.
And I, it just, it was so buoying. It really felt like, "Oh, this is something that matters. It's something that is beyond a solution for just myself." But 97 percent of our survey responders said that they were dissatisfied with the breast pump. And that's such an incredible dissatisfaction rate for such an essential piece of technology.
So those were two big wins for us early on. And then later last year when we were able to receive validation also from this huge federal scientific body that what we're doing is beyond like a feel good mission. It has scientific merit. It has significant potential to impact not only women's health, but human health by nourishing that next generation. That was a big win as well. And we're so excited for all of that collective experience to be really able to dig in this year to the research and development and start to make this idea a reality.
[00:17:25] Lindsey Dinneen: Yeah, absolutely. And Jennie?
[00:17:30] Jennie Lynch: Yeah, kind of echoing Ashley, she hit some of our big milestones in 2023. This year, I've had a couple friends and family members who've had little ones, and it's just been really interesting seeing a lot of my friends and how they're coming into motherhood. And how this product is something that they're probably not going to be using it for this child, but maybe in the future. And they're just really excited for us to be able to launch our product and for them to use it in the future. So that's something, just that verbal reassurance from our community is something that I think is what keeps us going.
[00:18:08] Lindsey Dinneen: Yeah, of course, that makes so much sense, and I'm so glad you have that, so much social proof, the stories of the people who are coming up to you, and then you've also, like you said, have this tangible grant that really did help say, "Yeah, this is very important, this is very needed," and I'm sure those things really help on the difficult days, so I'm so glad you have all of that.
But speaking of difficult days, I am wondering, in this journey, I'm sure there have been lots of ups and downs. What are some of the things that you have maybe been surprised about as you have gone about this new journey? And I know, Jennie, there's a lot of entrepreneurial endeavors in your background, but just in general, when you're getting into a new thing, there's always unexpected things that pop up. So just curious as anything come up for you yet?
[00:19:02] Jennie Lynch: Something that I have found unexpected and slightly challenging at times, something that Ashley and I constantly are thinking about is, how we're kind of in this in between space where we're kind of known as a consumer good, yet we are a medical device, and it's been really hard to communicate some of the challenges related to being in that in between space with a lot of either investors or cheerleaders or people who are just interested in our product. We're more complicated than that average consumer good, yet we're not going to be put into the body. We're not as technical as maybe other medical devices that are on the market. So we really are in this in between space and there aren't too many players who are as well, at least that we've come across in our own journey. So that is a weird thing that we've run into is how do we effectively communicate where we are on the market and the importance of the product.
[00:19:57] Lindsey Dinneen: Yeah. Yeah, absolutely. And Ashley?
[00:20:01] Ashley Mooneyham: Yeah. Jennie hit the nail on the head that continues to be a thorn in our side, but we are getting better and better at navigating this middle ground and explaining that's actually our secret sauce in a lot of ways, that we're not a simple consumer good, and we're not a complicated medical device. We exist in this elegant in between to hopefully be that solution. And then I think just what a lot of founders can relate to, the only other major challenge is fundraising for the effort and being really careful with the funds that we have raised to make sure that we can go as far as possible and really time the spends strategically. So that's been something that we're constantly evaluating, making sure that we're using our funds responsibly and constantly have our eye on future fundraise efforts to make sure that there's no major gap in funding that could hinder our progress. And I will just say having a co founder like Jennie through this experience has made every challenge much more bearable. So, I'm so glad that we get to go through it together. The hard days are much easier having a co founder like Jennie by my side and the good days are even more fun to celebrate.
[00:21:11] Lindsey Dinneen: Oh, I love that. So you both are absolute powerhouse women. I got to take a look at your LinkedIn profiles and I was just really admiring everything that you have done in your past, your education, your expertise, and then your commitment to community and the fact that you're still actively volunteering and you're doing all of these things. And it really struck me as not only incredibly impressive, but also I just have to ask, do you sleep?
[00:21:42] Ashley Mooneyham: I mean, I have a two month old at home, so no. But I will say, that gives me extra waking hours in the day, so that's always good. I don't know how Jennie does it.
[00:21:55] Jennie Lynch: Man, I think similar to Ashley, I do have a good support network and I think that makes all the difference. I don't think that I could achieve what I have without the friends and family who continue to uplift me. So that's what keeps me going too.
[00:22:10] Lindsey Dinneen: Yeah. Yeah. Good reminder about the importance of community, absolutely. That's phenomenal. What is your top piece of advice you have for other women medtech founders specifically, or women medtech leaders.
[00:22:27] Ashley Mooneyham: Yeah. I mean, it's something I constantly think about and learned through this journey is that being a woman founder is a strength. It's not a weakness. You don't need to justify being a woman founder. You don't need to justify pursuing a women's health problem with a women's health solution. I actually think all of that is a strength. And the second I stopped defending myself as a founder and defending my product and instead presented it as the opportunity it is and found like minded, passionate individuals like Jennie to join the journey, the more success we had. So I would just encourage all women founders, women entrepreneurs to remind yourself that you are doing something exceptionally valuable and your perspective is exceptionally valuable. And it's not something that you need to make excuses for or feel like you need to be on the back foot about.
[00:23:24] Lindsey Dinneen: Yeah. Yeah. Jennie, do you have anything to add to that as well?
[00:23:29] Jennie Lynch: Wow. Yeah, absolutely. The main takeaway that I have since starting entrepreneurship is create a community with people around you who will continue to support you. And mostly what I mean by that is Ashley and I have already established a community, both in Minnesota and nationally, that incorporates women health founders, and the amount of just brainstorming and good ideas that we get bouncing ideas off of one another is really wonderful. And it's great being able to connect with women who are in a similar position.
[00:24:06] Lindsey Dinneen: Yeah, that's great advice. Thank you both. Yeah, so pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, could be about what you're currently doing, but it doesn't have to be. What would you choose to teach and why?
[00:24:27] Ashley Mooneyham: Well, I can give an industry specific answer right away if Jennie wants a couple more minutes to think. This might be the more boring answer, but Jennie leads an exciting life, so she can back end this with something more fun. But like I said, my expertise originally was in helping companies secure that non dilutive grant funding. Honestly, I want to spread that message more to small businesses, because I hear over and over again how much funding ends up being a barrier to small businesses, especially in the earliest stages of ideation and de risking whatever it is that they think matters and should be introduced to the market space. And that ends up stopping so many great ideas from getting a chance even to move forward in the market.
So I am constantly working on this now without a million dollars, but if I had a million dollars I'd love to just be able to spread that message more, especially to the businesses that have that mission and heart behind them. So right now there's that White House initiative, as well as the National Institutes of Health Initiative to fund women's health research. Every female entrepreneur I meet in women's health, you can't get me to stop talking about federal grant funding and pursuing grant funding to really maintain ownership over your idea, ownership over that direction, which is going to be important for any founder, but particularly those that are trying to represent disadvantaged populations or underrepresented populations. You get to maintain your ownership and you get to de risk your idea so that you can move it forward. That's just where my mind goes to right away.
[00:26:09] Lindsey Dinneen: Yeah, excellent. Very needed too, so.
[00:26:13] Jennie Lynch: I guess if I had to teach a master class, I can come in with something a little bit more fun. So a couple years back, I spent a lot of time traveling. I was doing the digital nomad thing, so maybe a master class on all the ins and outs that come with how to work. And live on the road and you know how to organize your life a little bit to make that a little bit more streamlined. There was some trial and error for a couple years and I have this wealth of knowledge that's all living in my head, but it would be really cool to bring that to life in a master class, I think.
[00:26:48] Lindsey Dinneen: Absolutely. Yes, as a digital nomad myself, I fully understand what you're talking about and getting, that learning curve can be a little steep sometimes accidentally you think, "Oh yeah, I'm prepared."
[00:27:03] Jennie Lynch: Yeah, exactly. You never know what, what's going to come up when you're traveling around.
[00:27:09] Lindsey Dinneen: I always say there's never a dull moment. And then, how do you wish to be remembered after you leave this world?
[00:27:17] Ashley Mooneyham: Jennie, your turn to go first.
[00:27:20] Jennie Lynch: Sure, I can go first. Yeah, well, I guess if there was something that I would love for, I would love to be known as a very loving person, a kind friend, somebody who's always positive, and gives everybody the benefit of the doubt. I guess a distinct characteristic that I would love to be remembered for is maybe what my partner calls "activator energy." I really love just immediately tackling a project, bringing something from zero to one. So if I had one characteristic, it would be that kind of activator energy characteristic.
[00:27:56] Lindsey Dinneen: I love that.
[00:27:58] Ashley Mooneyham: I do too. And that's a perfect answer. Yeah, I agree with Jennie. What matters most are those interpersonal relationships and connections that you have in close community with. Those are the things that matter most to me. It's way more important to be a good wife, good mother, good friend, good daughter in the time that we have. But also obviously, I'm hoping with Momease to leave a legacy that does make an impact in women's health one way or another. And I try to keep that in perspective with our business goals always that any win that we have is a win for women's health. Anything that we achieve is validation that funding women's health is worth it and that this field is worth pursuing. And I hope that it continues to improve after our journey ends with Momease, wherever that ending point is. And I hope that's a way that we can leave our thumbprint outside of our families with something a bit greater.
[00:28:58] Lindsey Dinneen: Yeah. Yeah. Those are beautiful answers. Yeah, and then my final question. What is one thing that makes you smile every time you see or think about it?
[00:29:11] Ashley Mooneyham: Well, my answer is easy. I have children, so that's obviously a joy in my life. And another thing that keeps me going every day, I want my kids to know that if they have an idea that you should bet on yourself and pursue it. And I hope that I can model that for them, even in an uncertain, scary landscape like entrepreneurship. So yeah, grateful for my kids. I have a daughter and a son.
[00:29:38] Jennie Lynch: For me, it's just a nice cup of coffee, but immediate smile.
[00:29:44] Lindsey Dinneen: I can relate to that, especially in the morning first thing when you're just like trying to get recombobulated and here we go.
[00:29:52] Jennie Lynch: Absolutely.
[00:29:53] Ashley Mooneyham: Yeah, that first cup isn't even a smile. It's just necessity. And then if I get an afternoon cup, that's where then the joy comes in.
[00:30:01] Jennie Lynch: Yes.
[00:30:02] Lindsey Dinneen: That's fantastic. That's amazing. Well, thank you both so very much for spending some time with me today and sharing your stories and your advice, and I am so excited to see Momease continue to succeed, and I love what you're doing, and this is so needed, and you have this wide open space for it, and that's insane, but I'm so thankful that you guys are taking the time and the effort and the funds and everything to make it come to life because it is so needed. So, gosh, just thank you for what you're doing.
[00:30:36] Ashley Mooneyham: Thank you for being a platform.
[00:30:39] Lindsey Dinneen: Of course, and we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success.
[00:31:11] Ashley Mooneyham: Thank you.
[00:31:12] Jennie Lynch: Thank you.
[00:31:13] Lindsey Dinneen: Absolutely. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I would love if you would share this episode with a colleague or two, continue to spread the word about these amazing innovations, and we will catch you next time.
[00:31:31] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Dr. Shoreh Ershadi | Founder, ANTIAGING Institute of California | Apoptosis, Clinical Excellence, & Women in Science
23 Ağu· The Leading Difference
Dr. Shoreh Ershadi is the founder of ANITAGING Institute of California and a renowned expert in clinical biochemistry and pharmacology with over 40 years of experience. Dr. Ershadi shares her compelling journey from Iran to the United States, highlighting her unexpected entry into medical technology and the numerous challenges she faced as a woman in science. From setting up clinical labs and pioneering AIDS testing to founding her own antiaging company, Dr. Ershadi discusses her relentless pursuit of scientific innovation and passion for improving human health. The conversation also touches on her entrepreneurial ventures, the role of art in her life, and her vision for a healthier future driven by natural apoptosis-promoting supplements.
Guest links: www.Apoptosis.us | www.facebook.com/apoptosisnutraceuticals | www.instagram.com/apoptosisnutraceuticals | www.threads.com/apoptosisnutraceuticals
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 037 - Dr. Shoreh Ershadi
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm so excited to introduce you to my guest, Dr. Shoreh Ershadi. With over 40 years of expertise in clinical biochemistry and pharmacology, Dr. Ershadi stands at the forefront of scientific innovation in the field of nutraceuticals and supplements. Board certified by the American Academy of Antiaging Medicine and holding dual doctorate degrees, Dr. Ershadi brings a wealth of knowledge and experience to the world. Dr. Ershadi's distinguished credentials, including National Registry in Clinical Chemistry and Toxicology and American Society of Clinical Pathology certifications, underscore her dedication to precision and quality in laboratory practices. Her visionary leadership and unwavering passion for advancing human health has made her a trusted authority in the field.
All right. Well, Shoreh, thank you so much for being here today. I'm so excited to speak with you.
[00:01:51] Dr. Shoreh Ershadi: Thank you for having me. I'm very excited to talk to you, especially that you're going to talk about medical technology. And that is something that I have been doing or working at for, I would say over 30 years, easy. 1988, I got my license in California. So it's what, 32 years?
[00:02:17] Lindsey Dinneen: Yeah. Excellent. Oh my goodness. Well, this leads perfectly into my first question and that is, can you tell us a little bit about yourself and your background and how you got into medtech?
[00:02:29] Dr. Shoreh Ershadi: Okay. That is interesting because I was born in Iran and I studied pharmacology. And before I was graduated, the Department of Health in Iran was hiring pharmacists, pharmacologists. So we all went and took the exam and we passed the exam. We were still at the final stages of doing the thesis and going through final stages of graduation. And then they called me and a few other people for an interview. Apparently I had a high mark in the test, which I did not know.
So when we went for the interview, and I went to an American school and then later to a British school in Iran, so I was speaking English. At the interview, there was a gentleman who was back in Iran from United States, and he was a PhD in clinical biochemistry, and he asked me to read something in English. And I read it, and he thought that I had it by heart or something, so he flipped the book and found a more difficult page and said, "Okay, read this," and I read that, and he said, "Okay, I'm hiring you for the reference lab."
I had absolutely no clue what he was talking about, what was reference lab. I had no intention to even work for Department of Health because I was not even graduated at that time. And then they said, "Okay, start on such and such date." And when I went there the first day, he said he spoke in English and he said, "You're overqualified." Oh my God. What? I mean, it was funny. Without even planning to get into laboratory, I got into the reference lab of Department of Health. And what he was planning to do was to bring College of American Pathologists, the proficiency testing to all the laboratories in Iran. And he wanted someone who would speak English and who could communicate.
So first day of my job, I wrote a letter to College of American Pathologists and I said, "Hi, hello, I'm Shoreh Ershadi, I want to buy a thousand proficiency kits." And of course they responded. So just like that, I got into clinical laboratory. And I became the Director of the Quality Control for Department of Health. And that was before the revolution. So, that was my exciting start into laboratory.
[00:05:25] Lindsey Dinneen: Yeah, that's an incredible story. Thank you for sharing that. And
[00:05:28] Dr. Shoreh Ershadi: Not voluntarily, but serendipitously, yes.
[00:05:34] Lindsey Dinneen: There you go. So then at some point, you came to the U. S. and was that transition really difficult? Was it frustrating? Were you excited? Nervous?
[00:05:47] Dr. Shoreh Ershadi: There was a part in between before coming to U. S. There was another test by W. H. O., World Health Organization. So I took that test and I passed that test and I got a scholarship to go to medical school in England to do a master's degree. And when I went there, I told them, "I already have a doctorate in pharmacology. I don't want master's. I want to do PhD." And after a few weeks, they said, "Okay, fine, go to PhD. You don't need to do master."
So I was in England for about four years. I did my PhD in clinical biochemistry. And I went back to Iran. That was exactly during the revolution. So while I was studying in England, the country in Iran was on fire. It was, things going crazy everywhere. But I went back and I got married. I had my son in Iran, and I was working in a clinical laboratory in one of the best hospitals in Iran, and it got very difficult for women to work. They were saying, " Now you have to wear a scarf. Now, you can't see male patients, you can only talk to female patients." It was not right.
So, 1984, I came to United States, I came to California, and with some friends in Iran who had a clinical laboratory, and they were here before me and had started a lab in Orange County, California. I started a branch of the lab in Westwood, in Los Angeles. So that was my first job or position and that was my entrepreneurial side, which now I wouldn't dare to start a life, but then I did.
[00:07:51] Lindsey Dinneen: You didn't know the difference then.
[00:07:53] Dr. Shoreh Ershadi: Well, yes, I didn't know. I mean, it was a lot easier, I would say. At that point. The lab was not even accepting Medicare or Medi Cal. It was private insurance. I was doing the billing. I was getting the information. I was drawing the patients. I was separating the samples and sending them to the reference lab that was actually running the tests. But I was doing stat CBCs and I was in a medical building and so all the doctors were so nice to send the samples down to me. It worked. So
[00:08:33] Lindsey Dinneen: Amazing. Oh my.
[00:08:34] Dr. Shoreh Ershadi: Amazing. Yes. Now it sounds really amazing. It's surreal in a way. Yeah.
[00:08:42] Lindsey Dinneen: Yeah. Yeah. Well, so, so with that lab and embracing this entrepreneurial journey, and I'm so thankful it worked out so well for you, but were there any moments where you just thought, okay, I've, I, you have such an amazing background. You're so highly educated, you're brilliant. And then you're starting this entrepreneurial journey, which is kind of a different skill set in a way. How was that transition of becoming kind of your own boss and being in charge of everything?
[00:09:12] Dr. Shoreh Ershadi: That was pure ignorance. I mean, now I can say then, I thought I knew what I was doing, but it was a fast learning. First that I was in a different country, that I had never been in the United States. Second, that I had a three year old son that I brought with me and my then husband never came, so I got a divorce and I became a single mom. So, and nobody else was from my family was here. So it was very difficult because I had to take him to daycare and then come work and then go pick him up. And then there was a war, the Iraq war had started in Iran and my parents were in Iran and I was going through a divorce, so it was turmoil. And I had to work and learn in a way it was good because it didn't give me time to think about anything else. It was just forward, no looking sideways, no looking backwards. It was just moving forward.
But then again, something else happened that made it even more interesting. One of the days that I was at the lab, some guy came and said, "CDL, Central Diagnostic Lab, is looking for a technical director and they've asked me to come and talk to you." I had absolutely no clue if anyone knew me or knew of me or it was the, I mean, a lot of things happened, which, I mean, I'm happy now, but then it changed my life tremendously.
And I don't think I've ever talked to anyone about this in this detail. So, Lindsey, I would say you're the first person I'm telling the story of my life. But anyways, I went for an interview and I got hired right away. I had the lab, so I hired someone to do the work that I was doing in the lab. And then I started working at CDL, Central Diagnostic Labs, which was the largest privately owned lab in the United States at that time. There were 1, 200 employees. So that was a very interesting experience on its own because I was introduced to a world that I did not even know what was going on.
So, and that was during AIDS testing. Bio-Rad had just come up with Western blot testing and we did the clinical trial, which was very easy in those days. We had AIDS patients and we had a lot of AIDS samples accumulated or saved frozen and we used them to validate the Western blot by Bio-Rad and I went on National TV 1988 and I said, "CDL is the first lab in the world that is doing a confirmation for HIV AIDS testing." So then, that was major.
[00:12:40] Lindsey Dinneen: Yes.
[00:12:43] Dr. Shoreh Ershadi: But then, then my family came. My father passed away here. It was, again, a lot of complications going on. And one of the other people that I knew asked me to go and partner with them in a lab. Again, my entrepreneurial part took over and I went for the partnership, and I started from scratch. I started Path Labs practically from scratch. There were two pathologists working with Los Alamitos Hospital, and I went there and I started a lab from just buying test tubes, buying, from absolutely nothing. I was there for six years, I think. six or eight years with Path Labs. That was not so successful.
After that, I went to Specialty Labs, which is now Quest. Specialty wanted to start a toxicology lab. So, Path Lab was sold. But there was no money made with the partnership and all that. So that was not a very successful six, eight years of my life. Specialty was good. I went to Specialty and I started Department of Toxicology. I don't know if you remember or you were familiar with specialty. Dr. Peters was there and he was the founder, James Peters. He did only immunology testing. They would receive samples and send out everything else to other labs and only do the immunological tests or some specialty tests.
When I started the toxicology department, we started getting samples from all over the world. We were running heavy metals and all that. We had an ICP MS and I started running ICP, and the main test that I developed there was measuring iron in the liver biopsy of patients with hemochromatosis. So we would get one spot, in tip of the needle of the liver and then do a measurement and measure the amount of toxicity with iron in hemochromatosis, which was great. I wrote a paper and we were working with Mayo Clinic and they developed the test. So that was very exciting. Then I started the automated lab because all the chemistry. And all the hematology was going out, was sent out. So that brought a lot of money into the lab, but that was not my lab. It was Dr. Peter's lab. It was wonderful. It was nice. But he was the entrepreneur there.
So in the year 2000, I started ANTIAGING Institute of California. After passing the specialist chemist license in California, I got National Registry in Certified Chemistry, Certified Toxicology, and then I took the board exam with American Academy of Antiaging Medicine. And that was again entrepreneurial and I started the company, that would be 25 years ago. I've done a lot of consultation. I've been director of lab during COVID. I went back to city health. And I was Director of City Health running 4, 000 COVID patients a night for airports, for schools, for traveling, for a lot of stuff.
And then I worked with Siemens Healthineers on regulations for IVDR. So all the kits that Siemens had, over 700 reagent kits that were sold to the laboratories, they need to get the CE mark to be able to be sold in Europe under the new IVDR regulations. And a lot of it had to go through FDA as well because FDA had to approve if there were any changes made to the kits. So I've done a lot of regulation works. I've done a lot of hands on COVID tests, covered it all.
Actually, something else that was very interesting. And this, for MedTechs, I would think this would be interesting to know that it's not just one position. And there's so much you can do, if you want to expand your horizon. For about a year, I helped set up extremely high complex laboratory for testing mother's milk, for making milk bank from mother's milk for NICU for children who were born early and the formulas did not work with them. Some of them were so tiny, less than a pound. And so mother's milk bank, it's called Prolacta Bioscience, the company. And I worked there to establish the clinical lab and to get a license for clear and stuff like that. So.
[00:18:21] Lindsey Dinneen: Oh!
[00:18:21] Dr. Shoreh Ershadi: A lot of good work going into my up and down career, I would say.
[00:18:28] Lindsey Dinneen: I love it. Well, first of all, I'm so honored that you were willing to share so much with me. That is. I really appreciate it. And I really appreciate you being willing to talk about some of the amazing moments you've had and the really high, " Yay, we did this," but also some of the moments where it was a little bit tougher and even you being honest and transparent about, the one company didn't do as well as you would have hoped, but you kept going and you are a living testament to resilience and adaptation.
[00:18:59] Dr. Shoreh Ershadi: There is no other choice. I would hope that people would have many choices. I mean, you always make choices in life. Even now, this is a choice to talk to you and I appreciate the opportunity because, if I would choose or if I wouldn't know about you, that would be a totally different episode in my life. So I'm open to take chances. You can say that with my experience, living in three different continents and moving and just leaving Iran and coming to us with a three year old, not being here ever before. And then, just jumping in and, but there was no other choice except for moving forward, or we can say, except for success. Because failure was not an option. What would I do? There was nowhere to go back. Sometimes you may have an option to make a U turn and say, "Okay, I don't like this. I want to do something else. I want to stay home." There was no option, no going back. So it was only forward.
[00:20:09] Lindsey Dinneen: Yes, absolutely. So, coming here and like you said, having to move forward and I appreciated what you said, you kind of, you couldn't look to the side, you couldn't look back. You had to keep moving forward. How did you go about building a community that could support you, that you could be friends with, and colleagues with, and feel supported coming in from, not having that.
[00:20:36] Dr. Shoreh Ershadi: And that was not very difficult. There were many difficult times during that, that I mean, I don't mind talking about it, being a woman, being a young woman, being from a different background there was a lot of resistance. And I see that today as well. I mean, I can't say, "Oh, here I'm in L. A. and Los Angeles is so easy." It's not. I am hoping that women would not maybe experience all the difficulties that I went through. But we're talking about 40 years ago. I came to The States actually July 22nd would be exactly 40 years. I left Iran July 1st, 1984. So this is the 40th anniversary.
Being a woman, I thought, when I went to England one of the first things, the professor was my direct supervisor when I worked with him. And I know you can see my face. This is 40 years later. I have no claims, but the professor told me, "You're a beautiful woman. Why do you want to study? Why are you here for PhD?" And I thought that was the greatest insult in my life. So I fought with that professor for four years.
[00:22:15] Lindsey Dinneen: No, I'm sorry.
[00:22:17] Dr. Shoreh Ershadi: That wasn't easy, but it was so difficult to prove that I am not just a woman or a pretty girl or a young girl or a young woman, or. That was a major fight. I would say that was as difficult as fighting the revolution in Iran, because you wouldn't expect a British professor to say that to you. And I was the only girl, a PhD student, all the others were guys, and this was medical school. And to me, that was very surprising because when I went to University of Tehran, we had probably more girls than guys in the class. Girls were very prone to education in Iran, and they still are. There's still, I think, 60, 65 percent girls in universities, even here. But to hear that was very difficult. That experience repeated itself. in United States over and over till today that I can say I don't feel old. I'm antiaging, but now that I'm an old woman, I still feel that I have to prove myself that I am equal. And sometimes I would say I'm better, but, just to be honest and modest, you want to be treated equal. And that is very difficult.
[00:23:53] Lindsey Dinneen: Yeah. Yeah, you're absolutely right. And As much as I would wish things were improving rapidly, I'm not so sure that they are, but what have you found has been helpful in terms of, helping people understand who might come with a bias, but who, helping those people understand, "No I have this education. I am very capable." What are some strategies that you have found that have worked really well for you?
[00:24:22] Dr. Shoreh Ershadi: Not many. I have to be honest with you. I mean, if there are a few people, few women, a few even men who are, would be following the conversation, I want them to know that this is not easy. And maybe a part of my success is that I'm a fighter. And I didn't surrender, but I didn't smile my way up. I fought with everyone that went in that direction. And I don't want to get into details, but many of the stronger men would think that if they flirt with you, if they take you out, if they buy dinner for you, then you're going to do what they say.
And my story is, just, I have my guards up and I fought. I wouldn't recommend people to fight. Maybe they can find a better solution. I did not find many. Maybe the reason of working separate and starting my own company, maybe one of the major reasons was that I would not have to say yes to power that I did not want to say yes. I worked very hard. I worked hard, long hours. Medtechs, you have to stay there to get the results out.
One Christmas. I stayed from December 24th for I would say 72 hours in the lab, maybe two, three hours shower and sleep and go back because we had a lot of toxicology tests that were waiting and results had to go out. And the probe in the I-C-P-M-S was broken. There was no one to replace it during Christmas. It was, we had to borrow from somewhere, FedEx shipping it. Those things happen, you know that, and you have to work hard. It wasn't an easy journey to say, "Oh, I worked four hours a day." And they said, "Thank you. You're so good. Go home." It wasn't like that.
[00:26:44] Lindsey Dinneen: Right. Right. Yeah. Well, thank you. I appreciate you sharing that. And so one thing that was really interesting to me, I was looking at your LinkedIn profile and I see that art is a big part of your life in addition to the science and I saw you listed painting and sculpting and I'm wondering how-- well a couple of things-- how did you first get involved in art? And secondly, do you feel that is helpful in terms of having a sort of therapeutic thing to do that kind of maybe helps with some of those harder moments where it's a little frustrating?
[00:27:23] Dr. Shoreh Ershadi: Very helpful. But I was as a kid, I started painting at a very young age. And I was always coloring and painting and making things and all that. And my father, a very educated father, he had two master's degree from a University of Texas and came back to Iran. And that's why, we spoke English and we went to English school. So my father was educated and open minded, I can say. But he always said that "You should study art. And don't go to medicine, you'll get old." He passed away in 1988, and I always, when I started Antiaging, I always said "Okay, if you're looking, you will see that I'm antiaging, I didn't age, I went to medical school, I did all the studies."
But my logic, first that I love to do this, I mean, it wasn't just you know, forcing myself. I love science. And to this day I do a lot of research. I play with science. You can see the labels are all fancy. I do the paintings. I do all of that. But my logic, more than being scientific, was that this was a career and art would not be a self supporting career, even at younger age. But I always said that if I was a doctor, I could paint, but if I was an artist, I could not do the scientific part or the medical part that I was interested in.
But after the divorce, I was in a relationship for 14 years. And I was working hard, raising a son, being a single mother and all that. When that relationship ended after 14 years, the art just popped out. I started painting, sculpting. It was not under control. You can see that, things happen to me, things come out in a certain period. Maybe, I push them down, force them to stay within me, and then they just pop out in different directions. So art came out itself. But there was a period in between that there was no art. Maybe there was too much stress. Maybe there was a lot of, and right now there's no art. Right now it's more entrepreneurial, starting, scientific, all that. But the art pops out every now and then.
[00:30:07] Lindsey Dinneen: That's great. Yeah. So speaking of, what you're doing now, I was wondering if you could share a little bit about your company and maybe what you're excited about for its future as you continue along this path.
[00:30:19] Dr. Shoreh Ershadi: Okay. That is, this is now where all the passion is. So everything that I have forced inside for all my life is now just coming out into Apoptosis. Apoptosis is a Greek word and it means "falling of the leaves." In science apoptosis, if you Google it, you'll see it means "programmed cell death." So in our bodies in creation or creator or whichever you wanna put it, and I'm sure being a medtech and all the audience, they know there are thousands of reactions inside the body are happening for me just to sit here and breathe and talk. There are thousands and thousands of enzymes and catalysts and metals and oh, whatever is going on.
Programmed cell death or apoptosis is a main part of survival. So it's the future of antiaging because we all-- first of all that life expectancy is much longer now. Longevity is longer and younger people do not want to get old. So, at some point I would say my grandmother's generation and my mother is now 95 years old and she's, thank God, healthy and walking and all that, but even she does not want to get old. So, the image of being old and sick is combined together.
But we can age without being sick, without getting Alzheimer's, without losing our memory, without getting all these different kinds of diseases. And one major problem is cancer that was much higher with older people and now the statistic is showing that cancer is happening in younger and younger generations. So what apoptosis does is that it's a program in the body. I did not make it. I wish I did, but it's happening all the time. And apoptosis is getting rid of cancer cells, getting rid of damaged cells, getting rid of neurons that cannot connect and synapses with other neurons to take the message over. So if we encourage apoptosis, then all the damaged cells are removed just like falling leaves. They're removed from the body and they're replaced with new energized healthy new cells.
Every 10 years, our entire body is regenerated. So why do we get old? We should always stay at a 10 year age. So at 20 years old, we have recycled cells that even though we're growing, growth and youth is defined as between 20 to 25. From 25 to 30, it's sort of stable. There's a plateau. After 30, we start the aging process. So now, as 30 to 60, is still considered not so deep slip going down. It's sort of a plateau up to 60. And then after 60, 70, 80, 90, people are beginning to age. And it shows, I mean, with different diseases, with wrinkles, with memory loss, with all that.
So what I'm doing, I'm using nature's product, plant based products, and this has been proven in science that these plants support apoptosis. So, as we get older, just like all the other reactions, apoptosis does not happen at its ultimate way that it should happen. But if we encourage it, for example, we have here, this one is brain beet. This is all beet roots, and it's an organic product. It's all plant based, but it releases nitric oxide. And it works the same way that Viagra works, but it opens all the arteries, it opens the circulation to the brain, to the heart, so why not use it? Why not promote apoptosis the way nature has programmed it in our body, just help it to work better. So that is all my passion right now.
[00:35:28] Lindsey Dinneen: Excellent. Excellent. Well, I love that. Thank you for sharing a little bit about it. I'm excited for our listeners to go and learn more about it and, see how they can maybe also take part in the antiaging movement.
[00:35:41] Dr. Shoreh Ershadi: Yes, they can partner with us and I would be thrilled. Actually, this is something that maybe I have learned during the long life experience, is that the more partners you have, the more friends you have, the more you share your knowledge, the better it is. Because at some point, it was like people wanted to keep everything to themselves and they didn't want to share or, but right now it's totally different. If they go to Apoptosis.us, they can go to the science section, they can read the papers. And if they would like to partner, I'll be thrilled to work with as many people as possible and take the message out. Yeah, this is a healthy message. This is something that we should all be talking about.
[00:36:36] Lindsey Dinneen: Indeed, we should. Yes. Thank you. Well, pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach?
[00:36:56] Dr. Shoreh Ershadi: Well, the million dollar would be great.
[00:36:59] Lindsey Dinneen: Indeed.
[00:37:00] Dr. Shoreh Ershadi: Yes. Yeah. Would we all want that. But yes, I think that right now, as I said, I would use the million dollars to talk about apoptosis all over because I see even young children, every time I see St. Jude's children, and thank you for your donation to Save the Children. I admire that. And I'm hoping that all the children in the world would have a good, healthy future. The world is crazy. You can look at it right now and see that, I can say my experience has been crazy. It doesn't get any better. It's always up and down. Things are happening all over everywhere in the world. And I would like to talk about health, talk about antiaging, talk about Apoptosis and educate more and more of the young people to learn and to avoid all the toxins that we are creating and we have created, with what we're doing with industry and go back to a plant based life, go back to nature, enjoy nature, go back to art, if possible, all the good things that we can do with our lives.
[00:38:21] Lindsey Dinneen: Yes, absolutely. And then, how do you wish to be remembered after you leave this world?
[00:38:29] Dr. Shoreh Ershadi: Oh, wow. That's a very difficult... a fighter? Survivor? Yep. Strong women? I would support women all the way. Now in Iran, they're saying, Woman Life Freedom. I'm sure you've heard about that. And I cannot tolerate, to see women covered all over with a window to see outside. To me, that is very disturbing. So I would like to see equal opportunity for women and I would like to maybe be remembered as a survivor.
[00:39:14] Lindsey Dinneen: Yes, absolutely. And then, final question, what is one thing that makes you smile every time you see or think about it?
[00:39:24] Dr. Shoreh Ershadi: Oh, my granddaughter and my grandson. Yes, I have a five year old granddaughter. Her name is Julia and she is my sunshine. She is my life. The grandson is three months old. He's still too young, but he's getting there.
[00:39:45] Lindsey Dinneen: Aw!
[00:39:48] Dr. Shoreh Ershadi: Getting emotional.
[00:39:51] Lindsey Dinneen: I'm so glad. It's that's beautiful. That's wonderful.
[00:39:56] Dr. Shoreh Ershadi: Yes, that is continuation of the fight. That is when you see that what you've done is worth the fight, worth the hard work.
[00:40:08] Lindsey Dinneen: Absolutely. Absolutely. Yes. Well, this has been amazing. I so appreciate you telling your story and sharing some of it that maybe you haven't done before, and that's I feel very honored.
[00:40:23] Dr. Shoreh Ershadi: Yes.
[00:40:24] Lindsey Dinneen: Thank you. Thank you for trusting me.
[00:40:28] Dr. Shoreh Ershadi: Well, thank you for bringing all of this out. This has been sitting there suffocating, maybe.
[00:40:36] Lindsey Dinneen: Yeah.
[00:40:37] Dr. Shoreh Ershadi: Thank you.
[00:40:38] Lindsey Dinneen: Absolutely. And we are so honored, you mentioned this, but to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you for choosing that organization to support. And we just wish you the most continued success as you work to change lives for a better world.
[00:41:06] Dr. Shoreh Ershadi: Thank you so much, and thank you for having me, and thank you for making me tell the story. Thank you, Lindsey.
[00:41:15] Lindsey Dinneen: Of course. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we'll catch you next time.
[00:41:29] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Tom Salemi | Editorial Director, DeviceTalks | MedTech Storytelling, Event Collaboration, & the Power of Connection
9 Ağu· The Leading Difference
Tom Salemi, editorial director of DeviceTalks shares his accidental yet fulfilling journey into the medtech industry. Tom reveals his passion for storytelling, building communities, and highlighting the human aspect of medical device innovation. He discusses the evolution of DeviceTalks, its focus on collaboration and education, and the importance of personal connections within the industry.
Guest links: devicetalks.com
Charity supported: Feeding America
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 036 - Tom Salemi
Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey and I am so excited to be speaking with my guests today. Tom Salemi. Tom is the editorial director of DeviceTalks. He tells medtech stories with wonder, humor, and great respect. He hosts podcasts, conducts video interviews and organizes events, both virtual and in-person to ensure our innovative medtech ecosystem stays strong and saves lives.
All right. Well, thank you so much for being here, Tom. I'm so excited to talk with you this morning.
Tom Salemi: Oh, it's my pleasure. Thanks for having me. It's great to be on this other side of the podcast interview experience.
Lindsey Dinneen: Yeah, absolutely. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself and your background and how you wandered into medtech.
Tom Salemi: Sure. I'm a Massachusetts native, lived here my whole life. Always was aware of the healthcare industry, but I can't say I had a long time love for it or anything like that. My parents were not doctors. I am not an engineer, nor ever could be, but I did go to journalism school. And I wasn't quite sure why, it just always appealed to me. I went to visit a newspaper once, the Boston Herald, and I fell in love with the newsroom. It just seemed like the most fun place to be in the world. So I wanted to work there for a living, but later on, I think I found out it was more, I really enjoy building communities and that's gonna, I think, develop later on.
I found my way into medtech quite accidentally. I was at a local paper in Massachusetts and wanted to get a job at the Boston Business Journal 'cause I was tired of covering city council meetings and planning board meetings about the height of fences and things like that. And the only beat that was open was healthcare. And at the time, this was '97, that included all the Boston hospitals, the biotechs, and the medical device companies. So it was a lot, but it was intriguing. And, I'll say my parents at the time were older and starting to see doctors more and more. So I was like, "Well, it wouldn't be the worst thing in the world to understand that industry a bit better."
So I took the job at the Business Journal and then that led to an invitation to edit a venture capital newsletter that focused again, broadly on healthcare. So, that was in '98, it's called Venture Capital and Healthcare. Very very descriptive name. And from there, I just really grew to love medtech. I mean, biotech, is of course bigger and fascinating in its own right, but I never quite understood the whole molecule thing, whereas devices, you could see what this thing did and what it looked like. And how the pump worked and why I moved the blood this way or that way. It was just I think an easier and a better story for me to tell. So that's how I wandered my way into healthcare and into medical devices.
Lindsey Dinneen: Wonderful. Thank you for sharing. Well, and now with DeviceTalks, can you tell us a little bit about DeviceTalks, and maybe a little bit about what you're excited about for it for the future? Because I know there's just so much in the works and it just keeps growing and it's so exciting to watch.
Tom Salemi: Yeah, no, it's been an interesting development. So I joined actually DeviceTalks in 2019. It existed prior to me. It's been around for 10 years or so. It was a sort of the events business related to the Mass Device news site. So, prior to that, I was writing for magazines, wrote for InVivo and Startup. And then decided in 2014, I was I was done with writing. I just wanted to do something different. And at the same time, the company that acquired our magazine decided they wanna lay off the editorial staff. So it was it was quite a good bit of timing for me 'cause I don't think I ever would've got off the branch without a little boot in the butt.
So I started doing conferences for a smaller company, medical device conferences, and podcasts. And then the opportunity to join DeviceTalks again happened in 2019 to, to run their three meetings. Of course, 2020 came around. I joined November, 2019, four months later the world shut down and we didn't have our events. So, we pivoted and launched our podcasts and our webinars and went back to events in 2022. DeviceTalks' mission has been really focused on the people who make medical devices, who design them, who manufacture them, who get them through the regulatory process. Anyone who touches a medical device from inception to handling it to a physician to have it implanted in a patient. We try to track that whole process. We do a bit of sort of the venture capital stuff, which was where my interests were lying previously. But DeviceTalks' goal is really again, to focus on the engineers and manufacturing folks, those who were really on the front lines of making medical devices.
DeviceTalks has sort of morphed over time from just an events business to our podcast business, which is not only our weekly podcast, but we're working with a lot of the major OEMs to help them tell their stories through podcasts. We're continuing to roll out new series focused on specific OEMs or specific areas. We'll have a neuro one coming out soon. We'll have a structural heart one coming out soon. And we still, the DeviceTalks Tuesdays program that we launched in May 2020, because we couldn't meet the person, we did virtual like everybody else. I thought it would be something that would go away when we went back to in person, but it's only grown. So we'll continue. We continue to do about 35 of those a year. We take a month off in August and then a few days here and there for holidays. But next year we're going to be expanding that to bring some more kind of issues and OEM oriented conversations. So people seem to have responded to the opportunities to talk about medtech all the time and to listen to medtech all the time. So, as the host of a podcast, it's a pretty great time to be producing stories like these.
Lindsey Dinneen: Yeah, absolutely. Well, thanks for sharing a little bit about DeviceTalks and its trajectory. It's so exciting to see how it continues to grow and evolve over time. And yeah, it's been interesting to watch how so many companies have changed, obviously because of the pandemic, but then sometimes it's been a really interesting change where, what you thought was going to happen doesn't actually happen the way, but it's exciting. And, you just keep moving with it. So that's great.
Tom Salemi: I was listening to the first podcast we did in March 2020,. Chris Newmark and I were talking about, "Well, what does this mean? Like, are we not going to go to meetings? Are we going to have these conversations online? Like digitally? That's crazy. That doesn't make any sense." And we just literally described the world today, but we were both just flabbergasted, "This is nuts. This is just not going to work." So you're right. Things are evolved quickly.
Lindsey Dinneen: Yeah. Yeah. And it's great. So, you're coming at the medtech industry from a really unique perspective, and you are telling stories and sharing stories about people's, incredible devices and innovations and the journey from concept to actually producing something. And I'm curious how does that storytelling process work for you? Like how do you go about finding the hidden gems within a founder's story, and then being able to take that and really run with it so that it's not just a matter of, "Hey, this device is incredible. Look at all the shiny, cool, amazing things it does. But here's the purpose and the reason behind that, too."
Tom Salemi: That's a good question. I mean, I, like you, start the podcast with the stories about the guests, 'cause I'm really intrigued by their path into medtech. 'Cause I don't think it's, we know the industry itself isn't extraordinarily sexy. It's not on the front page of the Wall Street Journal. We're not talking about, well, these stupid app names that are missing vowels and people seem to get excited about it. We're a very kind of, I don't know, low key industry, but we're the industry, the people who make these devices, are literally saving lives.
So I think the guests that we talk to, you know, come to it come to this industry for a purpose. You obviously can build a very successful career for yourself. But I really do enjoy trying to find out what that why is and how it came to be, how it came to lead to a career in medtech. And then I really focused down on, we've all had those moments where we've made life decisions and we could have gone this way or that way. And we chose that way. And it worked out, but what was that? What was the thought process at that fork in the road? And why was that decision made? 'Cause I think really, I think that's something that everyone can connect with.
I remember talking with Mike Mahoney, the CEO of Boston Scientific at DeviceTalks Boston last year, talking about his indecision as to whether he was going to take the job at Boston Scientific. He was obviously a senior medtech guy at J& J. Why leave J& J for Boston Scientific, which was struggling at the time? And he just told this great story of how he had hired a consultant to review the situation and to give him a recommendation. The consultant was like, "No way, man, stay at J& J, you're doing great." And he was going to interview at Boston with the intention, I think, of saying no. And then he just took a moment and walked off and just looked in a mirror and said, "Do you want to do this or not?" And he said, "Yeah, I want to do this." And he just went for it and look what happened.
So, I think finding those human moments in medtech is important because, more so than tech, in other industries, I think it is a very human industry because, again, people are here for a personal reason. Many people have personal stories as to why they entered medtech. Talk to people who have lost childhood friends, when they were teenagers and that drove them to medtech, obviously the state of our parents, in my case, draws you here. I think very often there's a compassionate thread. I mean, sometimes people just, maybe they go into sales 'cause they see the cars in the parking lot of, and I think there's that and that's fine too, but I think those people also come around to, "Oh wait, this is, I can have my cake and eat it too. I can actually do some good while doing well." So, I do like to focus on the human part of our industry. And I think it's one that needs to be told more because too often it's a conversation focused on FDA approvals or recalls, and we're just talking about the machinery and not the people who make it.
Lindsey Dinneen: Yes. Very well said. And I completely agree with you. I think there's, oftentimes a little bit of, because to your point, it's not sort of on the front pages every day. And I will venture to say that sometimes when it is, it's for the reasons we don't want it to be. So, so it's so important to tell these stories. And the thing is, I came in from also from an outside perspective and my background is marketing and business development, business strategy. And so when I came in, it was a whole new world as well. And one thing that I realized is from an outside perspective, sometimes there's this sort of unfair stigma about people are in it solely for the money. And honestly, It's a really hard industry to be in if that's your only goal. So I think, telling these stories about these founders and the why behind it is just so compelling. And I love being able to do that. I'm so glad that you do that all the time as well. Yeah.
Tom Salemi: Yeah, no it's just, those are things that need to be reported on and focused on more, so I'm glad we're both shining a light on it.
Lindsey Dinneen: Yeah, absolutely. So, okay. So I know that DeviceTalks, it has so many different facets to it. One of the really interesting things that you guys do is put on events. And I was wondering if you could speak a little bit to that process and even just there, there are a number of different industry events available, but DeviceTalks pretty special. So I was wondering if you could talk to a little bit about that element and what makes it unique. Yeah.
Tom Salemi: Yeah. No. So when I joined in 2019, I came aboard to help find a direction, a different direction for the meetings to focus it more on the engineering and the device making, which was going to be challenging for me. 'Cause my, again, I really focused more on who raised series A, and who raised series B, and who's a late stage investor, and who's an early stage investor. And for me, for a long time prior, medical device coverage was just, you report on the company's financings, your report on their FDA approval. And then, I don't know, all that stuff in between and who knows what happens there.
So, COVID in a way presented an opportunity because we were able to focus on the podcasts and really give me an opportunity to learn about the industry, to learn about the engineering and the manufacturing about it, but also to get to know the device companies themselves and the comms teams there. So, by the time we resumed things in 2022, it sort of afforded me the opportunity to really work with the comms teams at the big companies, and the engineers and the folks who had on podcast, and try to get those stories that we told on the podcast on stage and maybe a grander fashion. Maybe there's a PowerPoint vote. Maybe there's two or three people who can talk about pulse field ablation, who can talk about the orthopedic business, who can talk about surgical robotics. So DeviceTalks, although we include some of that in our conversations, partnership and financing, especially in Boston, we've got The Medtech Innovator there and they run a great innovation, sort of forum investment forum. I just love working with Paul Grand and I love The Medtech Innovator crowd.
And I still love startups, the folks who start companies are just absolutely insane in a good way. God bless them. I love it. And so, but I really wanted to give an opportunity for the Strykers, for the Boston Scientifics, for the Medtronics to come and sit down in sort of a collegial atmosphere and say, "Look, this is, this is the device we're working on. These were the challenges we had in developing it. This is how we're looking at the patient population." And just go over different challenges that that they had overcome. So it really, I think, is an opportunity for everyone to sit down and talk about the designing, the making, even the selling. We're actually getting more into the selling of medical devices to talk about the business of medical devices in a very, almost. I don't want-- collegiate sounds weird-- but just a very educational, sort of open setting.
So we'll do, we have our keynotes, we'll have our big CEO keynotes. We'll have a venture panel from time to time. And like I said, we'd love to have the startups present, especially in Boston with MedTech innovator. We do that a little less of that at DeviceTalks West, but our bread and butter can sit continues to be engineering and manufacturing. And we really want folks to come down and talk about the intricacies behind their very cool and important and lifesaving devices, so people walk away with a better understanding of how to make their life saving device. And hopefully if they've taken the time to get to know this person who's achieved something great, and maybe they connect on LinkedIn, and it leads to a company being started five or six or 10 years down the road or two or three years down the road. Who knows? So we're all about again, open conversations about medical device development and about fostering the opportunity for personal connection as well.
Lindsey Dinneen: I love that. Well, and I love your focus on collaboration, and education and that, the knowledge is shareable and it's really important and I think it's really impressive that you've created an atmosphere where people do want to come and share and talk about the good, the bad, and the ugly of their process and being able to share those stories, like you said, could very well inspire the next generation of innovators because it's important to be honest and transparent when you can be. So I think that's really incredible that you've fostered this atmosphere that, that leads to that. So.
Tom Salemi: No, thank you. No, and I'm really grateful to those companies that take advantage. Sometimes folks will come and maybe their presentation is a little scripted. But I think just having that person in the room, the Chief Technology Officer or the Director of Engineering for some valve program is important. And it just gives people, I think as much as-- if I were to create a pie chart for the importance of stuff that goes with a bar graph that happens on stage versus like the 10 minutes after someone's on stage, it's probably the bars are probably pretty close.
I'm not sure which is more important, but I think just getting everybody together and we've actually, I initially fought this, I'll admit it, but first couple of conferences, we had like five minutes in between sessions 'cause I just wanted to pack so much in. This year, our conference team was like, "Can we do 15 minutes?" And I was like, "No!" If you add it up, you've probably lost like 30 minutes of programming, but the 15 minutes was really great for just to give people some comfortable time to like, "Hey, I heard what you said about X. Here's something I'm working on, what do you think about that?"
I think that those kinds of conversations are are very important and you can lead it up. You can leave it up to serendipity that, "Oh, if I'm at the conference and the Chief Technology Officer from major medtech is going to be there, I'll bump into him in the cocktail reception," but it's not always easy to do. So we try to, we really try to foster those connections so people get the insights they need and go home with some really positive insights and feedback.
Lindsey Dinneen: I love that. Yeah, I absolutely love what your company does for that. That's incredible.
Tom Salemi: Thank you.
Lindsey Dinneen: So along your journey, have there been any moments where it stood out to you that you had this realization that "Yes, I am in the right industry at the right time." And just something, like a story that you got to share or something that just made you go, "Oh yes, I'm in the right place here."
Tom Salemi: Interesting question. I mean, I have a lot of those moments. Some of those singular moments, I think, some are a just collective moment. Like I've said before, when I was covering the Newburyport City Council, there was literally a moment where they were arguing about the distance-- I was there supposed to be covering this meeting-- and they were talking about the height of fences. And I literally got up and just left. And I was like, "I can't spend, I don't want to dedicate another minute of my life to this." And I've never done anything like that before. I am this Joe Earnest, like I'm gonna stay to the end and make sure it goes. I had the whole journalism thing going on. But I was just like, "I just can't spend my life doing this."
I've never, ever had that moment in medtech. I've never come to work and said, "Why am I writing about this? Or why am I talking to this person? Or what, what is this even about? What's the point?" I've never even thought that. And I would have that conversation if I were covering insurance or even, when I was at my newsletter, got a company by Dow Jones. And I thought my only path up was really to like get into news wires and start covering earnings and things like that. And I was like, " I don't want to be covering earnings and being measured by like, did I beat AP or whomever or Bloomberg by 35 seconds?" No, that's not what I want to do. I want to write about cool tech and talk to cool people. So that's when I left Dow Jones and joined EnVivo and Startup, cause I really wanted to focus on medtech.
But, there are a lot of those moments where I'm really glad to be doing what I'm doing and there's singular moments too, where, I'm sitting in a plane and I look across the aisle and the woman next to me is just reading an EnVivo Magazine and she's got my article open. And I'm like, ah, I just want to tap her in the shoulder. " What do you think? What do you think about Right Medical, huh? Pretty interesting stuff, huh?" That was very cool.
I remember interviewing Kevin Lobo at the early medtech conference I did in Minnesota. It just went super well. He's a really great guy to talk to and very easy to talk to, very open and honest, and will answer any question. But just getting off the stage was like, "Wow, that was a lot of fun. I want to go up and do another one." Which is weird, 'cause I wasn't a big stage guy before, but I don't know, the opportunity to dig and find some cool stories and really see the humanity in these medical device folks is a great challenge and a great privilege for me. I'm really blessed to have the access that I have. So I'm very grateful.
Lindsey Dinneen: Amazing. Oh my gosh, I loved that so much. And yeah, I totally, it would be hard not to go, "Hey, what do you think?"
Tom Salemi: Exactly, right? Yeah. Then what? Then like, "Oh yeah." Then she's like, "Sure. Sure. You're Tom Salemi." And then it gets really weird. "Oh really?" I let it be, but it's one of those forks in the road moments. What would have happened if I just asked her if she liked the right medical story and maybe who knows? I don't know.
Lindsey Dinneen: That's so great.
Tom Salemi: I might've had, I might've met a future CEO and then had a great story to tell with her someday. So.
Lindsey Dinneen: It's still a possibility.
Tom Salemi: it still happen.
Lindsey Dinneen: Maybe you'll run into again.
Tom Salemi: She's hearing this, maybe. She's like, "Wait a minute, I did read an EnVivo Magazine on the plane once next to some weird guy who was..."
Lindsey Dinneen: "...weirdly watching me while I was reading it."
Tom Salemi: Exactly, while was reading a magazine.
Lindsey Dinneen: That's so funny. I love it. Well, pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach and why?
Tom Salemi: Wow. People say "that's a great question" to me all the time. And I always like, "I don't really have that many great questions. Like one or two of them are great!" But that's a good, that's a really great question. Oh, wow. I think For me, learning to speak publicly and enjoy the time on stage, I think has been a real blessing for me. So, and I know a lot of people have that ability as well. I think that would be great thing to, to share with folks.
But I think moreover, I mean, it's crazy to me that like people look to me like some sort of storytelling expert where I really just like, it's like, "You're really interesting. I'm not conjuring magic. You have a great story that you just don't know exists. I'm not some wizard who's just waving my wand and saying something in broken Latin and it all happens. It's all in you." And I wish folks could look inside and see their own stories and see the stories of others as well. And they're probably too busy designing that next great device that they don't really have that ability to look inward.
But, I think helping people identify their own stories, not necessarily to tell them in a podcast form, but just to have a better sense of, of who they are. I mean, I've talked to a few people who like you, I'll say, "Oh, I'll start the conversation learning about you." And they'll say, "Well, I'm boring. Just talk about the company." And I said, "You're not boring. I've never talked to a boring person." Believe me, like everyone has great stories and everyone has great decisions that they made and, it's just a matter of telling it, or at least knowing those stories are in there.
So, because I can't teach on anything of technical value, I guess I'll focus on that. Just helping people identify their own stories and and sharing them in the world in a way that's appropriate for them. Again, they don't have to have a YouTube channel, but they could just say, "Hey, I do important work. I'm interesting. And, I've made a difference in the world." That's pretty awesome.
Lindsey Dinneen: Yes. Well, I love that. And I actually think the wizardry component of it comes in with allowing people to feel safe enough to tell their stories, and comfortable, because it can be harder, especially when you're maybe telling a story that is challenging for you, that talks about something where maybe things didn't go the way that you hoped they would, or you failed at something. And so, so giving people, providing that safe space, basically, to allow people to share those stories and encourage it is, I think you've got that wizardry component.
Tom Salemi: Oh, I appreciate that. And that's a great point. And I think, like with the keynotes, when you're talking with someone who's willing to trust you a bit and say, "Look, when I do keynotes," I'm like, "Look, these are the things I want to talk about." Just allow me to, if I hear something interesting, I go, "Wait a minute, can I just pull that thread a moment," and just to have someone trust you that you're not going to take it in a really weird way, that you're going to see the positive, I think, is when you really have done your job and have a great keynote. Those are the moments, especially like at a conference where people walk away and say, "That was great."
Keynotes should be really great and interesting. They can be informative as well, but if you're just focusing on, why you designed this over that and why that, why it's important to help people with this dreadful disease, all of that's important, but I think the stories that really resonate with people are the ones when they, where the people in the audience can really form a connection with the person on stage. I think that's when you really hit the home run. So, just trying to do that.
Lindsey Dinneen: Yes. Yes. Yeah, absolutely. And I think to your point, another component that you do really well and that I think is important in that sort of wizardry aspect, is the respecting and honoring of the person's choosing to tell that story. So it is, like you said, drawing out the positive and honoring the fact that they've decided to share with you. And so therefore they continue to feel safe, and respected in sharing their insights and stories and whatnot. So I think you're absolutely right that it has to have multi layer components. And, and I love your thing. You've never met a boring person. That's so great. That's so true.
Tom Salemi: It's true. I mean, just talk to people. My son is going to be an engineer and he's like already 10 times smarter than I am technically. I teach him how to jump a car battery and he's explained to me, "Oh yeah, that's why the red has to be attached to the black." And I'm like, "I don't know that. I just know red and black. Don't tell me why the battery works. I don't really need to know that. I just need to know how not to set my car on fire." That's where my technical knowledge. But there are people in the world who understand how things work. And I just-- that's witchcraft. To understand, why planes fly and why batteries work. That stuff's amazing to me.
Lindsey Dinneen: I agree. I agree. All right. And so, on a bit of a more serious note, how would you like to be remembered after you leave this world?
Tom Salemi: Oh, wow. I mean, like I said at the start, I got into journalism cause I thought it would be fun. And I was also a shy kid and I didn't want to be in a cubicle all my life, 'cause I think, I don't think I'd ever climb out of it. I wanted to really force myself into the world. But then I came to realize that what I really liked was helping people connect and I think that's becoming harder and harder for people to do, not to get too heavy about it, but I think there are a lot of lonely people in the world who aren't finding connection or the connections they are finding aren't necessarily the most productive.
So I hope, I hope I, I ease that somewhat and I'm always --just last week, actually, I got a couple of great messages and I don't get a ton of these. It's just weird timing, but someone who said that they enjoy the podcast, and they're college students, and they went into biomed because of the podcast. They joined a startup competition. It's like, "Wow. I, with my stupid stories, I had an impact on someone in a positive fashion!" And I told this person, " Great. When you invent the lifesaving technology," I said, "I will take total credit because I'm the one who stirred you into medical devices."
I'm getting a few of those nice messaging, and it's, I hope that people remember that, we have a lot more in common... I hope people will think that I've reminded people that we have a lot more in common than we do differences, and that we have a lot more positivity to rally around the negativity. And it's the only way we're going to get things done in this world is if we're working together on it. So if I could help that happen a little bit, I think I'd be happy with that as a life lived.
Lindsey Dinneen: Yeah. Yeah, absolutely. Wow. And thanks for sharing that story. That's incredible. That is so exciting.
Tom Salemi: I'm so grateful. I told him, I'm so grateful that person wrote, "thank you so much," 'cause that, yeah, that people don't do that very frequently. So it's awesome.
Lindsey Dinneen: Yeah, and final question. What is one thing that makes you smile every time you see or think about it?
Tom Salemi: Huh. My first thought was my, my kids just seeing them find their way through life, seeing them find the things that energize them. It's great when you see that. Dogs, of course would be a good one.
Lindsey Dinneen: Yes.
Tom Salemi: I love a good dog. I don't know, everything that's coming to mind, it sounds kind of corny. I mean, obviously when you see people take a kindness on somebody else, or be kind to someone else when they don't need to be, I think is extraordinarily uplifting. So my kids, my dogs, my dog, any dog, actually most dogs will do...
Lindsey Dinneen: Yes.
Tom Salemi: Yeah. But my dog in particular, but no, I think I just, those moments that, unfortunately, we're not shining enough light on where people are overly kind and helpful to each other. I think we need to see more of that at this time.
Lindsey Dinneen: Yeah. Agreed. Well, I think that's phenomenal. I, I also am a huge dog lover. So anytime, I mean, really, it's like an instant happiness.
Tom Salemi: Yeah.
Lindsey Dinneen: Instant. So happy. So. Yeah, they are the best. Well, I just want to say this has been an incredible conversation. It's been so great to get to know you a little bit and also get to know a little bit more about the incredible work that DeviceTalks is doing. So I just want to thank you so much for being here and being willing to share your stories. This has been great.
Tom Salemi: Oh, thank you so much. It was an honor to be asked. It doesn't happen frequently and it was-- you've got some great questions. I may steal a couple of them. So.
Lindsey Dinneen: Absolutely. Well, thank you again. We are so honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger. And they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support and thank you for all the work you do to change lives for a better world.
Tom Salemi: Okay. Thank you so much.
Lindsey Dinneen: Thank you also to our listeners. And if you're feeling as inspired as I am right now, I'd love it if you would share this episode with a colleague or two, and we will catch you next time.
Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Jennifer L. Horspool | Founder, Engagement PR & Marketing | Turning Innovations into Brands, Effective PR, & The Future of AI in MedTech
26 Tem· The Leading Difference
Jennifer L. Horspool, a communication and public relations expert, global brand strategist, and founder of Engagement PR & Marketing, shares her journey from aspiring scientist to a leading figure in MedTech PR, emphasizing the importance of storytelling, branding, and patient persistence in the industry. She highlights how she helps startups and Fortune 100 companies turn their innovative ideas into well-known brands. Jennifer also discusses the transformative role of AI in MedTech and PR, providing valuable insights and practical advice for startups looking to make their mark.
Guest links: https://engagementpr.com/ | https://www.linkedin.com/in/jenniferlhorspool/ | https://www.facebook.com/EngagementPR
Charity supported: Paw Prints in the Sand
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 035 - Jennifer L. Horspool
Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome back to The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, [00:01:00] Jennifer L. Hoorspool. Jennifer is a communication and public relations expert, a global brand strategist, international speaker, and founder of Engagement PR and Marketing. As a brand growth and turnaround specialist, Jennifer has been employing her skills in PR, media, marketing, and messaging for more than three decades to grow companies from vision to multimillion dollars and "turn best kept secret brands into the go to experts of their industries." Jennifer works with companies of all sizes from startups to Fortune 100. She's been working with medtech, biotech, and pharmaceutical companies for more than 15 years, and has helped to bring some pretty cool products to market.
All right. Well, thank you so much for being here, Jennifer. I'm so excited to speak with you today.
Jennifer Hoorspool: Thank you, Lindsey. I'm so honored to be here. I'm excited.
Lindsey Dinneen: Wonderful. Well, would you mind starting off by telling us just a little bit about yourself and your background and maybe what led you to MedTech?
Jennifer Horspool: [00:02:00] Sure thing, actually. So I've been running Engagement PR and Marketing since 2015. I've actually been in the field of public relations marketing since the nineties, right? I'm 24 years old. I don't know how that mouth works. I don't really have to do numbers. I do words. Healthcare has been my vertical deep for all those 30 years, right? I've worked with some other people outside of health care, but for the most part, health care. I started off doing a lot in patient services and really like direct to consumer about health and wellness and stuff like that. And then got into drug approvals but from a PR perspective, right? So bringing drugs to life. And then that led me into devices, medtech. And then as AI has expanded, it's just been really fascinating in the medtech world. And I've gotten to work with medtech that does need FDA approval and medtech that does not need FDA approval.
So there's all different kinds of stuff. And one of the most fascinating things that I've gotten to do is work with a couple of different contract [00:03:00] research organizations. And so those are the companies that hold the hands of the inventors so that they can get their products through the FDA and to market in the United States. It's a fascinating journey. There's all kinds of different avenues to go down. And it's just been really spectacular of the things that I've gotten to learn in the inventors and getting inside the inventor's minds.
Lindsey Dinneen: Yeah, I can only imagine. Well, thank you so much for sharing a little bit about your background and whatnot. And so, okay. So I'm curious when you first, maybe as a kid, like would seven year old Jennifer have said, this is what I want to do with my life, or did seven year old Jennifer not know yet?
Jennifer Horspool: Well, seven year old Jennifer thought she was going to be a scientist. I was the girl that had all the, like the, I made my own soaps. I made my own potions and lotions. I did not think of myself as a witch. I thought of myself as a science, a scientist. And so I was always inventing this and inventing that and [00:04:00] constantly spilling things on my poor mom's brand new floor. And, you know, "Mom, I cleaned it up as quickly as possible," you know.
Lindsey Dinneen: Oh
Jennifer Horspool: No, I've always enjoyed science and I've just found it to be fascinating. And then and then I got lost along the way. I forgot about science. Quite honestly, I was taking it, but like those were hard and communication just came so easily to me. And then it became more about storytelling. And so I love to tell stories and one thing after another, I got into branding and brand building. And this is like in the nineties is when that terminology kind of first started maturing outside of your brand mark, which is your logo.
Before the, like the early nineties, early to mid nineties, we talked everything about a brand was really just your brand mark was your logo. We thought that was a brand. And then we came down to, no, it's actually-- the brand is the emotional components of who you are and who you are as a company and all the different things. And so I got to get into all of that and I got all into the words and the storytelling and the feelings and emotions of it. And now I got to represent [00:05:00] scientists. And so it's really been a really good match because I think I'm a natural communicator.
Lindsey Dinneen: Yeah. That's wonderful. And I think it's so helpful sometimes to bridge the gap because you have that background and that interest in science. And sometimes perhaps not all scientists can communicate as well as they want to maybe those of us who don't have that background and do need to understand what it is you're bringing to market so that we can purchase it.
Jennifer Horspool: Right, right, right. And it's uncomplicating the complications that they find simple, right? So it's, how do you take that scientific language and turn it into common language that everyone can get behind? And so, I've always said like really smart people can simplify everything.
Lindsey Dinneen: I love that. Yeah. I, there's a saying that something along the lines of "simple isn't easy, but simple is worth it." And I...
Jennifer Horspool: I love it.
Lindsey Dinneen: ...think a really good thing to, to remind yourself of is, when you can simplify processes or communication or whatnot, it [00:06:00] is worth it in the long run, even though, you know, like that famous, was it Mark Twain, who said something like, "I didn't have time to write a short letter..."
Jennifer Horspool: Yeah, "...so I had to write a long one." Exactly. Exactly. Because it's the truth, you know? And that's funny because in marketing all the time, they're like, "I need 11 words to fit right here." And people don't understand that it's much harder to write 11 words about something than it is to write 700. 700 is I get to explain it all. 11, I have to be impactful and those words really matter. And so it's actually much more difficult to write 11 impactful words than it is to write 700.
Lindsey Dinneen: Yes, it is. I love that. That's a good analogy too. So now what are you currently doing and excited about and what are you looking forward to as you continue to build the business and move forward?
Jennifer Horspool: Yeah. So because we do marketing, PR, branding, brand experience, love to work with brand new startups, love to [00:07:00] help them get their whole-- figure out that whole identity, get their websites going. Everything that's in the beginning, you would be surprised at how many emotions are tied into that first coming out brand. And it, people think it matters so much and it does matter, right? But it's like sometimes, "Get out what you know right now. Let's get something up. And then as your science matures, we can mature your brand. We can mature your website."
First thing we want to do is get something out there where we can start getting presence, getting you seen, known, trusted, and found, right? Getting found is the most important thing, and it's not the easiest, right? So, so there's all these different strategies that you do to get found first by your name, you know, by who you are, your company name, the founders' names, and also by what you do or what your promise of your technology is going to do.
And so I really enjoy working with people at all stages. I've, I've had the great fortune of [00:08:00] working with startups that are unfunded, startups that are funded, and then all the way through to Fortune 14 companies, right? So the entire gamut, I know who and how to work with. with. And we work with all of them. But our sweet spot really is in just either just launching or have already launched and are just starting getting ready to get known, really building that brand and pulling people to you, to your sites, to your social media, to the studies that you're doing, to all the different things so that we build that rise. And then you're found more easily because at the end of the day, if you're the best kept secret, you could have the best science in the world, but then no one gets to use it. So we take you from the best kept secret to the best known experts in the industry.
Lindsey Dinneen: Ooh, I love that. Nice.
Jennifer Horspool: Thank you.
Lindsey Dinneen: And I think it's so true too, because I think sometimes working with engineers, for instance, who are beyond brilliant and sometimes there's this, [00:09:00] there can be a disconnect of, "Well, it's so great. Like the product is so great and it should just be known." And we're like, "Yes, you're right. It should be, but there actually has to be a process to go through." Cause unfortunately the whole, "if you build it, they will come..."
Jennifer Horspool: Yeah, that movie threw everybody for a loop when websites came about because all of a sudden everybody thought, "Oh, if I build it, they will come." And it's like, no, that's a movie. The dream, if you remember, it was the dream field.
Lindsey Dinneen: Right.
Jennifer Horspool: So if you build it, then you have to market it so that they even know to come. And there's a lot of variety, like it really, it should be. fun. And it needs to be fun first and foremost, right? Like the excitement, you know, there's an acronym that I do about media. How do you get in the media, MEDIA, right? So your message is your magnet. The "M" is your Message. Your message is your magnet and your magnet is your magic that really pulls people to you. And then the "E" is Excitement. You have to deliver it with excitement cause if you're not excited about it, [00:10:00] how is anybody else going to be? But that passion really pulls people to why this is such an exciting breakthrough. What's it going to do that's different than something that's on the market today.
Then you have to distinguish yourself. The "D" in media is that: Distinguish. How are you different than what's already on the market? Why is that important? You know, you have to be interesting. The "I" is Interesting. It's like you deliver it with excitement. But how are you differentiating from everyone else? You have to distinguish yourself. You have to describe what's so important. How is it interesting. And then you really do that for your Audience. Who is the main target audience? And it's easy when your audience niche is small, but when people see it as a broad alternative to a lot of things, they get clustered, right?
Like, it's like, "Oh my goodness gracious. No, it's all these people. It's everyone." And the sad part is when you serve everyone, then you have to still niche [00:11:00] down into little buckets because everyone is not listening the same way. And when you start talking to everyone, you start talking to no one because it's too generic. People don't know to stop and listen. The whole thing is you're trying to stop that scroll. Everything, it doesn't matter if it's your video, if it's a meme, if it's a white paper, if it's your blog, whatever it is, we're all in the same scrolls right now, right? It doesn't matter if it's social media or on email or you're trying to stop that scroll. How do you get them to open your thing? And really, so the MEDIA: the message, the excitement, you know, all of that just really comes into play.
Lindsey Dinneen: That was amazing. Thank you so much for sharing that. You're obviously brilliant at all of this and I really appreciate that summary. I could not stop nodding my head because I was just like " yes." So thank you. And I love your acronym. That's perfect. Oh my goodness. Easy to remember. So what are some of the challenges or roadblocks that you see, [00:12:00] maybe especially with some of these startups, because a lot of startups are listening to this podcast. And so speaking of niching down, speaking to your people, but so, so what advice would you have? What kinds of challenges and roadblocks do you see? And what kind of advice would you have for somebody who is in this situation of, "Okay, I'm ready to start being known. I don't want this to be a secret anymore." What do you see and how can they overcome some of those issues? Thanks.
Jennifer Horspool: Yeah, that's an excellent question because patience is a virtue still today and we have less and less of it. Right? We think like, "We've been working on this for a year and a half and here we are, ta da!" And everybody's gonna be like, "Oh my god, they're here!" Right? You know what I mean? But that's not really how it is. We all, we have trust issues. issues. And in today's world, because there's so much online and because we have so much accessibility and because there's always new things being invented all the time, where's the credibility, right? So, and even if you're [00:13:00] the most credible person in the world, where's the credibility in the product? Where's the credibility in your launch? Where's the credibility?
And sometimes it's much slower to ramp up than you want it to be than, you think it's going to be. So the first initial, sometimes even press releases or outreach to media introductions to media, and you might get interviews, you might get like all different kinds of things where you're seeing a lot of groundswell, but it hasn't turned into stories yet. It hasn't turned into articles on the web. And it's very frustrating because you're like, "I gave them my time. I gave them all my expertise. I was as transparent and authentic as possible. I shared all this, like, where's our story?"
But they might still be just accumulating information on you and watching and waiting. They're seeing how your science matures because if they come out with it, it's an endorsement by their publication that this is authentic, that this is a real thing. And so, especially in credible publications, which is what you're trying to get into, right? And so [00:14:00] they're waiting and watching for the right time to release your story. They might interview you three, four, five times, collecting the data, building up the story before they actually cover you, before they actually release the interview notes, before they actually do something that you can really use on your site and to build out your stuff.
So in the meantime, you do the media interviews. You build the relationship with your key media who are writing about your topics. And you really, that's what you're doing is building the relationship. You're making them feel comfortable enough with you, your science, the results, your white papers, like everything that you're putting out, all of your studies, especially if you're presenting, by all means, share that with your media without necessarily expectation. You want the expectation, right? You want the story to come out of it, of course. But they might still be just collecting information and building up your [00:15:00] file and then what, once it happens, it could be something grandiose. It could be something really great that then you can really use.
And then don't be afraid to repurpose these when you get stories. Don't be a one and done. "Oh my God, we were the Wall Street Journal. Here it is." You're done. I think it's 8%, you know of LinkedIn followers even see your posts or even if they're exposed to your post, whether or not they're on social media that day. And it goes through down and through your feed. It's still in your social media, but repurpose it all the time. Pull out quotes from it, pull out interesting tidbits, share your infographics, like share that thing. Don't be afraid like 20, 30, 40 times throughout the year, you can take one study and really dissect it and share different pieces to it. Different people are going to see it. They're going to absorb the, and the same people are going to absorb it differently each time. It's like watching your favorite movie over and over again, and you grab new tidbits every time you're like, "I never even noticed that before." It's the same kind of concept with your [00:16:00] science.
Lindsey Dinneen: Oh, brilliant. Thank you. That was great. I really appreciate you sharing that advice with us too. Yeah, and I think to your point, it is hard to be patient because you're so excited about whatever it is that you're building and working on. And patience is such a wonderful thing to keep in mind. Like it's okay, you know, it will come just, you know, one step at a time.
Jennifer Horspool: When you get started on your marketing, it can take like three, four months before you really are starting to see real results because it's like AB testing all the time, right? What are people responding to? What are they not responding to? It's kind of the same thing with traditional media when you're trying to get in with a media.
Lindsey Dinneen: Yeah. Excellent. Thank you. Well, so I'm curious, are there any moments or a series of moments that stand out to you because they clearly reminded you why you chose this field and why you're specifically doing it for healthcare, medtech and whatnot.
Jennifer Horspool: So I think I feel like we're at kind of a pivotal point in health care right now. It's been [00:17:00] very much like one specific way. We've been a pill popping society for lack of a better way of putting it. We all wanted a pill to solve all of our problems. In fact, there was some show in the nineties and it was like all about the year 2025. And we were such a pill popping society that by the year 2025, you pressed a button and this pill came out and that was your entire meal. And you took your pill and that was your meal. And you just went on, you had all the proper nutrition. Like we thought, "Oh, we're not even gonna have to bother to eat anymore."
Well, foodies hadn't really come about yet. So foodies came about and they're like, "No we want to eat. Eating is the great part. Like, why would you take that away? Nobody wants to eat a pill." So I think with medtech, where it, is we're able now, especially combining it with AI, is that we're able to create new things that, that test the body in new ways. We're able to create new things that show us like even where your body's misaligned. And the part that's so important about the way your body is aligned is that has to do with nutrient delivery. [00:18:00] It has to do with injuries.
Most injuries we think, "Oh, it's because I was playing soccer and I twisted my knee this way." But it was actually because, well, your hip and your ankle were out of joint to begin with. You went and you played soccer and your body was already misaligned. You slept wrong or you had poor posture while you were watching television. You got all cranked up the wrong way. And then you went out and you played basketball, cause you always play basketball on Saturdays, cause you're a weekend warrior. Weekend warriors are the ones that get the most injuries. And that's because we don't do the training all the way along. And then you go out and you play and then you have injuries. So it's like getting ahead of all those things. Medtech today has such an opportunity to change the entire trajectory of the way we look and analyze the body, that I think there's no more fascinating industry than medtech right now.
Lindsey Dinneen: Yeah. Oh, I love that. And Thank you for sharing a little bit about some of the, even the technology that you get exposed to too, because that is [00:19:00] just so cool. And I am curious, you mentioned at the beginning how, and this is a hot topic because it's on everyone's mind, of how is AI impacting medtech? And I'd be curious to know how AI is impacting even the work that you do for medtech and healthcare.
Jennifer Horspool: Right. So two totally different things, right? Like when you say AI, to anybody today, they just go, "Oh, ChatGPT, right?"
Lindsey Dinneen: Right, right.
Jennifer Horspool: There's so much more than ChatGPT, right? I've been fortunate, I've actually been working with AI for 15 plus years because we didn't call it AI back then. We called it different things. We just talked about what it did. We didn't say, well, "the artificial intelligence is putting it together." Like we didn't do that. It's a term now, right? What we talked about was the application of it and taking all this data and getting the analysis out in an intelligent analysis that's going to help people. Or now [00:20:00] you can use AI processes that were developed for something else. You can plug and play it into your application and it can vascularize things that never were vascularized before. I mean, that's one of the things in certain types of medtech that people are working on galore is really in creating 3D printing organs, for example, 3D printing life saving aspects.
I'm working with one company and they're developing a, it's a 3D printed bio biopolymer wrap that actually, it's got bio absorbable materials. There's just, there's new materials, there's new stuff, there's new technologies. And AI is really the ability to speed up data analysis, the ability to combine mass amounts of data or mass amounts of processes and simplify it into something that humans can do, but nowhere near at the speed. So we're taking things that might have taken three months or three years, and we're able to get it down to three seconds or even [00:21:00] less.
We're able to take things like military applications or there's the God awful bombings that are going on, how are we getting medical care to areas where they're so remote that there's no medical care? So AI is actually able to connect things up where there is no technology. There's no wifi, there's no this, there's no that, but then you can do x rays and you can actually get your x rays and upload them and get them, get a diagnosis. get like intelligent insight back when you don't have access to the internet and to other things. And so it's really, AI is the ability to dream bigger and make those dreams actually truly happen.
And then in my field, It's a really great way to never have to start with a blank piece of paper. The blank piece of paper is the hardest thing in the world to start with AI right now, especially if you're going like ChatGPT, it's great for content. It's not so great for context yet. You still have to personalize [00:22:00] everything. Never take what AI does and just use it straight out. Everyone knows, first of all, everyone knows the way it writes. So then you just look lazy. And you look like you didn't really share your own stuff. No one cares what AI had to say. They care what you, the expert, had to say.
So, we do a lot of ghostwriting. We write a lot in other people's words. We might take it to AI to get that started or maybe get some ideas. It's fabulous for ideas for blog posts. It's fabulous for ideas for social media. It's fabulous for ideas, you know, then take those ideas. It's fabulous to get started, but not to finish. You need to take it and spend a good hour with it and really make it yours.
Lindsey Dinneen: absolutely, wonderful, thank you for sharing a little bit about that too, I, it's just always such an interesting, it will be a discussion point for years and years, probably forever, I don't know, but it is so exciting, I love the way that you described it too, of being able to not approach it out of a fear [00:23:00] or concern, but approach it out of, "Oh my goodness, I can actually make these dreams come true. And I can have a bigger, even more positive..."
Jennifer Horspool: ...impact, right? We, every, we're looking for impact and it's really, don't be afraid of it. I talked to some people and they're like, "Well, everything we do is just so personalized." Everyone wants to think that everything is so different, what we do is so unique. I know everybody's is so unique. It's so unique. We're all the same uniquely, but...
Lindsey Dinneen: Yeah.
Jennifer Horspool: ...we're all uniquely the same. I don't know, you know, whichever way you want to put it. But it's really about amplifying who you are. You can take it and create avatars to let it think in a certain person's tone. And then you can feed it that avatar. And you're saying like, you're telling it, "I want you to be this avatar, in this way of thinking with this tone and these personas, these personality traits" that you're giving it, "I want you to create now. something spectacular" and it can give you something that could might, it might even be 70, 80 percent done, right? But just never take it [00:24:00] straight out and just plain old use it.
But what it's also really good for is in finding gaps, right? Where you're like, "Here's everything I know about this and here's everything I know about this. Why aren't they, why aren't they working together? Find the gaps in this for me." Excellent at doing that, especially in medtech, where you can really then find out like what's happening today. What are the problems that we have with the medtech that's out there today. If you want a product, but you want it to go even bigger, maybe you want to change standard of care somehow by making something, taking what we have now and amplifying it to a whole another realm where you're taking the aspects of maybe three other products and you're marrying it with standard of care today. And you're saying, "this is how it's going to go that much better." It will find all those gaps for you, right?
You can create programs. There are AI program writers that you tell them, "I need this as my end result and they can design a program that's intelligent, that continues to [00:25:00] learn." There's a, another gentleman that I've been working with and he developed, it basically helps you make decisions and it helps you weigh all the decisions. And it's not like it's so profound that you couldn't have done it on your own, but you don't do it on your own, right? You plug the things in and now you get the answers back. And that's AI.
Lindsey Dinneen: Ooh, fascinating too. That is so cool. Yeah. I mean, the possibilities are endless and it's just the beginning, so it's going to be exciting to, to stay on it. Yeah. Well, pivoting the conversation just for fun, imagine you were to be offered a million dollars to teach a masterclass on anything you want, could be in your industry, but doesn't have to be. What would you choose to teach?
Jennifer Horspool: That is a fascinating question. I would talk about-- I, I would talk about the power of being you. You know, we are, we're born uniquely us. That is the one thing where you really do get to own the unique. You are [00:26:00] uniquely you for a reason. I grew up in the seventies and eighties. Like I said, I'm 24 years old. I'm sure you know that math. But it wasn't the time for girl power. It really was not the time for girl power. And then girl power came about and it was so great because watching the transition of girls into sports and really owning sports, right? And girls into science and STEM, like now females are owning STEM and there's femtech. Femtech is a real, true industry, not just a word, but an entire industry. And that is how are we serving women?
So we've been marketing to women for years because women are the caretakers of the family, but we haven't been taking care of those women. We've been empowering those women to take care of their families. So it's, we've been shamed, " Oh, you can't be conceited. If you love yourself, you're conceited." That's what growing up in the seventies and eighties was like, it was very much about, you're not allowed to love yourself and loving yourself in today's world, as we know, is the key to everything.
[00:27:00] And so the more uniquely and fantastically you are you, the better innovations you're going to bring to your life, to the people who know you, to the scientific world, if that's where you belong. You didn't get into science by accident. You didn't get into inventing by accident. That is part of what is uniquely you. You have a curious mind. And one of the things that we forget to do, we do it in science all the time. The hypothesis is designed to be proven incorrect. Incorrect. We think, "Oh, I'm trying to prove my science." No, you're trying to prove it incorrect. And if you can't prove it incorrect, the assumption is that it must be true until we can find something else or something better.
The same thing applies to your life. The same thing applies to yourself. And in fact, I'm going to challenge, but the same thing applies into the way that you're researching your politics. The same thing applies to the research and you're applying to your beliefs about everything in life. And if you can start to say that, "This is my [00:28:00] current hypothesis. This is what I believe based on all these things. And I haven't been able to prove myself wrong. Therefore, I believe these to be true." And if you start researching everything like that, you're going to find so many more discoveries in life and you're going to find so much more of your sweet spot and where, what makes you really happy and find your people who are going to go on this journey with you. And so I think that's what I would like to do. And thank you for the million dollars.
Lindsey Dinneen: Yeah! Well, that's a brilliant sounding masterclass, and I totally want to sign up, so let me know when you offer it, because I'll be there.
Jennifer Horspool: You got it.
Lindsey Dinneen: And then, how do you wish to be remembered after you leave this world?
Jennifer Horspool: Gosh, that's another nice question. I think as an empowering person who helps people to see the value in being truly and authentically themselves. I think the more we really embrace who we [00:29:00] are and all of our flaws and all of our own cuckoo, cause everybody gets some. We love to point the finger, right? And one of the, one of the greatest things I learned, and I don't even remember which coach I learned it from, but you know, when you're pointing the finger at everyone else, you've got three more pointing back at you. And so the most empowering thing about that is it puts you in charge. And that means it puts you in charge of being able to fix anything. And so, yeah, that.
Lindsey Dinneen: I love that. Yeah. Excellent. And then final question. What is one thing that makes you smile every time you see or think about it?
Jennifer Horspool: My dog, Bruno.
Lindsey Dinneen: Yay.
Jennifer Horspool: My dog, Bruno. He's the greatest thing that ever happened to me. He was homeless. He was sleeping under my friend's truck for about three weeks. She posted, "Hey, I have to find this guy his forever home." And and we met and it's just been a fabulous engagement ever since. He's the greatest thing ever.
Lindsey Dinneen: So sweet. I love that. Dogs are the best. [00:30:00] They're perfect companions.
Jennifer Horspool: Yeah.
Lindsey Dinneen: Excellent. Well.
Jennifer Horspool: He's spoiled now. He went from outside to a couch and a bed and all these other beds and he's a happy guy.
Lindsey Dinneen: Yeah, I love it. I love it. That deserves some love and attention and, yeah, pampering.
Jennifer Horspool: Right.
Lindsey Dinneen: That's phenomenal. Well, Jennifer, thank you so much for being here today. Seriously, it was value after value. It was nonstop amazing advice, amazing insight. We are so honored to be making a donation on your behalf as a thank you for your time today to Paw Prints in the Sand. Paw Prints in the Sand Animal Rescue is an all animal foster based animal welfare organization with a mission to give at risk animals a second chance at life by providing medical care behavior training and loving forever homes. Thank you for choosing that organization to support! Thank you for joining us and thank you for everything that you do to change lives for a better world.
Jennifer Horspool: Thank you. [00:31:00] And thank you for doing this. This was fantastic. I really appreciate the opportunity to come and speak with you and talk medtech to all the scientists out there. It's one of my favorites. It's always fascinating. And thank you for doing the podcast. It's fantastic.
Lindsey Dinneen: Yeah, excellent. And for those startups and founders that might need some assistance, where could they find you?
Jennifer Horspool: Email me at jennifer at engagementpr. com or or just go to engagementpr. com, fill out the form or you can go to LinkedIn, Jennifer L. Hoorspool, everywhere I am, get my L in the middle. It's I say, whether it's my middle initial or my last name, please put the L, it's really important.
Lindsey Dinneen: Okay. Excellent. Sounds good. Well, again, thank you for being here. And thank you also to our listeners. And if you're feeling as inspired as I am right now, I'd love it if you would share this episode with a colleague or two, and we will catch you next time.
Jennifer Horspool: You're the best.
Ben Trombold: The Leading Difference is brought to you by [00:32:00] Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Dasha Tyshlek | Founder, StratCraft | Entrepreneurship in MedTech, Technology Communication, & Innovative Problem Solving
12 Tem· The Leading Difference
Dasha Tyshlek, founder of StratCraft and strategic advisor to life science and healthcare tech companies, shares her inspiring journey from a dance teacher to a leading entrepreneur in MedTech. She discusses her passion for technology and problem-solving, and how she helps companies innovate and commercialize groundbreaking products. Dasha also highlights her podcast, "Biomedical Frontiers," which showcases transformative technologies and offers hope for the future of healthcare. Tune in for a compelling conversation on entrepreneurship, innovation, and making a difference in the world.
Guest links: http://stratcraftpartners.com | https://rss.com/podcasts/biomedicalfrontiers/ | https://www.engineering.virginia.edu/centers-institutes/coulter-center-translational-research/podcast
Charity supported: Polaris Project
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 034 - Dasha Tyshlek
Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am so excited to be speaking with my guest today, Dasha Tyshlek. [00:01:00] Growing up, Dasha knew she wanted to become an entrepreneur, leading people to change the world through innovative products and services. Her love for technology and problem solving led her to study engineering science, focusing on biomedical engineering and product development at the University of Virginia.
Today, Dasha is the founder, president, and chief strategic advisor of StratCraft, and is a strategic partner for growing life science and healthcare technology companies. Dasha has developed a strategy for advanced manufacturing spinouts such as Core Composites and MicroAnt GPS. She has led company wide strategy development and unique growth initiatives across multiple high tech industries, including biomedical device, pharmaceutical, translational research, automotive, financial, satellite, and defense.
Dasha is the director and host of "Biomedical Frontiers: Stories with Innovators in Healthcare," a life sciences and biotechnology commercialization podcast hosted by the Wallace H. Coulter Translational Research Foundation at University of Virginia, and she is a lecturer [00:02:00] at University of Virginia's Biomedical Engineering Department. Due to her deep technical understanding and ability to forge complex, multi company partnerships and agreements, she is a sought after advisor to innovative companies working to commercialize their new technologies.
All right, Dasha. Thank you so much for being here.
Dasha Tyshlek: Lindsey, it's such a pleasure.
Lindsey Dinneen: Awesome. Well, I was wondering if you would be willing to start off by just telling us a little bit about yourself and how you got started in the medical device field and what led you to what you're doing today.
Dasha Tyshlek: Yeah, absolutely. I think one of the things that's been a defining trajectory in my life is, is entrepreneurial pursuit. And I actually started out, I think you and I connected on this earlier, as a dance teacher early on in my life and decided even in high school since I was learning dance to, to try coming up with my own dance aerobics programs and try to pitch that to local Golds [00:03:00] Gyms.
And so that, that's been something I've, I've endorsed and participated in and tested out various forms of entrepreneurship over my life. But I'm also an engineer and I love interesting new technologies and the scientific approach to problem solving, kind of methodical, process driven, deeply curious ways of creating solutions.
And so, when I started my engineering degree, I met some people who were entrepreneurial engineers. And that really excited me that you could be a technologist who is working on solving a problem and you're not doing it just to then maybe write a paper and hope somebody notices, but then you do the steps necessary, bring the team together, find the customer, and, and then do it, do that transition, that bridging.
And so that really put me on a path even when I was studying to start exploring that. And I got to [00:04:00] participate with an organization called Venture Well, which is really famous for supporting STEM entrepreneurship even at undergraduate level. And at my university, I worked to create an organization that would help sprout kind of entrepreneurial innovation roots into the student community. So we created a Maker Space. We hosted a Medical Hackathon took people to startup trips to visit companies that were doing new technology developments. And, and also did some expos and speakers and things like that to expose students.
And that had some really great success. A lot of people got very involved. A lot of the people that went through that with me are now entrepreneurs themselves-- not all medical device entrepreneurs, although most of them were biomedical engineers-- but all of them, very entrepreneurial, and working on some really interesting technologies now, so I think that's that's kind of the defining piece of where my career began.
And then today I'm [00:05:00] consulting and helping companies, particularly companies with large portfolios of new technologies, who are trying to come up with ways to commercialize products, come up with that strategy for commercialization, taking one product, one technology at a time.
Lindsey Dinneen: Wow, that is an amazing backstory. Thank you for sharing all of that with me. And it is so cool to see how, first of all the synergy, the fact that you did have a dance background as well. And you were so entrepreneurial, even back then in creating this program. So I do have to ask, did that program ever get sold to a gym or to anyone. Have you developed it? Did you fully do that?
Dasha Tyshlek: Yeah, I actually had two Golds Gyms that I taught on a regular basis two different types of programs. And then since I was already a teacher with Golds Gym, they wanted to introduce some other dance programs from kind of well known brands. So they picked me as their [00:06:00] flagship dance instructor. So I actually ended up picking up some new classes and certifications through that.
I also had a private class, just my dentist and her friends wanted to do dance, but they didn't want to enroll in a gym. So I was like, "Here, I'll come over, you know, everybody pitch in, here's the price and I'll just bring the gear and everybody dances at someone's living room." So we even had and they were all really busy women. So. So I think it worked well for them to just, you know, be in the neighborhood and use a living room rather than have to kind of travel.
So you know, and, and we did, did some, there was two Golds Gyms, but there was also I was a substitute teacher and actually partnered with another dance trainer who was testing out ballroom dancing for people with disabilities. And so I was his like dance partner demo. So I just got to explore so many different opportunities through that and kind of see how you do business development and relationship management and new product rollouts and have to get, you know, prove that my class will bring in new [00:07:00] customers. So it was very fun.
Lindsey Dinneen: Oh, that is incredible. I absolutely love that. Oh my goodness. So, so you have always had this entrepreneurial bent, but then of course, like you said you've also-- you're so curious. You like exploring you like learning new things and you're clearly not afraid to go out and pitch those ideas to whoever will listen. So I'm curious, how did you come to the pathway of "I want to be an engineer. I want to go to school for this and develop that skill set as well." Because it's not that they're not compatible. They obviously are. But a lot of times people don't necessarily put the two together. So I'm curious how that worked for you.
Dasha Tyshlek: Yeah, when, when I was-- so, deciding to be an engineer was a little bit tough. I, I really like chemistry and I thought maybe to go into the chemistry side of things. But a lot of the people in my family are engineers. My grandmother is an engineer. Both my parents have kind of a practical math backgrounds. So, there was a lot of engineering in the [00:08:00] background of my family. And it seemed to me that the engineering focused a little bit more on kind of what's here and now, what you can build now. Science may be focused more on fundamental discovery. And so that that seemed to be kind of the difference for me is is I thought, "I'm probably like a little bit more like practical here and now rather than thinking in these like 20 year timelines."
And so I think it was just a better personality fit. And then once I got into engineering school, that turned out to be really a great fit because I loved learning about the technology. I loved working with other engineers who were very building, creating, designing oriented. And the way that you look at problems and investigate in engineering is very similar to scientific approach, but also tends to be then, you have to then think through, "Okay, great, we found out how this spring works or something like that, but how do you use this spring to do something now in the world?" And so I, I love that [00:09:00] translation from kind of, "We have a technology, we have an approach to, it has to work for people in the world in reality."
Lindsey Dinneen: It's so interesting because I love talking to people who are multi passionate and have a lot of different avenues that they have pursued over the years because I do think, overall, the more generalist you can be-- not that you shouldn't really hone in on some specifics-- but the more that you can have a lot of general experience and knowledge and skill sets, it seems to all end up working really well together in the end. And it helps you be a little more creative maybe when you're solving problems or approaching a new idea or a difficult conundrum and you're going, "Okay, well, you know what's interesting is, I have this background in science and engineering, and I have this background in dance and entrepreneurship and then blending it all together." I just love the stories of how it comes together.
Dasha Tyshlek: One of the things I learned when I was [00:10:00] in engineering school is, for a lot of the projects-- so I took some project types of courses, and the first one I did that was like a year long course-- what I learned is, first semester, there was somebody to train me how to do the thing, but then everybody left the class, and I was the only one left. And so, the second semester on the project, I was basically spearheading, like, this kind of modeling project, and I had only been doing it for a few months. And I noticed right in that project that I was able to keep a team really organized, really clearly articulate goals, and at the end of the project, aside from the technical work that I was doing on it, I was actually the person synthesizing the results and communicating.
And it led me to think, "Is there something there that's a real strength for me? And should I be doubling down on that?" And that, that's an area I've pursued a lot in my career is technology communication: clearly articulating what we're trying to achieve at the onset, developing requirements, [00:11:00] understanding the use case, et cetera.
And then on the back side of it, once we've developed something, there's an entire kind of art and science to it, to talking about technology because there's a lot of detail. A lot of the people who work in the detail of the technology want to share that science and process. But a lot of the people who then make decisions want to hear other information about the technology that might not relate to how it works or how it was built.
And so by, by actually having some of those experiences in engineering school, I was able to see that this technology communication and crafting of project goals was something that was really needed for engineering teams, and it really benefited when there was an engineer who was doing that, but you had to be in a different mindset and develop a different set of skills in addition to the design work.
Lindsey Dinneen: Yeah, absolutely. Now, when you, and thank you for sharing that. I love that, that bringing it all together and again, how things work [00:12:00] together to help you. I, and I'm curious. So you are, you were so well prepared, from an outside perspective at least, to go out on your own and become this high level, amazing consultant for these companies. Did you also feel ready, or was it still this sort of leap of faith when you said, "Okay, I'm going to go in, full time for myself."
Dasha Tyshlek: No, I was, I was very ready. I think, like any entrepreneur, I'm going through a process of discovery by learning exactly what it is my customer really needs help with, what industries and specific technologies I'm able to bring my skills to the best. And also what types of companies are looking for help I provide. So I can't say that I knew all of that information when I started out, but I had a good experience in, in the role I left.
When, when I started my business, having had walked into an engineering company that had great innovative products, but was sort of [00:13:00] underperforming in the market relative to their potential and the quality of the technology they provided and going through the process systematically of creating a company strategy with them helping them understand what pieces were missing from their business development side, and working through the marketing and the business side of things to help them better articulate their technologies. But also taking a look at the portfolio of technologies and recognizing that some of the technologies there didn't quite fit their main business model, but were really valuable, helping them figure out a path to get those out to market separate of their company, but in a way that still contributed to the overall value of the business.
And after I did that, I had several years of success and meaningful impact to look back on. And I said, "I've done it, I've proven it in one place." But in my experience doing this, I just kept meeting more and more companies [00:14:00] that struggled with a similar kind of problem. They had all the innovation. They had an amazing, talented engineering team, but they either lacked focus on which products had the most potential, or they would develop a lot of stuff that they didn't know how to move forward into the market. And so I could see the problem all around me. I was solving it. And so, after I've done enough at one company. I said, "Okay, I see the need and I know that I have the skills to solve it. Now I just need to kind of open that up and create a firm around this concept that helps other companies succeed in the same way."
Lindsey Dinneen: Wonderful. Wonderful. Thank you for sharing. And so since starting your own consultancy, what has been maybe one of the most impactful, or things that really stand out to you as one of the most exciting things that you've gotten a chance to work [00:15:00] on? What kind of goes, "Oh, this is why I'm doing it this way in this industry."
Dasha Tyshlek: Yeah. So, just generally, I get to meet so many interesting innovators who are changing, particularly healthcare. There are very interesting transformative technologies coming to the market that utilize virtual reality, that utilize AI technologies, to do things we weren't previously able to do in medicine to make me visualize your body in a way that no amount of human brain power could have done because of the way these models can work with data.
But the project or the specific thing that I think I am most excited about in terms of its general impact is, it's called Biomedical Frontiers: Stories with Innovators in Healthcare. And it's a podcast i'm producing on behalf of University of Virginia's Coulter Center for [00:16:00] Translational Research. It's a center that focuses specifically on biomedical research that has potential for commercialization, or you could say translation, into the clinic, and they fund that research. They help with the business development efforts to bring that research into the world.
And the podcast supports that mission by both highlighting the technologies that are a part of that portfolio, as well as that are connected to that portfolio, but also by educating people not only on the process of invention and the process of innovation in the medical and life sciences industry, but I think, very importantly, about what is coming: the hope and the good news about some of the incredible things that are coming to the market and to the world to help solve some of our intractable problems. So, I think in terms of human impact, that's probably the, something that I'm working on with, with a tremendous [00:17:00] vision that is available to all to participate in, to listen or, to be interviewed on.
Lindsey Dinneen: Excellent, excellent. And can you just share a little bit too about your experience becoming a podcast host because you have kind of an interesting, unique story with that. And then how can people listen to this podcast? Where is it available?
Dasha Tyshlek: Yes, of course. So public speaking and presenting technology, something that I've been interested in for a long time. And even before I started my business, in the Director of Marketing kind of roles that I've done, I've realized that video and audio communication, kind of deep diving in technology, helping create content that educates people because in a lot of engineering, even deep engineering technology areas-- you're working with other engineers who are deep in some technology area that you don't necessarily understand. There's a lot of miscommunication that happens because of that and podcasts are just such a [00:18:00] powerful way to bring more education and deep conversations about various topics, including very niche topics into the world.
So I've kind of experimented with interviewing video interviews for some time now. But when I started my business, I was working alongside another business, Sales Chasers, and the founder of that business, Michelle Page, she and I were just kind of throwing around ideas. How do you grow your business? How do you find customers? What things we were interested in? We started kind of collaborating because you know, when you're starting a business, it's just you and headphones and your computer and it you know, you kind of miss-- especially if you're in a business development communicator role-- you're like, "Ah, I need people." I'm, I, I need some, some sort of co working to go on because it's, it's too lonely. So she and I were each other's co workers in that way, kind of similar stages in our, in our different consulting firms.
So she and I decided to do a project called Go Go Grow, focusing [00:19:00] on business to business scaling with each of us coming up with some lesson plans on kind of key frameworks, tools, or ideas that are really important to business to business type of business growth. And so she and I developed that Go Go Grow together and put out a season focusing on kind of the fundamentals that we think are the most important, with some interviews of experts as well as some content that she and I kind of lesson planned together. And she's continuing on with that into other kinds of topics, but I was already working on this podcast, and I was teaching at University of Virginia, a class in the biomedical engineering department focused on engineers' professional development skills.
And so when I was talking to my co lecturer who is the professor at the University and the head of the Culture Translational Research Center, he had this idea of "We should do a podcast." And I said, "Let [00:20:00] me help you. Can I please do this?" So I created a vision for what we could do, tying his foundations' mission and the goals that we were both pursuing in the class in terms of professional development for biomedical engineers. And then presented it to the engineering department, to the biomedical engineering department, and that's how we got started.
Lindsey Dinneen: Amazing. Well, thank you for sharing that. And yes, please go check out her podcast. It's going to be just really informative. You'll learn a lot and you'll also get a lot of inspiration, like she said, about the fact that there's so many new amazing technologies emerging, there's a lot of reason for hope and optimism, and that's a good reminder, especially nowadays. So absolutely. Well, I'm curious, are there any moments or any one moment that stands out to you as just this [00:21:00] realization that you chose the right industry, you chose medtech for a reason, that it just kind of clicked into place, "Yes, this is why I'm here."
Dasha Tyshlek: I think there's been a couple small moments, but each meaningful. I think when I got my first client that was really outside of my existing network. It was somebody I met through the work I was doing of developing my business, and not somebody who I'd previously known or worked with or anything like that. I think that was a real key moment. That's like a line that you cross. You're like, "Okay, this is not about my network or the people who sort of know me. My value and the skills are clear. I can clearly articulate them to somebody else, and somebody else can put the trust in me to help them deliver something." So I think that was one is that first client that's sort of outside of of anybody you knew at the moment you started your business. [00:22:00]
I think the second one was really landing my first kind of big client, a company that really does a lot of technologies and they're not necessarily like a startup. They're mature. They have a lot of technology. They have a lot of process. That was, that was something that was like, "Okay, now I know that I'm starting to get into the kinds of companies that I'm envisioning helping and they are seeing the value that I can provide them back. So we're in agreement and it's starting to make sense."
I think the third moment was when, so I have an analyst on my team. I also have some different suppliers and people, other consultants that I work with, so kind of distributed network plus starting to build my internal team. And the first time a client approached me to actually hire somebody, my junior consultant, from my team on a project based on something that this person did for a project that I was primarily working on. And so really starting to [00:23:00] see that some of the processes and systems and ideas I'm putting in place, that it's no longer just because of me, but now it's starting to say, it's because of the company and, and their skills that other people on my team have that, you know, knowing that I manage them and knowing their skills, they, they want to hire them and me because of them. Now I know that I'm moving beyond sort of sole openership and into-- there's a company here and we're developing a shared capability. So that sort of reinforces the vision and opens up a lot of possibilities.
Lindsey Dinneen: Yeah. That is incredible. First of all, you know, congratulations because it's hard enough when you venture out on your own, but then to go ahead and have so much success and I'm sure-- you know, you have that daily grind so it's not always all sunshine and rainbows-- but to be able to grow your team and to have that moment of, "Oh my goodness, this is a company. It's not just me now, it's a company and there's other team members and we're all providing such [00:24:00] value to our clients." That is amazing. Congratulations. That is just the first step. So I'm really excited for you.
Dasha Tyshlek: Thank you. Yes, me too.
Lindsey Dinneen: Yeah, absolutely. Well, pivoting the conversation just for fun. Imagine you were to be offered a million dollars to teach a masterclass on anything that you want. It can be in your industry. It doesn't have to be. What would you choose to teach and why?
Dasha Tyshlek: Oh, that's a tough one. I actually have a competing hobby that I would probably choose from, and that is how to set up a wonderful backyard garden that produces food and flowers for the season. I think we I think we need more backyard gardens and more gardeners. But I think I would have to spend that entire million dollars on getting people to attend.
So maybe not the best choice of a million dollars, but professionally speaking, I think I would love to teach about setting up frameworks [00:25:00] for thinking about-- any kind of problem really-- but business development related problems. I think there's, there's a lot of really great frameworks out there teaching people how to use them in order to anchor your thinking and your decision making in kind of a shared understanding of priorities that requires a framework. So we could start with the frameworks that exist, but teaching people how to think outside the box and create their own framework for the situation, how to be basically their own strategy consultant in PowerPoint or on paper and help them think through problems that are complex and chaotic by creating frameworks would be, I think, really valuable to many people. I don't think it's taught very often. And certainly it's it's such a huge leg up on any kind of problem solving that you have to do to be able to kind of anchor yourself in a structure before you go and start making [00:26:00] decisions.
Lindsey Dinneen: Yeah, I love that. I love that idea too, because especially something that you said really struck a chord with me about solving the idea of chaotic and overwhelming problems and creating a framework for that. There's so much of life is, I mean, life is a learning curve, right? So there's so many times where it might be very helpful to approach even a personal problem or a personal challenge that comes up with the idea of a framework where you can say, "Okay. Yes, this feels overwhelming and anxiety inducing, and whatever other big feelings you have about it that make it feel so overwhelming you can't even get started." But what if you think about it in terms of a framework and how could that help you take it out of all of the emotion, maybe, and help you transform it into, okay, this can be resolved is some creative problem solving strategy. I think that'd be amazing.
Dasha Tyshlek: Yeah, and sometimes [00:27:00] when you put things in a framework, you discover that either pieces of information that you need to actually make a decision or a path forward are just missing. You put it in a framework, you're like, "Oh, of course, it makes sense, I'm missing this whole thing of information." Or, alternatively, so it can actually stimulate that aspect of creative thinking, but also it can prompt more idea generation. And, and I do find sometimes-- it's like the problem diagnosis-- sometimes if I come into a scenario where there's a lot of confusion about, "What do we do? How do we move forward? What product should we choose? What business model should we choose?"
The first thing to do is to create a framework for decision making because, you go and you do the research and you get the information, you still don't know which one to do because the information by itself, you know-- unless the information's like there's zero opportunity here, but there's never information like that. The information's always that there's some pros over here, and some [00:28:00] pros over here, and some cons, and some cons. So without the framework you just drown in the amount of knowledge. Facts without a framework don't lead to a decision, they just lead to a lot of facts.
So learning how to step back, when do you actually go back to a framework, and how do you create a framework for this situation, because sometimes it feels like you don't have a framework for this situation, the situation's unique. But you can then come up with your own framework, merging ideas from other frameworks, or utilizing your own creative skills to kind of draw up a structure within which you can make decisions. So. I think that would be, that would be a very fun master class.
Lindsey Dinneen: It would be fun and super valuable So I'll sign up for that when you give that Well, how do you wish to be remembered after you leave this world?
Dasha Tyshlek: I always focus on three areas of growth for myself. When people ask me what I want to be, I think "kinder, wiser, and more courageous" is what I want to be over time. And [00:29:00] so I would hope that, I don't know that those things have a definite end, but if I can be remembered as having worked towards that in a way that people felt in their lives, then that will be good.
Lindsey Dinneen: Yeah, that's a beautiful answer and finally, what is one thing that makes you smile every time you see or think about it?
Dasha Tyshlek: Flowers. I love, especially on the side of the road, when you're driving somewhere, and sometimes you see that nowadays on highways, there's been some wildflower planting. That's just so good. It's good for the environment, it's beautiful on the eyes, it's good for the bees. So, so always happy to see more flowers being planted for a more beautiful world.
Lindsey Dinneen: Yeah. Oh, I love that so much. Great answer. Well, thank you so very much for joining me today, Dasha. This has been such a pleasure, and I'm just so impressed with you and [00:30:00] everything that you're bringing to the world to help these amazing companies become even more effective, and this creative problem solving that you bring to it with your frameworks and whatnot. So, I just want to say, you know, a huge kudos to you for everything that you're doing: the podcast, I hope that all of my listeners go and check hers out as well. And yeah, just thanks for being here.
Dasha Tyshlek: Thank you for having me.
Lindsey Dinneen: Of course. And we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support. And we wish you continued success as you work to change lives for a better world.
Dasha Tyshlek: Thank you very much, and thank you for that donation on my behalf.
Lindsey Dinneen: Oh, yeah. And thank you also to our listeners for tuning [00:31:00] in. And if you're feeling as inspired as I am right now, we would love if you would share this episode with a colleague or two, and we will catch you next time.
Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit [00:32:00] velentium.com to explore your next step in medical device development.
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Holly Rockweiler | CEO, Madorra | Women's Postmenopausal Health, Entrepreneurship, & Human Connection via Communication
28 Haz· The Leading Difference
Meet Holly Rockweiler, CEO of Madorra. This episode explores the transformative journey of Madorra from a Stanford Biodesign fellowship project to a pioneering force in women's health aiming to revolutionize the treatment of vaginal atrophy and dryness without hormones. Holly's story is not just about groundbreaking medical devices, but also about the passion and determination that drive the quest for better healthcare solutions. Through engaging storytelling, this episode unveils the challenges and triumphs of bringing novel technologies to market, the power of female leadership in STEM, and the broader impact of MedTech on improving lives.
Guest links: www.madorra.com | https://www.linkedin.com/company/madorra-inc-/| https://www.facebook.com/MadorraMedical | https://twitter.com/MadorraMedical
Charity supported: Equal Justice Initiative
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 033 - Holly Rockweiler
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:51] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to introduce you to my guest today, Holly Rockweiler. Holly is co-founder and CEO of Madorra, a woman's health company dedicated to changing the treatment paradigm for vaginal atrophy and dryness. She co-founded Madorra as a spin out of the Stanford Biodesign fellowship, where she implemented ethnographic research to identify unmet clinical needs and define user market and product requirements for solutions and women's health, urology, and infectious disease. Prior to Biodesign, she worked as a Senior Research Scientist at Boston Scientific, where she developed therapies to enable more efficient care for patients living with heart failure. Her preclinical and clinical research has led to more than 20 pending and issued patents. Holly holds an MS and a BS in Biomedical Engineering from Washington University in St. Louis. Welcome, Holly. It's so wonderful to have you here today. Thanks so much for joining us.
[00:01:49] Holly Rockweiler: Thanks for having me.
[00:01:51] Lindsey Dinneen: Yeah, absolutely. Well, I was wondering if you wouldn't mind starting off by telling us a little bit about yourself and your background and maybe what led you to the medtech industry.
[00:02:02] Holly Rockweiler: Sure. So let's see. So my background is in biomedical engineering. I majored in biomedical engineering. Maybe I can say why, like I, I knew that I wanted to be an engineer. I felt like, well, first of all, as a woman in math and science growing up, when I did every teacher told me to be an engineer, but I didn't really know what that meant until I got to college, but I liked it. Pursued engineering and I started undecided, but very quickly found that I was, most just excited about the problems in the biomedical engineering field. I remember one of my classes was like "calculate the torque of a drill on a tooth," I was like, "Wow, that's amazing. I think I found it."
[00:02:41] So majored in biomedical engineering, got my master's and bachelor's at Wash U in St. Louis, and then I went to work for Boston Scientific. And so they are a medical device company. And so that's obviously how I got into it, but I did seek that out. When I was thinking about what did I want to do, I thought about... chemistry was never an area I felt very strongly about. I liked stuff I could hold in my hands and really conceptualize. And so I think that's what led me more in the device road and then had a incredible opportunity to work at Boston Scientific.
[00:03:15] And so I worked there for several years in their implantable cardiac division. So that's pacemakers and ICDs, working in the research department. So that was also really cool because we were on the front end helping to define the next generation products and was able to also work very cross functionally. So just because research conceived of an idea didn't mean it was going to be in the product development had to help it go forward, and obviously we were keyed in very closely with the marketing team to understand. What were the needs that we were solving.
[00:03:45] So it was an incredible introduction to our industry. And then I decided that I wanted to try a smaller company. There was just some broader themes of working in a large company that didn't totally jive for me. And so I was like, "Well, I don't know the first thing about startups." So I had heard about the Stanford Biodesign program, which is where I went next. And the company that I started, Madorra, is a spin out of that program.
[00:04:14] Lindsey Dinneen: Wow. Okay, so your path is really cool, and I love that you are an engineer, and I love your passion behind it too, just hearing you talk about that one random problem and your excitement about it. I adore that. I do. Because that is not my leaning. So whenever I hear somebody just get really excited about that kind of thing, I'm like, "Yes, tell me more."
[00:04:40] Holly Rockweiler: Well, then you're in the right field too, I would say.
[00:04:42] Lindsey Dinneen: Indeed. Indeed. Indeed. So, yeah. I'm just curious. Okay. So, so going back just a little bit, you started off at Boston Scientific and kind of developed this appreciation for the medical device space and innovation. And then with Stanford Biodesign, can you tell me a little bit about being a part of that and then how you were able to spin off into your own company? I mean, that's not, that's like a one sentence thing that you put in there, but I know that it took a lot of work, and I'd just love to hear about that process, and your experience.
[00:05:17] Holly Rockweiler: So, absolutely. So, the Stanford Biodesign program has many different facets. I was part of the fellowship, but they also have classes they teach and books and online resources. And then other universities have kind of sister programs around the world, frankly. So I was very interested in joining the program, like I said, to kind of-- what I was telling myself was like a way to dip my toe in the water of what a smaller company would be like. Now that's not at all what Stanford pitches the biodesign program as. Really what it is a an academic training program for an innovation process. And that's what they teach you. Now there are a lot of companies that end up spinning out of it.
[00:05:56] And so I thought, "Well, maybe, like I said, this is a way to dip my toe in the water, but also if I decided to come back to a larger company setting, this skill set still would be highly useful given what I want to do in my career. So that's what I set out to do. And so the program I love, I think is fantastic. It's as described initially, it's this innovation process and they teach you that in a very hands on way. So first you start with really understanding and building a list of unmet needs, and so that starts by looking for problems in Stanford Hospital. You kind of have this unfettered access as an engineer. It was the 1st time I had that, you know, observe and ask questions and talk to physicians and patients and other health care professionals and then. you end up with, obviously, a long list of problems that you can find, just like any, anywhere in the world, right? This could happen. But also this, in healthcare, it happens.
[00:06:55] And then you translate those problems into what the program calls need statements, to really-- there's a lot packed into that, but once you have those, then you spend the bulk of the program actually learning how to filter that long list of problems down into a couple key top unmet needs that you're working on. And so again, this is their goal is academic. They want to teach them their product is the people. They want to teach people this process and have them go out and share this process and use it to be successful in whatever, you know, vein they end up going down.
[00:07:32] And so I was like, I was just having a conversation with my husband this weekend. I was like, we were talking about something interpersonal and I said, "Well, the unmet need here really is..." So it certainly has, you know, I've drank the Kool Aid completely and love to share it. So, but anyways, so, but what happens because you're working hands on these projects you very often, which was the case for myself and my co founders, by the end of the year, you may have something that you're pretty passionate about.
[00:08:00] And so what has now become my about me description is working in women's health. I had no idea how passionate I would be about. I feel like I kind of backed my way into it, but now kind of reviewing that history, it's like, "Oh, maybe I was always kind of destined for this given my interest in, in, you know, activism." So kind of combining all of this together is what led us here. So, spinning it out was a consequence of having a lot of hard work with my team throughout the year. And we had other projects too, but this became the one that kind of survived every stage gate. And we ended up spinning out. into the company, Madorra.
[00:08:42] Lindsey Dinneen: Wonderful. Well, thank you for sharing a little bit about that. And also, I love the crossover into real life, not that's not real life, but I do your daily life as well. Oh my gosh. That's great. I'm going to start doing that. Okay, so can we talk now a little bit about your company and the product that you've developed and where you're kind of looking to take it in the future?
[00:09:05] Holly Rockweiler: Certainly. So, again, being born out of Stanford, we started with an unmet need around creating a treatment for vaginal dryness and atrophy for postmenopausal women that didn't rely on hormones. So this is a problem that I had never heard of before we literally met patients with this problem and talk to providers about this problem. And as we started researching, "Wow, up to 75 percent of all postmenopausal women are dealing with some, you know, degree of this. How have we not heard of this before?" That is a striking number of people.
[00:09:39] And so as we continued to do our research, very quickly learned the gold standard treatment here is hormone therapy, but even though this market is huge, only 7 percent of the market is using hormones today. And so that... there's a lot of reasons why, but that's really what motivated us to say, "Wow. There needs to be another option." Because if you don't want hormones right now, the only other FDA cleared product or category for treating this are over the counter lubricants and moisturizers. And those are like, both of the products that exist today are really, those categories are really great, but they're not enough.
[00:10:16] And again, with 43 million women in the United States with this problem, like we need more than just those two categories. And it really felt like no one had really looked at this. I mean, hormones, again, are a good solution for the patients who want to or can use them. But for patients who can't, for example, breast cancer survivors, they're stuck with, you know, just kind of subsisting off these over the counter products that really are not enough when your case is more moderate or severe.
[00:10:43] And so we said, "Well, let's look at this and see if there's a better way or, you know, something we could combine," and ended up developing the idea for what is now the main product that we're developing at Madorra, which is a home use device that uses ultrasound to really rekindle the body's natural lubricating process. And so our whole goal has been to be very supportive of the other products in this category. We think hormones should be used more often than they are, frankly, but that women shouldn't have to make a compromise. If they don't want to use hormones, then they should have other options, and that's where we come in.
[00:11:21] So our product, we will, it's not on the market yet. We're working towards that, but when it's out there, what we envision is a prescription happens from the gynecologist, and then the patient uses the product at home on a regular basis to, like I said, kind of revitalize that natural process. And what patients have told us they like about this is that It is restarting their own natural lubrication rather than some exogenous hormone or chemical. And there's less of a kind of a goop ick factor, you know, than having to use these over the counter things, which again, they like say that not to say that those don't have their place because they absolutely do, but it's not enough.
[00:12:01] And so, we're pre FDA clearance, but we have a breakthrough designation from FDA. So that's feather in our cap and will help us get through the agency more expeditiously. And we have done several clinical trials and look forward. We've published one of those trials in our first manuscript, and we look forward to putting more of our data out there to help really lay the foundation to say, "Yeah, ultrasound is an appropriate approach to treating this and has virtually no side effects." So this should be a great option to be available to as many people as possible.
[00:12:36] Lindsey Dinneen: Oh, that is incredible. Oh my goodness. Well, yeah, first of all, again, you know, it boggles my mind and it probably shouldn't anymore, but it continues to when you tell me statistics like this, that 75 percent of women who've are in this situation or have this concern or whatnot. And you're just think, you're addressing it in a way that's so innovative. And yet that hasn't really been addressed yet and it happens again and again with healthcare for women. And I'm wondering, you know, you mentioned earlier being very passionate about this. So I'm wondering if you can speak a little bit to fem tech and women's health and how you're involved in helping to push the conversation forward 'cause I know that can be a little challenging at times.
[00:13:23] Holly Rockweiler: Absolutely. Yeah. And well, it's super fascinating too, because we spun out of Stanford in 2014. So we're coming up on 10 years here and the conversation is so different today than it was just, well, just 10 years. I mean, it was a decade, but it feels like yesterday. Like a lot has changed. When we first were starting Femtech wasn't a hashtag, like that was not a conversation. And people would say like, "Ooh, that's a niche." Yeah. And that doesn't happen anymore, which is really great. So while that's, that's certainly progress, so we should acknowledge that and be proud of everyone who's worked towards creating that progress. So I think what's been interesting, though, it's like the pace of progress, maybe?
[00:14:09] So it's very exciting to know that there are, for instance, obviously I spend a lot of my time fundraising, there are women's health focused venture groups now. They, that's fantastic. That we just need bigger and bigger funds to be focused on that. We just need more and more We need more of everything, right? I mean, one of many things I've been very surprised to learn is how little training physicians get on menopause specifically. And so that has to change. And so there's just like a lot.
[00:14:40] And so to the point of activism, like there's a lot to say, and so I think, it's... being raised by parents who are feminists, that helps, I think, me just start by saying, "Well, no, this shouldn't be . We can do better, and we will do better." So that's helpful, and I think that's also what really keeps me going-- obviously, every job is hard, and in our startup world, this is certainly a lot emotional rollercoaster. And so when I think about when I have harder days, it's like, "Wow." We've had patients tell us, for example, "I can't believe you're even paying attention to this. I can't believe you're listening to what I have to say." And so one, that's disturbing that's, as little as it's needed to make someone feel better. Secondly, it's "Wow, we can have such an impact by just being out there." So like the fact that we exists, I always think is helpful and that we do things like this and have open conversations about vaginal health for an aging population.
[00:15:39] I will also say that, a year ago at the Super Bowl last year, there was an ad for a hot flash drug. And so that's like, you know, the world stage, menopause is being discussed. That was not happening 10 years ago. There is real progress being made. The last thing I want to say is that one thing I, I have also really appreciate about working in women's health and how supportive everyone is of everyone else. Every, anytime, even like our closest competitor, when I met their CEO, she was wonderful to me and, you know, shook my hand and said, "How can I help you?" And it's like, "Where else does that happen?" That's incredible. I think 'cause we all see there's a lot of work to be done. We can't do it alone. We want to support each other.
[00:16:19] Lindsey Dinneen: Oh, I love that. Yeah, that is something that I have really admired and appreciated about the medtech industry. I think because people are curious, and their mindset is very innovation problem solving, "how can I help?" It seems like even with competitors. Yes, we're maybe vying for similar people to sell to. However, there's this idea of camaraderie, which I don't find in a lot of industries. So yeah, to your point, I think it's really helpful to have those allies in the space because that's, it's a little different.
[00:16:53] Holly Rockweiler: Totally.
[00:16:54] Lindsey Dinneen: Yeah. So yeah. And I, I love what you were saying about these conversations are happening more and they're becoming more mainstream and less embarrassing or taboo, which sounds hilarious because it's 50 percent of the population or whatever. But anyway, the point being, it is exciting to see this continue to move forward. And I'm wondering, even as a company, obviously your next big hurdle is getting that FDA approval, going to market and whatnot. But as you continue down the road, what other kinds of problems are you looking to solve? Or are you not even there yet? This is just like, "Let's start here. We'll get into that later."
[00:17:38] Holly Rockweiler: Yeah. No, it's a great question. I think like what kind of harkening back to the just the prior question about the community of women's health. It's like you can't go a day without finding five other problems that you want to solve. So absolutely. I think that yeah, I mean, like with Madorra, we are very focused obviously on this technology and developing it, but we certainly have a roadmap of where this technology could go and other ideas of where to take it. And then what I find fascinating is that there is no menopause "brand." Like no one owns menopause, which I, if I worked at Procter and Gamble or Kimberly Clark, I would be like, hopefully 15 years ago, I would have said, "Guys, let's do it." So it's very surprising to me. So I think there's a lot of opportunities.
[00:18:23] So would Madorra be that brand? I would love that. We would need a lot of other products that come together with us. So what I really see is a roll up in the future of multiple women's health products together. So I think that's exciting. In terms of, also a little bit maybe more broadly speaking, and this is no surprise to you, I'm sure, or your listeners, that reimbursement is an area that needs massive... I don't know, I was gonna say like overhauling, but that sounds pretty drastic.
[00:18:53] It just needs to be clearer and cleaner and simpler. In terms of a process. I'm not saying that we should be handing out reimbursement left and right, but any investor conversation I have is, we go there immediately. And it's like, "Okay, what's the path? Well, why do you think that's going to happen?" And when, you know, X, Y, Z, other company had this happen and I can, we have a good strategy. I think I have a good pitch, but, oh, just... it just is an area that is really murky, and given that's a really critical piece in any business is how are you going to get paid? That's an area that I think there's a lot of good work being done. It just moves at a pace that is painfully slow. I don't have anything insightful to say about it except that, thank you to the people who are working on it, and I support you. I think the TCEP program is a step in the right direction, but even that has been very slow, and not without its own issues, so.
[00:19:53] Lindsey Dinneen: Yeah. Still work to be done, but thankful for the work that is being done.
[00:19:58] Holly Rockweiler: Well said. Yes.
[00:20:00] Lindsey Dinneen: So, yeah, so, okay. So obviously, listening to you speak about your background and about the industry, it's really clear how passionate you are about this. And I, I wonder if there are any moments or series of moments that stand out to you as kind of confirming that, "Yes, I am in the right place at the right time. I'm here for a reason."
[00:20:23] Holly Rockweiler: Oh, good question. Yeah. I'm trying to think like, there are plenty. There's plenty of times in the moment where it's like, "Of course, yes." And then there's like quickly like, "Oh, what's the next fire I'm trying to put out?" So it's hard to really think. I wish I had a super answer right away. I'm thinking, I guess I always come back to the patient and so like hearing-- so we've done some clinical trials in Australia and various team members of ours have gone over and been able to support the trials and be a part of them. And just hearing the stories that they bring back, it's just like, "Yes, we have to keep doing this."
[00:21:01] One of our employees was there and came back with a couple stories of one of them was just like after the study visit, the patient was speaking to her and was saying, "It's a conspiracy of silence. This is a huge problem. So many of us are suffering. We're so glad you're here." And then it's other things like we did, for instance, a human factors study that was really helpful to us. And we learned a lot from, and in that study, it was like patients came in to do mock use of the device so we could improve our training materials and also, you know, all parts of the user experience. And it was amazing to me.
[00:21:38] So patients, you know, participants, I should say, got zero benefit theoretically about being in that study. It was all for us to learn how to do this better. I mean, we did compensate them, but marginally, right? And so many people wanted to be in that study. And even if it was the early on patient who had-- I'm going to make it up. I had like, "Oh, the user manual didn't make sense to them" or something. They were still like, "I'm so glad to be here to help you because this product needs to be out there." And so it's like, " This is incredible. Yes!" And that part is really rewarding to me.
[00:22:09] For me, it's the patients and their feedback and just their enthusiasm. And then, I was gonna say also for the healthcare providers too, we have a lot of wonderful physicians that we work with and their support has been helpful. Like for instance, as I mentioned, we put a paper out there and one of our clinical advisors was highlight, or I think a couple of them highlighted to us that like, "We need to do a second paper on a specific subset of that data because it's super valuable and hasn't been out there before," which may be the clinicians do that for everything they do 'cause they, they know the scene and they know what needs to be published, but it just felt like we have a lot of people who really are rowing in the same direction and really want to make an impact like we do.
[00:22:49] Lindsey Dinneen: Oh, wow. Yeah, that's incredible. Thank you for sharing those stories. I think, you know, as you alluded to earlier, because your role has so many components, because that's the space you're in and you've got so much going on, I think it's really compelling to have something to hold onto when it gets hard and go, "You know what? I remember that patient who was so thankful just to have the opportunity to be a part of it and just wait until this gets into the hands of so many more."
[00:23:15] Holly Rockweiler: Totally.
[00:23:17] Lindsey Dinneen: Yeah. Yeah. Yeah. And so for you, you know, you obviously have a very strong background in engineering and innovation. How was it for you going from that to also now being an entrepreneur, and having a business, and having to also learn all of those skills as well. How was that transition?
[00:23:42] Holly Rockweiler: Fun. I think that-- there's a lot of personal growth, and I've learned a lot about myself and what where I find passion. So I think there's definitely a lot of hard parts too, but what, well, one thing is that I think there's also a heavy dose of naivete that was important. I didn't know what I didn't know. And so here I am 10 years later I think, you know, in the beginning too, I was not... what do I say? I wasn't convinced, yeah, I wasn't convinced that I could be a CEO, that I should be or could be. And so I think that was, and is maybe still a definitely a continuous journey to it. So why is, why did I think that? What does that mean to me? And where am I now? That's been certainly a learning process.
[00:24:31] But that's also like why I said fun, because I, I get to do such a variety of, like, I get to have this opportunity to speak to you on this podcast. I get to work with our clinical advisors on a paper. And I also get to apply for grants. And there's a lot of hard things that come with all those things, but I feel like it's been a really, I don't know, just an incredible opportunity to have a job that It requires so many different things. It also requires me to do financial modeling, which I'm terrible-- well, was terrible at-- have learned and much better at, but also don't really love doing.
[00:25:04] So it teaches you what, what you might look for in a future chapter of your life as well. But I'm someone who really thrives on, I have a very curious mind. So trying new things and figuring out new things. And that, I think that curiosity is well satiated by an entrepreneur's life. The managing your own psychology is really difficult, but that's why you have a great community of people around you, both within the entrepreneur community and outside of it.
[00:25:36] Lindsey Dinneen: Oh my word. I think I just need to take what you just said those last couple of sentences and just make it into a quote because that was so well articulated.
[00:25:45] Holly Rockweiler: Oh, thank you.
[00:25:47] Lindsey Dinneen: I cannot think of a better way to describe that journey. So thank you for, but also thank you for being vulnerable and willing to share that, because it is such a journey and it is a learning curve, but kudos to you for embracing it with an attitude of fun, like, "Let's just learn something new and it might not go great the first time, but that's okay. I'll try again."
[00:26:10] Holly Rockweiler: Yeah, I was thinking, I was like, "Well, if any of my investors are listening, I have gotten really good at a lot of these things, so y'all don't need to worry." But I do think that's maybe the blessing and the curse of being a first time entrepreneur. So I think, you know, there's certainly a lot of benefits for having done it before and knowing exactly what to expect. But I think with anything in maybe any regulated industry, or maybe any startup, really, there's always going to be curveballs. So that keeps you excited.
[00:26:41] Lindsey Dinneen: it's never boring. It keeps you on your toes. There's at least that.
[00:26:45] Holly Rockweiler: Yes, absolutely.
[00:26:47] Lindsey Dinneen: Excellent. Pivoting the conversation just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach and why?
[00:27:04] Holly Rockweiler: Oh, that's interesting too. And that's a nice paycheck.
[00:27:08] Lindsey Dinneen: Right? I
[00:27:10] Holly Rockweiler: Let's see. It's getting right to what do I think I'm good enough at to teach a class about. So, I mean, I think one thing that I've been thinking about a lot recently is scientific communication and how, how different voices get amplified and how the kind of stereotypical scientific persona is, it's not the one that wants to be necessarily on social media with a gazillion followers and all these TikTok videos. So I think that I would like to teach the class in concert with, I have a lot of ideas of like, who would be a great way, who would be great people to collaborate with in order to teach or really to help promote more scientific discourse in a conversation that's appropriate and approachable for anyone.
[00:28:04] I think that obviously our country has faced a lot of division and I don't think that's really true. I think that a lot of that is-- well, there certainly is a lot of division. I don't mean that. I just mean that I think there's a path to human connection via communication and that, wouldn't it be cool if we could help bridge conversations. And obviously I'm, I am a scientist. I think of myself as a scientist, so I want to think about ways to provide other voices out there to be amplified as well, or perhaps amplify the right voices to help promote just a more enriched dialogue than what is often presented as the country's dialogue today.
[00:28:48] Lindsey Dinneen: I love that.
[00:28:50] Holly Rockweiler: It's kind of rambling. I can get back to you with my course description, but that's probably where I would go.
[00:28:56] Lindsey Dinneen: Syllabi due Tuesday. No, I think that is absolutely incredible. And I love that because I think that is something that's missing and there's some translation error that occurs. And one of the things that I'm passionate about is helping to bridge that gap between-- so I'm right on board with you-- but to bridge that gap between maybe taking some what are traditionally considered complex ideas, concepts, whatever, and distilling it down to a more accessible format. And because everyone learns differently, it's just helpful to have a wider range of options.
[00:29:35] Holly Rockweiler: Totally.
[00:29:36] Lindsey Dinneen: So I love what you would be passionate about sharing. I mean, I would sign up for that masterclass.
[00:29:41] Holly Rockweiler: You can help me teach it, I think.
[00:29:43] Lindsey Dinneen: Okay. Deal. We'll get back on that.
[00:29:45] Holly Rockweiler: Okay.
[00:29:47] Lindsey Dinneen: Excellent. Yeah. How would you wish to be remembered after you leave this world?
[00:29:53] Holly Rockweiler: You have some great questions. Yeah, let's see. You know, I've honestly never thought about that. I think that I would, what would I want people... well, I think about like what I would want my friends to think. That, like, they were loved and that they hopefully shared that love broadly. But then, well, let's see, that's not really, like, remembering. Yeah, I guess, maybe it is. So, yeah. That I'm a lover, a curious person, and that I, there is a lot of beauty in the everyday, and so there's a lot to be excited about even on the hard days,
[00:30:32] Lindsey Dinneen: Yeah. I love that. And then, final question. What is one thing that makes you smile every time you see or think about it?
[00:30:41] Holly Rockweiler: Certainly my family. I have a four year old son and he is, keeps me very present and cracks me up continuously. And so, my husband and I are very lucky to have him. And obviously my husband makes me laugh. A lot. And so I really appreciate them. And so even when, you know, the work day is hard, I feel really fortunate to have a very rich personal life outside of that. So my family and then my friends also.
[00:31:09] Lindsey Dinneen: Oh, yes. Of course. That's wonderful. And I'm so glad you have that amazing support system to bring that smile to your face, especially on the tough days.
[00:31:19] Holly Rockweiler: Absolutely.
[00:31:20] Lindsey Dinneen: Well, Holly, this has been a wonderful conversation. I'm so thankful for you and what you're doing in this space and the fact that you're tackling an issue that affects so many people, and that you're just bringing all this innovation to, and you're so passionate about sharing that in a way that resonates with people. So I just want to first say, you know, thank you so much for the work that you're doing. I know it's not easy and there are probably days where you, you just kind of want to, you know, toss something in the trash, but honestly, thank you for continuing to do the work you're doing. It's not nothing. And I want to appreciate that.
[00:31:59] Holly Rockweiler: Well, that is very kind. Thank you. And that means a lot. And thank you for doing what you're doing, too, to give people like me a chance to share, and also us to listen to others sharing their stories. And for asking, I will say, asking questions that are more about me as a whole person too. I think that when I've been in other conversations sometimes are really-- and there's nothing wrong with those, but it's fun to have, we can ask these questions. I'm like, "Wow, I would do some thinking this weekend about how I want to be remembered" because I've never thought about that.
[00:32:30] Lindsey Dinneen: Yeah. There you go. I love it. Well, and we are so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you for choosing that organization to support, and we just wish you continued success as you work to change lives for a better world.
[00:32:59] Holly Rockweiler: Well, thank you. It's been a pleasure. Thank you.
[00:33:03] Lindsey Dinneen: Me too. And thank you so much for our listeners for tuning in. And if you're feeling as inspired as I am right now, I would love if you would share this episode with a colleague or two, and we will catch you next time.
[00:33:16] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Mark Oreschnick | Evolve Engineering | Fractional Consulting, Leadership, & the Power of Networking
14 Haz· The Leading Difference
Mark Oreschnick, a MedTech industry leader and the founder of Evolve Engineering, shares his journey of nearly 30 years in engineering and leadership, starting in aerospace before landing in the medical device industry. With a passion for mentoring and helping startups, Mark discusses the importance of right-sizing staff and systems for success. This conversation not only showcases the human side of technology, but also highlights the power of networking and building relationships for personal and professional growth.
Guest links: https://www.linkedin.com/in/mark-oreschnick-82367a8/ | [email protected]| www.evolve-engr.com | https://www.linkedin.com/groups/14248328/
Charity supported: Feeding America
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 032 - Mark Oreschnick
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey and I am so excited to introduce you to my guest today, Mark Oreschnick. Mark is the founder, owner, and president of Evolve Engineering, LLC. With over 25 years working in and leading engineering and operations in small, such as four employees, to large, such as 15,000 plus employees, companies, he has gained valuable experience he will use to complete your project as efficiently as possible. Mark's career has focused on developing products, processes, people, and businesses. Mark, thank you so much for being here. I cannot wait to talk with you all about what you're doing and your background. So thanks for joining today.
[00:01:36] Mark Oreschnick: Thank you. I'm happy to be here.
[00:01:39] Lindsey Dinneen: Wonderful. Well, I would love if you wouldn't mind starting off by sharing just a little bit about yourself and your background and maybe what led you to MedTech.
[00:01:47] Mark Oreschnick: Okay. I've been an engineer and leader for nearly 30 years. I started in the aerospace industry in college, and while I was an intern, I was offered a full time position to work as an engineer for my last year of college. So I did full time school and work, which I think very much set me up for my life in startups because I was sleeping about two and a half hours a night.
[00:02:15] Lindsey Dinneen: Oh my word.
[00:02:16] Mark Oreschnick: So, after that, I just kept having bosses challenge me with a variety of different projects. I've designed and built buildings for two different companies, automated. Equipment doing 16 million packages in four months, shipping out of a company, totally different industry and 20 years ago, coming this Valentine's day, I started the medical device industry. So, I'm coming out of my 20th anniversary right now. And within the medical device industry, I've been in really large and really small companies, both on the operations and manufacturing side and the R&D side. And I'm currently working with my seventh startup. So that's, like I said, the world of startups I've really enjoyed.
[00:03:02] And now I've moved into consulting full time, and I'm working with startups as a fractional CTO. So I'll put together their technology roadmap, help build their R&D team, work with the founder on what I've learned from my experience. What are the good things to do? What are the bad things to do? And how to right size your staff and your systems to be successful.
[00:03:26] Lindsey Dinneen: Oh, that's incredible. Well, thank you for sharing about that. It's so much fun to see how little bits of threads throughout your career kind of interweave, and then all of a sudden they've produced this really cool thing. And that's now you doing this on your own and consulting. And I just love hearing about that. Several things just stood out to me and I'm curious. Okay. So, so you said you sort of set yourself up for success by being like full time college student, full time working at the same time. And then yes-- so can you start by: where did this drive in this passion come from, because clearly your work ethic is astronomical and wonderful, so maybe start there.
[00:04:11] Mark Oreschnick: I would say it comes from my parents. Definitely did not grow up on the rich side. So everything that we had in our lives, we worked hard for. And I learned that if I wanted something, I needed to go out and get it. So, I think that was a good attitude that my parents put into me. And then they also, I won't say over expected things from us, but it was more, if you say you're going to do it, you're going to do it, figure out how to get it done. Just live up to what you say you're going to do. And that I think automatically put a drive behind me to just, all right, and you offered me a full time job. I'll be successful at it, but I'm graduating. So I got to be successful there and I'll just figure out how to make it happen.
[00:04:59] Lindsey Dinneen: Yeah. Yeah. And then you alluded to the two and a half hours of sleep a night. I hope that's still not the case moving forward.
[00:05:08] Mark Oreschnick: No, it's better than that now, but I've had 24 hour days as things come up throughout a career, and it's, you do what you need to at that point for your company and to get things done or you're having a team work extra hard. You get in there, you work with them, make sure that they're getting the support they need and they know you're there for them. So, sometimes it's insane. Other times you get to relax a little bit, but that's also, like I said, the life of a startup, you have your big pushes and then you get to relax for a little while and then you hit your next push.
[00:05:47] Lindsey Dinneen: Yeah, so true. It seems like you have quite a passion for helping startups in particular, and you obviously also have your own entrepreneurial bent and endeavors. And so where did the interest in helping startups in particular come about? Because I know that's a, can be a different skillset in terms of you often wear a lot of different hats and you end up pitching in so many different ways. So, so tell me about your heart with startups and entrepreneurship.
[00:06:17] Mark Oreschnick: Someone who has now become one of my best friends, we, my very first medical device job, I worked with him and when I left to go to another company, we looked for a position for him to join me. There wasn't a good fit, but a couple of years later, he went to a startup, which he had already been in startups previously, and asked me to come over and work with him there. And I came in, I saw that I could do a lot of things to help people. And that's kind of been my career also is how can I help people do things easier, better, just make their life easier. So if I saw a gap where there wasn't someone to jump in, I just jumped in and filled it. And that's what you do in a startup and it just really worked with my attitude of, I get to help a lot of people because, today I'll work on documentation with the quality side, next week I'll go build a fixture for production and whatever was needed at that moment. It let me get that joy of helping people.
[00:07:23] Lindsey Dinneen: Oh
[00:07:23] Mark Oreschnick: And that's ... If you get joy out of everything you do in work, it makes going to work really nice.
[00:07:29] Lindsey Dinneen: That is so true. I love that. That is so true. And so, you know, then you also have the skill sets to be able to help in lots and lots of different ways. And one common theme as I've been doing some of these interviews is that it seems like having that generalist background-- I mean, obviously you're highly specialized as an engineer. You're incredibly incredibly gifted and talented in that way. And you've built that skillset, but then you also have the opportunity to draw from multiple different industries that you've been a part of. So how has those various other kinds of influences in your life maybe contributed to your success now?
[00:08:13] Mark Oreschnick: I would say one of the ways that definitely benefited me a lot was getting into a non technical industry. The industry where I did the packaging automation and built my first building is called Consumer Fulfillment. Literally at that time, you were getting in buckets of mail, manually sorting it, data entering information into a computer, typing in UPC codes, like not technical, not anything like that. But it made me look at that world in a big picture format. And how could I help the process and make things flow from department to department much easier. And I just had to step back and kind of, all right. By making this process easier, I'm helping on the finance side. By making this less labor intensive, we have less workman comp.
[00:09:14] And it was just, what affects each piece of it? And as you kept digging deeper and deeper, you got to learn what the IT group did and how they could change the software to make it better. You'd figure out what the shipping companies are doing. We actually figured out how to load semis and make sure that the addresses were in the order of the post offices that they were going to. So the last bag onto the mail truck was the first bag that they took off. And we built that into our computer system so the trucks could drive direct and never have to backtrack or unload extra things. So it's just, you have to start looking at that big picture and you got to learn about every department to see how they all work together and make sure everyone's efficient, not just your little group.
[00:10:05] Lindsey Dinneen: Yeah. Well, and I love that approach. Being able to look beyond maybe what you feel like is the daily task or the task most important at hand and have that zoomed out view of, okay, this isn't just important for the success of this one department. It affects everybody else. And I love that. So now in your current role and in your current business with Evolve Engineering, you get to have that more eagle eye perspective again. Is that true? So when you're coming in, you're able to help?
[00:10:36] Mark Oreschnick: At the beginning, yes, if it's a new founder, and there tend to be two new founders that I've met lots of. They've, almost all of them have never been in a startup before. So that's a common theme. And they either come from not within the medical device industry or from a very large company within the medical device industry. So changing the mindset and getting real expectations and real realistic goals and budgets is where you kind of start with that. So I work with them to talk about, here's how much you can expect to spend on this project. Here's how long it's really going to take.
[00:11:21] If you're from a big company and you're still having five different computer systems that are managing your inventory and your sales and everything else, we're going to be running on QuickBooks and Excel, and that's what we're going to live by. Because if you want to put those systems in, you're going to hire 20 people to manage those systems rather than 10 people to get the product out the door. And get this design finished. So it's teaching them to just have a total different mindset about everything. And still knowing how all those systems have to work together. But trying to get it down onto the micro, basic scale, rather than going on to buying a great enterprise system, but we're not actually going to sell anything for five years, so we don't really need it.
[00:12:15] Lindsey Dinneen: Yes. Yeah. Yeah. Thank you for sharing a little bit about the two different types of these startup leaders that you're encountering. And I'm wondering, so part of your role, it sounds like, is not just getting into the very specific nitty gritty details of the actual company operations and technology and whatnot, but it's also having a little bit of this even broader range of, how do I help you as the leader develop the skills and priorities that you need to. So it sounds like you're in a, you're in a very Diverse mentorship kind of role in addition to like, let's get down to the nitty gritties, but you're also helping them develop those skill sets. Yeah?
[00:13:00] Mark Oreschnick: Yep. That's my goal is to help them become a good leader of a startup and understand what it takes. And I met with a doctor who had found me on LinkedIn about his company. And I wasn't sure exactly what he wanted, but as we were talking through things, I told him, "if you plan on being the CEO, we are going to figure out what day you fire yourself from that position." I said, we will do it to save money in the beginning, but you're a doctor. Be a doctor. Let's bring in a professional CEO when we get to the point where you stop saving the company money and possibly cost us money." And, he didn't want to be the CEO.
[00:13:43] So it wasn't a conversation that had to be had, but trying to put the mindset of, you're a great inventor, kick me out of my job, become the company CTO, drive development once we get to that point. I'm totally fine with that because it's the best for the company and it'll get us to the sale of the company or commercialization spending the least amount of money and getting there as quickly as we can. So being part of it's, be open, have those conversations with people and do that type of mentorship in the beginning. And if somebody said, "no, I'm going to run this thing until the end, I'm going to be the greatest CEO." I probably know from the beginning, I'm not the one to work with them.
[00:14:29] Lindsey Dinneen: Sure. Yeah.
[00:14:33] Mark Oreschnick: We probably won't gel in the end.
[00:14:36] Lindsey Dinneen: Yeah. And do you find that it's partly because perhaps the idea of, the things that got you to where you are not the same skill sets that are going to get you to the next level? Is it partially just because usually that somebody who comes up with this great idea and has the passion and the vision for the company can really get it off the ground and maybe get those first rounds of investment, but then they might not possess the skill sets to get them to continue growing and scaling. Is that part of it?
[00:15:10] Mark Oreschnick: That's 100%.
[00:15:11] Lindsey Dinneen: Okay.
[00:15:12] Mark Oreschnick: What normally it is and truly that passion in the beginning as the CEO gets your team driven. You get a lot done. It is a wonderful thing. But once you start to look at the commercialization and how do you grow a business, that creativity and passion don't directly translate. Now it's getting into nuts and bolts, black and white, a little more ruthless and you have to do what's right to make the company commercial.
[00:15:43] And the, I think it's lots of times not even ego of the founder. It's the passion. It's their baby, and they don't want to give up control and worry that somebody is going to ruin it. But that's why if you move yourself out, but stay within the leadership role in a different way, you're hand in hand with the CEO and you can move the company forward together rather than having a board kick you out because you're not doing your job and then you've lost all connection to your company.
[00:16:20] Lindsey Dinneen: Right.
[00:16:21] Mark Oreschnick: So I look at it as a, here's a way you can grow and you can learn from that CEO so the next time you do this, maybe you are the person who can take it another step, bring in the new CEO, one step farther down and finally you'll get to be that person who runs the company from start to finish, but you got to learn it. You got to live through it and protect your baby by moving into a different seat.
[00:16:46] Lindsey Dinneen: Oh my goodness. Yeah. What a challenging thing to overcome. So it's helpful that's your perspective from the start so you can help people prepare for that and that this is actually a wonderful thing. It's a growth thing. It's not a demotion. It is not a, you are any less important. You aren't. You're as still as important, but you're just moving into a role that suits you and suits what the company needs. Yeah. That's really interesting.
[00:17:13] Mark Oreschnick: And there are some investors who, if they hear that day one, that you know you're the one to bring it up to a certain point and then you will transfer it that will give them more faith in you because they know that you understand where your skills are and that you need the commercialization person to move the company to sale and they're going to appreciate that.
[00:17:37] Lindsey Dinneen: Yeah. Yeah. And so with your consultancy now, can you tell me a little bit about how that came about? And then I'd also love to hear, because I know that you've started, or co-founded, a very successful networking group in Medical Alley. And I would love, if you wouldn't mind sharing just a little bit about that, because that's a really cool opportunity for people in the area. But I would just love to hear a little bit about your origin story as well.
[00:18:04] Mark Oreschnick: So my origin actually started about eight years ago.
[00:18:07] Lindsey Dinneen: Aha.
[00:18:09] Mark Oreschnick: And the gentleman that I talked about who brought me into my first startup, we were at two different startups and he asked me if I could do a side project for him for his company to help it out. So I started Evolve Engineering.
[00:18:24] Lindsey Dinneen: Okay.
[00:18:25] Mark Oreschnick: And they brought me into interview to see if I was the right guy to do this project for them. And they liked my overall skill set and offered me a permanent position. So I wound up not consulting.
[00:18:39] Lindsey Dinneen: Sure.
[00:18:40] Mark Oreschnick: But it was something that I'd always thought, yeah, someday I'll get into this because one of the things great about startups is doing lots of short term projects. Even if your company lasts for seven years that you're there, you've jumped around a lot in it because that's what the company needed. So the idea of consulting and knowing that I'm going to be jumping around is exciting because you're always doing something new. So that got me hooked.
[00:19:07] Lindsey Dinneen: Yeah. Yeah.
[00:19:09] Mark Oreschnick: And then I was with a startup and I was looking for, what do I want to do next. I knew it was time to be moving out of that startup. And I started researching consulting and got myself connected with a bunch of people. And then another company offered me a permanent position.
[00:19:27] Lindsey Dinneen: Okay.
[00:19:29] Mark Oreschnick: So that postponed me for about another 16 months. And then in late 2022, I made the decision that "No, it's really my passion. I want to get back helping as many startups as I can." And I just dove into it. One of my former employees became my first client. And then another group called me up of a bunch of employees that I used to work with at a different startup, and I started working with them. And then, like I'd mentioned, a doctor called me up, so I have a deal going with that company. And it's all these little pieces just coming together. And right now, I have two different companies that are submitting me for projects that they're just waiting on funding for. And someone that I connected with through this networking group. He called me up and said, "Hey Mark, in, in February, I'm going to need your help on one of my projects." So he used to be the founder of a startup. Now he's doing the exact same thing I'm doing and he's my competitor. And he called me up and said, "I want you to work with me."
[00:20:37] Lindsey Dinneen: Phenomenal.
[00:20:39] Mark Oreschnick: Yeah, it's good competition and those are the people that I still have around me are people I've worked with in the past or met in the past. We don't look at each other as competitors. It's, "You're going to be better at this one than me. So you take it and you'll tell me about one that I'm better at than you." So, so that's got me kind of up to today. And you had mentioned my networking group, which is called The Twin Cities Medical Device Networking Group. I was in a group pre COVID that actually died before COVID. So COVID wasn't the killer, but it made starting a new networking group a real challenge during COVID. I tried bringing the old group back. We had one event and then a new spike, and it died again.
[00:21:32] Lindsey Dinneen: Yeah.
[00:21:33] Mark Oreschnick: So working with one of the startup accelerators that I'm involved with, I went to a medical presentation that they were having a showcase about all of their startups that they were working with, and met a gentleman named Kris Bauerschmidt. And he and I actually already had a call scheduled for the next day through a different networking group and we just happened to run into each other in person. So we started off, we did the call the next day, and I toured his company a couple weeks later. And I brought up, "Hey, I'm thinking about starting a networking group." And he said, "Oh, I'd love to be a part of that, can I help you?" And that was on Thursday, so April 29th, which was a Saturday, I started the group. And it took about 16 days to get up to 100 people.
[00:22:24] Lindsey Dinneen: Wow.
[00:22:26] Mark Oreschnick: About another month to get to 200. And then it started slowing down a little bit. So now we're at eight and a half months since we started it, and we have almost 850 people.
[00:22:38] Lindsey Dinneen: Wow.
[00:22:39] Mark Oreschnick: So it's growing basically a hundred a month.
[00:22:42] Lindsey Dinneen: That's amazing. Congrats.
[00:22:45] Mark Oreschnick: So each month we just post on LinkedIn, "Hey, we're doing a happy hour at this brewery." People come out, get together. We normally have around 70 people show up to each of our events and people sit around and you talk a little bit of business, you know, "Hey, what do you do for a living? What cool projects are you working on?" that type of stuff. And many of these people have now got to the point of, "So how's your son's basketball game last night?" And we've become friends and we're building relationships. Business is going to come out of that naturally because now we've actually built trust in 70 other people that we meet, and really it's probably about 150 people rotate through our events, but there's always around 70 that show up. So this 150 out of 850 is getting to be a tighter network every month.
[00:23:40] Lindsey Dinneen: That's incredible.
[00:23:42] Mark Oreschnick: And out of that, we wound up doing a presentation at startup week, Kris and I, for other people, we did a panel discussion on Networking 101.
[00:23:50] Lindsey Dinneen: Nice.
[00:23:52] Mark Oreschnick: A college brought out their entrepreneur program and we had 20 plus students from that, and it was a total of, like, 80 people showed up to hear us talking about networking.
[00:24:03] Lindsey Dinneen: Nice.
[00:24:04] Mark Oreschnick: And that's one of the keys in the med device industry, or actually in any industry, network, know the people you're working with. If you ever get laid off, fired, you're in transition, you instantly have a group of people to go talk to. But the big thing that we've seen in our group, lots of the people are there really just to help.
[00:24:26] Lindsey Dinneen: Yeah.
[00:24:27] Mark Oreschnick: Much less about, "What can I get out of this," and it's, "What can I do for you?" So, it's really nice that, you know, people are saying, "Hey, let me introduce you to this recruiter. Hey, let me introduce you to this person. They might be able to help with your project." And it's much more of the giving side of things. And it gets kind of funny when you have two people who are both givers, who have are meeting for the first time and trying to talk about something, and both of them are trying to give and neither wants to receive.
[00:24:59] Lindsey Dinneen: Yes.
[00:24:59] Mark Oreschnick: So eventually somebody has to just step out of the zone that they're in and say, "This person's honest and trying to be helpful. I need to accept that."
[00:25:10] Lindsey Dinneen: Yeah.
[00:25:11] Mark Oreschnick: It's quite funny when you start to see these interactions of people who really network on a regular basis and are out there just to meet and help people.
[00:25:21] Lindsey Dinneen: Yeah, that's incredible. And I love that. I love that that's the spirit of the group because I think a lot of times where networking groups can get challenging is it seems to be kind of the opposite. And it's sort of "what can I get from this group" versus "how can I give and contribute," but that's, that's such a part of who you are. In fact, you've recommended a couple of books to me that I have thoroughly enjoyed. And I wonder if you wouldn't mind telling a little bit about maybe how that philosophy has impacted even your own life and the way that you've approached your entrepreneurial endeavors and your networking endeavors. Would you like to share about that?
[00:26:02] Mark Oreschnick: Sure. So, similar to the words that I was just saying.
[00:26:06] Lindsey Dinneen: Yup.
[00:26:07] Mark Oreschnick: I know the book she's talking about right off the bat and that is " The Go Giver" and it's tells the story of how somebody is out there trying to get sales and bugging everyone trying to get leads, trying to just close the deal, worrying about the end of the quarter. And eventually he meets a series of people who talk about being in things for the right reason, and you can't sell something to someone, someone has to want to buy from you. So you have to give them value, and then they will choose to purchase from you, because you cannot force a sale. You can't make somebody sign on that dotted line.
[00:26:54] Lindsey Dinneen: Yeah.
[00:26:56] Mark Oreschnick: So it's all about: connect with people, meet them, figure out how you can help them. Karma's going to come back, help you in the end. And I have definitely seen that in my career, you know, like I'd mentioned earlier, somebody who is a direct competitor of me calling me up and saying, "I want you to work on my project." I was trying to help him find investors at his last company. And I didn't have any stake in the game in that, but he seemed like a really good person doing a good thing. So I wanted to help him.
[00:27:30] Lindsey Dinneen: Yeah!
[00:27:30] Mark Oreschnick: The thing that for me about "The Go-Giver," I read it and I went, "Okay, this reinforces what I've been doing. And here's a few ways I can do it a little bit better and a little more intentionally." So I highly recommend, read the book. The guy who I founded the networking group with, I gave him a copy. He absolutely loved it. He now recommends it out on LinkedIn. The author wound up seeing that we had been recommending it to people and connected with us and commented. So, and I'm actually in another group that has about 230 people, and the first time you meet with the founders of that group, they're going to say, "You need to go by "The Go Giver" and read it." So right off the bat, that's just their first conversation. It's kind of, "If you go forward with this attitude, your business will be successful."
[00:28:22] Lindsey Dinneen: Yeah.
[00:28:22] Mark Oreschnick: And then the other book, it's from the same authors and it's called, I believe, it's "The Go Giver Guide to Marriage."
[00:28:28] Lindsey Dinneen: Huh.
[00:28:29] Mark Oreschnick: And I actually read it while I was on my 10th anniversary with my wife in Napa. And it was again about intention. You can tell your spouse that you love them, you can tell them they're beautiful, all these things, but why are you doing that and making sure you do it with reason and not just because I should say I love you every time I walk out the door.
[00:28:53] Lindsey Dinneen: Yeah. Right.
[00:28:55] Mark Oreschnick: And there are lots of really good tips in it that is just kind of, okay, I'm doing things good, but I can do it better. Here's a way to do it better. And it's the reminder of why you're in your relationship, why you love the other person. And it was a fun book to read. And the fact that I chose to do it on our anniversary weekend was a really good thing.
[00:29:15] Lindsey Dinneen: Nice.
[00:29:17] Mark Oreschnick: It was the right time to reinforce everything.
[00:29:19] Lindsey Dinneen: There you go, folks. Life and business advice all wrapped up into one. It is a great series of books. I recently finished "The Go Giver Leader" too and that's another brilliant book. I was listening to it on audio book and I kept having to rewind so that I could take notes because I was like, there are too many amazing quotable quotes in this book. It's,
[00:29:43] Mark Oreschnick: Yes.
[00:29:43] Lindsey Dinneen: Highly recommend. Yeah. So just out of curiosity, looking back over your life, do you think six year old Mark could have ever imagined being where you are now? Or is this engineering and business and creativity? Has this always been a thread of your life or has this evolved over time?
[00:30:07] Mark Oreschnick: So engineering and creativity, yes. The business side, no. If you would have asked six year old Mark, what he was going to be doing, I actually know the answer from my parents and I was going to be a garbage man.
[00:30:20] Lindsey Dinneen: Yes! Coolest job ever! You get to hang on!
[00:30:25] Mark Oreschnick: I love trucks. I loved big equipment and that part of me has never changed. I am a mechanic. I have two cars in my garage, one up on the lift, one underneath it. I'm always working on something mechanical. And that mechanical side of me, along with the creative side of me has helped me design different devices and keep that vision. And I know how things work on the inside, and now I can design something because I know the different pieces, and I can put them to use for a different reason. So one of my products was an upper arm orthotic that helped people eat and drink and do activities of daily living when they had upper limb weakness from muscular dystrophy. So I was able to watch a lady who couldn't put her, push her glasses up. She put our device on and held a bottle of water for three minutes.
[00:31:19] Lindsey Dinneen: Oh.
[00:31:19] Mark Oreschnick: Another lady went back to painting.
[00:31:22] Lindsey Dinneen: Oh.
[00:31:24] Mark Oreschnick: And she hadn't painted in five years since her injury. So, but it was a completely mechanical nut and bolt type system, my side of it that I worked on, and my brain just knew how to make that stuff work.
[00:31:38] Lindsey Dinneen: Yeah. I love it!
[00:31:41] Mark Oreschnick: That's from when I was a little kid building with Legos and working on lawn mowers and mini bikes, and it's never stopped.
[00:31:49] Lindsey Dinneen: Yeah. Sure.
[00:31:52] Mark Oreschnick: The business side of things, I think it still fits with my analytical brain and, you know, you can have things in columns, things have a right way of doing it. There's a process to everything that just, so that aspect of it fits me, but no, I would have never thought of that when I was a kid.
[00:32:10] Lindsey Dinneen: Sure.
[00:32:10] Mark Oreschnick: It doesn't sound like fun to a six year old.
[00:32:13] Lindsey Dinneen: Okay. Well, I have to nerd out for just a minute because as a, I think I was maybe a little older than six years old, but for one of my early birthdays, it would have had to have been like seven or eight, or actually for Christmas, I asked for a bunch of office supplies, because I am that nerd and so I was like setting myself up to play office ever since I was six or seven. And I would have, I had my little fake phone and my little fake receipt thing. I, it was a blast. So yeah, I, I...
[00:32:48] Mark Oreschnick: And your organization skills have led through to this day.
[00:32:52] Lindsey Dinneen: I know. Yeah. Yeah. All the hard play worked out in the end. It's really paid off. So anyway, you've actually shared a couple of very touching moments, even those last two stories that you shared were really sweet. And I'm wondering if there are any moments like those that kind of stand out to you as reinforcing the idea that, "Hey, you're in the right industry doing the right thing at the right time."
[00:33:18] Mark Oreschnick: Yeah, they're definitely, I remember the first time that I had that moment. I had always thought once I got into medical device that I was in the right field. It fit me really well. It worked with how my brain worked. We have to do all these steps to prove everything because it's a human. We need to do the right stuff because we're dealing with people and we want to save lives, not hurt lives. But the first startup that I was in, we had a whole bunch of patient videos of interviews of patients that had used our, had our device used on them and how it affected their life.
[00:33:54] And the one that I always remember, there was an older gentleman who had bad circulation in his leg and a doctor told him he needed to have a below knee amputation. And he was going to be in a wheelchair for the rest of his life. Luckily he didn't like his diagnosis and he got referred to a doctor who is using our product, and the doctor was able to go in and clear out the blockages in this gentleman's leg and get blood flowing to his foot again. So all of his sores healed, all of the swelling went away. His foot became normal again. And in a very short period of time, he went out, and golfed nine holes, pulling his bag. He walked for nine holes.
[00:34:44] Lindsey Dinneen: Oh.
[00:34:44] Mark Oreschnick: So he went from, "I'm going to have my leg chopped off and be in a wheelchair" to going back to the sport that he loved. And being able to actually walk, not even have to ride a cart.
[00:34:56] Lindsey Dinneen: Wow.
[00:34:57] Mark Oreschnick: That was that moment that's kind of, "Yep, I'm where I belong."
[00:35:02] Lindsey Dinneen: Yeah. Oh my goodness. Thank you so much for sharing that. That's a powerful story and what an amazing testament to the power of medtech and being able to be a part, even play a small part, in those developments and realize that you're impacting lives. Like there's, you hear these incredible stories of, you know, even if it's just one person, which it never just is, but even if it's just one person, you change their life. That's incredible. Yeah, nothing more rewarding.
[00:35:36] Mark Oreschnick: Yeah, I said, that story, I'm never going to forget. I can still picture the guy and this is 14, 15 years ago. So.
[00:35:46] Lindsey Dinneen: I love that. Well, so, so amazing and pivoting completely for fun. Very different. Okay. Imagine you were to be offered the opportunity to teach a masterclass on any subject you want. It can be in your industry. It doesn't have to be, but you're going to get paid a million dollars to do so. What would you choose to teach and why?
[00:36:11] Mark Oreschnick: So it's actually what we've already talked about and it would be networking. My experience with networking is it can have a huge effect on your career from day one. And luckily I've always liked talking to people. So I've been networking as long as I can remember, but people always say, "it's not what, you know, it's who you know." There is a, I'm going to say that should not be a truth. And if you actually live that way, there's a little problem there, because you should get the job because of what you know, and you should not take a job because it's just who you know and you're not qualified. But as long as you are qualified for that position, the who you know is going to introduce you to so many more opportunities, and if you go into all of those relationships trying to figure out how you can help others, people are naturally going to help you.
[00:37:10] But as a student, you know, one of the things from our networking one on one class, we had the student saying, "what do I have to give to people when I'm networking? I'm still in school. I just, I'm about to graduate." During the conversation, ask them the type of people they want to meet at that event. And when you're walking around talking to others, if you meet that person, bring them over and introduce them. You can be their ears and talk to more people for them. You always have something to give no matter what.
[00:37:46] Maybe they have a kid who's thinking about going to school and you could talk to their kid about what school you went to. You always have something. So going out, having that attitude, but every job I have gotten throughout my career, someone has introduced me to that position. My first internship was one of my lab partners in college. " I'm doing an internship. Would you like to meet my boss?" So yeah, I wasn't networking to do that, but we were friends from a class, so it was the who I knew.
[00:38:24] Lindsey Dinneen: Yeah.
[00:38:25] Mark Oreschnick: And every, like I said, every job has been that way. The doctors that found me on LinkedIn, they found me because of my posts about networking.
[00:38:37] Lindsey Dinneen: Nice.
[00:38:38] Mark Oreschnick: So direct indirect, my networking had me meet those doctors and turned into a client.
[00:38:46] Lindsey Dinneen: Yeah.
[00:38:47] Mark Oreschnick: So it's just, it always happens. Go out, meet people, talk to them, learn how to do things out of the goodness of your heart, and it will take you a very long way in your career. And when I think of people you and I both know that we've worked with, how many relationships have those people made throughout their lives that have now become business? It's just always happening. And so, yeah, that would be my courses to, especially with young engineers, young anyone, teach them, "You're getting into industries, start networking, learn the people in your company, learn the people at your suppliers, build your network, be good." And it will help you.
[00:39:34] Lindsey Dinneen: Yeah. And be a go giver. I love it. Yeah. I love that. That's a great idea for a masterclass and it does not surprise me at all that's what you chose.
[00:39:44] Mark Oreschnick: Yeah. So during startup week, I did two classes. It was the networking and "Key Considerations When Starting a Medical Device Company."
[00:39:54] Lindsey Dinneen: Nice. Yeah. That seems accurate. Phenomenal. Phenomenal.
[00:40:00] Mark Oreschnick: Go to your strengths.
[00:40:01] Lindsey Dinneen: Yeah. Yeah. I love it. Yeah. Okay. How do you wish to be remembered after you leave this world?
[00:40:10] Mark Oreschnick: Definitely want to be known as someone who took care of his family because family is obviously important, but within my career, I was the guy that helped. Whatever it was, I figured out a way to help people.
[00:40:25] Lindsey Dinneen: I love that.
[00:40:26] Mark Oreschnick: So.
[00:40:27] Lindsey Dinneen: Yes. Absolutely. Okay. And final question. What is one thing that makes you smile every time you see or think about it?
[00:40:36] Mark Oreschnick: My daughter.
[00:40:38] Lindsey Dinneen: Aww.
[00:40:39] Mark Oreschnick: So, that's an easy one. I have a 17 year old daughter. And I'm the first person to have a female in my family. I'm one of three brothers. My brothers have three sons and then I have the daughter who's the youngest of all of us. So I'm thinking, "Okay, I'm Mr. Mechanical. I love working on things. I love nuts and bolts and stuff." When she was two, she grabbed a screwdriver when I was working on the refrigerator and put it on the screw. So it's kind of, okay, there's my kid. She's definitely mine. And as I've watched her growing up, she has the same analytical mind as me, likes to divide things into even sections, things must be uniform, must be organized. But as she's growing up into a young woman, she is now a member of our church's youth group and she is a mentor to all of the other students. So she goes out and works with other kids and helps them at camp and does confirmation and she's just become a really good person. So looking at her, always smile.
[00:41:57] Lindsey Dinneen: Oh, that's so special. Yes, and you're her up for massive success and sounds like she's just a lovely human, so.
[00:42:06] Mark Oreschnick: She is.
[00:42:08] Lindsey Dinneen: That's incredible. Well, this has been so much fun, Mark. I am so thankful for you and your time today. And, you know, we are so honored to be making a donation on your behalf today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger. And also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support and...
[00:42:40] Mark Oreschnick: Thank you.
[00:42:41] Lindsey Dinneen: Yeah. Well, and thank you so much for everything that you're doing. I just wish you such continued success with your business, with your networking group as you work to change lives for a better world.
[00:42:54] Mark Oreschnick: Thank you very much for having me on. I enjoyed this.
[00:42:57] Lindsey Dinneen: Excellent. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two and we will catch you next time.
[00:43:10] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Tim Balz | CEO, Kalogon | Wheelchair Innovation, Advanced Seating Technology, & Staying Sharp as a Leader
31 May· The Leading Difference
Tim Balz, a former SpaceX engineer turned CEO of Kalogon, shares that his passion for MedTech began in high school when he founded a wheelchair refurbishment charity, Freedom Chairs. From creating the Intel connected wheelchair, endorsed by Stephen Hawking, to running a company developing innovative seating technologies, Tim's story is one of relentless innovation and profound impact. His mission? To enhance the quality of life for people with disabilities and beyond. This episode is a testament to the power of engineering and empathy in creating a better world.
Guest link: https://www.kalogon.com/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 031 - Tim Balz
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Tim Balz. Tim is a former SpaceX engineer with over a decade in the wheelchair seating space. He has 12 years of firsthand wheelchair experience. He founded a wheelchair refurbishment charity at the age of 15 and has donated over 150 wheelchairs, including orchestrating an international expansion into Moldova. He created the Intel connected wheelchair endorsed by Stephen Hawking, and has been invited to design a custom wheelchair for Hawking himself, which has been named the number one IoT device of the year by Intel. Currently Tim serves as the CEO of Kalogon.
[00:01:37] Well, Tim, thank you so much for being here today. I'm so excited to talk to you and hear more of your story.
[00:01:44] Tim Balz: Yeah, I'm excited to be here. Thanks so much for having me.
[00:01:46] Lindsey Dinneen: Of course. Well, I would love if you don't mind starting off by sharing a little bit about yourself and your background and maybe what led you to MedTech.
[00:01:56] Tim Balz: Yeah, absolutely. So, so I'm Tim Balz. I'm founder and CEO of Kalogon. So I've been working in and around the wheelchair space specifically for well over a decade now, starting with a nonprofit in high school now leading up to Kalogon where we make the world's most innovative seating for people, such as people use wheelchairs and really anyone who has to sit for long periods.
[00:02:17] Lindsey Dinneen: Yeah, that's incredible. Would you mind starting a little bit at the beginning and sharing, how did you even come up with the idea to start the nonprofit, and you were so young and that's such a wonderful thing. How was that even received? Just what led to that whole part of your journey so far.
[00:02:33]
[00:02:33] Tim Balz: That's, yeah, it's actually kind of an interesting story, 'cause I was a part of a robotics team in high school, and so I kind of started learning to, to build things with my hands. I didn't really have any plans to go to college or anything like that, and my grades weren't the highest, but I had a neighbor that actually found a wheelchair in a dumpster, and he gave it to me to mess around with the robotics team, but I noticed there was this student in the school, Steven, and he would pull the recycling behind his manual wheelchair, and he'd go from classroom to classroom, and they would dump the recycling in it.
[00:03:01] But after a while it would get so full that he would just be stuck there waiting for someone to come wheel him back. And so I asked his teacher, why didn't he have an electric wheelchair? And he actually his teacher actually said that the insurance company denied it, because he could move something like a hundred yards under his own strength. And apparently there's this, like, in the home rule and because of some unnecessary red tape he wasn't given the equipment that he very clearly needed.
[00:03:24] So that first wheelchair was unfixable. So I traded my moped for a wheelchair on Craigslist. I tricked it out. I added like a sound system to it, added leg rest, added a hitch so he could pull his recycling, put his name on it, and really made it custom for him. And it totally changed his life. And then from there, I just had a bunch of people start coming to me in need. And, I was always raised to not necessarily have to wait for someone to ask for help in order to offer it. And I was raised that if there's something you can do to solve a problem for someone else, you should do that. And that's how I started out my nonprofit Freedom Chairs.
[00:03:58] Lindsey Dinneen: That's incredible. What an amazing story too. Thank you for just sharing about that. And being willing, like you said, I love your emphasis on, you don't necessarily even have to be asked. You saw a need, you saw a way that you could help, and then you just took it and ran. And I love that. Yeah. So since then, you know, since that was sort of the inspiration, but then since then you have done so much with this organization. Do you mind sharing a little bit more about the work that you all do now, even with that?
[00:04:28] Tim Balz: Yeah. Yeah, so Freedom Chairs would refurbish and we give away primarily power wheelchairs, but also some like manual wheelchairs and scooters. So we still run that. It's not at the same scale, you know back when I was in high school and college I a lot more free time than I did now, so we still probably give away five six seven chairs a year. But we actually took Freedom Chairs all the way to going international. We actually took a bunch of wheelchairs into Moldova, and that was a really cool project went over there a few times and then so still run that.
[00:04:59] And then actually off of that, I realized I learned a lot about how these chairs work from repairing them and actually got hired by a design firm that was designing an all terrain wheelchair because of that experience. And so working with them, I got my name on the patent and actually helped design a wheelchair that's on the market today. I'm not associated with the company in any way. I was employed by the design firm, but that was where I started figuring out that, oh, I could give away these wheelchairs, but if I can actually improve the products that are available, I can help a lot more people than what I ever could hope to with a small nonprofit.
[00:05:31] Lindsey Dinneen: Wow. Yeah, that makes a lot of sense. And so you then from starting this nonprofit, then from there, you've obviously had quite a bit of really amazing experience. You've been a SpaceX engineer and whatnot. Can you share about how those past experiences and your desire to help people have merged with all of your technical expertise over the years to create your company and what that has looked like?
[00:05:58] Tim Balz: Yeah, absolutely. So, you know, I became an engineer because of what I learned with Freedom Chairs. I learned that with engineering, you can change a lot of people's lives. And so, the first thing I did was I knew that technology for people with disabilities was way behind the rest of the world. So that's where I did the the proposal for the world's first smart wheelchair and actually got that funded by Intel. They sponsored the project,, and then Stephen Hawking endorsed it, and it was named the number one smart device of the year by Intel. So that was really cool. That was where I was able to take technology and really advance the state of technology and in the space, but from there I knew that I still had a lot to learn before I could go start a company or something like that in the space.
[00:06:36] And so I knew SpaceX was the place where my friends would go and they would learn so much more working there than other places, partially because you work such crazy hours. When you're doing 80 to 100 hour weeks, you're learning twice as much as someone that's working 40 hours. And that's what I wanted. I wanted to learn as quickly as possible, and I wanted to be at the forefront of technology so that I could take those learnings back to the back to people with disabilities so that they didn't need to have technology that was a decade plus behind what the rest of us get in our day to day life.
[00:07:03] And so I stayed at SpaceX and actually moved to multiple different teams that were different phases in the product development and commercialization cycle so that I could learn how is it that SpaceX, this scrappy startup, was able to completely disrupt a space that was dominated by multi billion dollar companies. And with those learnings, that's where we started Kalogon and we actually structured a lot of our processes based on the learnings I had from working there.
[00:07:30] Lindsey Dinneen: Yeah. Yeah. That's incredible. And so now can you share a little bit about what your company does and the products that you're really excited about and... yeah, I'll stop there, 'cause I, I'll ask too many questions all at once.
[00:07:46] Tim Balz: Oh, no worries. I'm so, I love geeking out on the technical side.
[00:07:49] Lindsey Dinneen: Excellent.
[00:07:50] Tim Balz: So, you know, Kalogon, when we started Kalogon, what was really important is focusing on the need first and then building the technology for it. So many people just love technology and they're like, "We just want to shove technology into the end user's face. And we'll try to find a need based on the technology we want to build." And we didn't want to do that. So, we first went out and just started interviewing as many people as possible and said, " What are the big challenges that you have in your day to day life because of your disability?"
[00:08:16] And we talked to everyone from the clinicians to the end users to even the family members to try to understand what are the largest unmet needs for people with disabilities. From there, we discovered pressure injuries. And we did this actually while I was still working at SpaceX full time, I even bought a house and all the co founders with me, they all moved in the house and we made it where their rent was able to pay for the mortgage on it. And we started using that to prototype and really start building the team. So we start with the team and the need. And when we found out that this need, these pressure injuries killed more people than any cancer in the US other than lung cancer, we were like, "That's crazy. Someone else has got to be solving this problem. We're probably way behind on this because of how big this is."
[00:08:59] And then we looked and we're like, "Oh my gosh, there hasn't really been any innovation in like 50 years." And it just was mind blowing this something at the scale of cancer And the, still the leading technology that was being used to try to prevent these sores for people in wheelchairs was like twice my age at that point. And that was just crazy. So, so we said, "All right, there's the problem we're going to solve. Now let's go dive into that, become experts in that, and try to figure out how we can start iterating a solution to solve that problem." And that's how we created Kalogon Smart Seating technology.
[00:09:30] Lindsey Dinneen: Wow. That's incredible. Was there ever a time as you're creating this technology and you're talking to the people who are going to be using it and so deeply affected by it, was there ever a time when you just kind of had this moment of realization where you went, "Yes, this is why we're doing what we're doing." This is a moment that really kind of enforced that.
[00:09:53] Tim Balz: It's almost like a weekly basis. Like some of the early ones, we had early prototypes that we, we didn't expect them to succeed, because they were so early. And we had a, an individual where their, their wound care doctor came to us and was like, "Hey, I've tried every cushion on the market, their wound's not healing. It's probably going to take them out. And so I heard about what you were doing from, you know, some of the people that you were asking questions in the community to try to understand this problem. I was wondering, do you have anything?"
[00:10:21] And we're like, "We have this prototype. It's completely unproven, but if you want to try something, if you're at the point of, almost, it felt like giving up, let's give it a shot." And being able to see that progression and finally hear from-- actually, what my favorite part with that one was-- a couple of months after we provided that, that cushion I was out at at a lunch with a prospective investor. And all of a sudden I had someone like call over to me. I turned around and it was the individual that we given this cushion. I'm like, "What are you doing out?" And she was saying that the cushion was so successful, that they let her go out for lunch with her friends and then come back to the rehab facility, and that she thought she wasn't ever going to get to do that again.
[00:10:58] And that, that along with the fact we get multiple Christmas cards every year from people that say we changed their life and that they thought they wouldn't be able to go visit their grandkids again, or that they're able to now, instead of sitting in a chair for two to three hours a day, and that's all they get to go live their life, because of the pain reduction from the technology, they're able to be out for eight to 12 hours. Those instances always really fuel the passion because start ups a rollercoaster.
[00:11:23] Lindsey Dinneen: Yeah.
[00:11:23] Tim Balz: There's ups, but there's typically a lot more downs than ups in a startup. You're trying to solve problems that have never been solved before. And that's hard. That's really hard. And that's the startup kind of journey. It's lonely. You've got your co founders, but it's tough. And those moments are always the ones that make it all worth it. Every, any one of them is enough.
[00:11:38] Lindsey Dinneen: Oh, I love that. Yeah. And I love your perspective on that too, where you said all of it matters. And it's just one, you realize how many times that one person has made a difference, and that one person matters so much. And I love that perspective because like you said, it is such a roller coaster and that's a lot of challenge that you're dealing with on a daily basis. It would be easy to get discouraged or feel like, "Oh my goodness, is it worth it?" So being able to talk to a human being who goes, "Yeah, it is worth it." You know, that's, there's nothing quite like that. That's very rewarding. Wow.
[00:12:15] Tim Balz: It's true. And then at the end of the day, the people that change the world are the optimist. And so knowing that, I'm not going to give up, the team's not going to give up, until we succeed. That's that along with the positive reinforcement from hearing these stories, people's lives were changing, it really does make it all worth it. 'Cause at the end of the day, if we were in it for the money, I should have stayed at SpaceX. I walked away from a lot of SpaceX stock that was still left unvested, and I regret nothing because at the end of the day, I'm doing what I need to be doing in the world. My goal is, let's say, when I die, I want to know that I put in more than I took out. And so I want to create the largest net positive on the world possible. And I think Kalogon is my way to be able to do that. I'm solving problems that wouldn't likely get solved if Kalogon wasn't doing it.
[00:13:04] Lindsey Dinneen: Yeah. That's incredible. And so what are you looking forward to as you continue to grow the company and even for yourself, you are continuing to grow in this role too. But, for yourself and then for the company, what excites you coming up?
[00:13:22] Tim Balz: Yeah, we've got a, we've got a Series A coming up in 2024. So we're really excited about that. One of my favorite things about the job is, in a startup, especially when you're a first time founder, you've got to make sure you grow personally at a rate faster than what the company is growing otherwise it's going to outgrow your competence.And so I'm always looking for and getting feedback from our board, for example, and then the team is, "What are the things that I'm going to need to do six months from now? What are the skills I'm going to need to have to be able to successfully run this company?"
[00:13:53] And then that means I get to do tons of learning. And with that learning, I know I'm growing as an individual. It's going to make it where someday, post Kalogon, I'm going to want to start something else and solve more problems. And the learning I'm getting is one that's, it means having a new challenge every day where I don't already know what the answer is when the challenge pops up. That keeps me motivated.
[00:14:15] Like this morning I woke up at 3am and I was like, that's what we need to do for our CNC machining on that part. And even though I'm the CEO of the company, I literally was like texting one of our engineers. I'm like, "Oh yeah, here's what, like check this out," like moment of clarity. "This is going to totally improve the efficiency and solve that challenge that we have in the organization."
[00:14:34] And while typically I'm not solving challenges at that level anymore, I'm more equipping people and putting the right people in the places, and they're truly the ones doing the innovation now, I still like to try to make sure I understand what are the challenges that are limiting Kalogon's ability to impact more people's lives. And and that's like my personal litmus test. I've always said, even when I was at SpaceX and one of the reasons I left was, if I'm not doing something that's so interesting and challenging me so much that I, that it doesn't keep me awake at night thinking about it, then it's probably not, it's probably not the right thing for me to be doing.
[00:15:09] Lindsey Dinneen: Yeah. And so how was that transition for you? Did you enjoy going from sort of more of a doer role to a leader role? Was that an enjoyable thing or was it really challenging at times to sort of, you know, you have the heart of the company. So was it a little hard to go from being so hands on to being at a little bit of a higher, eagle eye view?
[00:15:32] Tim Balz: Yeah. I'd say the process was a bittersweet one. At the end of the day, if my goal is to have the largest net positive impact, this is what I need to be doing. So from a, from being a rewarding side, it's so rewarding. I would say like, it was something where, of course, there were times when I had a hard time letting go of specific tasks that really I'd outgrown that as being something that I should have been doing in my role. There were times where I had a hard time emotionally giving it up, but I never had a time where I like wanted to jealously guard something just because I enjoyed doing it.
[00:16:04] At the end of the day, I look at my job as, I wear a lot of hats, and if I'm doing my job effectively, I'm setting other people up so I can take that hat off, give it to them, so that I can be putting on a new hat for what the company needs next. And so if I'm not doing that, then I'm not doing my job. And so being able to take a job that I love doing and equip someone else and see them be successful in it, that's where I get my rewards now.
[00:16:30] Lindsey Dinneen: Yeah. Oh, I love that. I love that perspective too, and I think it's very telling about your leadership that you are so willing to learn and grow at a pace that will enable you to continue leading at such a high level, because it is, that is challenging and, I'm sure that there will, like you've mentioned, every day you have a new opportunity to solve a problem that might have been a little just out of left field, but if you're continuing to help grow your own skills and you're able to continue to lead the company well. So out of pure curiosity, what kinds of learning tools have you found to be particularly effective?
[00:17:10] Tim Balz: Yeah. So one, I'm a big reader, but like audio books. So I'll look at what are the skills I need. And I'll go, so one, mentorship is huge for me. I have a ton of mentors, and often I'm working directly with those. I have a technique I call verbal iteration, where I just like, will throw ideas at people who have good insights. And I'll have them tear it apart, throw it back. And I have no ego about things needing to be my ideas, so I steal the best of their ideas. And now I change my new idea, and then I'll throw it at someone else. And that way I can get a lot of diverse opinions and diverse perspectives. And so that's one way where I'll kind of change my mental models for how I look at the world.
[00:17:47] And then another thing I do is, so lots of audio books, I listen to very specific podcasts. I'm a big fan of podcasts. When I'm driving, I often you use audio books and if I'm doing like tasks around the house, I'm always listening to podcasts. And I go on runs in the morning, always got a podcast on, but besides that mentorship is the big one. And then I do have a strategy coach 'cause strategy is one of those things that, it's so abstract, it's hard to truly absorb it from just a one way transfer of information from audiobooks. And so I do have a strategy coach that, we look at like case studies and, and he'll help me apply those to our business and make sure that I'm truly leading the company in the right direction.
[00:18:26] Lindsey Dinneen: Yeah. Yeah. That makes a lot of sense. Thanks for sharing that. I'm always just intrigued because it's fun to keep learning and growing and everyone has different methods of doing so, and I'm always just fascinated to hear how someone wants to do that, enjoys doing that. So you know, looking back over your life so far, could your six year old self have possibly imagined what you'd be doing now, or is this completely out of left field?
[00:18:53] Tim Balz: I love that you use that analogy there because one of my favorite things, whenever things are going rough, like I have to do a ridiculous amount of travel. And I think a lot of people romanticize work and business travel. We're a startup. I'm sharing hotel rooms. I'm trying to get the cheapest I can get. I'm flying Spirit, back row, middle seat, red eye to save money.
[00:19:16] Lindsey Dinneen: Yeah.
[00:19:16] Tim Balz: Because at the end of the day, we're a startup and any dollar I can put back into the business is, it's more innovation. And so for me, when I'm in those moments, I'll always think back, would younger me be proud? And I'm like, man, younger me would have been so jealous of being able to fly on an airplane. I got to fly on one or two airplanes when I was a kid. And I'd be like, okay, younger me would be pretty proud of and pretty, pretty jealous that the older me gets to go fly around the world to have business meetings and go try to solve engineering problems. So I really do think that six year old me would never believe that I would be so fortunate to be in the position I am to be able to build and innovate and change people's lives.
[00:19:58] Lindsey Dinneen: Yeah. Yeah. That's incredible. And it's helpful to have those perspectives too. We talked about earlier a little bit about knowing because you can, and because people send you cards and they talk with you, it's like being able to know that your younger self and the people that you're currently affecting are grateful and proud and whatnot. It just, it really does help, like you said, because those red eyes are not always super fun, I'm sure. And there are days where it's a little more demotivating than others. So
[00:20:30] Tim Balz: Absolutely.
[00:20:31] Lindsey Dinneen: So what kinds of other big engineering challenges would you be thrilled to help solve?
[00:20:40] Tim Balz: I mean, one thing we've kind of realized is, our initial goal was to take technology for people with disabilities and try to at least bring it up to the level of what's provided to people without disabilities. And one thing that ended up happening was, we truly went to solve this need and did such a good job of it, that we realized our technology can solve problems for a lot of other areas in the world where people have to sit for extended periods. And that was something that wasn't the initial intent. We just went to go build what was right, not what was easy.
[00:21:12] And what's exciting for me is we've now got contracts outside of the wheelchair space where we're able to keep funding and putting more money and effort into R&D to just understand and become the world experts in seating. And so the way I look at it is, there's no one in the world that knows more about dynamic seating and seating that actually changes based on the user, no one can do anything like what we're able to do. And so I'm excited for things like. airplanes, automobiles, long haul truckers, construction equipment.
[00:21:41] There's so many different areas where people have such a negative impact on their health and wellbeing because they have to sit for long periods. I mean, look, office chairs. And so I am really excited to, to make Kalogon's technology available to those people so that they can, at the end of the day, go home and play ball with their kid, or pick up their kid without, without back pain, or without one of the many other medical issues that can arise from sitting so much in our days.
[00:22:09] Lindsey Dinneen: Yeah. Yeah. Oh, I love that. And I'm very thankful for what you're doing. I love that the work that you all do and that you are so passionate about becoming experts to help solve some problems that have-- like you said it's kind of wild when you think about it-- that the technology hasn't evolved, or maybe emphasis hasn't been placed on this kind of technology, and lots of people are affected by it.
[00:22:35] Tim Balz: The average person sits more than they sleep, which is crazy to think about, yet the research in the space on sitting is so narrow, and it's still in its infancy. Like the fact that a company our size can become leading experts so quickly, it's post a testament to the team we have, but it's also, it just shows that there's so much runway here because this is a problem that it's just going to keep getting bigger as the world ages and as more people are sitting as part of their job.
[00:23:06] Lindsey Dinneen: Yeah, of course. Well, I just think it's really amazing what you guys are doing. And it's cool to hear all about it. So I'm, I just, I want to pivot just for fun. Imagine you were to be asked to give a masterclass on any subject that you want to. It can be in your field. It doesn't have to be, but you're going to get a million dollars to do it. What would you choose to teach and why?
[00:23:31] Tim Balz: I believe. So I think I would start with, what is the criteria that would help me decide what area to teach? And I would say, what is a skill that I've had to build where I was not able to find a lot of resources to help me learn how to do that. And so, there's a lot of things out there. There's 20 masterclasses in leadership and project management and those things. So no one needs another, no one needs another masterclass in that. And there's a lot of people, a lot smarter than me at that stuff.
[00:24:00] I would say, how to innovate as a hardware company, and how do you do that in a cost effective manner? I think one of the things I learned at SpaceX, I have a very different approach to product development, especially with hardware products. We at Kalogon, we treat hardware like software in a way that very few companies do. And I think sharing that so that other startup founders who are afraid to go do a hardware starter, 'cause typically people think you need a huge amount of capital, and people build products without properly iterating with customers in the loop. So like empathy driven design and early product manufacturing, test, and iteration, I think is something that there's not a lot of great resources out there. And I think a lot of people could learn from it.
[00:24:49] Lindsey Dinneen: Yeah. Yeah, I think that would be an incredible masterclass, exactly for all the reasons that you mentioned. And it is a difficult subject area, so that would be phenomenal.
[00:25:02] Tim Balz: Where a lot of companies die too, is they don't get the product market fit right. They don't create a system to be able to validate and do a bunch of tiny pivots to make sure that they truly build a product that solves a problem, and solves a problem that's worth solving. So, so I think there's a lot of companies that have to fall into those traps.
[00:25:22] Lindsey Dinneen: Yes. "Solving a problem worth solving." I really like that. So, how do you wish to be remembered after you leave this world?
[00:25:32] Tim Balz: For me, I don't care super much about what people think about me. I care about my reputation, and I think that's really important. But for me, I more care about building lasting businesses that, when I'm gone, continue to drive value, and specifically drive value for their customers above all else. That would be a pretty cool way to be remembered. The teams I've been a part of if, if they're continuing to be successful, I'd love to have people in that business remember me because a lot of people I work with are like family. You spend more time with their coworkers a lot of times than your significant others during a week, especially in a startup.
[00:26:09] And so, so definitely would like to be remembered as someone that always put the customer first and made sure that. That I was providing value for others above all else. And then, of course, I want to make sure my family remembers me fondly. I want to make sure that one day I can actually throttle back and, have kids and be a good dad. And hopefully they can feel that I did a good job raising them one day. But right now I have no kids. So.
[00:26:30] Lindsey Dinneen: Yes. Okay. Perfect. And then, final question. What is one thing that makes you smile every time you see or think about it?
[00:26:40] Tim Balz: I mean, it's going to be my wife. She's pretty amazing. Totally out of my league, way smarter than me. And, and having a startup founder as a husband is-- it's, I don't know what it's like. I can assume I have, I know I can be pretty difficult sometimes not knowing if I'm gonna have to stay super late to help with a product launch or the stress of doing an investment round is, it's a lot. So I would say anytime I actually get to see her and spend time with her, that's, that's my favorite activity in life.
[00:27:09] Lindsey Dinneen: That's special and it is worth holding on to. I love that. Amazing answer. Well, I just want to say, this has been so much fun to get to know you, get to know your company, and get to know the heart behind everything that you're doing. I love hearing the story of what first sparked your interest in this particular thing that you couldn't have necessarily predicted would end up being something that you really chose to focus on. But I love the synergy that has occurred throughout your life so far and that you've been able to take all these little pieces and put them together, and it's just really cool to see that. And so I just wanna, again, just say, thank you for the work you're doing. I know being in a startup, , running a startup, is a lot of work, is really hard. But, thank you for being here.
[00:27:59] Tim Balz: And thank you for sharing the stories. There's a lot of founders out there that, they're out there solving problems that are, they're really important. And I love the perspective you're trying to bring so that people, understand that a lot of people, especially in the medical space, they're out here not just in it for the money. We're in it because we want to change the world. If we're in it for the money, it's so much easier to just go work for Johnson and Johnson or GE Health or something like that. And it's it's a tough road. So I appreciate you putting the spotlight on on founders.
[00:28:25] Lindsey Dinneen: Yeah, sure. Absolutely. My, it's my pleasure. I get to meet amazing people like you and I love that. So, I'm happy. Well, again, thank you so much for joining us. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support. And we just wish you continued success as you work to change lives for a better world.
[00:28:59] Tim Balz: Absolutely. Thanks so much.
[00:29:01] Lindsey Dinneen: Thank you. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am at the moment, I'd love it for you to share this episode with a colleague or two, and we will catch you next time.
[00:29:14] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Roy Morgan | CEO, Eagle Medical | Innovation in Medtech, Intentional Leadership, & the Importance of Creativity
17 May· The Leading Difference
Roy Morgan, CEO of Eagle Medical, shares his unique journey in the MedTech industry, starting from a pivotal one-question interview in 1997 that set the trajectory of his career. He reflects on his experiences in leading groundbreaking projects, emphasizing his deep-seated desire to improve and save lives. Roy's approach to leadership is both inspiring and intellectual, demonstrating a commitment to excellence and a profound understanding of the impact of his work. Guest link: www.eaglemed.com
Charity supported: Sleep in Heavenly Peace
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 030 - Roy Morgan
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:51] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to be speaking with my guest today, Roy Morgan. Roy has had a distinguished career at multiple medtech corporations. His experience includes team building, platform strategy, intellectual property filings, project management, budgeting, and scheduling. His project design and engineering skills are highly sought after in the medical device field, and Roy has a BS in Mechanical Engineering, a BA in Semiotics from Brown University, as well as a degree in project management from the University of California at Berkeley. Roy currently serves as the CEO of EagleMedical.
[00:01:32] Roy, thank you so much for being here.
[00:01:34] Roy Morgan: Well, it's wonderful to be here, and thanks for having me.
[00:01:36] Lindsey Dinneen: Course. Well, I would love if you don't mind starting off by sharing a little bit about yourself and your background and what led you to MedTech.
[00:01:45] Roy Morgan: Sure. So, my journey into medtech started in 1997 with a one question interview phone call. And it was an amazing moment in my career. I'll never forget it because it was only one question, and the question was, "Can you invent?" And I'll never forget it because I'd never heard that question asked before. You know, looking back now on a 30 plus year history in med device, I think I answered the question right. But some days I'm still not sure.
[00:02:15] I started out after that working for the Stryker endoscopy division of the Stryker corporation, was the lead innovator commercializer of their, I guess it's currently called the Crossfire Electrosurgical System. So I drove, you know, those things into market. I worked on their sports med team for a while, went on from there to work for some small startups doing other RF innovations in you know, tissue excision spaces, treatment spaces, then did some interesting work for Abbott diabetes care that launched I think people can see that now on television, it's called Freestyle Libre, it was originally known as Navigator. I was part of that development team in the early 2000s that got that off the ground and into the market
[00:03:07] Subsequent to that, went to do additional in vitro diagnostics and diabetes work for some startups in florida And then came back to the Bay Area, and found myself kind of wanting to do something a little bit different, and chose to work with a company called Eagle Medical to drive sterilization, packaging, and innovations in assembly technique and you know, speed to market from the last operations process standpoint. And that's where I find myself today.
[00:03:42] Lindsey Dinneen: Very nice. Well, thank you for sharing a little bit about your background. Did you always think that you might be an inventor or was this something that kind of came about over time?
[00:03:53] Roy Morgan: Well, you know, it's interesting. That question, if you can imagine yourself taking a phone call and thinking like the recruiter building this up as like, "Wow, this is the next greatest company since, you know, I don't know, Johnson and Johnson" or something like that. And you feel all this pressure. And then it's one question. And I can't tell you exactly how I answered it. It was something to the effect of, "Well, I can't be 100 percent certain, but I believe with every cell of my being that I can do it." And I guess it was good enough to get the next round of interviews. It worked out.
[00:04:29] And today I'm blessed to have been part of just an amazing industry. The things that I have been able to participate in, that I've seen done that are going on today, and that we continually, through Eagle, help produce for the greater global community, just amaze me. It's remarkable what we are able to do. It's even more remarkable the things that we're targeting to do in the coming years.
[00:04:56] And so all of that just kind of makes me think: I hope I can continue to invent and do things. I've been blessed and fortunate to have more than a few patents to my name at this point. So I think there's some truth to the answer I gave, or at least I, you know, I kidded myself into believing it and it worked out.
[00:05:15] Lindsey Dinneen: Well, yeah, you believe it and then you do it, right? So hey, you're just...
[00:05:19] Roy Morgan: There's lots of phrases for that. I won't use them here, but you know, it worked out is what I'll say.
[00:05:25] Lindsey Dinneen: Fantastic. Well, if you wouldn't mind sharing just a little bit about your work today with Eagle and just share a little bit about your heart behind it. I know you're very missions and values driven, and I would love to hear more about that too.
[00:05:39] Roy Morgan: Sure. I'll start with our why, because I think that's the biggest and most important thing to understand. Our mission here at Eagle is to provide just the absolute best quality of service to our customer base, and our customer base comes in layers. But I always try diligently to remind our staff at every level in the company that the most important layer of customer that we have is the end recipient of the products that we package here.
[00:06:15] They, as I like to tell them, they don't get a say. They're under anesthesia. They're unconscious. They can't see the quality of our work. They don't know, perhaps, even that it's part of the surgical process that there'll be receiving on any given day, of course, there's an implicit faith in our system that these products will be delivered in sterile conditions, that they are able to provide all of the benefit that surgeons, clinicians and support staff say that they can, and because our patients don't get a say, we have to do it right every time, all the time, without exception.
[00:06:56] And that's something that we really try to drive home here to, to everyone that works at Eagle. It's part of what we do, and the other thing that I remind people about is that everything that comes through our facility has UDIs and part numbers on them, but that's really a misnomer. Each and every product that comes through here really has a name on it. And that name could be a sister, a brother, father, mother, could be your own name. And so remembering that, I think, really brings home the importance of what we have to get right every day.
[00:07:33] Lindsey Dinneen: Yeah. Yeah. And have you had any particular moments where it just really stood out to you as confirmation that you were in the right place at the right time in the right industry? This awareness of, "Oh, wow, yes, this is why I do what I do here."
[00:07:51] Roy Morgan: Wow, that's a great question. It's I don't know that there's like one moment. There are strings of moments that, that I can piece together in my mind. Most of it I think comes down to something that's deep seated in myself that has to do with desire for spreading good health to everyone around me, and I think it's... how do I say this? It's really something that's almost unconscious for me. There's a desire to see healing in people.
[00:08:28] Without going into it really in my own background, there's healing that's had to go on for me and others in my family that are important things to support, to encourage, and to help along in the world. And those I think are, they're just very powerful beliefs for me. And so the moments in my career that kind of lend themselves to that, have been moments in operating theater with patients that are conscious.
[00:08:58] Without getting too much into it, some very high profile athletes that have thanked me for the innovations that we brought into that operating theater that would enable them to continue their championship level sports endeavors. So it's about giving people a continued opportunity in life to do what they love to do to restore the life that they want and to have second chances when injury or misfortune might befall us, as it does all of us.
[00:09:30] So I think those moments really stand out in my mind as, "wow moments" where, you know, you may not be expecting it, you, it catches you off guard and it gives you a little bit of introspection about your own why. Why am I doing this? What's my mission? So, yeah, those are the kinds of things that, that count.
[00:09:51] Lindsey Dinneen: Yeah, and I love the way that you put it earlier where you were saying how-- and I think it's very human nature-- we get into the nitty gritty of the details and, and sometimes it does feel like, well, it's just, it's a component, it's a part number, it's whatever. And I love the way you put it about how actually those are, they get assigned to people. Those are humans who are affected by each and every one of the things you produce. And I love your emphasis in general, just listening to you speak, your care for human life and bettering it and helping the next generation.
[00:10:26] So I just want to say thank you for your perspective, because it's easy to lose sight of that when you're having to do such detailed work, I think, and I love that you continue to remind the folks that work with you and yourself, I assume, too, about how important this is, and it's, it's not just another day for somebody who's affected directly by what you're doing. And I think that's pretty cool.
[00:10:49] Roy Morgan: Yeah. Yes. Thank you. It's really my honor to serve in this role.
[00:10:54] Lindsey Dinneen: Yeah. Well, what are you excited about next as your company continues to grow, you continue to invent and innovate. What's exciting for you?
[00:11:03] Roy Morgan: Well, so, you know in our industry, the past couple of years with the pandemic and other industry related challenges have made it a difficult time for a lot of med device manufacturing . Just to, to name a few, you've had supply chains that have gone upside down and sideways and every other way you can imagine. You've seen sterilization modalities come under intense environmental pressure, forcing closures throughout the industry of certain types of modalities, and putting pressure on the balance of the system to rise to the occasion and meet the excess demands, which of course, something like a pandemic raises to an entirely new level. I don't know if we understood it, prior to 2020, in the visceral manner that I think we do now that a strong healthcare supply chain, a strong healthcare technology sector is really a matter of national security. It's really a matter of being able to sustain our population and sustain our society at a level that is functional.
[00:12:14] I think the events of the past two years have highlighted for everyone that importance. So, I speak about those things in terms of how it's raised awareness. The excitement that it creates within me for the coming years is that I see tremendous innovation in how we're going to make things more resilient, how we're going to make them more capable, more scalable. And here at Eagle, what we're doing specifically, is implementing new digital transformations of this last operations process workflow so that we are able to spool up to demand levels that might seem insane. But to do it without breaking the machine, if you will.
[00:13:02] And I think a lot of a lot of companies out there, a lot of my compatriots that I speak to, CEOs across the industry, I hear the same echoes that, wow, there was just so much that had to be done that it was very difficult and nearly broke us to try and reach those levels of production. So I think building those systems now and putting those in place for us, really is exciting to look at the future to say, "Okay, we'll be much more ready next time around."
[00:13:32] Lindsey Dinneen: Yeah, I mean, fingers crossed and all, there won't be that same. But I love that you are actively working towards it because I think you're absolutely right. It took so many people completely off guard and without having come up with a way to handle it ahead of time, it was very difficult for many people. So I love that you're going ahead and putting those systems in place to be prepared and, tackle it head on in the future.
[00:14:00] Roy Morgan: One, you know, one of the things that we're doing just as part of evolutionary innovation in the packaging space, we've developed a new system that's called the "PATH System." It's our Packaging Accelerated Timeline Help. And what it is, it really represents the first step of digital transformation of packaging validation. Traditionally packaging validations have been thought of as the rigor that terminally sterilized device has to be subjected to, to get all the way through distribution to actual operating theater, and it is and has been so for many decades. But, we have continually been testing the same types of packaging for decades.
[00:14:43] We, Eagle, just ourselves within our own production database, we've got millions of test data points that we can mine and use to our advantage. And in fact, we've done that. And what we've created is our own engineered proxy device that we validated inside of a packaging solution. So, PATH is really, I call it a time machine because what you're buying is not a pre validated sealed package that contains nothing but air. You're getting a full digital data package of a validated proxy device.
[00:15:21] It can be adopted as a worst case for any product family that's out there. The short story is, you're buying time, which helps a lot of companies out there that are trying to bring life altering technologies to market. They can save that time and that money, of course, because they both go hand in hand, getting to market sooner and being able to deliver that life altering technology to potential patients so they can benefit from it.
[00:15:47] We saw this as a natural innovation in the space of time compression, of the utilization of massive amounts of data in the historical canon that we have, and that other companies also have. So really, it just kind of made sense for us to move forward with it. It's now available. And we're seeing lots of interest and we expect to see a few companies take advantage of it in 2024 to get to market much more rapidly.
[00:16:12] Lindsey Dinneen: So exciting. Oh my goodness. Yeah. Thank you for sharing about that. I'm excited to look into it a little bit more too, but it's great to see all the innovation coming out of this space and keeps the hope very much alive that there continues to be passion and innovation moving forward. So, you know, throughout your career, you've held multiple leadership roles, of course, and I'm wondering how you view leadership. What is your own leadership style or philosophy and what's your advice for someone who might be looking to get into a more of a leadership role in the medtech industry for themselves?
[00:16:50] Roy Morgan: Sure. I'd say my leadership style is, I lead with inspiration and I follow with intellect. So it's pretty straightforward, but not easy to do. The inspiration is, I think, been popularized lately by Simon Sinek, who talks about start with "why." Well, that's what it is. Inspiration is the why. The intellect, that's what I call the mechanics of how to get it done. And that's really how I've gone throughout my career in tackling the various leadership roles that I have had the privilege of being a part of.
[00:17:30] I guess what I would say is to anyone looking and thinking about how to be an effective leader, it's a, it's as much an exercise in vulnerability as it is an exercise in your commitment to your own mission. You've got to know what that is. If you're going to be a leader, you want to be a leader in some particular endeavor, it's going to require a personal commitment to believe in that, to move toward it, and to live up to it. You're going to lead by example, which is generally the best way. But you're going to put your own success in the hands of others.
[00:18:16] I can't say that as a leader, the success is all mine, it's not. I've worked with some of the most amazing teams, the most talented engineers, the most amazing people who help make things happen in a way that leads to that success. And so that's the exercise in vulnerability. I often tell people being a leader means that you're willing to underwrite failure after failure without loss of enthusiasm.
[00:18:43] Lindsey Dinneen: Yes.
[00:18:45] Roy Morgan: And if you're, you know, if you're able to do that you'll get there. So.
[00:18:49] Lindsey Dinneen: Yeah. Thank you so much for that advice. I really appreciate your perspective too. Yeah. And so how do you see that play out especially nowadays where, you're in this obviously top leadership role, and one of the things that you are so passionate about is this sense of mission and core values and why we're doing what we're doing. And so I'm wondering, what are some ways that you have found to be effective in shaping culture to reflect the core values and help ensure that alignment, because I know sometimes, it's lovely to write those statements and we believe in them and we want them to be true, but it can be hard in the day to day operations when things get tough and difficult decisions have to be made to really adhere to them. So I'm wondering, how do you go about that particular component of leadership?
[00:19:43] Roy Morgan: You've caught me at an opportune juncture in my career. Let me give you the setup and then I'll tell you what's going on. For the past 20 plus, 30, almost 30 years now, I guess, yeah, 30 years, I have used a performance management system, a goal system, which most people are familiar with, that I'll work with individual team members, my direct reports and their sub teams, et cetera, to establish a set of goals. That's worked very well. It's been successful and has provided a great amount of accomplishment over that time period.
[00:20:17] But recently I felt like I was getting stuck in a rut, that the goal system as effective as it is has become-- I'm not sure what the best way to put it-- other leaders out there who go through this sort of self check in or appraisal, if you will, will understand what I'm getting at. You're just wondering if, "Gosh, I haven't innovated myself in a long time." And I would say that this is the other challenging thing about being a leader: if you let yourself get stuck in a rut, you develop complacency. Just like teams, just like company, it all happens, but it can happen to you. And I think in 2023, I took a look in the mirror and I said, "You know what? I'm feeling a little complacent. I'm feeling a little bit like this goal system is just my go to thing. I've done it for 30 years."
[00:21:09] And so this year, I am trying something very different. We're trying the Four Disciplines of Execution, the 4DX approach, to how we're going to run our team goals. So, people out there who are familiar with it will know what it is. I'm not going to go, it's not going to go into the details of it here. But Lindsey, what I'll tell you is, for me, it's terrifying at the outset because it feels like I'm taking my hand off the wheel. I'm entrusting my teams to develop their goal set, to set their timing, to set their commitments.
[00:21:50] Sure, I took part in setting the what they call the "WIG," the wildly important goal for the year, right? But I didn't set it by myself. I had to call the team in and say, "Look, guys, this is where we are. This is the struggles we're going through. This is what we want to achieve going forward. Is this the right goal for us to focus on?" I created a proto goal, but it was modified and I was okay with that. So, it's basically a starting line, a finish line and a deadline, right?
[00:22:21] And so we did that. They changed it. It's now created and I'm uncomfortable. I'm in that, I'm in that gray space of uncomfortableness where I'm trusting that the system, which has many successful reports is going to work for us in the same way. It's knocking me out of my comfort zone. And I did that to myself on purpose. I'm doing this because, for me, I know that's a growth zone. I'm going to have to stretch. I'm going to have to grow. I'm going to have to think differently moving forward. It's terrifying.
[00:23:00] And I would say to other leaders out there, this is what you have to do. This is what you have to do to achieve growth, having mentors, having other inputs, those are valuable, and they work for me too. But really this is a question of courage. It's a question of courage. You have to step up to the plate. I'm taking a swing. I'm hoping I hit the ball and if I do, I hope it goes over the fence.
[00:23:28] Lindsey Dinneen: I love it. Thank you. Thank you for sharing that. I I really appreciate first of all, you being willing to talk about that because it is uncomfortable when you're going through a growth season maybe whether it's your choice or not, but even more so, when it's your choice and you're going, "I'm doing this because it's like you know taking your daily vitamins or whatever, maybe something you don't love, but you know it's for your benefit in the long run," and, but I understand that curve of, "Oh boy, this is, there's a lot of change and we're gonna, we're gonna see how it goes." But I commend you for that. I really do. And I'm excited. I hope we get to check back in a year and all things, "Say, hey, how's it going?"
[00:24:08] Roy Morgan: Great. Yes. I hope to have great reports for you.
[00:24:11] Lindsey Dinneen: I love it. Well, that was great. I really appreciate that. Pivoting just a little bit for fun. Imagine someone were to offer you a million dollars to teach your masterclass on anything you want. What would you choose to teach and why? And also, it doesn't have to be in your industry. It can be, doesn't have to be.
[00:24:31] Roy Morgan: Sure. I think for me it would be it would be about creativity. It would be about, it would be about how to organize your life to have creative moments at as many turns as you possibly can, because creativity in itself, people ascribe for whatever reason, I guess in Western culture, we talk about it as a, an element of productivity or an element that's woven into capitalism, if you will, in a way that I don't think it's necessarily-- no, in fact, I know this-- it's absolutely not meant to be that.
[00:25:11] Creativity is a source of fun by and large at its core, at its absolute core. It's like being... How do I say this? Well, this happened to me the other day. I was out on my, my, on my bicycle and I came over this hilltop after a long, hard climb and I began this descent and it was it was so overpoweringly filled with joy, that for a moment, you forget what you're doing. You have to get back on task quick 'cause it's a mountain road and you don't wanna make mistakes. But in that moment, it's, it's just about the joy and the fun.
[00:25:45] I think I would teach about that because there are so many, I guess, so many challenging moments in human life for so many people, that to have a structure to help themselves to bring themselves joy, well, that would be really rewarding. Yeah, so I think that would be what I would talk about: how those elements in, in my own life got me through some difficult periods and, saw me through to the other side.
[00:26:26] Lindsey Dinneen: Yeah. I love that.
[00:26:28] Roy Morgan: That would be it.
[00:26:30] Lindsey Dinneen: I would totally take that masterclass. I'm all about creativity and joy, so, yeah. That sounds like a fabulous class to teach. How do you wish to be remembered after you leave this world?
[00:26:41] Roy Morgan: Ooh, wow. That's, that's a question that combines both austerity and optimism in the same note. How would I like to be remembered? I guess if I had to put it in one sentence, as a song. I don't know, I don't know that, yeah, I don't know that song is fully written yet.
[00:27:04] Lindsey Dinneen: Yeah.
[00:27:06] Roy Morgan: Yeah, I think that's how.
[00:27:07] Lindsey Dinneen: Okay. Now, would it be instrumental or would it be a lyric-ed song?
[00:27:15] Roy Morgan: It would probably have few lyrics and it would be mostly music.
[00:27:21] Lindsey Dinneen: Okay. I'm digging it. That's by far the most creative answer I've ever gotten for this question. So I I'm loving it.
[00:27:29] Roy Morgan: Well, it's, there you go, creativity, right?
[00:27:32] Lindsey Dinneen: There you go.
[00:27:33] Roy Morgan: That's what it's all about.
[00:27:34] Lindsey Dinneen: Reoccurring theme. I love it. Yeah. And, and final question, what is one thing that makes you smile every time you see or think about it?
[00:27:45] Roy Morgan: Oh, wow. One thing, there's so many things I'm lucky like that, that do that for me. I, well, the one thing that pops into my head right now is the sunrise. And I guess that, that kind of ties it in for me. I have this saying that I tell people, in fact, I was just doing a whole bunch of it here on New Year's Day. I say this all the time to myself and to others, "Well, here is another 365 chances to be great."
[00:28:15] Lindsey Dinneen: Yeah.
[00:28:16] Roy Morgan: So with each sunrise, a new chance to be great.
[00:28:21] Lindsey Dinneen: Yes, and that's definitely a reason to smile. There's new hope every day. I love it.
[00:28:28] Roy Morgan: May sound a little corny, but it works for me.
[00:28:29] Lindsey Dinneen: I'm all about the corny when it works. Sometimes even just the corny for corny's sake. Let's be real. Yeah, well this has been an amazing conversation. I really appreciate you. I love the work that you're doing, but I especially resonate with and so value the emphasis that you put on remembering that what you're doing and the work that you're producing matters so much and it matters to humans and it's not just another part coming out. And so I just want to reiterate again how much I appreciate the way that you talk about that and the way that your company actively works to change lives for a better world.
[00:29:09] So thank you for what you're doing and what you're bringing to the world. And I just really appreciate it. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. And thank you again so much for being here. This has been a wonderful conversation.
[00:29:36] Roy Morgan: It's been my pleasure, Lindsey, and I wish you and all your team there a wonderful 2024.
[00:29:42] Lindsey Dinneen: Thank you. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
[00:29:55] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Annmarie Ison | VP & Head of Service, Elekta | From Physics to Medtech, Oncology Innovation, & Helping Others
3 May· The Leading Difference
Annmarie Ison, Vice President and Head of Service at Elekta, share her remarkable career focusing on life-saving medical technology. Annmarie reflects on her initial aspiration to be a doctor, her pivot to physics, and the serendipitous turn that led her to a startup revolutionizing radiation oncology. With a personal touch, she shares insights from her childhood fascination with science, her transition from aerospace to the dynamic world of Silicon Valley startups, and her commitment to improving patient care through technology. The conversation not only showcases Annmarie's technical expertise but also her deep passion for making a tangible difference in people's lives.
Guest links: https://www.elekta.com/ | https://www.elekta.com/products/oncology-informatics/elekta-one/
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 029 - Annmarie Ison
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guest today, Annmarie Ison. Annmarie serves as the Vice President and Head of Service at Elekta. With over 25 years of experience as a software development professional, Annmarie specializes in product development and software architecture for information management systems and radiation therapy delivery devices, specializing in software, inter connectivity, machine functionality, and clinical workflow. She is highly effective and directing all aspects of the software development life cycle. And is passionate about new technology, customer relations, and products that have the potential to enhance the standard of care in oncology.
[00:01:37] Welcome to the show, and thank you so much for being here.
[00:01:41] Annmarie Ison: Oh, thanks for having me, Lindsey. I'm really excited to be here and chat with you and see where this goes.
[00:01:49] Lindsey Dinneen: Absolutely. Well, I would love, if you wouldn't mind starting by telling us just a little bit about yourself and maybe your current role.
[00:01:58] Annmarie Ison: So my current role is Head of Service for the software products at Elekta. And these products support radiation therapy and medical oncology and for clinics to deliver therapy, both chemo and radiation therapy, in a more efficient, safe, and effective manner. I actually for many years was in engineering and this role in service is fairly new to me. It's only been about a year that I've been in this role. I sometimes wonder how I got here, but I think it really comes from the fact that I love interacting with customers.
[00:02:42] I started with the company as a startup, and there were only about 20, 25 people when I joined. And so you did a little bit of everything. And one of the things that got me really excited was working with our customers, talking to them, finding out what they need, why they need it, what they're doing. And also occasionally having those uncomfortable conversations on why things aren't working and how we can make 'em better and how we can fix stuff. And so I think over the years I've done different, as I said, different roles.
[00:03:22] I did some product management and went back to engineering again, and then recently took on this challenge of service because, yeah, I just love interacting with the customer for good and for bad, and I really want to help them be better, help us be better by helping them be better and do their jobs in a easier way so that they can focus more time on the patients and less time on the stuff that they have to do. The computer systems are everywhere. We all have to use 'em, right? We have email and we have everything. And I don't want our software products to be burdensome to them. I want them to be easy and streamlined and make their life easier, and again, so that they can make the patient's lives easier.
[00:04:19] Lindsey Dinneen: I love that. Oh, thank you so much for sharing a little bit about yeah, your story and how you ended up in this new role. This sounds like a wonderful blend because you have this, I can already tell, this heart for other people making a difference. And then you have that combined with your love of people and your enjoyment with working with them and that's not always easy. So I love the fact that you're able to combine some of those passions. And I'm curious, how did you start getting involved with the company at the beginning, when it was first a startup? How did that all come out?
[00:04:58] Annmarie Ison: That was really just by happenstance. I'm gonna go back even further and say, as a child, as a kid, nine, 10 years old, I loved science. I was always into science. I had experiments. I had a chemistry set in my bedroom. But I always just assumed that I would be a doctor. And I, it wasn't, this is gonna sound really weird. It wasn't that I wanted to be a doctor. I just assumed that's what one did. If you were good in science, you became a doctor. That's, that was the only path, and I really never gave my career choice-- it wasn't a choice, actually. It was the only path.
[00:05:40] I never really gave it much thought until I got to college and of course I was pre-med and I started meeting my new classmates and talking with them about what, why they wanted to be a doctor, why they were drawn to the practice of medicine. And I realized really quickly that I wasn't, that wasn't me. That isn't what I wanted to do. I didn't have that-- I didn't aspire to practice medicine. And so I kind of pivoted and I went away from that completely and I studied physics. And I focused on physics. And to me, I picked physics because to me it's foundational. And plus, physicists have the best toys. We get to play with all sorts of cool things.
[00:06:26] But to me it was foundational and it really helps you understand a lot of other disciplines, and at the same time I was into mathematics and other staff and-- this was many years ago, for those younger folks listening-- computer science as a degree, as we know it today, didn't actually exist back then, or at least not at a lot of universities, and certainly not the small liberal arts college that I went to. And the, but the courses around computer science were taught outta both the physics and mathematics departments, and so I was really fortunate to have these great professors who were, I consider on the forefront, at least to me, they were on the forefront of figuring out how to use computers, and I'll really say PCs, as a tool to connect the physical world and the digital world, and use it to do the things that computers are really good at and let humans do what humans are good at.
[00:07:35] And, you could focus on the physical situation and the data collection and data analysis was all done by the tools that we take advantage of or take for granted today. Excel and things like that didn't exist back then. It's a long time ago. So anyway, it, kind of pivoted away from that, from healthcare and being a doctor altogether and focused on physics, went to graduate school. And when I left graduate school, I really wanted to do exciting things like pay rent and eat.
[00:08:09] So I found myself in aerospace and it was really interesting. I, I also found myself in Silicon Valley. I met my husband who grew up there, so that's where we wound up, and in aerospace I had, like I said, it was a cool job. I liked it. I was working on satellites. I, GPS was kind of a new thing then. It was really just coming into its own. And I even got to work bit on the space shuttle, so I, I was very excited. I was happy to stay in that role, but unfortunately the job moved out of the Bay Area and I had found myself going what do I wanna do with my life now?
[00:08:58] But there were so many exciting things happening in Silicon Valley at the time that I I mean, it looked, it felt like there was a startup on every corner or really in every garage, right? And I just really, by happenstance, found this startup. And during my discussions with 'em, I met the principals and they shared their vision with me and it just resonated. They were working to change the face and the trajectory of radiation oncology, and when they explained their vision, I saw it, and I also saw a path to get to that vision.
[00:09:48] Even more so, I felt like I saw how I could bring everything that I had done up to this point-- my physics background because there's a lot of physics in radiation oncology, my safety background for man's space flight, and my desire to do good and help people from when I was a little girl thinking about being a doctor-- I was able to bring all of that together into this one job. And I'm gonna say I was hooked and I haven't looked back. I've been doing, I've been with the company aiming for that vision really for the last 29 years. And I'm still striving for that vision because it really was a visionary that we're not quite there yet. There were paradigm shifts along the way, and we hit those and helped change how things are done and really form a market, but we're still striving. We're still striving to do better.
[00:10:48] Lindsey Dinneen: Yeah. Yeah. Thank you. Thank you for sharing about that background. I love how, I just love when a pathway isn't, isn't as straight as we necessarily think it's gonna be. It's kind of funny how, you said looking back, it was almost like this expectation of, I'll be a doctor. And then you were able to, yeah, to take your interest in science, but your interest in lots of other things as well, and then form this career path that's probably looked unexpected, but seems to have wound you up in a place that you feel at home?
[00:11:23] Annmarie Ison: Yeah totally. I do feel at home and sometimes I wanna go back to that nine, 10 year old self and go, "see, see, there isn't one path, there are options." There are so many different people and disciplines and viewpoints and technologies that are all needed to change healthcare, to advance the standard of care and the standard of practice. And you can make that difference by bringing your own set of skills, your own viewpoints, your own passion, and by just being you. And I hope that people hear that and realize that there isn't one path.
[00:12:06] Lindsey Dinneen: Yes. . Thank you. I am completely in agreement with you, but I also just appreciate that, that you shared that particular advice because I think you're absolutely right. There are always multiple avenues to a dream and what might work for one person might be a different path for someone else. Well, so are there any moments that stand out in particular as just having this moment of realization that you are where you're supposed to be, like you're in this field, you're at this company, you're doing this particular work. Just any, anything that stands out in particular as, "Yes I am, I am in the right place at the right time."
[00:12:51] Annmarie Ison: Oh goodness. I mean there, it's been a long career. So there are so many things that I'm proud of, but there's a moment that sticks in my head from many years ago. Maybe about two or three years after I joined the company, there was a new forum, a new technique in radiation therapy that was trying to become --I'm gonna just call it mainstream or standard clinical practice-- but there was a challenge there that the amount of data that was involved in preparing the patients for the treatment was huge. Hundreds, thousands of pieces of data that the medical physics team had to check and recheck and do measurements on. And it took a lot of effort and we were working with some of our customers to tried to streamline that process and provide them the confidence. Some of these checks, again, people can do those checks, but computers can do those checks really fast. And so we were working with a number of customers and there was one night, and like I said, it sticks in my head. I was in a, can I say I was in a bar in Saddlebrook, New Jersey of all places?
[00:14:06] Lindsey Dinneen: Of course.
[00:14:07] Annmarie Ison: You're up in New Jersey, so maybe that's why it sticks out. But where I was talking with a colleague, a customer, and we were gonna give a seminar the next day, and he had just, he was putting his slides together and going over them with me, and he had told us that he was able to get this effort that took him like 30 to 40 hours down to about an hour, and we were like, "Wow, that's awesome. That's fantastic." And we were really excited about that. But it was the thing that he said next that really stuck with me. And there's two points on it. The first is he said, "And now we don't have to choose. If the clinical indication requires this kind of treatment, we can offer it."
[00:14:54] And that just hit me and I was like, "Wow, we moved the needle. Right? We really moved the needle." And I just, I was really excited about that statement, but it also hit me in a slightly different way. It reminded me that in all the rush to, in the day-to-day responsibilities of getting these features to the market, and who has to sign what paper, and what form has to be done, and what project plan has to be completed, and all those things that I actually didn't think about the patient. I'd forgotten about the patient.
[00:15:35] And really since that day-- I actually felt bad about myself when he said it. I was frustrated and angry at myself for not thinking, not keeping that patient and that set of patients in mind-- that really since then, every day I think about the millions of patients that are impacted by the products that we work on. And I also think about each individual patient. When I'm never sure about, "Is this the right thing we should do? Are we working on the right thing? Is it good enough?" I think about the patient, the individual who could be anyone. It could be your brother, your sister, your spouse, your next door neighbor, child as well as I think about that vast set of patients that can be impacted.
[00:16:24] And it helps recenter me and refocus me to make sure that I know I'm doing the right thing. And it's just stuck with me all those years. I'm a little bit of a broken record at work when I say, "Two and a half million patients, two and a half million patients," , or I say, "What about the patient? What about the patient?" But, I think in the end, it serves us well to do that, to always keep that in mind.
[00:16:52] Lindsey Dinneen: Yes, absolutely. And, thank you so much for sharing that story. That's powerful. And so I know that women's health and advocacy for femtech, whatnot, that's something that you are interested in and passionate about. And I was wondering if you could share just a little bit about maybe your experience.
[00:17:13]
[00:17:14] Annmarie Ison: Yeah, so I think that access to care is really the key thing. And, whether it's women's health-- which I think is a huge issue of getting access to care-- but it can be anyone really. As I mentioned in the previous discussion about bringing these advanced techniques to the clinical setting, there are areas of the world that, that don't have the resources. And the resources could be basics like electricity and access to power and things like that. But also, the resources of skills. Right?
[00:17:56] As I mentioned, medical physics is a big part of radiation therapy and if you don't have really skilled medical physicists around, it can be difficult to use these really advanced techniques that can, provide better care, fewer side effects, shorter treatment times. Again, when if you're looking at someone who has to travel a long way to get to care, you don't want them to have to come back every day for 25 or so days. If you can shorten that down into a week or so, which we can with some of these really advanced techniques.
[00:18:35] But again, you need those resources, you need those expertise, and I think that's where I. The digital world comes into play again. And if anything, the pandemic taught us that we can do so much remotely. I can be, and we have this already today, can have medical physicists from some of the leading clinics in the world, here in the United States as well as in Europe, looking at and supporting countries that don't have that same baseline of resources and technical expertise.
[00:19:10] And I think, women's health comes into play there a lot in that there are many indications in that are managed by radiation therapy. So I think, again, being able to offer these advanced techniques, shorter timelines, hopefully higher cure rates, or at least control rates, to these emerging markets, and expand access to care is really important to me. And I feel that's the direction that we have to go with in the, in healthcare in general. Access to care is the key.
[00:19:47] Lindsey Dinneen: Yeah. Yeah. Thank you for speaking to that and elaborating a little bit on, on that, and I, I, I appreciate the fact that that you and your company in particular are aware of those issues and are thinking through them and talking about them and, that's how change is gonna happen. So, it's always exciting to see that.
[00:20:08] Annmarie Ison: Yes.
[00:20:09] Lindsey Dinneen: Yeah, absolutely. So, pivoting the conversation, just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It could be within your industry, but it doesn't have to be. What would you choose to teach about and why?
[00:20:30] Annmarie Ison: Oh my goodness. I think fundamentally I have a hard time with this question because I don't consider myself a master of anything. I always consider myself an intermediate, because as I learn, I realize how much more I don't understand about them. But for the million dollars, and I'll take it, I think it would have to be something around cooking. I love to cook, but I wouldn't want to talk about technique, mastering a specific chopping technique or sauteing technique or whatever. But I think I'd call it "collaborative cooking." I have so many friends who are intimidated by cooking and, "Oh, I don't know how to cook. I don't have a recipe." But I just can't think of anything more fun than to work as a team, bring everyone's different perspectives and skillsets and passions, if you wanna use that word, together, to bring a nice meal on the table and if things go wrong, well, that's part of the experience.
[00:21:38] I also think that if you don't cook and you can still be a part of the team. My, my family does this, my family and friends, we do this all the time. Someone, we have three or four people in the kitchen, all cooking together. Someone made the menu, someone else has picked the wine, someone setting the table. Hopefully someone's pouring the wine too, but we all come together and it makes everything less, like I said, intimidating. You don't, you shouldn't be intimidated by cooking. It's fun and there's nothing better than enjoying a nice meal prepared by all of us together.
[00:22:16] And that's my feeling about a team also is when you have a team working with food, like I said, dinner, it's no one's thing. It's everybody's thing. We all came together to make it so it's no longer, "I cooked this." It's, " We cooked this, we did this, and we made this wonderful evening or afternoon or whenever it is." You're enjoying it. So that would be my theme of the masterclass, if I could.
[00:22:50] Lindsey Dinneen: I love that. Oh, I love that.
[00:22:52] Annmarie Ison: Yeah, just, cooking with my nieces and nephews is always fun, and everyone coming together to enjoy and celebrate.
[00:23:01] Lindsey Dinneen: Yes. . Yes, that is very exciting. And hopefully, like you said, the, the teamwork component of it will be joyful as all the families get together .
[00:23:11] Annmarie Ison: It can also be, I call it, "passionate." It can be . It can also be passionate at times, like...
[00:23:19] Lindsey Dinneen: I love it.
[00:23:20] Annmarie Ison: ...someone can feel strongly about the temperature that cookie should be cooked at. I don't know.
[00:23:25] Lindsey Dinneen: Yeah, that's right. And we're all working together towards a common goal, so gotta figure it out. . Amazing. Amazing. How do you wish to be remembered after you leave this world?
[00:23:38] Annmarie Ison: This question, I'm gonna have a hard time with answering without getting very emotional. My husband passed away a few years ago, and he was in medical devices as well. We actually have a very similar background, he was a physicist, went into medical devices and we actually talked about this when we knew the end was nearing. And his answer was, "I want to be remembered that I helped." And I can't think of a better answer. I would love to be remembered that way, that I helped in some way, in all sorts of ways, that I helped my family and friends in times when they needed help, whatever that was, might be cooking something for them. But also that I helped forward this vision that the founders of the company had that I helped clinicians help their patients, and that I had some small impact on the standard of care and the direction of oncology. Yeah, that's the way I would like to be remembered, that there was some help. I can't think of anything better than that.
[00:24:51] Lindsey Dinneen: Yeah. That's beautiful. That's a wonderful thing to aspire to. Thank you for sharing those stories, really appreciate it. And last but not least, what is one thing that makes you smile every time you see or think about it?
[00:25:07] Annmarie Ison: Oh man. I feel like I should say something honorable like my family and friends and things like that, but they would all know that I was lying if I said that. They know the answer. The answer is pandas.
[00:25:25] Lindsey Dinneen: Yes.
[00:25:27] Annmarie Ison: I love pandas. As a little girl, I had a stuffed panda instead of a teddy bear, and I became a bit obsessed, and I consider myself now a recovering panda- holic. I had a rough week when the pandas left The National Zoo. It was very emotional for me, but I still lean towards pandas. I can't help but smile and laugh when I see them, and if you were to look under my desk on my early morning teams calls, chances are that I'm wearing my big fuzzy panda slippers while I'm taking those morning meetings.
[00:26:09] Lindsey Dinneen: Oh.
[00:26:09] Annmarie Ison: You dunno that, but I've got my big fuzzy panda slippers on most days.
[00:26:15] Lindsey Dinneen: I love it! Thank you so much for sharing that. That just makes me smile. I love pandas, oh my word, and I just, every time I see those videos of those care takers trying wrangle the babies, oh my goodness. I love it.
[00:26:34] Annmarie Ison: I, I, if I wasn't doing what I was doing and helping people this way, I, that's my dream job.
[00:26:40] Lindsey Dinneen: Yeah. I have often said my retirement gig is gonna be a animal caretaking in some way. Oh my word. Well, this has been such a pleasure to speak with you today, Annmarie. I really appreciate you sharing a little bit about yourself and your background, how you came into this industry, and just your heart and passion for people, and making a difference. I really commend you and I just I thank you. Thank you for everything that you're doing to change lives for a better world.
[00:27:10] Annmarie Ison: Oh, thank you. Thank you for having me. And I've actually listened to a number of your podcasts, so I feel honored to be a part of the group that you've talked to. And thanks. Thanks for inviting me here. I really enjoyed it.
[00:27:24] Lindsey Dinneen: Thank you so much and thank you so much also to all of our listeners, and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we'll catch you next time.
[00:27:39] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Essa Abdool-Karim | Emerging Companies Lawyer | Medtech Legal Considerations, Optimism, & An Abundance Mindset
19 Nis· The Leading Difference
Essa Abdool-Karim, an emerging companies lawyer specializing in medical technology, shares his intriguing journey from sports and entertainment law to finance law, before finding his passion in MedTech legal affairs. He discusses the vital role of contracts, liability considerations, and the complexities of navigating regulatory landscapes, especially when expanding into international markets. Essa offers invaluable insights into the importance of strategic investor relationships and the distinction between "smart money" and "dumb money." His optimistic outlook and dedication to facilitating breakthroughs in MedTech make this a must-listen for aspiring and established entrepreneurs.Guest links: https://www.linkedin.com/in/essa-abdool-karim/
Charity supported: Sleep in Heavenly Peace
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 028 - Essa Abdool-Karim
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey and I am so excited to introduce my guest today, Essa Abdool-Karim. Essa is an emerging companies lawyer who helps his clients build their businesses. This can be through raising capital, producing the correct contracts or structures, navigating regulatory hurdles, or purchasing new businesses that will either expand or open a new market for their current businesses.
[00:01:17] Essa, welcome to the show and thank you so much for being here.
[00:01:21] Essa Abdool-Karim: Thank you for having me.
[00:01:23] Lindsey Dinneen: Absolutely. I'd love if you wouldn't mind starting off by telling us a little bit about yourself and your background.
[00:01:30] Essa Abdool-Karim: Yeah. So a little bit about myself. I am an emerging company's lawyer, some would say a venture capital lawyer as well. I, I have sort of like a general practice, but my emphasis are in several technology companies, but I have a special interest in medical technology companies, representing them from their early sort of incubation stages all the way up into hopefully one day, some IPO or other form of exit. And a lot of my practice is helping sort of build that out and almost acting as fractional general counsel to a lot of the activities that they do.
[00:02:03] Lindsey Dinneen: Excellent. And then would you mind telling us a little bit about your background, maybe how you got into this field and specialty in the first place?
[00:02:11] Essa Abdool-Karim: Yeah, my journey is quite interesting actually. It is not, it's not a straight line by any means, right? So, I actually started as a, so after I finished law school, I went and worked for sports and entertainment law firm where I was representing athletes, entertainers, at sort of international tribunals and contracts sort of negotiations, mediations. There was contract drafting as well. So it was really cool. It was a lot of fun and I don't know what possessed me to say, "Hey, I want to go leave this and go to the exciting world of finance."
[00:02:41] So I ended up in the the finance industry. I worked for an broker dealer in Montreal. So I did sort of a quasi-legal role there. But at some point I just missed private practice. So I left, ended up starting my own shop and then joining up with the firm I'm currently with. And yeah, so as I was developing my practice, I realized that I loved working with startup companies and growth companies or companies in a growth stage. I found it to be very exciting.
[00:03:11] How the medical technology thing sort of happened. It sort of lined up with my interest and I had one client that sort of reached out to me that was sort of a larger, they had a more established medical technology company than they all also had an early stage medical technology company. They had a couple. And it sort of through that, I really sort of delved into the world of medical technology and all of the legal issues that these companies typically face, both in local markets and international markets. Prior to that, however, I've always been interested in the space. I just didn't know exactly what the space was or meant. Right? So yeah, that's that's a bit of background about me and sort of how I ended up where I'm now.
[00:03:51] Lindsey Dinneen: Yeah. And so out of curiosity, did you growing up think, "oh my goodness. One day I'm gonna be a lawyer?" Like, was this always a goal and interest of yours or has that evolved over time?
[00:04:03] Essa Abdool-Karim: Yeah, weird. It's kind of weird how that happened. Law has always been sort of something of interest to me and from a very young age. And it is something that I've often entertained. I did wanna do something a little bit different, but it was like, "oh, it would be nice to be like a marine biologist. What do they do? It'd be nice to be an astronomer, but I do just look at the stars all day?" I'm not sure, right, what that sort of entails. So I was like, "okay, I understand what lawyers do, I think for the most part. So I'll just do that". So, yeah, how that happened.
[00:04:32] Lindsey Dinneen: Okay, . Okay. So, so first was just sort of, okay, I have an idea of what you do, but then, I mean, that's a huge commitment in terms of education and time and all sorts of things. So, how has becoming a lawyer and then going from sort of industry to industry, how has that been a compelling thing in your life in terms of career trajectory as you've gone from one industry to another?
[00:05:00] Essa Abdool-Karim: Yeah, Yeah, Yeah it's been interesting. I kind of like it personally just because when I first started, and even a little bit right now, I'm sort of industry agnostic. I wouldn't have been where I am today, if not for the journey that I've had. I kind of done everything that I wanted to do. Like prior to law school, I taught, I was a teacher because it was always like, maybe I should become a teacher. Then I went to law school, wanted to work in sports entertainment. I think every entry class has about 30% of the students want to enter into that. I was very fortunate that I ended up in there. So, and then I went, I've always wanted to try the world of finance. I tried that, got to see what that was about. It was interesting. Not interesting enough for me to stay, but interesting, so.
[00:05:43] Lindsey Dinneen: Sure.
[00:05:43] Essa Abdool-Karim: So it was, it's good. It's been a very good journey in that regard. And I'm just happy that I ended up dealing with medical technology as one of my major verticals. So that's been, it's been really cool and I've been very fortuitous to have that experience, and it's exciting. I enjoy the pace of it.
[00:06:01] Lindsey Dinneen: Yeah, for sure. So with medical device companies in particular, I imagine that each industry, and of course each company has different focus points in terms of legal considerations, but MedTech is a very heavily regulated industry, so what are some of the top considerations that you help-- especially very young startups, maybe it's their very first invention or product-- what are some of the considerations that you always help them to think through from a legal perspective?
[00:06:35] Essa Abdool-Karim: It's a loaded question and I don't wanna, don't wanna. No, it's a very loaded question. It's a good question though. I don't wanna give you the lawyerly answer and say it depends but in, in a way it does, but I think the essentials are, there's, there's a few.
[00:06:50] So, you know, contracts are very important. Obviously having the right contracts in place is, there's a very good starting point, especially with your founders. You, everyone sort of starts your relationship thinking, oh, this is sort of like a "kumbaya kind a moment. We're all gonna be fine. Everything's gonna work out." But the reality is, you know, I'm not paid to think about the kumbaya moments. I'm paid to think about, you know, what's the worst that can possibly happen and how do we account for that, unfortunately, right? So that's one thing that's very important. Understanding where everyone's responsibilities are, outlining that in a document is a very good starting point.
[00:07:22] The other critical starting point I would say is liability, particularly in the medical technology industry. It's a highly regulated industry. There's a lot of money flowing around, and with that, there's a ton of risk. So, as an example for Canadian companies they will be receiving any sort of regulatory approvals that you need to receive from the relevant Canadian authorities. And once you obtain that, you have it, you're in the market, but more often than not, you're looking to expand to the United States, as an example.
[00:07:54] Now there are a number of considerations when you're having to do that. There's obviously FDA regulations that you have to worry about, certain sort of disclosures that are required to be made. And this isn't even going into the intellectual property element of patents and other sort of important intellectual property issues. But just both focusing right now on the corporate side. When, and I'll speak from a Canadian perspective and I'll transition into the US, but when a Canadian looks at the US the, they're, the biggest thing they're afraid of is getting sued and understandably so. The United States is the most litigious society on earth in the entire world. I think I saw a statistic where it said there's a lawsuit literally every second. And.
[00:08:38] Lindsey Dinneen: Oh my word.
[00:08:39] Essa Abdool-Karim: Yeah, so it's understandable. There's a high risk, high reward because the United States is such a large market, and there's so much promise here, people want to enter into it, but they wanna be very careful when entering into it. And I typically advise them the relevant corporate structure to enter in to this market for it. Now there's a distinction, right? There's the early stage elements where we're dealing with startups, making sure the contract correct contracts are in place. There is a basic corporate structure in place. And you're working towards some sort of intellectual property ownership because that's critically important, particularly in this field, although I'm not an intellectual property lawyer.
[00:09:17] I do, I shouldn't say-- I'm not a patent lawyer. I do some intellectual property work. I'm not a patent lawyer specifically. You know, I'm familiarized with trademarks, copyrights, but patents that are very sort of technical area of law. But it's critically important to have your eye on the prize and want to work towards that. So I do liaise with patent agents, patent attorneys and other relevant legal minds. So that's all part of the process.
[00:09:45] I think building your vision very early, understanding how you want to get there and where you want to go is all critical and part of the process. In my experience, patents take a very long time relatively to secure, but I think that's the end goal. And even with that, there's time limit after you obtain it to, to file for it in other countries. So it becomes a global thing as well. But yeah, so at the early stage you wanna work primarily on the structuring, get the right team together, make sure that everyone has the right documents in place. Could be employment agreements, could be independent contractor agreements.
[00:10:15] It depends on how you wanna structure your company, how much appetite you have for it, what's your relationship with the employees or independent contracts ought to be. anD even the boring stuff like share classes, understanding how those work. And then there's raising money, and that's a big one because everybody needs money to operate their company, and to get it off the ground. So those are some of the early stage considerations. When you're sort of like at a growth stage, what you're looking at is market entry, how to enter into foreign markets, which obviously I help my clients with as well.
[00:10:48] Lindsey Dinneen: Yeah, so lots of considerations. So we can just barely scratch the surface, and folks should hire you if they need additional supports.
[00:10:56] Essa Abdool-Karim: For sure.
[00:10:58] Lindsey Dinneen: You know, it's so interesting. Thank you for sharing some of those considerations and bringing to light some things that you might not think of initially, especially like you mentioned, it, it does feel very exciting when you start a company and you have all of these like celebratory moments, 'cause everything is exciting and a big deal. And then like you said, but you have to think it is your job to think about what could go wrong though, and then prepare for that. So I am curious though, that sparked a question for you personally in your own life, how are you able to separate or negotiate the fact that a lot of what you need to do is look for worst case scenario, when probably you wouldn't wanna do that in your personal life all of the time. So I'm curious how that works where it's like your work is so heavily focused on being proactive in a preventive way, however, at the same time, for you personally, how do you balance that?
[00:12:00] Essa Abdool-Karim: Yeah. Yeah, it's interesting. It's a good question too because we have... listen, I'll be honest with you, lawyers are pessimistic by nature, right? I think generally speaking, we just think of the worst case scenario. I'm not like that personally. I'm an optimist. I'm a cautious optimist, a realistic optimist, whatever you wanna call it, right? My philosophy is always hope for the best, but prepare for the worst. I think it's critically important to do that. I do that in my personal life. I do it in my professional life. And just because you're thinking of the worst case scenario, it doesn't mean it's gonna happen, right? You just have to calculate for it. My job is to make sure we don't get to that point, right? But you have to account for it nonetheless.
[00:12:39] Lindsey Dinneen: Yeah. So, so you are able to keep the perspective of we're doing this as a, as something to be prepared for as a preventative and not get to that point, so therefore it can be a little bit more optimistic and a little less...
[00:12:54] Essa Abdool-Karim: Yeah, and it's so difficult. It's so difficult too, to be honest with you, just because so much of my job is, you know, thinking about that stuff,
[00:13:04] Lindsey Dinneen: Yeah.
[00:13:04] Essa Abdool-Karim: It's very easy to get down on yourself outside of work. So you need to be really good at sort of detaching. And I have a good support system in place. I think that's very important. I didn't marry a lawyer. I know a lot of people that do, like lawyers marry other lawyers. So I think the fact that I'm not married to one probably helps.
[00:13:21] Lindsey Dinneen: Yeah.
[00:13:23] Essa Abdool-Karim: I know me if I was married to one, we just bought talk shop when I got home. So, and I know a lot of lawyers that are married to other lawyers and it works for them. I think they probably make it a point to probably detach and they probably understand each other in, in that sort of capacity. But I'm married to an accountant, so very different world and I think is beneficial for me.
[00:13:45] Lindsey Dinneen: Yeah, that makes a lot of sense. . Yeah. So with the medtech industry specifically-- when you do get to work with those clients, what are some of the things that stand out to you as being particularly noteworthy or enjoyable? What in particular do you like about this industry?
[00:14:04] Essa Abdool-Karim: Oh, I love how brilliant everyone is. Everyone is so smart, so much smarter than I am. Like it's It's amazing.
[00:14:11] Lindsey Dinneen: Yeah,
[00:14:12] Essa Abdool-Karim: It's
[00:14:12] Lindsey Dinneen: I get that.
[00:14:13] Essa Abdool-Karim: It's really cool. It, there's so many smart people in this industry. Watching, not only watching, but also being in that room with people who are trying to solve a problem makes such a massive difference because I feel it pulls myself up as well. I really have to be on my A game. And because of that, it's just so enjoyable working with them. So yeah, definitely. It's definitely the intelligence. That's one thing.
[00:14:37] Another sort of element is-- and I went to law school with this intention-- I always wanted to be able to provide for my family, but I always wanted to do good. I wanted to be able to sleep at night and knowing that I was doing good. And, when I'm servicing medical technology companies, I know, yeah, obviously you have to care about the bottom line. That's, that's part of the business side of it. But a lot of the founders I met their intentions aren't just the bottom line.
[00:14:59] Their intentions are, we wanna change the world for better and we want to make the world a better place. We want to make it easier for, for everyone who's going through this particular difficulty and we want to make their life easier. And I think that's remarkable. So one of the greatest pleasures I have is I'm trying to help 'em achieve that goal and I'm trying to help them realize that success and that is really cool for me.
[00:15:22] Lindsey Dinneen: Yeah. Yeah, absolutely. Yeah. Thank you for sharing that. I think those two things are-- I agree with both of them. I really enjoy both those elements. I also really like-- I don't know what your experience has been-- but one thing that I very much enjoy about the industry is how friendly people tend to be, and they tend to be just very welcoming. And us about you, tell us, you know, it is, it's just a very inclusive place for the most part. And I hope it will continue down that pathway because
[00:15:47] Essa Abdool-Karim: I think, yeah, I for sure. I think the people I've met are very receptive, and that's, and I think that's really cool. Typically, and I'll be honest with you, in some industries there's almost, I wanna call it a fraternity, where they try to keep people out. But I haven't found that in the medical technology industry. I found that people are very receptive, very open, and I think the worldview actually is a little bit different from other industries in that sense. There's very human side to this that I think everyone appreciates. And I think that's really cool.
[00:16:18] Lindsey Dinneen: Yeah. Yeah, absolutely. And so, are there any moments along your lawyerly journey where you had this realization, maybe you were helping a client, or it could really could be anything, where you just had this thought of, wow, this is why I do what I do.
[00:16:38] Essa Abdool-Karim: Yeah, that's a very good question. There's a really basic one I had recently a couple of months ago. So I drafted up an independent contractor agreement for a client and things didn't work out. Independent contractor got upset. They parted ways. Independent contractor comes back threatening to sue. Client goes, "Hey, look at the contracts. You can't do that." And I was like, "yeah I drafted that. So this is what I do. Okay, cool. So there's purpose to my job and the work I do." So that was, so that was good. That was a full circle moment. That was really cool.
[00:17:16] Lindsey Dinneen: Yeah, exactly. Seeing it in real time, the protections that you've put in place, actually helping your clients, which of course you want them to, but if they're not tested... there you go.
[00:17:27] Essa Abdool-Karim: For sure. And when, and one of the other, one of the other things I think that was really cool recently was one of my clients launched in in another jurisdiction. And I helped set that up and knowing that, and I've seen testimonies about the product and the treatments that the clients were receiving, and to be a part of that is really something special.
[00:17:44] Lindsey Dinneen: Yes. Yes. Absolutely agree. Absolutely. Yeah. And so, coming down the line, what are some of your things that you're looking forward to with with your firm, with your clients, or, you know, continuing to expand? What are some things to look forward to?
[00:18:00] Essa Abdool-Karim: Yeah, it's it's an exciting time for me just because I'm expanding my, my practice a little bit in the sense that I'm really digging into sort of medical technology community, even to an extent the health tech community. So it's exciting for me because I'm moving in that direction. And I'm really doubling down on helping my clients open up their companies into international markets. So that's been really exciting. We do quite a bit of work in the Middle East, for example. But I. The United States for a lot of people is a big, a big market. So expansion here is very important, and even for US clients, expanding outwards is still really good for simply diversifying your portfolio. And there's many companies that do this.
[00:18:40] The Canadian market is really good for that as well because we do have a robust economy. We do have a good set of regulations in place. Market entry is a little bit difficult because of the regulations, but we have a very sophisticated consumer market and a very good infrastructure, which is the appeal of Canada, which is something I didn't realize until earlier this year, I, in my mind it was, why come to Canada when you can go to the US, right? And it still very much is the case. And if you just look at the consumer market, ours is smaller naturally. The US has, I think, the second largest consumer market in the world behind China. So, makes sense why companies would wanna open up in the US over Canada. But for us, companies that are already established here, I think it's a very good move for them to establish themselves in Canada, just because there is a very sophisticated user base and consumer base for the products that you would launch there.
[00:19:30] Lindsey Dinneen: Yeah, so continuing to expand even more into helping those clients as they look towards more global reach essentially. And yeah, continuing to build up that medtech portfolio. That sounds good.
[00:19:44] Essa Abdool-Karim: Yeah. Yeah. And it's a lot of fun, again, just because of the people you meet. Super, super exciting. I mean, there's been. There's been there's so many anecdotal stories. There's a saying amongst lawyers, we'll do everything for you. Just give us the book rights, right? Waive-- your story is so phenomenal-- just waive your book rights, so when, you know, at the end of my career, I can put it in my book and tell people about it, sort of thing, right? Because we do a lot of that and...
[00:20:08] Lindsey Dinneen: Right.
[00:20:09] Essa Abdool-Karim: Some of the stories we see are truly sort of remarkable. And a lot what we do, it's kind of sad, but funny at the same time because like my, one of my mentors says, and one of the principal lawyers in my firm, he says, "Listen, they're either gonna get us on the way in or the way out. You know, one way or another, you're gonna need us. Either when you're starting the company, you're gonna hire us or you're gonna make a mistake down the line and you're gonna need us down the line." And unfortunately, I've seen the latter situation where down the line things have gotten really bad. And have you had just spent a little money upfront, this wouldn't have cost you a million dollars later on. And that has, and it has happened. I've seen it happen firsthand and it's super unfortunate.
[00:20:47] Lindsey Dinneen: Yeah, so in general, I it, I'm not putting words into your mouth, but it sounds like one of the first things if you establish your own company is to consult with a lawyer.
[00:20:57] Essa Abdool-Karim: I think so. I think I, I think as far as... and obviously I have my bias here, but you know...
[00:21:03] Lindsey Dinneen: Sure.
[00:21:03] Essa Abdool-Karim: Again, I've seen, I've, I've seen companies, that started barely anything, right? And they built into this thing that they never thought they'd be, like this massive company. And not to say that they never wanted to reach that point, or they never wanted to get to that point, but it grew into something that they never thought, even dreamed possible, right, in a very good way. The problems, the foundational documents and the relationships they had with maybe vendors or licensees, weren't the best in nature. And then I have to come in and I'm doing crisis management at this point. I'm either managing their litigation or if I'm not managing their litigation, I'm trying to diffuse the situation so it doesn't get worse, could be through mediations and out of court discussions, right? Even though I'm not a litigator, I do this sort of litigation management. All that to say in long-winded way of answering your question is, yes, please consult a lawyer as early as you possibly can, as early as you can afford it.
[00:22:00] You want to be able to resolve issues before they get to court, generally, right? When you're not the offensive side, but even when you are suing, right? Because obviously if you have a patent interest in something or someone's infringing on your patents or you know, maybe there's a commercial disagreement. Even if you are the party suing, you have to be very careful when going to court. And the reason for that is you cannot tell who the judge is gonna be and how they're gonna view things. It's always, you always throw the ball up in the air.
[00:22:29] You know, even we as lawyers, we can do as much case law research as we want. We can look at the legislation as hard as we want. We can really scrutinize it. We can go into the wording, we can make our arguments, but we cannot guarantee that things will end up in your favor even if you have a really strong case. Because when you go into court, anything can happen. From witnesses to, to, to the judge's opinion, maybe their own personal experience in something, you don't know. So even in that situation, it often is better to settle outside of court or have some sort of discussion. But yeah, it's it's an important sort of strategy to note that dispute resolution is a critical part of any legitimate litigation strategy, in my view, at least.
[00:23:14] Lindsey Dinneen: Yeah. Yeah, that makes a lot of sense. I absolutely see the value, of course, in that. And then, and like you said if you end up sort of inviting in non-controllable human elements into the mix, if you do end up.... yeah. Yeah. Okay. Yeah. All right.
[00:23:32] Essa Abdool-Karim: it's not I think. I think if a lawyer tells you, "This is a slam dunk," you should be very cautious. Yes. I think that's a big, I don't like, maybe it's a red flag. It's definitely like an orange flag. Not even a yellow. It's like an orange flag, right? So you definitely wanna watch out for that because a lawyer's telling you, "oh, this is a slam dunk. This is not a problem." I like, okay, are like, "are you a psychic? Do you know the judge person?" Like, you know what-- there's a lot of things that can go wrong.
[00:24:01] And by the way, it's all very expensive to go to court. It is very expensive. And this bothers me 'cause even lawyers are expensive, right? I know this. It's unfortunate because access justice is something very important to me. But the problem is there's a big paywall behind it. So, and it's one of the things a lot of early stage companies struggle with. So how can you get legitimate and valid legal advice when you can't afford it?
[00:24:23] So there's actually two ways I have in my mind and I guess I share with you right now. And perhaps your listeners will find value in it. One of them is obviously to join some sort of incubator or accelerator. Those are always good, because the network you can build in them. Even, so one of the other thing is, and perhaps if you'd like, we can talk about investing right after this, you'd be able to connect with, you know, could be venture capitalists, could be angels, but what's important, you open up sort of a new network for yourself in a myriad of different ways. So that's the first element.
[00:24:55] The second element, and I posted on this on LinkedIn a couple months ago. It's, you can have an advisor committee where you give maybe one or 2% of your equity or whatever the advisor wants. But you can bring a lawyer onto that advisor committee for equity. That way you're not actually paying liquidable cash for that advice, but you're actually bringing them in to advise you on how to set things up while giving maybe one or 2% of your company away, which maybe a lot, maybe a little, depending on how valuable the lawyer is, but it's a good way to save upfront cost.
[00:25:28] Lindsey Dinneen: Those are great suggestions. Thank you for that. That's great advice. And then you mentioned the investing side. Do you wanna talk a little bit more about that too?
[00:25:35] Essa Abdool-Karim: Yeah, absolutely. So financing is a difficult thing, right? Because you're very sort of, subservient to the markets in a sense, right? And we're in a little bit of a down market right now, but people are still raising capital. I know people are, that completed about a $50, $60 million raise like about four or five months ago. So, I mean, money is still being moved.
[00:25:53] But the sort of important thing here is, and I cannot emphasize this enough, there is an important distinction between smart money and dumb money. And what I mean by that is, it's sounds crazy, but anyone can go out and get money. I, you know, you can go and you get in front of the right person and they'll just give you, they'll write a check for a 300,000, $400,000, whatever, right? The problem is you don't want to just take cash. I mean, you can. But it's not gonna open up a network if that person doesn't have the network that you need.
[00:26:24] The smarter way to go about it is to make sure to get it, bring in an investor that can actually open up a network for you, because at some point they might want a board seat and those shouldn't be given away just to anyone. It has to be very strategic. And one of the important things I find is that if you have a very good investor, someone who actually has a market behind them. And since we're talking about the medical technology space, we want someone in that invests into medical technology companies that understands the vertical. Because when they come in they likely already have an ecosystem that you can use.
[00:26:57] They might, I don't wanna say have a relationship with the regulators, but they might be familiar with the regulators and maybe familiar with certain professionals that they can introduce you to. They may have in their own portfolio connections to distributors. That could be huge, that could be more valuable than the million dollars they just gave you because it might open up a $10 million market for you, just by virtue of the fact that you got introduced to distributor because of this person's reputation. So you have to scrutinize your investors as much as they scrutinize you.
[00:27:24] And I know that's difficult sometimes because obviously there's a huge power dynamic between early stage companies, even growth companies, growth stage companies, and an investor when you're literally might be on fumes and your runway is at its the very end, maybe like a month or two away from giving out. So it's very difficult to sort of stand there and tell them like, "look, you need to open this and this door for me, you to bring me in." Very difficult to put yourself in that position, but that's the position you ideally wanna be in. Connect with someone who can open, open market for you. And I think that's one of the most important things about bringing investors in,
[00:28:01] Lindsey Dinneen: Yes. Thank you. That's really great advice and that's the first time I've heard that particular advice, so I really appreciate you sharing that.
[00:28:08] Essa Abdool-Karim: You are welcome.
[00:28:10] Lindsey Dinneen: Yeah, I think I, that brings a lot of value to when people are looking for those resources. And like you said, maybe the million dollars, I mean, it is cash, it's gonna be useful, but might not be, as you said in the long term, as impactful to your business as those relationships in this context can be. So something to really think about, and take seriously.
[00:28:31] Essa Abdool-Karim: It can be very difficult sometimes to remove those investors that have invested into the company that you don't want anymore. And they're just taking up a spot in your cap table...
[00:28:42] Lindsey Dinneen: Yeah.
[00:28:42] Essa Abdool-Karim: ...with not one really bringing anything. And that's very difficult. And this is one of those other issues, is if you don't have something in writing that allows for you to both parties to sort of set the step away amicably, they'll be stuck on there.
[00:28:57] Lindsey Dinneen: Yeah.
[00:28:58] Essa Abdool-Karim: And that's happened and I've had sort of like these business divorces that I deal with, which is not fun, but it is sort of part of the game as well. But there are strategies you can employ at a high level without breaking any laws that will help remedy that. But again, situation by situation
[00:29:17] Lindsey Dinneen: Absolutely. So you have shared lots of great advice, but I would just say when I summarize it in my mind, one of the biggest things is talk to a lawyer early and often.
[00:29:28] Essa Abdool-Karim: Yeah.
[00:29:28] Lindsey Dinneen: Yeah, there you go. There you go. Amazing.
[00:29:34] Essa Abdool-Karim: Play the long game. You know, make a friend, be like, "Hey listen, you'd make a great lawyer one day" and just kind of push them to law school. Yeah, just push them into law school.
[00:29:43] Lindsey Dinneen: And maybe, maybe offer to contribute to the law school tuition a little, just you know.
[00:29:48] Essa Abdool-Karim: I just believe in you so much
[00:29:53] Lindsey Dinneen: That's amazing. I love it. Pivoting a little bit, just for fun. Imagine you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your field, but it doesn't have to be at all. What would you choose to teach and why?
[00:30:10] Essa Abdool-Karim: I think I'd want to teach people how to motivate themselves. I have a background in coaching, coaching sports. So I've always found it and no matter what sort of industry I've been in, what position I've been in I find great value, in, in being able to motivate others. I think it's very important and I find great satisfaction in it. And it's really, it feels really good when you, when you see people becoming successful, perhaps not, I don't wanna say as a result of it, your advice, but partly as a result of your advice or your encouragement. So I would probably put together some sort of masterclass on how to get out of bed in the morning, how to set your goals, how to set your visions, and how to execute on those visions.
[00:30:54] Lindsey Dinneen: Yeah, that's a great masterclass and one that I'm sure a lot of people would sign up for, because it's so important. I recently actually listened to just a snippet-- I need to go back and listen to the whole thing-- but of a TED talk where the woman was talking about how we often treat confidence as a" nice to have" instead of a "must have." And what a difference it makes when you do treat it as a must have. And anyway, that I thought of that immediately when you were talking about the motivation and sometimes you need a coach to kind of come alongside you and help with that and say, "Yeah, no, you can do this. Let's figure out how we're gonna do this together."
[00:31:31] Essa Abdool-Karim: Yeah, Lindsey, it takes, honestly, it's, it can just be one person, just one person that says, I" believe you can do this." It makes an entire, huge difference. And I don't think some people maybe do realize this, others don't realize how big that can be.
[00:31:46] Lindsey Dinneen: Yeah. Yep. Absolutely. And I just kept thinking though, , is a very, that was a very good point and a serious one, but the first thought that popped into my mind was like, "Okay, who do I know that I can tell, ' Yes, I think you'd make an excellent lawyer.'" Oh man.
[00:32:03] Essa Abdool-Karim: You're always giving, Lindsey. It's really good. I like the way you....
[00:32:05] Lindsey Dinneen: Yeah. So giving.
[00:32:07] Essa Abdool-Karim: Helping propel everyone forward. It's really good.
[00:32:11] Lindsey Dinneen: Yeah, exactly. Exactly. Oh my word. Oh my goodness. Okay. Yeah. So how do you wish to be remembered after you leave this world?
[00:32:21] Essa Abdool-Karim: Yeah, it's a good question. You know, I deal with some incredible entrepreneurs that at this point in their careers, they're not even thinking about, you know, exits or companies. They're thinking about legacy and they want to be sort of remembered as luminaries and experts, not just experts in the field, but people who sort of change the world. So for myself, I do eventually want to get to the point where I can change the world. I don't know what that's gonna look like or how it's gonna happen, but I want some sort of positive lasting influence in the world that I played a part doing. Now interestingly mentioned like how do I want to be remembered? I don't necessarily have to be remembered for doing it. But I want to know to myself that I was a part of it.
[00:33:02] Lindsey Dinneen: Yeah. Absolutely. Yeah. And then final question, what is something that makes you smile every time you see or think about it?
[00:33:15] Essa Abdool-Karim: My life. Just...
[00:33:19] Lindsey Dinneen: Yes!
[00:33:20] Essa Abdool-Karim: You know, retrospect really is 2020. And it's this crazy, life is just crazy thing, right? You know, we go through so many difficulties and everybody does. You just can't see it, right? We all go through these difficulties, these ups and downs, these mountains and valleys, these peaks and valleys, and no, not everybody sort of broadcast what they go through, right? A lot of times you only share the good things particularly with social media today, and that can have a negative effect on a lot of people's mental health.
[00:33:49] But I look back on my life, and I think, if that hadn't happened, I wouldn't have ended up there. And I really was happy doing that over there. But, and if that didn't happen, if that did happen, I wouldn't have ended up there and I probably would've been miserable over there in that sort of situation. And I realized, and I look back and there's this puzzle forming, this beautiful tapestry, and I realized how beautiful it all is.
[00:34:09] And I smile because I like to sort of sit and think, like I can sit in front of an ocean or something or some sort of skyline view and just sit and just think about this sort of stuff in retrospect about all of this sort of stuff and how all these sort of things happen. And in the moment you can't see it, you're blind because we can't see forward. We can only imagine forward. Right? But, when you look back on everything, everything happens for a reason. I truly do believe that good and bad and a better day will come.
[00:34:37] I smile because you can't see it then, I probably can't see it now in whatever situation I'm in now, right? But, you know, there might be a day where I'm gonna look back, laugh at it, smile at it like I often do. So yeah, my life is probably one of the things that I smile at one of the one of the most, just looking back in retrospect.
[00:34:55] Lindsey Dinneen: Yeah. I love that answer and I'm so glad to hear it. I love that enthusiasm for life and that perspective of there's a reason for things, and if this didn't happen, then I wouldn't be where I am today.
[00:35:06] Essa Abdool-Karim: Yeah.
[00:35:06] Lindsey Dinneen: Yeah. And I think that helps. Go ahead.
[00:35:09] Essa Abdool-Karim: Absolutely. No, and I think that intro spec is critically important because it, you have to try to make sense of things, right. And I, the problem is, in my view, right, we're so caught up in the grind that we don't take that moment to just go to sort of reflect. And I think if you do there, you achieve some sort of clarity. Everything seems clouded right now. And entrepreneurs will tell you this, they're doing a million things at once and I'm not even exaggerating. They probably have a hundred things on their to-do list. And you get so bogged down in it, you can't look up.
[00:35:39] \But one of the best solutions to that is to step back and think about how things have played out in your life thus far, and where you are today and how that happens. And even if you're not where you want to be today, tomorrow is still there. So I think taking that moment for introspection not only helps you sort of process everything that happened in the past, but you know, also helps you move forward into a better future.
[00:36:01] Lindsey Dinneen: Yes. Absolutely, could not agree more, great perspective. And it keeps you sane too 'cause there's so much out of our control that if we can control our attitude and our perception and the way that we choose to process and reflect, then we can still choose to see the good even when it's, when it might be a little bit tricky 'cause it doesn't feel good in the moment.
[00:36:27] Essa Abdool-Karim: Absolutely. Absolutely. And there's an interesting sort of, I don't know, I don't know if I wanna call it a theory, but scarcity mindset versus an abundance mindset. And I, for a long time was part of the scarcity mindset model. And for those who may or may not know, scarcity is where you think there's just, "oh, there's never enough business out there for me. I'm never gonna be able to make, you know, enough money. Or make the right connections or people." And when someone else does it, you're like, "oh no, how could they have done it? Now I can't get it anymore," sort of thing. But that sort of thought process is very defeatist. It's self-defeating, actually. Where, whereas if you come from the thought process of an abundance mindset where like, "oh, okay, they did that's great for them. I can do it too! There's more than enough people. There's more than enough business and more than enough opportunities for me to execute on. And sort of take advantage of. And, we're all gonna make it one day." So,
[00:37:18] Lindsey Dinneen: Yes. Yep. I Fully agree with that and could talk about that forever, so I'll have to restrain myself this time. I fully agree with you this has been a fantastic conversation. I so appreciate you sharing your advice, your background, some things to consider, and just your very positive outlook on life. I think that's incredible. So we are really honored to be making a donation on your behalf as a thank you for your time today...
[00:37:48] Essa Abdool-Karim: No, thank you.
[00:37:50] Lindsey Dinneen: ... to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you very much for supporting that particular organization, and I just wish you the best continued success with your abundance mindset and your and your zest for life as you work to change lives for a better world.
[00:38:10] Essa Abdool-Karim: Thank you. Thank you so much. Thank you for having me, and you're a wonderful host and I love what you're doing with the podcast. And I hope for your success in the future, for continued success.
[00:38:20] Lindsey Dinneen: Well, thank you! very much appreciate that. And thanks also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love if you share this episode with a colleague or two and we'll catch you next time.
[00:38:33] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Alexander Ballatori & Shane Shahrestani | Founders, StrokeDX | Stroke Care, Grit, & the Clinician/Entrepreneur Life
5 Nis· The Leading Difference
Meet Alexander Ballatori and Shane Shahrestani, two innovative minds revolutionizing the medtech industry with their groundbreaking company, StrokeDX. Their story is not just about technological innovation; it's a tale of resilience, determination, and a deep-rooted desire to enhance stroke care. Amidst financial hurdles and skepticism, their commitment to transforming stroke diagnosis and treatment shines through. Their episode is a must-listen for anyone intrigued by the confluence of medical technology, entrepreneurial spirit, and the profound impact of personal experiences in shaping healthcare solutions.
Guest links: https://www.linkedin.com/in/shane-shahrestani/ | https://www.linkedin.com/in/alex-ballatori/
Charity supported: Sleep in Heavenly Peace
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 027 - Alexander Ballatori & Shane Shahrestani
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guests today, Alex Ballatori and Shane Sharasani. They are the creators and innovators extraordinaire behind StrokeDX, and I'm so excited just to talk with them, find out more about the innovation and see where they're going from here. So thank you all so much for being here.
[00:01:11] Alexander Ballatori: Yeah. Thank you so much for having us. We're really excited to be here.
[00:01:15] Lindsey Dinneen: Excellent. Excellent. I'd love if you two wouldn't mind starting off by just sharing a little bit about yourself, your background and, well, let's stop there. Let's do that first.
[00:01:26] Alexander Ballatori: Great. I'll go ahead. So, I'm Alex. I'm originally from upstate New York, from Rochester, so very grateful to be in sunny California at the moment. Now that we're entering the winter period. But I went to the University of Rochester to study biology and chemistry. I was really interested in medtech and medicine in general. And I want to take some time before deciding what type of graduate degree I was going to pursue as well as learn a bit more about the startup ecosystem. So I ended up living in San Francisco for a few years. I really got to see a lot with respect to medtech in general, predominantly in the orthopedic in the pediatric health space, and then I ended up choosing to go to medical school where I met Shane is my first roommate in medical school and we hit it off right away started.
[00:02:07] This is our 2nd business together and yeah very passionate about stroke. Stroke has impacted my family numerous times and when I saw this creative solution that Shane developed during his PhD and also just given my long lasting interest in medtech, it was a no brainer to start this company with him, but I'll let him kind of take over from there, give him some background, and then we can dive into more about our story as a company.
[00:02:32] Shane Shahrestani: Thanks, Alex. Yeah, so my name is Shane Sharasani. I grew up in sunny Southern California, very different from Rochester. And I was at UCLA for undergrad. I studied neuroscience and then I did my MD PhD, my MD at USC and my PhD at Caltech. And the way they designed that is you do 2 years of med school, you do the full PhD and you come back and you finish med school. So in the first 2 years, I saw the effect that stroke had on patients. And when I went into my PhD, I wanted to develop technology that can solve that problem. Namely, having timely access to stroke care diagnosis that you receive faster treatment because time is brain. So that's where this idea came about.
[00:03:13] We pivoted this tech from the aerospace industry and developed this tech for stroke detection. And when it came time to spinning out of Caltech, there was no other partner that I wanted on this other than Alex. He's my best friend and also my first roommate, as he said. So it made sense to work together and we work very well together. So since then, it's been a exciting journey since the end of 2020 when we spun out and filled with highs and lows. And we're happy to be here today on this podcast. Thank you.
[00:03:46] Lindsey Dinneen: Yes, of course. Again, thank you all so much for being here. And it's just fun to hear how you guys got connected in the first place, and the fact that, you know, this roommate, which could be so hit or miss, let's be honest. And it just turned into this fantastic friendship and now business partnership. So I love hearing those kinds of background stories. So, you know, Alex, you mentioned having a personal connection to stroke, and perhaps Shane, you do as well, but I would love if you would share a little bit about your, your own experience and kind of what really motivated you all to tackle this issue and to try to make a difference in this arena.
[00:04:26] Alexander Ballatori: Yeah, so, I mean, it started really close to home with my grandfather, actually, as well as a couple other uncles and great uncles, unfortunately. And, you know, my, so both my family, both my parents are clinicians by training. And so, when I saw them, and I saw the care that they received, my, my family was always, my, both my parents were very strong advocates for anyone in my family that became ill. And when I saw my family members go through stroke care, I saw that even if you have the best advocate at one of the best hospitals, there's still so many inefficiencies in the care that we can deliver.
[00:05:00] And then going to medical school and seeing it firsthand when we are now. I was functioning as the provider at that point, there's just so, it's just so many issues. And despite all the advancements we've made from surgical technique and therapeutics, we haven't put a dent in stroke outcomes in multiple decades. So, you know, when we, when I first saw what this technology could do, the chain had developed at the price point that it can, also at the safety level and in the amount of time that it can deliver this information, I saw all of those problems from at my, within my family and within my medical training. That could be solved just with this simple, elegant, low cost solution.
[00:05:42] Lindsey Dinneen: Yeah, that's incredible. And Shane, do you have anything to add to your own experience with stroke and what motivated you to develop this?
[00:05:51] Shane Shahrestani: Yeah, of course. So I briefly touched upon the fact that I went to the PhD, I already had some experience with stroke in terms of dealing with patients in medical school and really looking at the inefficiencies there. Why are we ordering so many CTs? There has to be a better way to monitor at the bedside. And why do we not have that? Right? And now I work as a neurosurgery resident and those problems still exist. So many patients every day have to be sent back to the scanner just because something changed about their exam, and we have no idea what happened until we send them down to this big, bulky, expensive machine that requires transport. It uses radiation and there have to be better ways to solve these problems and provide the information at a point of care at a efficient cost to the patient in the hospital system.
[00:06:41] Lindsey Dinneen: Yeah. And so I would love if you both or one would share a little bit about the technology itself, kind of where you are in process with approvals and all that fun regulatory excitement and just, you know, what do you envision for your company as it grows?
[00:07:01] Shane Shahrestani: So from a tech perspective, there are sensors that they use in aerospace to look for cracks in airplane wings. And we have methods for non destructive detection. That's what they call it: "non destructive testing and detection" that we use every day in other fields. So what we did is, we took this technology and we optimized it for the human body, specifically for the brain and by doing so you can create a non invasive handheld, small, cheap, portable, non radiating technology that you can use anywhere to quickly assess objectively how the brain is doing in terms of its cerebrovascular health, right?
[00:07:52] And the idea is it works a lot like a metal detector, right? And in stroke, you can either have too much blood in the hemorrhage or too little. And in ischemic stroke, where you're literally stopping blood flow. And if you have a metal detector that's tuned for the human body and for blood, then you can quickly assess how is the blood flow changing and what are we going to do about it? So that's the technology, and I'll pass it over to Alex to talk about the rest.
[00:08:17] Alexander Ballatori: Yeah, so absolutely. So given that this technology can differentiate, localize, as well as produce an image of where the lesion is, and in stroke, again, there's two types of stroke. You need to know what type of stroke they're having. And then once they have the stroke can progress over time. So back in 2020 and 2021, when Shane was first validating this technology with an NIH funded grant awarded to Caltech and USC, we saw that it could provide all of that critical information in a very compact form and in a very low cost form.
[00:08:48] So once we published that information in Nature Scientific Reports, we went out and started the company. We went out and started to raise money. And one of the, one of the things that we knew is that our basis, the basic form of our technology the common baseline principle, how it works could impact the entire stroke continuum. Right? So the stroke space has a lot of problems. So, for example, 1 out of 6 stroke patients in an ambulance goes to the wrong hospital because we can't evaluate their brain. Often stroke patients are just found down. Right?
[00:09:20] So as an EMS personnel, all you want to do is get them to the closest hospital. But unfortunately, not all hospitals can manage stroke patients. So, one out of six times they're wrong, and that leads to hours in their delays in care. And like Shane said, time is brain. Every minute that passes, you lose a million neurons irreversibly. So, that's the first problem. It's kind of like the EMS.
[00:09:38] Then in the emergency department, it still takes quite a while to rule in stroke, because we rely on CT scans. And there's also just a whole slew of things that have to happen for a patient in that process of getting admitted to the hospital. So stroke on average takes over two hours to diagnose from the initial symptom onset. So that's kind of the pre hospital, early hospital problem within stroke care.
[00:10:01] The other big problem in stroke care is we don't have any way of monitoring patients at the bedside with a disease that's rapidly progressing. And so currently we just send patients back down to CT, on average four times for admission. And so 80%, unfortunately, these repeat scans are negative. Nothing had changed in the brain, but we require objective information to manage these patients appropriately. So we keep sending them back.
[00:10:26] The other problem not to get too into the weeds with this is that most stroke patients are above the age of 65. They are enrolled in Medicare and the Medicare bundled payment system. Ever since it came out, hospitals have been losing money across the board route on stroke care, and a big contributing factors are inability to monitor and image the brain in a timely manner. So that problem also goes into the neuro rehab setting where hospitals are now pressured to push patients into neurorehab where they're getting paid, you know, per diem. And also can kind of close the DRG.
[00:10:56] So you can kind of look at the stroke continuum as two problems. The early hospital, pre hospital, and then the inpatient inability to monitor this rapidly progressing disease. We have built an automated device for that second space, the inpatient and neurorehab space. Which is an automated, lightweight device that takes our sensor and has two mechanical arms that move it around the patient's head in a completely automated fashion, removing the human element to the path and the scanning path.
[00:11:23] And so what that enables us to do is it enables us to put this device-- it sits right at the head of the bed-- all you have to do as a user is set them up in it, which takes less than a minute. You press go on a tablet and it scans everything and tells you all the information that's happening right at the point of care. It also enables us to leave it on and monitor patients over time, which is going to be a game changer in inpatient stroke care, where currently it takes quite a while to get patients to CT.
[00:11:48] And again, 80 percent of the time it was a negative scan. So it's a completely inefficient process. That's actually we estimate to be over a 6 billion in efficiency in the U. S. alone. So we're first pursuing that, but not to say that we're not interested in the pre hospital space. We still are very interested in prehospital stroke ruling and so a lot of our diluted first round of our first round of funding, which was just about a year ago, we came to our 1 year mark, like 4 or 5 days ago, is spending a lot of time on improving our sensors capabilities, which we've improved about 3 X from what it was back in 2021.
[00:12:21] So ultimately we are pursuing the inpatient space first, because there's a very clear problem for us to solve that we can solve, but it's not to say that we're not going to go for the outpatient space at a later date. We are still very actively pursuing it because our technology will be the one to solve that problem as well.
[00:12:39] Lindsey Dinneen: I love it. And I love how bold and confident y'all are in your ability to do this because it's exciting to see that there are such amazing innovations and there's progress in this space. So thank you for doing the work to make that happen. I know that's going to impact so many people's lives. And also, I want to say congratulations because y'all are winning so many awards. I was looking at your LinkedIn pages and it was so fun to see, you know, post after post. So tell me a little bit about some of your recent wins, if you'd love to share that. You've been part of the MedTech Innovator Accelerator cohort for a year ish now. So yeah, just tell me about your experience and what you're celebrating.
[00:13:25] Alexander Ballatori: Yeah. I mean, it's been an incredible process. MedTech Innovator is by far the most significant thing we have participated in since forming our company. The doors that were completely shut and locked and sealed that we could never potentially even knock on are now wide open because of MedTech Innovator. So yes, we've been participating for the past year and it's been a wonderful experience. First, starting off at the the pitch events at UCLA, where we pitched to the judges, where they narrowed it down. They had about 1200 early stage companies. I think a total of 1900 applications in total. And they, after those pitch events, which there were five, they narrowed it down to 61 companies total and about, I think it was 40 early stage companies.
[00:14:06] So we enrolled in that program and got assigned to some incredible mentors, got to meet all of these amazing alumni that were either first time founders or seasoned, seasoned founders that have been through a lot. And we just had this complete access to this amazing network of people that we could talk to. And so, you know, it started off with Wilson Sonsini, the Innovator Summit, and the Wilson Sonsini medical device conference where we were picked to be in the top five for the vision award, which is based on the criteria, "would you invest in this company? And would you want to work for them? And do you find them inspirational?"
[00:14:38] So we made it into the top five, which we're pretty surprised about, honestly, because it was a cohort wide boat. And then we had 7 minutes to pitch very similar to the finals, which I'll get to in a second. And we won that, and that was the first kind of wave of, you know, just increased interest in us, a lot more visibility for us, and a lot of validation. Our 2022 was a very very trying time for us, which we can talk about later. But anyways, that was the first big win for us.
[00:15:05] And then we participated in the cohort and got to know the MTI team and our mentors and go through the value proposition program. It was so helpful for us in so many ways, and it culminated in us making it to the finals at the AdvaMed medtech conference, whereas a similar setup, we had about 7 minutes to pitch, try to explain all of the wonderful things about our technology in just a couple of minutes. After a crowd vote, we ended up winning. And so, it was really special for us because in 2022, as young innovators, you get a lot of doubt, you get a lot of no's, you get a lot of people saying you're crazy. And so to win that was really special. And I want to give Shane a moment to say anything else with respect to that too, but it was just a really sweet moment for us after what we've been through.
[00:15:48] Shane Shahrestani: Yeah, a hundred percent. You know, we were two young guys in medical school, no previous business experience, trying to spin out a medtech company while also being in medical school. And the number of times we got said no to, we completely lost track. So to be able to build back up and to make it to a point where we're actually the top startup in medtech in the world was, you know, we didn't even believe it. And also, you know, a couple other things it was, Alex and I just went so much. It was awesome working together as a team over the last year and figuring out all these other problems that came up. And at the same time, at MedTech Innovator, we met so many other people going through similar problems as us. And there are so many amazing cohort companies that we got to meet who are going to change how medicine is provided in the U. S. and globally. So it was an absolute pleasure to work with all of them and to work together to solve so many problems in MedTech Innovator. It's cool.
[00:16:47] Lindsey Dinneen: Yeah, that's incredible. I'm so glad that you guys had such a great experience with the cohort. And again, yeah, congratulations for winning the whole thing. That's fabulous. And I think it does speak to the innovation that y'all are bringing to the world and how important it is. And obviously you're getting some really good external validation. I mean you know the value that you're bringing, but it's always nice to have an outside person saying, "yes, we agree," you know, and to that point, I'm really curious about your 2022, because you kind of mentioned that that was a little bit more trying. So if you'd be willing to speak to that, I'd love to hear a little bit about that.
[00:17:28] Alexander Ballatori: Yeah, absolutely. So like Shane mentioned, we were both full time in medical school. We were in the hospital for, I don't even want to admit how many hours. I don't think I'm allowed to say how many hours. And you know, trying to form a pitch deck. And, we're both heavy in science and research and we know how to build the presentation typically for the scientific community, right? And so, and again, we're clinicians, like, one of the reasons why I mentioned before, I think, before the recording, one of the reasons why we're so excited to come to this podcast is that this podcast is really about increasing and bringing technology to increase human health and improve human health.
[00:18:05] And, you know, one of the things that we were passionate about, and still are very passionate about, is that we want to bring this product to market because we know it's going to help a lot of people. But one of the things that we had to learn is that we needed to pitch a company, right? We needed to pitch a vision and a mission, which we had the vision and the mission. It's gotten much more refined. But we had, that was our, I think our first learning curve, which we give a lot of, we have got to give a shout out to Helen McBride and Julie Schoenfeld from Caltech, as well as our lead investors at Freeflow for helping us with that one.
[00:18:33] But it was tough. We were pitching during our lunch breaks and we were pitching on the weekends and we had investors lined up and then unfortunately, the day before the round of funding was supposed to come through, the markets went south and they said, "Hey, we're not investing right now. So sorry." And we were in a good amount of debt. And so, it speaks to one of the value or one of the most important things when starting a company is kind of faith in your mission and faith in your founder.
[00:18:57] We were sitting and just looking at each other like, "man, what are we gonna do right now?" Like, we were still fully deep in school studying for our board exams, and we were in debt and we couldn't even build anything. And so, you know, we kept going at it and we really believed in what we could do. And we ended up finding Freeflow Ventures with David Fleck and Kevin Barrett who believed in us and, and saw our vision as well as the individuals at Caltech, and then we ended up finding quite a few other angel investors who are all directors of stroke centers, neuroradiologists, triple board certified neurologists, and you know, experts in clinical trial neuro design.
[00:19:34] And they all believed in us. And so we got the money that we needed. And we've been sprinting ever since, which is why we've been able to accomplish so much in the last year. And, you know, now looking back, Shane and I were just talking about this, after we'd won MedTech Innovator finals and we were like, you know, 2022 was really tough, but it put us in a really good position because it forced us to study everything about the market, learn everything about our competitors. And really hone in on where are we going to bring this thing first? Right? Because like I said before, there's an entire continuum of stroke care where the sensor could be applied and we will apply it to all of those areas.
[00:20:12] But what did we want to do first? Right? And so I think us having to go through that tough time is one of the reasons why we're so successful in such a short amount of time. So it was a tough time, but we're obviously, I think we're doing much, much better out of it. Now we can, you know, when you look back at it, we're grateful more than anything else. It's taught us a lot and definitely earned our stripes.
[00:20:35] Lindsey Dinneen: It sounds like it. Shane, do you have anything to add to that?
[00:20:39] Shane Shahrestani: Pressure makes diamonds. I mean, we felt the pressure. We definitely felt the pressure. It's an understatement, but you know, we learned a lot and we were able to thoughtfully revise our pitch decks, our business plans, our engineering plans with all the no's that we were getting and the feedback that we were getting underlying those no's and that's how we were just able to learn and grow. And I think there's something to be said about being young and trying to run a business. I think a lot of people don't necessarily believe in you, especially when you're asking for millions of dollars. So, we learned that we, as Alex said, earned our stripes and proved ourselves and that we were serious and we knew what we were doing.
[00:21:27] Lindsey Dinneen: Yeah. And you know, what's so interesting is, when I was looking at both of your LinkedIn profiles and just seeing, I kept thinking, do you guys sleep? Do you have time to sleep?
[00:21:40] Alexander Ballatori: We're sponsored by caffeine. That's actually, so Shane and I, before we even started this. We, I don't know, Shane, how many papers we published together and like 30 at least and so many conferences. And it was honestly like that, that the number of nights where we consumed hundreds of milligrams of caffeine, just working together is how we knew we were going to be great business partners. And so, you know, again, we're StrokeDX is sponsored by caffeine.
[00:22:06] Lindsey Dinneen: Amazing. Can we get that official so that you actually don't have to pay for your coffee or whatever? Your caffeine of choices. Incredible. So this journey from, and obviously you probably wouldn't consider it a complete pivot or anything, but this journey from clinician to entrepreneur, and everything that entails, you know, obviously, like you said, 2022 was this huge learning curve. What would be some advice that you might have now looking back and being able to say to somebody who might be in a similar situation, maybe what's a one or two pieces of advice that you would say would be beneficial?
[00:22:49] Shane Shahrestani: All right. A couple of things. One, find a co founder that you trust with your life, who is your best friend, that you'd rather be awake drinking Monsters at 3am than being asleep. That's very important. Two, every time someone says, no, that's an opportunity to learn and grow. And if you have the resilience and grit to keep your head up when you're being told no and to learn from it and to keep going forward, it will always work out.
[00:23:20] Alexander Ballatori: Yeah, that's exactly, literally exactly what I was going to say. You know, someone gave us a good piece of advice. They said, expect to receive 200 no's. And so when you get your 113th, you know, you're barely, you've just barely crossed the halfway mark. Just keep going, because you should expect 200, right? And that was something that, you have to be a little crazy to do this. But also, I think, in addition, like what Shane was saying, you need to have someone that when you hit a low, you know that you can trust the person next to you and you just say, "okay, let's learn from this. Let's refine our approach. Let's , amend our deck and our plan. And let's keep going." Right?
[00:23:58] And also, I think really taking the time to understand the market is really-- what you have, first of all, this is before you even get to this point-- you need to understand what you have, how it will be applied. And I think that was actually one of the one of our biggest benefits is that we work in medicine and we understand clinical utility, clinical need and as well as what we've learned that was very easy for us to learn because of we are clinicians is the whole pay/ payer system, right?
[00:24:25] And, you know, price points and pricing strategies, it's all kind of coming from a clinical side. And seeing these products that I know how people use them. I've seen them use. I've used them. It just made it a lot easier for us. But yeah, ultimately boils down to having a strong partner. And and not taking things too to heart when people tell you that you're crazy.
[00:24:51] Lindsey Dinneen: Yes, indeed. You know, that reminds me, I remember one time somebody saying, " when you hear no it's very rarely no forever. Never going to consider it, the end, close the door, slam it, and lock it." It's usually, "no, not right now." So if you can take that with a grain of salt, if you can take those no's with a grain of salt, eventually, you'll get to either them changing their mind or somebody else saying, no, I agree with you, you're absolutely right.
[00:25:22] Alexander Ballatori: Yeah, we got a lot of "not nows." And I think it really boiled down to the fact that our first prototype was handheld. And so we were confident in our decision to go into the inpatient setting. And so now the pendulum has swung the other way. And now that we've validated that our automated device has worked in this translation, translational project of automating this technology has been successful, all of those people that were the not nows are the, "are you raising money now?" questions, which is obviously a great feeling. But yeah, no, definitely. We learned a lot. There were-- also be frank. There are many times where they ask us questions that we studied for weeks afterwards and learned so much from so all those not now is really they shaped us in such a positive way.
[00:26:07] Lindsey Dinneen: Yeah, yes, I can imagine. Anything to add to that, Shane?
[00:26:13] Shane Shahrestani: No, I totally agree. As Alex was saying, a lot of the previous no's are now reaching out to us. So table turn for sure, but it just takes hard work, great resilience. Got to keep your head up, keep fighting and it works out.
[00:26:30] Lindsey Dinneen: Yeah. Yeah. Excellent. Out of curiosity, going back to your childhoods, could you have possibly imagined where you are now, back in the day? I mean, did you always have an interest in medicine? Is this something that sort of developed over time? Did you think you were going to be a business owner?
[00:26:50] Shane Shahrestani: So ever since I was in fifth grade, I always loved the brain. I knew I wanted to do something related to the brain and now I am working in neurosurgery, but my deep passion is medtech. That's what I wake up for every day. I look forward to working with Alex and our team and solving complex problems and creating new devices that can save brain. Right? So I knew I'd be somewhere in this field, but I had no idea that I'd be able to work on a product so amazing that can really just change the paradigm and stroke care, which affects so many people every year. So, so, I never thought I'd be a business owner. I knew I'd be in the brain somewhere, but this is super exciting.
[00:27:35] Alexander Ballatori: Yeah, and for me, I, so I grew up with two rockstar parents. Both came from nothing from, you know, farms in Italy, but both were very naturally gifted when it came to science and medicine. And so my parents actually met while my dad was completing his PhD at the University of Rochester. My mom was finishing up her MD. And they both saw that they had Italian last names, and then the rest is history. And then I grew up in Rochester, New York, and clouds and snow for the first 22 years of my life. But, I was very, whether it's nature or nurture, I was always very drawn to science and medicine, and both my parents actually were both entrepreneurs as well in the medical space.
[00:28:13] So my dad was a pioneer in lipid and bile metabolism in the liver and developed a lot of enzymatic targets and a lot did a lot of the early work in understanding bio reabsorption. And my mom is a surgeon with multiple devices under her belt and actually is pursuing, it just gotten one of her products just got FDA cleared at the moment. They're launching right now. So I grew up in a very unique household where this is kind of dinner conversation, but I didn't know what I wanted to do. I knew I wanted to be in medtech. I knew I wanted to some sort of degree in medicine.
[00:28:44] And so I took time off after I graduated and I got a degree in biology and chemistry. And so I kind of went into my time off just trying to explore as much as possible. I got my hands on so many different startups. I also got to learn from kind of the bigger medtech corporate world is getting more in respect to the orthopedic world. And so I knew it was for me, but then I was deciding PhD or MD. And for me, I liked kind of the wide breadth of knowledge that you get from the MD because there's so many problems in medicine that need to be solved.
[00:29:16] And one of the things that really sticks with me is that this whole definition of "gold standard" or "standard of care," or "this is the best that we got" that I just don't, I don't like accept fully, maybe that's just kind of how I was raised or what, but I knew that I was going to, I wanted to go to medical school because I knew that there were so, there's so much more I could learn with respect to how we take care of patients that is so behind with respect to where it should be and can be, especially when you look at what's happening at some of these top universities, like a Caltech and USC and at the lab or at the benchtop.
[00:29:52] So, of course, the PhD would have kind of pigeonholed me into one very specific area that I couldn't decide what I was super interested in. So to tell to go back to your question, if I, if you ask me 5 years ago, if I would be doing exactly what I'm doing right now. No, there's no way. But given my background, given my experience with stroke and then, you know, working with Shane, it just really harmoniously kind of just worked out very well.
[00:30:17] And I'm really looking forward to the next few years and seeing where we can take this and then the next one as well. And the next one after that. Shane and I have a very common, one of, one of the we're I keep saying we're crazy. We kind of are in many ways where when a finish something a little bit, when we finish a task and we like finish our to-do list, the next thing we say is not like, "let's go grab lunch or grab dinner or something." It's "alright, what's next? What do we do next?" Right? And so I know the day...
[00:30:40] Shane Shahrestani: I'll call Alex at like 6, 7 p. m. and be like, "Alex, I'm itching to do something. Like, just tell me something to do. What needs to be done?" He's like, "dude, you just worked a 14, 16 hour day. Why do you want more work?" I don't know. I just, it feels wrong.
[00:30:56] Alexander Ballatori: I was like, Shane, go to sleep.
[00:30:57] Lindsey Dinneen: It's all that caffeine. You've got your system wired, ready to go. Oh my word. Oh, that's incredible. Oh, my goodness. So out of curiosity, are there any moments or maybe one moment or whatnot that kind of stand out to you? It could be through medical school, it doesn't necessarily have to be with StrokeDX, but just a moment that stands out to you as saying, "yes, I know exactly why I'm here. This is it." It's reinforced for you: "I am in the right place at the right time doing the work that I really feel passionate about."
[00:31:37] Alexander Ballatori: Yeah, you know, I think there wasn't one specific moment, but more so a process over 2022. And being told no, so so many times. And then finally battling through debt, and thank you so much to our lawyers for being very flexible with us on that. But when we finally got the amount of investors that we needed and the amount of money that we needed, everything, just we were on fire. We were so ready and we had such a strong plan. The moment the money came in, it was we were already starting to send it out the door to our engineers to start paying. And we started working that the same day that the money came in, we had a meeting with our engineers to start working. And I think just that transition point from going from trying to sell the mission to actually executing it was definitely a highlight for us. So I don't think there's one specific moment. But I think it was that kind of transition and seeing all of our incremental improvements in our sensor and seeing this device come to life. It's just been, it's, I think it's almost the whole process is really just validated that this is where I'm supposed to be.
[00:32:45] Shane Shahrestani: Yeah, I think to the families of people who had a stroke and explaining to them what a stroke is and the prognosis and what's going to happen to their loved one, and then seeing people unfortunately pass because of stroke, and maybe they live too far from a hospital and their life could have been saved if they came in a little bit sooner, or they didn't know that they were having a stroke and they tried to sleep it off and woke up and couldn't move half their body. Right? And the stories go on and on. You see it in every permutation and every variation. But then, at the end of the day, these are people and their loved ones are in the hospital with them and you're trying to keep them alive and all our odds are against you and it's a function of losing brain cells and that is a function of time and efficiency, right?
[00:33:41] So a big why is just so much suffering, sadness, loss can be prevented by creating new technologies that can just make healthcare more efficient for people, right? Faster, cheaper, better diagnostics, better assessment tools, better ways to monitor. And you know, that's another reason why I think Alex and I, you know, share that in common and we just work tirelessly just to create new things to just change the paradigm, change the standard of care, make things better for people. 'Cause that's just where our heart and our passion lies.
[00:34:20] Lindsey Dinneen: Yeah. Yeah, absolutely. I'm very glad that you both did not let all the no's deter you. I'm glad you were willing to come back to your why and just keep at it. Yeah, that's, that takes a lot of grit and determination, but glad y'all are doing what you're doing. So, pivoting just for fun, imagine that you were asked to teach a masterclass on anything that you want. You're going to be given a million dollars for this. What would you choose to teach and why? It also doesn't have to be related to your industry at all, although it could be.
[00:34:58] Alexander Ballatori: I, so my family and my my, just family events and cooking is, and my Italian heritage, is very important to me. And so I, it's, when I'm not working, I'm cooking or I'm spending, I make wine for fun. It's just it's all the traditions from my family. So I think if I had to teach a class, it would probably be sharing some of my family recipes, and also I love to cook and host all the time. So I like have had cooking classes at my house with friends and every year I make wine. It's always a big event and always have people over it. It's a really simple process. It seems so daunting, but it's quite simple, especially when you do it the old world way. And so, yeah, I guess I guess that would probably be mine.
[00:35:45] Shane Shahrestani: First of all, I would go to Alex's masterclass. I'd pay however much he charged. I'd be there. His wine is like the only wine I drink now. If I had to teach a masterclass, so there's two things about me that I don't even know if Alex knows. I can identify the Latin name for any insect, any insect. And also I can classify like any saltwater fish, like tropical fish. So, somewhere between insects and tropical fish, just like, you pointed out, I'll just tell you what it is.
[00:36:17] Alexander Ballatori: No way. Get out of here. We gotta go to the Galapagos. We're going on a trip.
[00:36:23] Shane Shahrestani: Dude, I'm ready. We'll be the new Charles Darwins.
[00:36:28] Lindsey Dinneen: Okay, so if I were to just take a random photo of a bug, I could just send it to you and you'd go, yeah, that's a...
[00:36:34] Shane Shahrestani: A hundred percent. I can tell you like what order and like species that bug is.
[00:36:41] Lindsey Dinneen: Amazing.
[00:36:41] Shane Shahrestani: Yeah.
[00:36:42] Alexander Ballatori: Incredible.
[00:36:45] Lindsey Dinneen: We learn something new every day. I love it.
[00:36:48] Shane Shahrestani: Just when you thought I couldn't be more nerdy, Alex.
[00:36:52] Alexander Ballatori: No, so the reason why I'm laughing is because I used to do the exact same with any, you could show me any dinosaur skeleton and I knew I could do the exact same thing. I definitely can't anymore. I definitely cannot anymore.
[00:37:05] Shane Shahrestani: That's so funny.
[00:37:06] Alexander Ballatori: That's definitely just harsh parenting on like repeated flashcards. It was some genuine interest there, but
[00:37:15] Shane Shahrestani: That's incredible.
[00:37:17] Lindsey Dinneen: Amazing. I see how, you know, your, some of your childhood interests or pastimes have led you to successful careers in medicine, 'cause that amount of memorization must be daunting, but it clearly isn't because y'all have been doing it your whole life.
[00:37:32] Shane Shahrestani: It's been the journey, from insects to here, you know.
[00:37:38] Lindsey Dinneen: Amazing. Alright, on a slightly more serious note, how would you like to be remembered after you leave this world?
[00:37:46] Alexander Ballatori: That's a great question. You know, I had a mentor at UCSF that was in a very similar position to where I kind of see myself in the later years of my career and it's very difficult to be a clinician full time and still spin technologies out, run the kind of the business end of things. And, he was someone that did it. He was someone that did both, and that's something that I also aspire at some point. And, we had this conversation where you kind of have to view it as, "do you want to be the person that takes care of the tree? And you can see the impact from your own hands on that one person? Or would you rather maintain the forest and drive things that can impact the entire forest?" It's something that sticks with me always.
[00:38:35] And like I was mentioning before, just this whole concept of standard of care or gold standard, the best way to do something that I never really fully accept. So I think it's kind of not fully concrete, but I think continuing to spin out technology that these amazing technologies that are stuck at the benchtop. And through this kind of bureaucratic tech transfer process, I really see myself down the line. I would like to be remembered by our ability to take these amazing technologies and not accept that things are just the way that they are because they never are, right? We used to operate without gloves and not that long ago and wondered why our infection rates were so high. So I think for me, just down the line, I'd love to be able to be remembered by bringing new technologies and not accepting that what we currently considered the best way to do it, the actual best way to do it.
[00:39:23] Shane Shahrestani: Yeah, I think, similarly, I think we all have family and friends that we love and we cherish. And I think everyone's biggest fear is losing someone that they care about. And I think we have one shot in life and my personal mission statement is just to do whatever I can just to spread positivity, happiness, ways to, to maximize that love and keep people around. Right? And I really think that medical devices and medicine and new technologies are the way to just create new solutions to problems that affect everyone. Or will affect everyone at some point in their lives. So, it would be great to be remembered as innovators, someone who can create that device that saved my brother or my mom, you know? And I think that's also a big dream or aspiration that, that we work towards every day.
[00:40:26] Lindsey Dinneen: Yeah, absolutely. Yeah, and final question: what is one thing that makes you smile every time you see or think about it?
[00:40:36] Alexander Ballatori: I mean, I love seeing a big table filled with food anytime, because it's, again, it's my family. We used to get together every Friday, every Sunday, no exceptions. Everyone is there, 50 to 100 people. And so every time we open a table and it's like I'm going back to upstate New York for Thanksgiving and for Christmas. And so every time I see there, I think about it, you know, we've all grown now and we're all kind of all over the place. So we don't get together as much. So anytime I think about that's definitely that's definitely my, my, what makes me smile for sure.
[00:41:06] Shane Shahrestani: Lately I've been smiling, looking at that big check we won at MedTech Innovator.
[00:41:16] Alexander Ballatori: Me too. Me too. Me too.
[00:41:17] Shane Shahrestani: Yeah. So we'll leave it there.
[00:41:20] Alexander Ballatori: And our new device rendering also makes me smile.
[00:41:22] Shane Shahrestani: That's oh yeah. Yeah. That makes me smile.
[00:41:25] Alexander Ballatori: It's also both of our phones screensavers. So we're smiling a lot.
[00:41:31] Lindsey Dinneen: I love it. That's fantastic. It's just motivation day in and day out. You just look at it and go, "yeah, this is great. This is what we're doing." Oh my word. That is absolutely incredible. And this has just been so much fun. I really appreciate you both joining me today and sharing more about your backgrounds and your passion and all of the really exciting innovation coming out of your company. Again, thank you. Thank you for what you're doing for the world. It matters. And it's really cool to see you take the challenge and get past the no's to get to those yeses. So thanks.
[00:42:08] Alexander Ballatori: Yeah, no, thank you so much for allowing us to share our story and make sure you follow us as we are moving very quickly and starting to collect clinical data. And so it's a very exciting time to, to start following us. If you aren't already, it's now is the best time to start.
[00:42:22] Lindsey Dinneen: Yeah. Yeah. Yes.
[00:42:23] Shane Shahrestani: Appreciate you for having us today. It's been a pleasure chatting and hopefully we do this again soon.
[00:42:29] Lindsey Dinneen: Yeah, absolutely. And we are so honored to be making a donation on your behalf as a thank you for your time today to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that organization to support. And yeah, we just wish you continued success as you work to change lives for a better world.
[00:42:52] Alexander Ballatori: Thank you so much. Thanks again.
[00:42:53] Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in. Please go follow StrokeDX. Like they said, they are moving quickly and you will definitely want to be on top of that. And if you're feeling as inspired as I am, I'd love if you'd share this episode with a colleague or two, and we will catch you next time.
[00:43:14] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Laura Yecies | CEO, Bone Health Technologies | Osteoporosis, Fostering Better Patient Support, & Leadership Lessons
22 Mar· The Leading Difference
Laura Yecies, CEO of Bone Health Technologies, shares her journey from a tech and marketing background to leading a company that's revolutionizing the treatment of osteoporosis with Osteoboost, a wearable device using NASA-proven vibration technology. Laura's diverse professional experiences highlights her personal motivation to improve people's lives. Her story illustrates a passionate commitment to developing non-pharmacological treatments and fostering better patient support, emphasizing the significance of technology in advancing healthcare.
Guest links: www.bonehealthtech.com
Charity supported: Equal Justice Initiative
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 026 - Laura Yecies
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm excited to introduce you to my guests today, Laura Yecies. Laura is the CEO of Bone Health Technologies, makers of Osteoboost, which is the first clinically proven, safe and effective non-pharmacological treatment for low bone density. Osteoboost puts NASA proven vibration in a wearable, comfortable, convenient belt form factor. Laura, thank you so much for being here today. I'm so excited to chat with you.
[00:01:23] Laura Yecies: Me too. Really happy to be here.
[00:01:25] Lindsey Dinneen: Wonderful. I would love, if you wouldn't mind starting off by telling us a little bit about yourself and your background and maybe what led you to the medtech industry.
[00:01:35] Laura Yecies: Sure. My background's in business and tech primarily. I went to college on the east coast and after business school, in 1988, I came to California. I grew up in New York, but my husband was from California and so we decided to give it a shot out here for a little bit. And I started working in tech doing marketing, first in enterprise software, relational databases, and developer tools. And then I moved into consumer softwares, started off at Netscape. And when I was at Netscape, I took on larger roles and responsibilities. I was Vice President of the browser division, managing a group of over 200 engineers, and we were responsible for Netscape 6.1 and 7.0 and the Mozilla spin out. I then led the mail team at Yahoo, when we were sort of the number one email provider.
[00:02:30] And then I also worked at a tech startup and spent some time at Checkpoint, which is a large internet security company heading up marketing there as well. And then I was CEO of two different tech startups, Sugar Sink, which is a sink and share company, and that's now owned by J2 Global. And then I became CEO of a small company called Catch. We had a note taking app and we were able to sell that company to Apple and the Catch team became the core part of the Apple Watch team. So that was very exciting.
[00:03:03] And after that when I was thinking about what I wanted to do next, I worked on some ideas for my own startup with some colleagues and, some things that happened in my life that really drew my attention to healthcare. And also I grew up in a family of doctors, both my parents, two of my siblings. And then at that point, my two older sons were in medicine, and I'd always been interested in that and had a bit of flexibility because of this exit and decided that, I'm gonna, I'm gonna make a pivot. And so I switched and started looking for roles in the healthcare area.
[00:03:40] And everyone sort of wanted me to work in more of the pure software side of healthcare more of the billing and receiving and revenue cycle management and staffing and logistics. And that's interesting and important. But I found that I really wanted to work on something that had directly a health or therapeutic or diagnostic benefit for patients. And so I started consulting. I consulted with companies in the genomics field, MS. And then I was lucky to get my first CEO role at a concussion diagnostic company. And that company, now called NeuroSync had great science. I think they went on to get an FDA clearance for diagnosing concussions. But after a couple years, the board and I had different ideas of what to do. It sometimes happens.
[00:04:26] And so I left, I spent a year consulting at Achille Interactive and at Fabric Genomics and a couple of other companies while I was looking for my next CEO role, and I was really excited to have the opportunity, just over three years ago, to join Bone Health Technologies. I knew a marketing consultant that had been there and was connected to the company, and as soon as I saw what they were trying to work on and solve and have, frankly really make a dent in this issue of osteoporosis, I was interested.
[00:05:01] I mentioned that my parents were doctors. My dad had been Medical Director of a nursing home, and I worked a couple of summers during college as a nurse's assistant. And people seemed, my recollection was that they were in the nursing home typically for one of two reasons: Alzheimer's, or they broke their hip. And, my grandmother had osteoporosis. I'm a small person. It certainly runs in my family. And so I recognized that it was an important problem, a big problem, an unsolved problem.
[00:05:30] And so my really, my only question for the company was, does it work? We had this innovative treatment for osteoporosis and the founders shared the data with me. It was not a sure thing, but I found the data to be very compelling and so I joined and we're three years down the line from that point in time. And one of the most important things that's happened is we finished our pivotal trial and we got the results. Now it takes a while to do a trial for osteoporosis, but we had excellent results from the treatment.
[00:06:03] Lindsey Dinneen: Yeah. First of all, thank you so much for telling us a little bit about your background. You have such an incredibly diverse background. So many questions just emerge from that, but I would love to hear about your current device and the way that it works and whatnot.
[00:06:18] Laura Yecies: Sure. So it's a wearable treatment. It's a belt that has a vibration pack that you wear over your lumbar spine, specifically at the sacrum. And so we're applying vibration to the hips and lower back, and those are to the key areas that experience fractures from osteoporosis. So hip fractures are very life impacting, deadly for almost 30% of people. Spine fractures, you can imagine, are very painful and debilitating. And so we're focusing vibration, which has been proven to improve bone density on the vulnerable anatomy. And, there's a body of evidence from NASA where they did whole body vibration to try to reduce bone loss for astronauts.
[00:07:05] So when astronauts spend time in space, they lose bone. And what they proved was that standing on a whole body vibration platform can improve bone density. But those companies that make these platforms, they have very good products. I'm a believer in the science, but those products haven't gone mainstream. They're people that tend to not comply very well with them, and the good ones are expensive. And so we're aiming to take this proven science-- and by the way, before NASA did the whole body vibration studies, there's a lot of studies in animals and cellular research showing the same thing. There's really a lot of science to support this.
[00:07:45] But our device, we aim to solve the ease of use challenge by making it something wearable. And then most importantly, the vibration is applied locally to the vulnerable anatomy. So that's what we do. And what we showed in our pivotal trial is that we reduced bone loss by over 80%. So we measured the lumbar vertebra with a CT scan at baseline in one year. And the patients who were on the active treatment lost about a half a percent of their bone strength. And those on the placebo or sham treatment lost just under 3%. Our patients, we kept them clinically, essentially stable and slow this bone loss so you don't outlive your bones.
[00:08:29] Lindsey Dinneen: Wow. That's incredible. I am. . I . I say this a lot and I know it's used as sort of a more tongue in cheek manner, but for real, what a time to be alive. That is so cool how so much innovation is just constantly coming through and the, there's this, people like you are doing this incredible work to bring new devices that are really impacting patients' lives. So that sounds like incredible results. You guys must have been thrilled with those numbers
[00:09:03] Laura Yecies: Yes. And this was really our first attempt. We had done a pilot study, but this was our first one year study and we just applied for a grant to do another study with in basically a longer treatment duration, essentially a higher dose of vibration. So from my point of view, this is a great result, but this is like the beginning.
[00:09:26] Lindsey Dinneen: Yeah. Yes, which is so exciting too, because it just leaves room for so much more as you continue to go down this path. So that is exciting. And so that's your next step. I'm imagining, is this, next level of treatment and what do you envision the company to, to do or be doing in say, three, five years from now?
[00:09:50] Laura Yecies: So in three to five years, my goal is first of all, that we have this device very widely used in the market or with patients. So there's 52 million patients with osteopenia and other 12 million with osteoporosis. Our trial was for patients with osteopenia, and so there are a lot of patients out there who I think would benefit from this device. We also want to start to develop a relationship with those patients. Not just sell them a device, but support them in their overall bone health optimization. So we today have created an OsteoBoost application. So we help patients remember and comply and we remind them and give them encouragement to use the device. We help them get the optimum amount of calcium by tracking that exercise.
[00:10:41] And then, our vision is to add community and other elements of optimizing bone health and potentially to have other services. We never wanna get in the way of a patient's relationship with their doctor. So if their personal physician is supporting their treatment of their bone density issues, that's great. But in many cases they're not. And so we wanna have services available for that as well. And it's interesting if you look in the app store or look at a lot of startup activity, there's many companies doing these kinds of solutions for diabetes or cardiovascular disease or asthma or depression, but there's really not much out there for bone health. And yet it's really a key part of staying well and independent and living, living healthily, and it's such a common problem. So we're excited, that we have something unique, yet very much needed and not in a, in a small group it's not a rare thing. It's very common.
[00:11:46] Lindsey Dinneen: Yes. Yes, absolutely. And is your plan to sell directly to the consumers or will you be going through, insurance companies, doctors, whatnot, or do have you gotten that far yet?
[00:12:00] Laura Yecies: We haven't finalized the details of that. So we're not ready to share them. But but what I will say that I think we are quite certain about is first of all, it is a prescription device, so there will be a doctor involved to write prescription and some of the details, and we will certainly have a way where the personal physician can write that prescription. We may have some other options for patients, but a doctor's involved, which is appropriate because they have a condition that puts them at risk of fractures and other health issues.
[00:12:34] But the other thing that I am confident about is that we are going to want to appeal to patients to generate interest. We have seen tremendous inbound interest into the company with not a lot of marketing. I mean, I've done things like this podcast and I speak at conferences, but we have not spent money on advertising or things like that because the product's not on the market yet. And I hear from patients all the time, they are searching for an innovative treatment. They're searching for ways safely to slow their bone loss. I, I'm a member of a number of Facebook groups for osteoporosis and hear how patients talk about this, and so I believe there's tremendous interest by patients and that we wanna tap into that to build the business.
[00:13:24] Lindsey Dinneen: Yeah. Yes. And part of the reason I brought it up, the question in the first place was exactly for that reason. I was thinking there's gotta be so many people who are searching for a solution and yours is so innovative and accessible. I'm so excited to see where it leads. Yeah, that's gonna be incredible. And it really struck me, you talked about your background being heavily in marketing back in the day and so obviously those skills are still very present today. So it's fun to see how, elements of things that you've done throughout your life will lead to this success, in this next endeavor.
[00:14:01] And I'm actually very curious also. yoU talked about some really amazing positions that you had, and then those led you to have these CEO roles. So I'm curious, how was that transition for you stepping into your first CEO opportunity? Was that exciting, daunting, energizing? How are you feeling in those moments?
[00:14:25] Laura Yecies: Those, you captured many of the feelings. So you know, a bit of context. So it was the very end of 2008. And so the world from a financial markets point of view was kind of falling apart. I had led large groups. I had been a general manager, but I'd not been CEO. I had never raised money before, and so I stepped into a company that had been through some trauma. They were supposed to be acquired. The acquisition, the plug got pulled out because of the markets collapsing. The founder had left before I got there. So it was, the company was really in a crisis, I would say. The employees were very afraid for their jobs. We didn't have money and, the financial markets were terrible. It was really challenging to go in and stabilize things and kind of pull the team together and then, build the business in a challenging environment.
[00:15:23] Existing investors gave us some runway, but it was limited. They had already kind of been in investing quite a while, and so I had to find outside money, which in 2009 was challenging. But it was exciting. I loved the product that I was working on. I had been a user of it. It was something that was in my wheelhouse of, I had worked quite a bit on productivity tools for workers and business people and consumers. And, and I, we had great technology. So it was exciting. But it was It was intense. But we built that business. When I joined we had essentially zero revenue and we got to essentially in the 20 million run rate in four years.
[00:16:07] Lindsey Dinneen: Wow.
[00:16:08] Laura Yecies: That was great.
[00:16:09] Lindsey Dinneen: Yes. That is great. That is kudos to you and your leadership for being able to step into such a challenging situation and it around. Yeah.
[00:16:19] Laura Yecies: You know, one thing I learned then, because we did have all these challenges, but we also had a market where the latent demand and need was growing. It was a rising tide. Just to be specific a bit-- and then I'm gonna give an analogy to bone health technologies. So at that time we had a sink and share solution. We were a little bit more niche, but you could think of it as it was quite similar to a Dropbox or a box.box, what was then box.net, and that was also the time that iPhone sales, laptop, Netbook sales were growing very quickly, and so the need to get your data into the cloud was I mean, you could argue that it was always useful to be able to access your data remotely. And there, there were always kind of some niche solutions like, Go To My PC.
[00:17:12] But suddenly, because the environment was changing where people were having these devices the market demand and the market opportunity was growing. Okay, so fast forward, oh, 14 years, 13 years, and osteoporosis and osteopenia is growing. But the other thing that's growing is awareness. And our target demographic, postmenopausal women, I'd say our typical patients are in their sixties. I don't know, what's the joke? Sixties is the new fifties or the new forties. Like these are women who wanna stay active, right? They may be still working if they're not working. They're very involved in the community, they're very involved with their family. They may have, they may be at a point where they've educated their children, they've saved some money, so they have disposable income that they want to take care of their health. And so it's a demographic that spends money on their health. They also are very social and community minded.
[00:18:16] Let's imagine a six year old woman with osteopenia and she's going on a hike or a walk with her girlfriends. What are the chances that her female friends also have osteopenia That's probably 80%, right? If similar in age, and so I see this set of patients and who we're going after as being very interested in safe non-pharmacological solutions that are easy to access. You can call it the Amazon effect. They're used to things being convenient and seamless. And they, they want this type of solution to help them stay kind of active and healthy and be in a way preventative of the need for medication. So I see this as in a very different way than Sugar Sink, still a rising tide market.
[00:19:08] And oh, by the way, at the same time talking about health concerns related to menopause is suddenly, and as it should be not just socially acceptable. It's a hot topic, right? Oprah, Michelle Obama, Gwyneth Paltrow, they're all talking about menopause symptoms. And by the way, osteopenia is very much a result of menopause. You're losing bone density slowly typically starting your thirties, but in the five years after menopause, there's rapid bone loss, and that's typically when women get into that osteopenia stage.
[00:19:44] Lindsey Dinneen: Yeah, absolutely.
[00:19:46] Laura Yecies: Oh, by the way the women who are in their sixties today, when they were going through menopause 10 years ago, or 12 years ago, or 15 years ago, they were told no. Hormone replacement therapy unless you're completely miserable because of findings in the Women's Health Initiative. And that pendulum has now swung back to a more moderate position. But today's 60 somethings are less likely to be on HRT or to have even been on HRT, so they're more likely to have bone loss.
[00:20:21] Lindsey Dinneen: . Yeah. And. Speaking of this, and you were talking about thankfully, there's much more awareness, there's much more conversation happening about women and menopause and going through symptoms and whatnot. I've just been reading lately how much it is still a struggle despite that for women founders, especially of medtech companies to get the funding that they need. And I'm curious, what was your experience when you were fundraising, what were your challenges? What were your triumphs and maybe even suggestions for other women founders who are gonna be going through this soon too?
[00:21:01] Laura Yecies: There's no controlled experiments on these questions, right? So if my fundraise on a difficulty from zero to 10 was a seven. Right? Would it have been easier or harder if I were a man? I really don't know. I know that women, there's less funding going to women, but I have felt that, at least for this company, I don't have any reason to assume that to be the case. If anything. I believe that investors, many of them, they even talk about this, they're looking for founder product or founder market fit. And I'm not the founder of the company. I was brought in as CEO after it started, but I feel like a founder. I operate that way. This is my adopted child. And I love it no less than if...
[00:21:56] Lindsey Dinneen: Yeah, of course.
[00:21:58] Laura Yecies: ...if I gave birth to it.
[00:21:59] Lindsey Dinneen: Right, right.
[00:22:00] Laura Yecies: I am a user of our product, right? And I empathize with very deeply and connect with our patients. And I think if a, a 25 year old man were sitting in my shoes trying to raise money, maybe he would've even had a harder time. So I, I know. I don't know. Women's health has been under invested in, I believe it still is under invested in. And why is that? It's very hard to tell. I will also say that devices are a harder field to raise money for, independent of gender. There's more investors investing in digital solutions or pharma than devices for a variety of reasons. The size of the device investor market has shrunk.
[00:22:51] And I think that's unfortunate and because I think there are a lot of solutions that are less invasive, less systemically invasive. Osteoporosis or osteopenia is one example. But we see devices for other women's health areas like pelvic prolapse or stress urinary incontinence, or a number of things that are of concern to women, but also things that affect everyone like migraine and these device solutions are very safe. They don't completely replace pharmacological solutions, but I think it's really important to have other options and so I do think it has been challenging, especially in the early stages in that field.
[00:23:37] Lindsey Dinneen: Yes, exactly. Yeah. But I thank you for your perspective too. It is, I think quite refreshing to hear from somebody who was a woman who went through this raising capital and actually did have a really good experience, 'cause you hear so many of the opposite, so sometimes it's easy to go, "oh gosh, it's not changing fast enough." But it is so encouraging to hear from somebody who has had a really good experience, so I appreciate your telling me about that.
[00:24:03] Laura Yecies: Yeah. And for women's health if most of the investors are men, a good investor should be able to appreciate concerns outside of their personal experience. But I think human nature is such that we tend to connect with problems that we've had. And so the fact that most of the VCs and investors are men makes the whole women's health field, I think, more challenging for fundraising. But we'll see. That's changing too.
[00:24:35] Lindsey Dinneen: Yeah. Absolutely. Yeah. . So what are some things that you are excited about, either personally or professionally in the coming, coming couple of years? What are, what's gonna, what's gonna get you up and ready to just tackle the day?
[00:24:52] Laura Yecies: Yeah. It kind of goes back to what we were talking about before that most of my career I've spent more on the commercial and marketing and sales side. And since I've been at BHT, we've been very much in sort of science and research mode, which has been very interesting, fascinating. I've enjoyed it, but I'm really looking forward to this next phase where we can get the product on the market. I mean, I hear from patients multiple times per week. "When is this gonna be available?" And I don't like saying "it's not available today."
[00:25:27] Lindsey Dinneen: Yeah. . Yeah.
[00:25:29] Laura Yecies: I wanna say today, and that feels tantalizingly close. I'm very much looking forward to that. And, first doing it at a small scale, we have a waiting list of patients. And I wanna, kind of put a shout out on that. We will first go to the waiting list. To make the product available and people can sign up at bonehealthtech.com and the front of the line are the patients who, the citizen scientists who participated in our pivotal trial, and they're, we have another trial going on. They're first in line. They have contributed so much and did it really out of a total generosity of spirit. They had minimal compensation. And then of course to get to the next level of, hitting the gas and growing the availability and distribution of the product. I'm imagining, I talked about hiking before and that's because I love to hike and I'm imagining, osteo boosting hiking groups or something like that. I know that sounded corny, but.
[00:26:27] Lindsey Dinneen: Oh, I love it. . No, it's fun. And that is so exciting. I am really cheering you on as this next phase comes to reality. That's, yeah. That's incredible. Pivoting just for fun, imagine you were to be offered an opportunity to teach a masterclass on any subject you want. It doesn't have to be in your industry, but it can be, and you'd get a million dollars for doing so. What would you choose to teach and why?
[00:27:00] Laura Yecies: I think I would want to teach around marketing and commercialization, sort of product management, and then really the full life cycle of bringing products to market. I've been doing it for 35 years. I hate to say that. Sounds like a long time in various formats. I mean, I've, some of it has leaned heavily on the digital marketing. Some of it has been more B2B sales, business development. So I feel like I've spent a lot of time in that area and I have lessons learned to share. I actually enjoy teaching. I spent some time, when I first came out to the Bay Area, I taught marketing at Santa Clara Business School. I enjoyed it, but I enjoyed working in the marketing field more, and I had young kids, and so between a full-time job and kids, there wasn't also time for teaching. But I would love to get back and do more teaching. And I do executive coaching and I informally coach and that's a very rewarding part of my job.
[00:28:07] Lindsey Dinneen: Yeah, absolutely. That sounds like a great masterclass and very needed. So we would sign up for that one.
[00:28:13] Laura Yecies: Thank you.
[00:28:15] Lindsey Dinneen: And how do you wish to be remembered after you leave this world?
[00:28:22] Laura Yecies: Oh I mean, I'm a family first person and I am lucky to have great husband, four kids and today's six grandchildren. And the first thing that goes through my mind when you ask that question is, to have had just a really positive impact on them and the other family members and friends in my life. And then, work-wise if this device or our solution is effective it provoke small changes, but in our field, small changes over time can have big results. And, if we've prevented fractures and help people, I would be really honored to be able to be known for that.
[00:29:00] Lindsey Dinneen: Yeah, of course. And final question. What is one thing that makes you smile every time you see or think about it?
[00:29:10] Laura Yecies: My grandchildren getting to play with 'em when they want, when they come through the door every Friday.
[00:29:16] Lindsey Dinneen: Aw.
[00:29:17] Laura Yecies: We have a family dinner almost every Friday night. And I look forward to it all week and when they walk through the door. So that's my mental image and I for sure smile with that one.
[00:29:29] Lindsey Dinneen: Oh, I love that . What a great tradition. And I, it's so lovely that all your families, or at least some of your family, is close enough to be able to do that. How fun.
[00:29:40] Laura Yecies: Yes, it's really fun. It's fun. And I grew up with that so I'm trying to continue, with the next generation.
[00:29:47] Lindsey Dinneen: Yeah. Yes. That's fantastic. Laura, thank you so much for joining us and sharing about yourself, your background, and the incredible work that you and your company are doing. I'm so excited to see it come to market and just really impact lives. Thank you for the work you're doing.
[00:30:06] Laura Yecies: Oh, my pleasure. And thanks for the chance to share it with people and for inviting me onto your show.
[00:30:11] Lindsey Dinneen: Of course, and we're so honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongfully convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So thank you so much for choosing that charity to support. We just wish you continued success as you work to change lives for a better world.
[00:30:40] Laura Yecies: Thank you very much.
[00:30:41] Lindsey Dinneen: Thank you, and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
[00:30:55] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Richard "RJ" Kedziora | Co-Founder, Estenda Solutions | Digital Health Solutions, Bettering Lives, & People-First Cultures
8 Mar· The Leading Difference
Richard "RJ" Kedziora, co-founder of Estenda Solutions, dives into the inspiring world of digital health solutions, where innovative minds are not just developing technology, but also saving and improving lives. RJ shares his journey from early software development days to creating impactful healthcare technologies, highlighting the importance of understanding patient and provider needs. With a focus on people and process management, RJ's story is a testament to the power of technology in making a tangible difference in healthcare through human compassion and the drive to better lives.
Guest links: https://www.linkedin.com/in/rjkedziora/ | https://estenda.com/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 025 - Richard "RJ" Kedziora
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to welcome as my guest today, Richard "RJ" Kedziora, co-founder of Estenda Solutions, focusing on people and process management which also provides strategic technical direction, guidance, and innovative insights, creating digital health solutions that improve patient outcomes, reduce costs, increase efficiencies, and improve patient provider satisfaction. RJ received an MBA from Westchester University and a BS in Computer Science from Duquesne University, where he received the excellence in computer science award. RJ is a frequent podcast guest, has spoken at numerous technology and healthcare conferences, and has coauthored articles in technology and peer reviewed clinical journals.
[00:01:37] Welcome to the Leading Difference, RJ. And RJ, I would love if you would start by telling us just a little bit about yourself and your background.
[00:01:46] RJ Kedziora: Yeah, Lindsey, thanks for having me. It's a pleasure. I look forward to our conversation. My background is through software development. Graduated with a computer science degree back in, in the early nineties before web and mobile and internet. So crazy days. And came up through those software development racks. Started out programming, got into requirements analysis, understanding what a solution is about, project management, general management. And then in 2003, with a good friend, we were working with together at a large consulting company in the pharmaceutical space, we went off and started our own company called as Estenda Solutions and remain there today. We just hit our 20th anniversary, which is always crazy when I can talk about decades, but it has definitely been an interesting journey. So my day to day is, I think of it as a digital solution architect. So helping a mix of large companies and small companies, startups develop tools, technologies, algorithms, better ways of looking and dealing, handling data, to make a difference in the lives of people.
[00:02:56] Lindsey Dinneen: Wonderful. That's incredible. So 20 years. Congratulations. That's no small task. . So I commend you for that. That's really exciting. I. Yeah. So how did the idea to start your own company come into being? Did you identify a gap basically in the market?
[00:03:15] RJ Kedziora: It's something probably even early on as I was graduating from college, always in, in the back of my mind to make a difference, to go off and try something new and really drive what I wanted to do. Even before starting my own company, as I worked in various different roles, I'd be hired by a company, I'd come in with a defined role, and then I'd always just find a niche. They'd be like, "okay, where does this company need help? Where can I make the biggest impact?"
[00:03:40] And that's how I went from software development into like more of the analysis and project management , 'cause I quickly realized software development, developing a digital product, it, you know, technology is important and you have to understand how to program and how to test, but it's very much about the people, the process, understanding what they're going through, and realizing those things. It was sort of a natural evolution of like, "okay, I need to strike off on my own and really drive projects and things like that with my talents and capabilities and now our team's talents and capabilities."
[00:04:17] We were fortunate in those early stages to have a Congressional grant for the development of a diabetes disease management application for military healthcare. That's how we got our start. So we worked with people like Walter Reed Army Medical Center, the Boston VA, the Indian Health Services, which is responsible for the Native American population here in the United States. Still working with 'em 20 years later, which is crazy that we have 20 year clients-- bunch of other clients that we've been working with, 10, 11, 12 years a across the board. So, it's been enjoyable from that perspective.
[00:04:53] And I always talk about, I've developed accounting systems, I've developed inventory management systems. And even a railroad car scheduling system, it's like, "Hey, great. We need to get that railroad from here to here. It's important!" You know, it's essential and the economy's important. But healthcare, there's that sense of giving back, of making a difference.
[00:05:16] Lindsey Dinneen: Yes. Absolutely. Yeah, I, that is one of the things that I really enjoy about being in this industry is you're right all of those things matter that you could do with your skills, because obviously you have those skills and can use them in all sorts of capacities but in healthcare and med tech, it's this really great extra layer of feeling like you really are able to impact people's lives directly. And it, it just, it has a different sort of feel to it.
[00:05:46] RJ Kedziora: Yeah. And our projects are typically on the R&D side, work, working with the R&Ds, working with academic medical centers, work with PhDs, with doctors, where they'll have an idea. It's like, okay, here's a different way of treating a patient with diabetes. A different way of looking at the data that you can collect around diabetes or other chronic conditions. I, I wear the Aura ring. It's there's a lot of data that's available there now. And so as we develop those solutions, it's one thing for us and the doctors, the PhDs, the corporations we work with to say, "okay, yes, this really works." But they, you know, they have to go to clinical trial. They have to go and do, they work in the real world. So we also have a couple PhDs on staff to help drive those discussions and do the planning around those clinical trials.
[00:06:34] And ultimately, in certain situations, things then have to go to the FDA to be approved and validated. These days, there's a new terminology called digital therapeutics that we're getting heavily involved with. It's a relatively new term, probably 2017, 2018 that came around. And if there's probably 300,000 digital health applications out there. Systems, you know, some of which we've helped create over the years. But there isn't extensive clinical evidence that they work. There's some, but not extensive, and I think of it as the difference between, supplements and prescribed medications. And so there's lots of supplements out there. You can go to your CVS, your Rite Aid and pick them off the shelf, and there's some evidence they might work, but the evidence isn't exactly clear.
[00:07:25] But then you go to prescribed medications, go through a very extensive, rigorous process of development of clinical trials, and then the FDA or other global regulatory bodies look at these and say, "okay, yes, this does make a difference." And that's the idea of digital therapeutics today is there are lots of digital health applications out there, but now people are taking these digital therapeutic applications: evidence-based, clinically validated, approved by regulatory bodies that can be prescribed by your doctor, by your provider. And more importantly than reimbursed by the insurance company. So making a difference.
[00:08:05] You know, and we talk about health, healthcare, and being able to make a difference. There's not enough healthcare professionals out there, particularly in mental health. There's a mental health crisis in the United States. We just can't train enough people fast enough. Digital health is a way to approach that, to scale, to increase access and equity to these systems, to the care and treatment people deserve, and so that's the idea of digital therapeutics. They can get out there, provide this treatment, share the information with your provider, and make a difference.
[00:08:38] Lindsey Dinneen: Yeah, absolutely. So what does it look like when somebody comes to you and says, "Hey, I have this idea for this app, for this software, whatever." And then how does it work when they start approaching you, and this is a brand new, never before , you know, project and you step alongside them. How does that work?
[00:09:00] RJ Kedziora: Yeah, it is. It is a great question. And we work with a mix of Fortune 50 clients, so big customers, global customers, lots of people, processes, technology. We do happen to be ISO 1345 certified, which quite simply means we have a, well-developed quality management process of how we do software development, very template driven, process driven. It's like, here's how we're going to do it, and then we demonstrate that we do it. We get audited regularly by external third parties, by our clients.
[00:09:32] But then we also work with startups who, in some cases don't really understand software and don't understand regulations and what's required to create one of those digital therapeutic applications. So when a customer does come to us in the, in those early stages, it's very exploratory. It starts out with prototyping understanding the problem in the domain space. One of the things that differentiates Estenda from a lot of other companies is we are going to provide the entire development team, software developers, QA from the ground up, educational training, medication training. So if you're working in diabetes or congestive heart failure or lupus, multiple sclerosis, the better the entire team can understand the condition, have empathy for the patient, can understand the provider, the care professional's journey about what they're dealing with and how they can care and treat that patient, the better off they're gonna be.
[00:10:27] So it's those early stages of experimenting and playing and we start with, you know, black and white wire frame diagrams and really get those going and gradually build them up. And I think about it as you, you have a problem and you want to get across town as fast as you can from one end to the other, and you can walk. Great. Okay. But it's not very fast. Okay? I have this idea for a car. I can get across town really fast, but it's gonna take a long time to build that car and realize value. So, let's first build a skateboard. Very simple, can do it very quickly, provide value, get feedback, from the stakeholders, from the customers, from the patients, from the doctors, the nurses, whoever we're developing that application for.
[00:11:15] And so you figure out the unknowns, you know, so what, aren't we sure? What areas are showing promise? So we build that skateboard and then it becomes a scooter with a handlebar, you know, okay, I'm getting across town faster. It's not the ultimate goal. But I can get there. And then you can build a simple motor on it,, and then you build a body around it and you progress gradually until you get to that car. But along the way, you're adding value very quickly, which is important.
[00:11:47] Lindsey Dinneen: Absolutely. Yeah, that sounds like a really good process to work through. And I love your illustration. That's such a great way of capturing the essence of the process and the way that you go through all of that. So, I'm curious, have you always had an interest in and passion for computers, technology, software development, or is this something that evolved over time?
[00:12:08] RJ Kedziora: Yeah, I was very fortunate. My parents were able to buy an IBM PC Junior when I was in probably seventh grade in the mid eighties. I went to a local parochial school. They had a computer lab, you know, as one computer in the classroom. But, for the eighties, that was phenomenal. And so I knew going into college that I wanted to do software development. A good friend had a Commodore 64, which is typically a gaming, and so I'd be over there and it's like, "okay, games are fun, but what can we make the computer do?" You know? So I was very early driven by what can I do and the possibilities of digital everything.
[00:12:49] College, I really thought I was gonna go and get the PhD in artificial intelligence. Very much enamored with that idea. Ultimately as I got ready to graduate, I got offered a job and was like, huh, money and so that, that turned my, you know, immediate trajectory there. You know, I did start working in programming kind of thing, but always followed AI and things and applied those ideas and principles and what AI is, has evolved a lot over the years. We've developed some AI systems in the past, but you know, now when you look at them, they're really like rules engines, and think things of that nature. And they were considered AI at the time, but nowadays it's like, "okay, that really wasn't AI."
[00:13:36] But you know, the idea is, and the principals were there, and one of my senior thesis projects was genetic algorithms and how do you apply the idea of genetic algorithms to solving computer problems? And that was at the early stages of the internet kind of thing, just as a browser were coming out. So that made research interesting 'cause you could even at that early stage reach out globally to people and seek ideas and thoughts and stuff like that which led me down that road. But fast forward 30 years now and AI is everywhere. It's all that, that the media can talk about these days. Rightfully so.
[00:14:15] Lindsey Dinneen: Yeah, and actually that brings up a great question that I had for you, because I did notice on your LinkedIn, you do share a lot of articles about AI, and you're obviously very involved in that. How have those tools helped your work or how has it changed your work or whatnot? How do you feel about all of that?
[00:14:33]
[00:14:33] RJ Kedziora: It really comes down to data. That's the core of AI. In the past and today, you need data to be able to train the AI systems to do what they're capable of. And it's interesting, our journey as Estenda is, as I've been reflecting on it was one of data scarcity. You know, 20 years ago, getting data was the difficult challenge. In diabetes, it was typically finger sticks, and people would, you know, do it a couple times a day and EMRs were there. They existed. We were lucky working with government organizations that had them, the military, the VA had them. Now it's, you know, fast forward 20 years later, there's an overwhelming amount of data. So early on it was like, how do you make decisions with limited data? Now it's like, okay, how do you use all of this data and pick out the important, salient things to be able to make decisions on and drive recommendations,
[00:15:29] And the same thing is true with AI today. As you're developing a system, you need a robust set of data to train the AI systems. The broader data that you have, the better off you're gonna be. Day-to-day. I think today, generative AI, you know, the Chat GPTs, the Bards, what everybody's really, the media is talking about are amazing. You need to know and understand how to use these tools today. And it's not so much where they are today because there are challenges, there are problems, you know, they make up stuff. It's called hallucinations. And so you do have to fact check what they do. It was interesting is I was sharing, we do a monthly all staff meeting kind of thing, and I was sharing my experience with chat GBT and one of the people on the call sort of googled, like, tell me about Estenda. And it made him the president of the organization kind of thing. It was like, he's a great guy, does amazing work us, he's not the person. And it was just one of the odds of that, in that moment, kind thing. It was like, yeah, that's not true.
[00:16:34] Lindsey Dinneen: Right.
[00:16:34] RJ Kedziora: So you do have to fact check it. But that's today and where we are. And so imagine where we're gonna be 10 years down the road. And Bill Gates said a long time ago, "Humanity overestimate what technology will be capable of in, in the 18 months, two years, underestimate where it's gonna be in 10 years." And I think about Estenda, if the iPhone didn't exist, Facebook didn't, Instagram, Twitter, X, none of these things existed when we started, and here we are a short 20 years later and the world's changing. In terms of AI now it's really an efficiency thing. And it's like, "okay, I need to do some blog posts." And yeah, I can sit there and come up with the blog, post ideas, but it's like "Hey, ChatGPT, gimme 10 ideas for blog posts," you know, and I might not like four of 'em. Okay, "gimme four more." I don't like this. "Gimme four more."
[00:17:29] You know, and it's just, it's an efficiency thing. Even in healthcare, that's what we're seeing. So there are, a lot of, I think it's over 400 now, approved, FDA approved AI algorithms very much in the idea in the area of radiology and looking at images. That's by far the biggest use of . Today, if you have those images, you can train systems to recognize certain things, you know, whether it's breast cancer or diabetic retinopathy. You can train systems to recognize what you need to see in those images instead of a person looking at them all the time. So, again, you can scale much more effectively, which is nice. But in, in healthcare it's very much, it's that efficiency question.
[00:18:09] Lindsey Dinneen: Yeah.
[00:18:10] RJ Kedziora: It's like, okay, I know how to write a prior off letter for this patient, but that takes time. So have ChatGPT write the prior off letter. And then you as the physician, the trained professional, have to look at that and evaluate. And you can't just send it off. You do have to look at it, but you know, EMRs, there's a plethora of data in the EMR. Let the AI systems...
[00:18:35] Lindsey Dinneen: Yeah.
[00:18:35] RJ Kedziora: ...you know, surface what is important, is a challenge. EMRs is a general idea, are very much around capturing data for billing, not the best, usable experience. If you can use AI that's just listening in the room to then document that encounter, that provider's now not heads down on the computer typing, trying to make sure they get everything in and not looking at the patient and not paying attention to the patient.
[00:19:02] Lindsey Dinneen: Right.
[00:19:03] RJ Kedziora: It can reverse this kind of thing. It's like, okay, the doctor can now pay attention to the patient and look at that person and really understand their situation better and pick up on those cues of just their body language kind of thing, and not have to worry about typing away at the computer. And then there's a lot of duplication in clinical records. So it's like, let the AI systems get rid of that duplication, make it better. And then just, you know, enhance. And I saw an article, I think I posted about it, the idea of collaborative intelligence, but a lot of people are asking is, AI going to replace Doctors, software programmers, software developers, insert profession X, is AI gonna replace it? And then people are like, "AI is not quite there. AI makes mistakes. It has biases. AI Hallucinates."
[00:19:50] I love my doctor, but my father has said over the years, " the doctor that graduates last in his medical school, what do they call him? Doctor!" You know, they're human. That, and that's what it amounts to. It's, they provide a great service, but they're human too. And they might not recognize everything. And so if we work collaboratively with the AI to balance that out we can improve overall care and treatment. So.
[00:20:18] Lindsey Dinneen: Yeah, so a lot of potential for it, and I love your idea of using it for some of those more tedious, time consuming tasks and just giving you your first draft because it's not, like you said, it's not gonna replace the human. Let's look through this. But it can help. And if you're using it appropriately, there's a lot of good uses for it too. So, yeah. So, you know, there's a couple of things that I noticed from your LinkedIn profile I'd love to chat with you about. One of the things that stood out to me was in your headline, you mentioned Chief People Officer as being most important. So I would love if you would speak a little bit to that and why you feel that way.
[00:21:00] RJ Kedziora: I can do a lot, but I can't do everything. So I, the people that work for us are very important. I can make an impact. A team can make a much bigger impact. A company can make an even a bigger impact. So that is, that's why they are important. I talk about family first a lot. And, we provide fully paid healthcare benefits for you and your family. You want to have that sense of safety, want people to feel that they can take risks, and do their best work kind of thing. And the better they feel, that emotional safety, that the better off we're gonna be as an organization. They'll be able to provide more value to that customer, be more productive, 'cause ultimately that's what it amounts to is we need to get software out the door. We have customers and clients that have needs and demands and we have to meet those, but you know, you have to balance that with life. So.
[00:22:02] Lindsey Dinneen: Yeah, absolutely. And I love the emphasis on people first, and I'm, I'm wondering if that's something that, is that an ethos that developed over time for you as well as how did your leadership skills evolve? Because going from starting a business to then and then growing it, I mean, it's a whole thing. So, yeah, I'd love to hear a little bit about that.
[00:22:24] RJ Kedziora: Yeah, it definitely has grown and evolved o, over the years. It there, there's this concept of being a 10x software developer, one person making the impact of 10 people. And that's somewhat of a myth, but there are people that are more productive than others. And the idea of empathy and understanding that other person's perspective and experience is what's driving to that next level to become that 10x developer. You're not developing for yourself. You're developing for the end user, but we embody it in, we have a professional development process, and the idea of helping others is embedded in that.
[00:23:01] You'll see that we do one-on-ones, not as great, as frequently, as I would like. But we try and do those. But as part of our structured plan, we do a self-assessment and we ask everybody that question, "how have you helped other people?" as part of the goal process, "how are you helping others?" But even as you're developing in that day to day when you're writing code, "how is it helping you in the future understand what you're doing? How does it help the tester better test that software? How does it help the support person provide better support?"
[00:23:37] So it's really thinking about how you're helping others along the way. And ultimately the whole company is driven by that of working in healthcare. But it starts at that bottom of every person. It's like, "how, what you're doing, helping the next thing?" So we try and constantly reemphasize that when we can.
[00:23:54] Lindsey Dinneen: Yeah, that's a great approach. And so, and because that is so much the heart of your company and your people, I'm curious if there's any particular moment that stands out to you as you've gone along this journey, that kind of really reinforced, yes, this is why I am here doing this work. Is there anything that, or a series of moments, just things that really stand out as being a very sure "yes, this is correct" for you?
[00:24:20] I
[00:24:21] RJ Kedziora: Yeah. It, I would say it's more a series of moments, because as we've developed software and then it's used by the care providers or patients, we've constantly over the years, hear those anecdotal stories of "Hey, I was using your software, what you developed for us, and found this and helped this patient." There's a series of those, but then it even goes up, it bubbles up that we do those clinical trials and we've done five year NIH funded National Institutes of Health funded RO one study. So it's like a five year study to then demonstrate that the software we produced does make an impact kind of thing.
[00:25:00] But even more importantly, as we're part of that process, we've had several customers put our names, our developers' names on patents, or as those articles have gone to clinical journals, peer review journals that our software developers and QA, other staff have been authors on those. That, that's just rewarding where, okay, yes, we are helping people, but then our customers are also recognizing how much of a part of this journey we are. You know, if you really know what you wanna do and have it, here's my 10 requirements kind of thing. We're probably not the company for you. Let's explore and create something together.
[00:25:38] Lindsey Dinneen: That's really cool. So it's always a collaboration it sounds like with your clients. It's not just a one way or the other, them dictating to you or you dictating to them. It's this, let's figure out the best way for us to work together.
[00:25:50] RJ Kedziora: Yeah, it says how do we add value? How are we, you know, we want to contribute.
[00:25:56] Lindsey Dinneen: Yeah. That's amazing. Yeah. So, one other kind of random question. Based on your LinkedIn profile, when's your next triathlon?
[00:26:04] RJ Kedziora: How much time do you have?
[00:26:06] Lindsey Dinneen: Yeah.
[00:26:06] RJ Kedziora: I, yeah, that's a whole 'nother podcast.
[00:26:08] Lindsey Dinneen: Yeah, sure.
[00:26:09] RJ Kedziora: I think I'm, I think I'm, I think I'm done for this year. I live in the Philadelphia area, the temperature's getting, yeah, temperature's getting a little colder and that type of thing. But, you know, take a little rest for a month or two before I get back into training. And, but there are definitely ones I do every year. There's one escape from Cape May, Cape May, New Jersey. You jump off the back of a boat, the ferry, into the ocean and swim to shore. I did escape from Alcatraz two years ago, which is interesting because they take you out in a boat, in, into the. And jump off the boat from Alcatraz and swim to shore. Always interesting kind of thing to, to do those, but it's very much-- it's interesting because my day-to-day at Estenda, my own company, and how I get involved in projects is 'cause I enjoy the challenge of it.
[00:27:00] And in triathlon, yes, there, there's a definitely a physical aspect of training and, but it is also very mental to, and that's really what I think drives me in the sport of triathlon. It's like, "okay, I need to get up at 4:30 and go jump on the pool and swim for 45 minutes and then hop on a bike" time and time again. And I thoroughly enjoy it. But yeah, it is that mental challenge. I've done just pure marathons in the past and it's like, "okay, get to the next telephone pole. Get to that next half pot." It's that mental, keep pushing kind of thing is drives me.
[00:27:34] Lindsey Dinneen: That's incredible. It just reminds me-- tangent very quickly-- it reminds me, I remember I was running a 10k with my husband and I'm not a runner, I don't claim to be, but I was doing this challenge for myself, and I just remember we, we were getting close and I was so exhausted and, you know, kind of miserable at that point. And he was like, "it's all downhill from here. It's all downhill." And I was like, "it's literally sloping up!"
[00:28:00] RJ Kedziora: Yeah, but it's, you know, it's like, yes, for me, try, it's hard. It's difficult kind of thing. but I'm also good enough that I'm not out there it's like, for a a marathon, I can-- in the past it was like 3:20 for a marathon.
[00:28:16] Lindsey Dinneen: Wow.
[00:28:17] RJ Kedziora: But there are people out there that are five hours, six hours. I think that is so much harder, so much dedication for that individual to be out there for five hours. It's kudos to you for being out there for, you know, it's like, yeah. I'm not saying I, I have an easy time of it by any means, but I'm not out there for five hours and they did it. So I just, I'm astounded by those people and they're not on the couch. And I know I, I look to have a long lifespan and a long healthspan. I want to hit a hundred years, but with a good quality of life. And I have a couple friends that are in, still out doing that 5k at 70 years old, and they're like, "I won my age group! I was the only one in my age group..." but you weren't on the couch! Like you did it! And that's motivation to, to keep going out there as well. So hopefully I'll be that person.
[00:29:10] Lindsey Dinneen: I love it. That's brilliant. Excellent. So, pivoting just for fun, but imagine you were to be offered a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why?
[00:29:29] RJ Kedziora: Oh wow. It would probably be about health.
[00:29:34] Lindsey Dinneen: Okay.
[00:29:35] RJ Kedziora: Which, which combines sort of everything I do. The triathlon, the training, the fact that I'm in software development in the health field. It brings all of those things together. And just a lot of people don't know what they don't know. And so if I could impart that knowledge on more and more people, I think that would make an impact that would make a difference. So yes, I could teach a software development course on cybersecurity. Interesting.. I could teach one on AI. Yes, interesting. But if it, if you really just focused around the idea of eating better, moving. You don't have to do a triathlon, you don't have to do a 5k. And it's like park a little further away from the supermarket and walk. You're gonna be better off, have that longer lifespan, longer health span. So yeah, it's, if I have that million dollars and it is probably health in in general, which encompasses a lot. But yeah, it would be health.
[00:30:37] Lindsey Dinneen: Yeah, absolutely. Yeah. And then, how would you like to be remembered after you leave this world?
[00:30:44] RJ Kedziora: Huh. Wow. Then I've made an impact and I've made a difference in, in some small way. I don't have to win the lottery, I don't have to be the billionaire kind of thing, but that, that I've made a small impact and, the lives of the people around me and hopefully a bigger audience through the work that I've done, that our company's done. And yeah, I've made a small difference and made a few people laugh.
[00:31:12] Lindsey Dinneen: Yeah. Yeah. I mean, I've already laughed today. So , you're succeeding. Excellent. And then final question, what is one thing that makes you smile every time you see or think about it.
[00:31:26] RJ Kedziora: Family, I, that's, you know, wife. I have two daughters, 24 and 21, doing very well. Yeah, any chance I get to see them? Family.
[00:31:36] Lindsey Dinneen: Yeah.
[00:31:36] RJ Kedziora: And oldest of six. So you get to see them and their family kind of thing. Family's important, yeah. Yeah.
[00:31:43] Lindsey Dinneen: Yeah. And you've mentioned that several times: family first and people first. So it's a running theme. . That's great. RJ, this has been so much fun. I really appreciate your time today and just thank you so much for joining us. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational and safe environment. So, thank you so much for picking that, that organization to support and we just wish you continued success as you work to change lives for a better world.
[00:32:24] RJ Kedziora: Thank you very much. This was a great interview. Thank you.
[00:32:27] Lindsey Dinneen: Excellent, excellent, and thank you so much to our listeners for tuning in and if your feeling is inspired as I am right now, I'd love if you'd share this with a friend or two and we will catch you next time.
[00:32:38] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Dr. Scott Bertrand | AllCore360 | Spinal Injuries, Core Stability, & Changing the World Through Medtech
23 Şub· The Leading Difference
Dr. Scott Bertrand, the inventor of the AllCore360 therapy optimization platform, shares his journey, beginning with two significant spinal injuries that led him to question conventional physical therapy methods and ultimately steer his career towards chiropractic care and MedTech innovation. He discusses his invention, which revolutionizes core training by focusing on isometric exercises, benefiting a wide range of individuals, from spinal injury patients to elite athletes. Scott's personal experiences and challenges fuel his passion for MedTech and his desire to impact lives positively. His story is one of perseverance, innovation, and the power of using personal challenges as catalysts for creating solutions that can change the world.
Guest links: www.allcore360.com
Charity supported: Sleep in Heavenly Peace
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 024 - Dr. Scott Bertrand
[00:00:00] Lindsey Dinneen:
[00:00:05] Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:14] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:20] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:33] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:43] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:47] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:55] Hello, and welcome to The Leading Difference podcast. I'm your host Lindsey, and I'm so excited to introduce you to my guest today, Dr. Scott Bertrand. Scott is the inventor of the AllCore360 therapy optimization platform, and currently the chief research officer with AllCore360 America. He is retired after 35 years of caring for the chiropractic needs of a wonderful community in south Atlanta. He is a proud a 101st Airborne veteran and honored member of Mensa, but most importantly he's married to his wonderful wife, Lori, has two incredible children, Stephanie and Luke, who have blessed him forever with five precious grandchildren. Thank you so much for joining us today, Scott. I'm so excited to have you on the show and hear from you.
[00:01:40] Dr. Scott Bertrand: I appreciate the opportunity to speak with your audience and to you.
[00:01:45] Lindsey Dinneen: Excellent. I would love, if you wouldn't mind starting off by telling me just a little bit about yourself and your background, and let's start there and then we'll get into some of the other fun things.
[00:01:58] Dr. Scott Bertrand: Let's go back to where probably my medtech life started. I had two separate spinal injuries that kind of thrust me into the healthcare world. One when I was 19 years old and I had a fracture in my lumbar spine, and when I was 19, I was brought up in a blue collar, middle income family and my parents, you know, believed that medical providers were set next to the Pope. I, it was whatever they said, whatever they did, that's how we looked at it. And I thought, I felt no other way. I had, I'd injured my spine and fortunately I wasn't paralyzed at all, but I was definitely beat up and pretty painful.
[00:02:36] But I went into the therapy process at that time just excited to recover. In my mind, the medical doctor would fix me. That's all. I mean, I knew I was broke, but that was his job, and I believed that's what he would do. He goes on and, you know, I'm not putting fingers at anybody. I realize that he was doing the best he could with what he had at the time he had. So I, I'm not, this isn't anything negative, but he refers me to a physical therapist, of course, which he would. I excitedly go to my physical therapist and instantly he requests me to do things that were incredibly uncomfortable, very painful. And I remember kind of leaning back and going, "whoa, wait a minute, that this problem isn't a good thing. This is quite similar to the trauma. Let's probably not do that." But, you know, he kept insisting that I needed to do these movements, and these movements were brutal.
[00:03:30] I was 19. I was an athlete. I had been in the 101st Airborne. I was a, I guess you could quote, kind of a tough guy, but, you know, this was incredibly uncomfortable. And I, I finally, after several visits going back and forth with him and complaining that this was obviously not the right approach, he just looks at me and says, "Hey, you know what, Scott, what you need to do is suck it up." And, you know, this really wasn't a suck it up thing. I mean, I know what suck it up is,
[00:03:57] Lindsey Dinneen: Yeah.
[00:03:58] Dr. Scott Bertrand: That really wasn't it. And I was incredibly disappointed and everything just kind of fell into my like, oh my gosh, maybe they don't know everything. It was kind of a, oh my gosh moment for me, but I ended up going, you know, this isn't gonna work for me. I'm gonna have to, I'm gonna have to quit.
[00:04:14] And so I look over at him and he takes a stamp and puts "non-compliant patient" stamp on my file. I remember going, wait a minute, I'm not "non-compliant." There's nobody that wants to get healthier than I do. He released me and that's how I was. That's my name. I'm a noncompliant patient. So I was really frustrated at that time and I thought, this is really not right. I, but what it did do though, is it focused me in healthcare. You know, I'm a young man and I'm not sure what my career is gonna be. I don't know what I want to do in life exactly. But I went, oh my gosh, some missing links here. And I, at least I need to know more about it for my own self, you know, my own health.
[00:04:54] So I started pursuing a career in health, and I ended up going into the chiropractic profession because I had injured my spine. And these people seem to be the ones that were the spinal professionals. So I go to school I'm going through this process. I'm learning about the spine and the body, the miracle machine we drive, which these are the first kind of early things that are going off in my mind going, oh my gosh. We're blessed with a miracle and we're just trying to learn how to take care of it.
[00:05:23] I'm getting ready to graduate from chiropractic school. I'm at my brother's wedding. I dive off the high dive. I shouldn't have been up there to begin with. I hit somebody in the pool and I break my neck. Okay? It's like, oh my gosh. Here we are again. I'm thrust into this space again. I'm not paralyzed,
[00:05:38] Lindsey Dinneen: Oh
[00:05:39] Dr. Scott Bertrand: and I say that because I've treated and worked with so many people who are...
[00:05:42] Lindsey Dinneen: Yeah.
[00:05:43] Dr. Scott Bertrand: That I don't wanna put myself in that basket. I wasn't, but I was, you know, it was a shocking experience to say the least, and incredibly uncomfortable, and it took a long time to heal, but it's been a good eight, nine years since the first trauma, and now I'm almost a chiropractor. I'm graduating from chiropractic school. So I've got a really strong background, at least anatomy and physiology and how the body works, and excitedly. I go off to therapy again, and I look across the table and he asked me to do the same movement again that they recommended 10 years ago.
[00:06:13] I'm like "whoa, wait minute. I know that doesn't work. Let's not do that. What else do you have?" " No, that's what we do." And I go, " no." And we went back and forth. And then he said to me, Scott, "you need to suck it up." The second "suck it up" got me to walk out of there and say, "look, there's something massively wrong with how we're treating this. I don't know what it is yet, but there's something wrong and it needs to be corrected."
[00:06:36] Medtech is coming up with some innovation that addresses a concern in the medical world that hadn't been addressed that way before. So there's a long process between "I have a problem and I'm trying to figure it out," and "I come up with a solution." I don't wanna underestimate the time that requires. There's a long gap of time in there, but then, okay, now we have a solution. And I guess really, Lindsey, that's kinda where it starts. I invent the AllCore360. That's an interesting conversation if you wanna go into that. But that's what threw me into the MedTech industry.
[00:07:10] And that's where I realized that, when you come up with something in MedTech industry, it's not like a better windshield wiper, which Lord knows we might need better windshield wipers, and that's good. But when you're impacting people's lives and the way that we got to do that, and it's a global reach. It's not just like across the street, across the neighborhood. When you can impact a human being, there's a strong possibility you can impact us all. The awareness of knowing that I can help the world was the motivation in everything. That really was, I think, that's what drives everybody in the medtech industry.
[00:07:44] It's an innovation that can impact society in a way that it needs, but it can do it on such a grand scale and it's not . I know you have a lot of medtech industry, so I know I'm preaching to the choir, but it's not about money. You'll be rewarded certainly, but you'll spend your money, but I'll never be able to spend the hug from the mother who I took care of their daughter and help her to walk. Not only does, I can never spend that, that just gets interest. That just gets better and better, and then they tell somebody else and it grows and it's, it's a, it's just a wonderful industry to be in. Tough, hard, really hard, but oh my gosh, are the rewards amazing.
[00:08:24] Just anybody in that space and is struggling and Lord knows I know how hard that is, please don't give up. It's so worth it. You know, we all say if we could just take care of one person. Back to what I said, if you can take care of one person, you can probably take care of 'em all. And that's, that is pretty exciting. And I've been able to do that. That's where we're at now. I've, you know, it's taken my whole life to get here and decades, but, you know, we're here now and we're really, I'm really proud and I could not be more happy with what the company and our team has been able to do.
[00:08:57] Lindsey Dinneen: That was fantastic. I loved hearing it. I love hearing your background and what motivated you to get into this field, so thank you for sharing, especially some of those really personal stories of challenges that you had to overcome, which ended up being the catalyst for. This new stage. So I wouldn't, I certainly wouldn't wish those injuries upon you by any means, but I am, I want to recognize and thank you for taking those kinds of really challenging periods of your life, but using them as catalysts for good. I think that is very commendable and not easy.
[00:09:34] Dr. Scott Bertrand: No, and I appreciate you saying that. And I kind of joke, but only a little joke that this kind came to me. This invention came to me after months and months of studying on all the issues I was trying to resolve in that kind of hypnagogic state. You know, that's that dream state. It actually came to me in a dream, and when I realized what it was, I realized that was a gift. I'm giving this gift, and now the job is to share that gift. You know, in medtech it's a lot easier said than done, but that's kind of the next step. And they know we've been able to do that. We finally have and it's been a blessing that I've thoroughly enjoyed.
[00:10:14] squadcaster-bf62_2_10-20-2023_140435: Yes. Yes, absolutely. And like I said, thank you so much for sharing about that. And there's so many questions that I have that popped up from it. But I'll start with, I would just love to hear more about your company now and your incredible device and how it works and how it's changing lives.
[00:10:32] Dr. Scott Bertrand: Oh, wow. Thank you for even giving me the opportunity to share that because that's unique and that's why, I guess it's an invention. It's not been out there before. So to do this real quickly, the, the design of the device is to train the core. And when I started, the core was an apple core. People didn't know what cores were. We used to call it the trunk, but anyway, it was, it's the core. And so what we're gonna call "the core" is from the base of your skull to your pelvic floor, that tube of muscles that is who you are. We plug arms and legs into it, and if you're an animal of flippers or fins or wings or whatever, but we're all just this tube of muscles that is that core.
[00:11:12] And so the design of our, my device is to train that core. And so the, here's how we do it contemporarily. We take the core instead of, you know, really realizing we're a tube, we're a round tube. We call ourselves a box. I'm not sure where we came up with that, but now we say our tube has its front and a back, and a right and a left when tubes don't have front and back and right and left. But for some reason we called ourselves a square and then, and that was our first mistake, but we just all just accepted that like, "okay, um, our eyes are pointing forward, so let's make our box pointing that way." So what we did is we took this square, we decided what the square could do.
[00:11:54] The square could bend forward at the waist. It can bend backward at the waist. It can bend to the right at the waist. It can bend to the left at the waist, and we're gonna challenge it that way to make it better. You know, I think what happened was people did that and they got better. There were, it does that kind of works. It wasn't a horrible thought. It was just a, an incomplete thought. So what the AllCore does is it takes this 360 degree machine, it's really a 360 degree machine that can go in any direction. It can bend and twist in any direction, and it takes it and challenges it in every direction. If we took our box example and we bend forward, bend backward, bend right, and bend left, that's four degrees. That's four separate degrees of movement.
[00:12:40] We've only left out 356. What about all those other movements we just left out? And I'll tell you where one of the lights went off that I, this is kind of what makes it so unique, I believe. We are, we train the core isotonically, and by isotonically, I mean, we bend and twist and move. So right now, 99% of the people that run down to their local workout gymnasium center, they go in to do their core and they bend in half. Let's call it like a sit-up. They do sit-ups. When I was like 15, we were doing sit-ups, so you know, that's not anything new. Okay. And then they, we got really clever and we started calling our sit-ups "crunches." That's the same thing. A crunch is a sit-up, but we somehow thought that was even better. And then we went we can make a machine to do that. And then we had a crunch machine. But what we have, it's the same concept. It's bending in the middle of our bodies.
[00:13:40] This was one of the, oh my gosh moments. They, one of these things that eureka moments, if you will. I walked out of the gym one day and I'm a gym rat. I live there. I, that's what I did. And I realized that . If for some reason I'd never walked into the gym, I would've never done a sit-up in my life. Sit-ups are not things we do. These are not positions we get our bodies into. There's no sport where everybody lays on the ground and bends it half 50 times. I started to go, "why in the world are we working so hard to do this one movement when we never ever do that movement?"
[00:14:19] And I thought, "oh my gosh." My next Eureka moment comes in. Now I'm outta chiropractic school and I'm working really hard and I realize we're working with this miracle machine body and I, all of a sudden, I had to start laughing at the way we treat the body 'cause I was reading old medical journals and old history medical journals. I mean, there was a time when they thought smoking cigarettes made you a criminal. I mean, I know that medicine only took what we could take and we believed it and we taught it and we treated it. But what I really realized now, the things we think are true now may not be true in the future, unfortunately, but what I realized, what medical providers and medtech providers really need to do this to me became the bottom line.
[00:15:02] We were blessed with this incredible healing miracle machine. To ever think that somehow our brain that read that book knew better than our body did on how to take care of our body was ludicrous. Our body knows how to do everything. We're the best survival machine on the planet. This machine knows how to heal. It knows how to do everything. In fact, it's a lot better if we just stay the heck outta the way. The more we get involved, the more we screw it up. So here's what I think physicians really need to do, and this is what I kind of decided to do at the medtech, is realize what the body does to survive.
[00:15:43] Because that's really all it's about. It's about survival. There's no extra parts on the body. I mean, everything on the body has a survival value. And if you want to improve the body, you help the body in its ability to survive. So what I did was I looked at the core, and this is, these are these eureka moments. I looked at the core and I said, "what really is the survival value of the core? Why am, why do I have a core? I mean, what do I do with it that helps me survive?"
[00:16:12] It dawned on me almost immediately. The core, as much as we think the core is designed for movement, there's not a lot of survival value to movement. I'll take that back and say, if a rhinoceros was coming after me, I need to step outta the way. So I understand there is a survival, I gotta move, but let's say I didn't move when the rhino hit me. How was I damaged? I was damaged by being bent around the rhino's head. My body went beyond its normal range of motion. So what really is the core designed for?
[00:16:48] And here's the key. It's designed to isometrically maintain your posture in the most efficient, safe position possible. Your perfect posture is so perfect. It's almost hard to get damaged where you're in that perfect posture. When you bend to the left and pick up a weight, you took yourself out of the perfect posture and oh my goodness, he blew a disc. You know, you took your posture, got it out of position, and then challenged it. So that's not how you should challenge your posture. You should take your posture, put it in a perfect position, and then isometrically challenge it because that's how we use it: isometrically in the 360 degrees of its potentiality.
[00:17:31] It needs to be able to do all those things isometrically, and at the end of the day, the AllCore360 takes your body, your only athletic ability has to have the ability to sit. You know, sometimes you go to the gym, you look across the floor and you go, "oh, that looks like a great exercise, but I know I can't do that." The AllCore, all you gotta do is sit and what that does is that adds everybody on the planet. That's your senior citizens. That's people in wheelchairs, that's people that don't have legs. It addresses so many people in the population. All you have to be able to do is sit and we can make your core better.
[00:18:10] At the end of the day, like I said, the core is everything. So what's the survival value of the core? It's not to bend. It's to stop from bending too far, 'cause if you bend too far, something breaks. So what you do is you stop it from bending and you stop it from bending in every direction, and you do that isometrically. That's how you need to challenge the core in the way it was designed to perform. Once you do that, once you develop a very balanced, coordinated strong core, that core can go hit golf balls and baseballs and do anything it wants, but you can't train a core by hitting golf balls and baseballs and all those things.
[00:18:49] You train the core the way it's designed to perform. You make it efficient and strong and high endurance and balanced. What you're really doing is taking your God-given miracle machine and making it the best it can be. As opposed to what most of us do is we take this incredible miracle machine and we beat it up until we kill it. So it's a better way to look at it. We really should take care of it. But yeah, so it allows most of the population, and 99.95% of the population treat their core in a balanced, optimal fashion and it only takes 10 minutes, three times a week.
[00:19:29] One of the problems with therapy, and one of the problems with fitness is always I don't have the time. I don't have the time. My goodness. 10 minutes. It takes you longer to put your gym shorts on. All you gotta do on this machine for 10 minutes. That's how it works. And because of that, people really -- they're compliant. Back to my non-compliant patient status, if it's only 10 minutes, you can kick people to come and do 10 minutes.
[00:19:56] Lindsey Dinneen: Yeah.
[00:19:56] Dr. Scott Bertrand: To have someone come in and do an hour and a half, and now they need all kind of other things in their life that they can use for excuses.
[00:20:02] Lindsey Dinneen: Right.
[00:20:02] Dr. Scott Bertrand: 10 minutes isn't a big commitment for the remarkable, miraculous results it gets for some people. That's kind of how it works. And it's, like I said, it's a it's a blessing, and it started in this spinal cord injury space because what it did for people who only have their cores, I mean, this is what they have. They don't sometimes have arms and legs. This is what they have. So it started in that space, but when those patients and clients started sporting six packs and losing 10 pounds, all of a sudden, everybody wanted it. Everybody wants a six pack, everybody wants to lose 10 pounds. And that's great.
[00:20:39] So we definitely are in this spinal cord injury space, this extreme rehab space, this weekend warrior rehab space. But we're also in that elite athlete space. We're at a lot of colleges, university, sporting clubs. They're seeing that, it's much better to prevent injury than always trying to fix it. Doctors go into the world praying that they get to take care of people and they teach 'em how not to get hurt. But really what they do, they get thrown into this world of broken bodies, the people that don't take care of their bodies and they don't listen to you and you never get a chance to teach them even how to take care of it. Right? So it was an opportunity for us to really impact lives. We don't need a lot of time, we just need you to show up and this, and it works that way.
[00:21:21] Lindsey Dinneen: Wow, that is incredible. And yeah no, it is incredible, and I love that there are two extremely important case uses for-- more than two-- but I was thinking about it in terms of, like you said, injury prevention, just in general, health, wellbeing, physical optimization, versus also, then you have the Yeah, versus also, then you also have treating,
[00:21:47] Dr. Scott Bertrand: Right.
[00:21:48] Lindsey Dinneen: Right. Yeah. So I think it's incredible
[00:21:51] Dr. Scott Bertrand: That opens up such a big market.
[00:21:53] Lindsey Dinneen: It could exactly right because everybody could benefit from this. This is literally something that could impact everybody's life who participates. Holy mackerel.
[00:22:02] Dr. Scott Bertrand: And the nice thing was, it's if you knew where there was one or you used one, I. What I get to do every day, although oftentimes it's cry because these stories are so overwhelmingly wonderful, but I get to hear on a daily basis almost about these recovery stories and it's because we weren't doing it right. It's not that-- I mean, I appreciate the fact the AllCore is the, it's my device and our device, and it's doing what we said it would do-- but it's the body. The body-- if you treat the body right, it just does the right things. It just needs someone to kind of just help it a little bit. It's a miracle. We just need to kinda encourage it sometimes, and that's what this really does.
[00:22:43] And the, again, because it's the results and the responses are so rapid, people enjoy maintaining the schedule. And the longer you maintain the schedule, the more and more of those results improve. And once you finally develop a balanced core, like I said, I've been an athlete my whole life. But I didn't have a balanced core. I thought I did, but I didn't. And when I developed a balanced core, I was, I'm overwhelmed and I can, I can't tell you how many athletes that are starting to experience those same things. You would think an athlete would come in and get on our device and max it out, you know, show me something that, wow, only an Olympic athlete can do. But I can have an Olympic athlete come in and when they get on the machine, I can say to them straight to their face, "I've got a woman in a wheelchair that can make you look horrible." And that is the honest to goodness truth. What the core actually can do when it's taken care of is an amazing thing.
[00:23:43] I wanna make this one really quick story. So I had a beautiful woman come in that was, had been in a wheelchair for decades. And we had to transfer her from her wheelchair to our chair. It's just a matter of lifting her and setting her down here. And I don't wanna sound negative when I say this, but when I lifted her up the first time, she was soft, you know, fluffy, kind of, you know, 'cause she couldn't, she didn't have a lot of muscle tone and Lord knows, how could she? She spent her life in this wheelchair. So I, it didn't surprise me. I would put her in the wheelchair or we put her in the machine.
[00:24:19] Lindsey, I will say probably in three months, maybe, when I would reach over to help her, instead of reaching around somebody that was fluffy, I was reaching around somebody that felt like a granite statue. She was solid rock, and I saw that happen and I saw what that did for her life. She could get in and on and off the commode on her own now. She could get in outta the car. These things that make a difference with independence, these things that are so important that we take for granted.
[00:24:49] Lindsey Dinneen: Yeah.
[00:24:49] Dr. Scott Bertrand: I saw these incredible recoveries and I knew then that I was absolutely on the right path. It wasn't about our six packs and our low back pain. It was about these people that had been almost forgotten and deserved so much, and now they're having an opportunity with hope and getting some great results. So that's the reward of MedTech. That's why, and all your listeners, hang on. It's worth hanging on. It's taken me three decades. I mean, you can't expect to go out and be tampering with people's lives and not expect it to take a long time to get there. People aren't just gonna let you start messing with them until you can prove you're doing the right thing. But it's so, but don't give up. Do the research, keep doing it. And that one person that you help, maybe you'll be a million.
[00:25:33] Lindsey Dinneen: Yeah.
[00:25:34] Dr. Scott Bertrand: I know that's what's gonna be happening to us.
[00:25:37] Lindsey Dinneen: Yeah. Oh, yes. And thank you for that encouragement because I, like you said, it's a long road. So it's helpful to have people on the other side of it going, "Yes, it's possible. It's absolutely it. It'll take time, but you can do it." yeah. So, looking back ?Over your life, I'm just always curious about this, you know, do you think, is there any way that six year old Scott could have possibly had an inkling of what was to come in the future? What your path may have turned out to be?
[00:26:09] Dr. Scott Bertrand: I, you know what's funny? I'm so that, that's such an interesting question. I'm writing a book and the book is, you know, it kind of goes through some of my life and I was just doing this the other day and, yeah, there was a six year old Scott that had an occurrence that happened to him that made him stop and think and go, "my God, I'm driving a miracle." and I was only six. And I remember it like it was yesterday, and it stuck with me. Long story short I was, I shouldn't probably be alive, but due to just natural reflexes, I got outta the way of something. And what I had to say, and I realized is I moved on from that potential horrible trauma that my body moved me out of the way.
[00:26:50] Scott didn't, little six year old Scott wasn't smart enough. My body pulled me outta the way. And that reflexive action, that right there is what the AllCore relies on. So I don't know if that was the very first little thing, the very, you know, the little spark that said, Hey this machine you're driving is not just a bucket of bolts. You know, this is pretty impressive. And I got to, I still get to see that miracle every day. It's amazing.
[00:27:17] Lindsey Dinneen: Yeah. Yes, it is amazing. Yeah, thank you for sharing that story. That's pretty, pretty interesting how that ended up being a, you know, of course, like, like you said, six year old Scott wouldn't have known where that would've led, but hey, It's, it's just, it's cool to see those threads looking back.
[00:27:35] Dr. Scott Bertrand: Yeah. That's what they're the little seeds that found some fertile ground somewhere down the road that'll let 'em grow. But they, it's all those little things. And I can go through my life and point out about a dozen of those and that. You know, you go through life with all kinds of paths that present themselves, and you right or left. And where you are today is dependent on all those choices you made. But I can go back and look at so many of those and go, "thank God I turned that way because that allowed me to get here." And
[00:28:05] Lindsey Dinneen: Yeah.
[00:28:06] Dr. Scott Bertrand: That's almost pure luck. I don't know. So,
[00:28:09] Lindsey Dinneen: Or Destiny or both?
[00:28:12] Dr. Scott Bertrand: You know, I prefer to say that too. I think we're all put on this world for a reason. I think one of the things I say to people all the time, and the two biggest moments or greatest things in your life is the day you were born and the day you realize why you were born. And that, I realized that day, when it finally came to my mind why I was here that my job on this planet was to make sure that people knew that there was an alternative, and just make sure it happened before I died. You know, I just I remember one time sitting on a couch and all of a sudden realizing that if I don't do this, it might not get done. That was a frightening place, it really, it scared me. I was kind of thinking in my mind that someone else will come up with it, and I was okay if somebody else did. I just knew it needed to happen, but all of a sudden I realized maybe somebody else isn't going to, and I knew it was my job, so.
[00:29:09] Lindsey Dinneen: Yeah. Yeah, that, that brings up an interesting point. I mean, my initial thought was that quote from Spider-Man where there's the whole " with great power comes to great responsibility." And, you know, and it's not exactly applicable here, but the idea of when you've been presented with a series of challenges that have led you to a possible solution. Yes, I think there is some sort of feeling of I have this responsibility to, to help because this isn't just about me anymore. This is about the planet. Who else could I impact if I can bring this successfully? And there are, and that's probably something really helpful because, I'm sure as a founder and you know, and you're leading your company, there are days where it's tough and you have to go back to your why of, you know, why are we here? Why are we, you know, going to all this effort and expense and whatnot.
[00:30:12] Dr. Scott Bertrand: Right, right, right. You know? Yeah, exactly. It's every company, and I think a lot of people have, we all have dreams, you know, we have dreams, we wanna do this and do that, and dreams and goals, and those things and they all drive us forward, and they're good motivation. But when it goes to a mission, when it goes from a dream to a mission, it's a total different thing. It's a mission is one of those things that you think about it when you go to sleep, but it wakes you up in the morning and starts beating you on the back until you go ahead and get it done. I was almost fearful of if I didn't do it, God was gonna throw me off another roof and break something else. I needed to get this done.
[00:30:50] Lindsey Dinneen: Oh no.
[00:30:51] Dr. Scott Bertrand: Hit me twice. He told me what to do. He's like, pay attention here, gotta get this together. So, but anyway, I did. It took me a little while, but you hit me in the head a few times. I'll wake up . so, we did, and here we are.
[00:31:06] Lindsey Dinneen: I love your honesty. That's fantastic. In the end, you followed that calling or leading or whatever you wanna call it. So go. This is so much fun just to hear all of your stories and whatnot, but I wanna pivot and take it in a slightly different direction completely for fun. If you were given the opportunity to teach a masterclass on anything that you want, it can be within your industry, but it doesn't have to be. You get paid a million dollars for this. What would you choose to teach and why?
[00:31:40] Dr. Scott Bertrand: I'd listened to the offer. What I've learned, and I could probably share better than most things would be, how important perseverance is at the end of the day. It's the ability to focus and not give up. It's that day to day responsibilities that lead to the final goal. It's, I just know, like I said before, it's not going to be easy. So if you want something easy, you need to pick something else. I would think I would just explain to people not only how to persevere, and by that I mean sticking to a recipe, maintain your vision and your passion because you are the one who has to protect that vision. And then do everything you can again, I guess, to make it happen. But that it's, you just don't give up. No one said it'd be easy and, you know, you gotta do it again tomorrow. But it's there. It's there. It's there. There is a ladder and the rungs are hard, but one step up is one more than yesterday, and I'll take that.
[00:32:40] Lindsey Dinneen: Yeah. That sounds like a fantastic masterclass. So yes. How would you like to be remembered after you leave this world?
[00:32:48] Dr. Scott Bertrand: You know, this is a powerful thing that we're doing here with the AllCore360 and to possibly able to be the inventor of a device that can really impact millions upon millions of lives. I don't think there's any legacy anybody could ever ask for that could be greater than that, but I think what's every bit is important and I think in medtech and all these innovative companies, I really know that-- it took me a while to realize this-- but you can't do big projects alone. You can't take on gigantic projects of changing the world by yourself. So you really need to develop a really good team. And I took a little too long to develop that good team. But the legacy I would like to leave, not just for the device and my name, this group took on that mission of changing lives just like I did. And they've invested their energy just like I did. So my legacy needs to include their legacy. They need to be just as proud of changing the world 'cause they have, and I could not have done it without the help. So it's that it's all of us, you know, it's that legacy. You know, two generations from now, their granddaughter needs to say, "daddy, you worked on that, didn't you?" "Yes, I did." And I want them to have that pride. I really do. That'd be a great legacy. I could wouldn't ask for more than that, you know.
[00:34:16] Lindsey Dinneen: Yeah. Yeah. That is a great legacy. Absolutely. And final question, what is one thing that makes you smile every time you see or think about it?
[00:34:28] Dr. Scott Bertrand: Gosh, there's several of those. You obviously can go to the birth of children and grandchildren. Those are hard to beat, but I, in, in, if not down that line. Yeah. Yeah. I'm a, I'll tell you a really quick story that, and I'll try not make it too long, but it was one of these individuals that had been in a wheelchair and were working with me on the device. And like I said, these things are always so rewarding and I love them so dearly, and I have many memories, but one that I will always smile. The girl's name was Lori, and like I said, I love Lori.
[00:34:59] But so, you know, it's hard to explain, but the device is a, it's a challenging device, and so, I could put it at a certain angle and it would be more difficult than maybe the angle you did got on. So we could compete, you know, I could do more than you, or you could do more than me. So I was using the device, obviously myself, and so I had a certain range that I went to that I was proud of. In fact, I, you know, I'm pretty tough. I'm down here. I'm doing a really good job. Here comes this gal on the wheelchair, by the way, the gal I'm talking about that turned into a granite statue. It's that gal. But so we start out, and I am way ahead of her, you know, and I am, I'm way ahead of her. Of course I am. But then like a two weeks later, she's gaining on me and three weeks later she's gaining on me and six weeks later she's on my rear end and I'm going, oh my gosh. I finally had, I stopped one day and I just had to look at her and I said, "Lori, How in the world are you doing this?" Because you know, I knew where I was at and she took her finger and put it in my face and went, "how are you not?"
[00:36:07] And I will never quit smiling on that day because she struck me to the ground and basically said, "here I am sitting in a wheelchair and I'm kicking your rear end. What is your excuse?" I mean, she brought me to my knees and I will never forget that. And I'll smile because that showed me power that I've never seen. And I only pray I can be as motivated as she is someday, you know? But I will always smile. It was a wonderful day.
[00:36:36] Lindsey Dinneen: That is incredible. I love that story and I also love the fact that that makes you smile that sort of Very much, you know, confrontation. And this is, she's gonna speak her truth to you. And you know, you took that as a good thing, as a challenge to keep, you know, doing what more of what you can do. And I,
[00:36:56] Dr. Scott Bertrand: She was right. Yeah, she was right. She hit me right where I live and I thought, you know, I don't think there've been many people on the planet that would even do that or even try that, you know? Yeah. It was came right at me.
[00:37:10] Lindsey Dinneen: I, love her boldness.
[00:37:11] Dr. Scott Bertrand: Love her dearly for it.
[00:37:12] Lindsey Dinneen: That's fantastic. Oh my goodness, this has been so much fun. You are incredibly inspiring. I love hearing what you're doing to really make a difference. I'm so thankful it has made a huge difference for you personally. But then, like you said, all of the ripple effects and all the lives you're touching, I think it's absolutely incredible. So I just wanna really, you know, basically say thank you. Thank you for the way that you are choosing to lead your life, and thanks for joining us today.
[00:37:43] Dr. Scott Bertrand: No, that's I really appreciate it and I hope in the time we spent, I could leave your listeners with maybe there is some hope for some of the people that mo so many people I know, people have had a stroke or in a wheelchair and loved ones that could, there's, I just want them to know that, hey, reach out, look around. We're growing as fast as I can grow it, but there may be one close by and I would like to at least try because it's for some, it's remarkable and I appreciate you giving the opportunity to share that.
[00:38:09] Lindsey Dinneen: Yeah. Yes, of course. We are also so honored to be making a donation on your behalf as a thank you for your time today to Sleep in Heavenly Peace, which is an organization that provides beds for children who don't have any in the United States. And so just thank you for choosing that one in particular to support, and we just wish you continued success as you work to change lives for a better world.
[00:38:35] Dr. Scott Bertrand: Lindsey, I so much wish that and to you. I've enjoyed your podcast. I know you're gonna do wonderfully well as you do more and more. Keep me in the loop and I'll look forward to talking with you next time.
[00:38:45] Lindsey Dinneen: Sounds great and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
[00:38:59] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Marina Daineko | Biocompatibility Consultant | Regulatory Compliance, QMS, & Women's Representation in Medtech
9 Şub· The Leading Difference
Marina Daineko, a biocompatibility expert with a background in analytical chemistry, shares her journey from a research assistant in physical chemical problems to a prominent figure in the medtech industry. Marina discusses her passion for understanding the regulatory compliance and quality management systems in medical devices, reflecting on her curiosity and desire to make a difference in people's lives. She also shares her commitment to increasing women's representation in the medtech field.
Guest links: https://www.linkedin.com/in/marinadaineko | https://www.intrinsicmedicalgroup.com
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 023 - Marina Daineko
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:52] Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I'm excited to introduce you to my guest today, Marina Daineko. Marina, a certified biocompatibility subject matter expert with an MSc in analytical chemistry, shines as a dynamic figure at the intersection of medtech and chemistry. Her knack for seamlessly bridging biocompatibility, regulatory compliance and materials science, sets her apart. Marina's captivating presentations at conferences, including the prestigious Women in Tech Global Conference 2023, underscores her multifaceted expertise in the medtech industry.
[00:01:31] Welcome. Thank you so much for joining us. I'm so excited to have you here today.
[00:01:36] Marina Daineko: Hello, Lindsey. Nice to meet you. Thank you very much.
[00:01:40] Lindsey Dinneen: Yes, absolutely. I was wondering if we could start off by you just sharing a little bit about your background and yourself and how you got into the medtech industry.
[00:01:51] Marina Daineko: Oh, yeah, absolutely. Actually, it's very interesting story because I have started with medical device industry, not from the very beginning. But since I was young, I have always had a keen interest in learning more about the properties and different forms of matters and understanding how this undergo changes. So all in all, I fell in love with chemistry while I was in high school, and knew that I need to proceed with chemistry in my adult life. So anything that can be touched, tasted, smelled, seen, or felt is made of chemicals. And I was inspired by this fact and yeah, so I decided to connect my life with it.
[00:02:36] And it's interesting because I started my career as a research assistant in the Research Institute for Physical Chemical Problems. And here I had a really scientific background because I published several articles, put my hands into patent work, and so on and so forth. And everything related to non resist photocatalytic lithography and nanoelectronics. So far away from medtech industry. And yeah, but it was interesting for me. And it was sometime after that it was time of self discovery through challenges, because I wanted to do something in my career that is challenging, interesting, and makes a difference in people's lives on a daily basis.
[00:03:23] And actually around this time, I found out that my ancestor, Vladimir Galalyev, was a researcher in medicine and published academic papers dedicated to rheumatism and the morphology of allergy. So, I found it interesting and I decided that I might delve into this area, into this domain. So all in all, I started look for opportunities and found out RNC position. And that's why I joined MedTech industry as R&D and my background in chemistry and material of science helped me a lot here. And I'm a curious person, so when I was working as R&D, I also was trying to understand, "Okay, what are the sources of different requirements?" What are these come from, what are all these regulations that some people are talking from time to time.
[00:04:20] And as a result, yeah, that was really interesting for me. Okay, I need to understand the source. I need to understand the matter, what I'm doing, why I'm doing. So, and as a result, I started to look into regulatory compliance area and overall, like, quality management system, just understand how the things work and to understand medical devices from different areas, right? Because it can have very different requirements depending on what aspect you're looking from, right?
[00:04:51] So I was really fascinated and thankfully I had the chance to, to join biocompatibility and biological evaluation team as R&D also understands the requirements with chemical background in chemistry. So I started to look into biological evaluation to, because it's so interesting for me, look here, it's mixture of science, also medical device, and additionally some investigation, some topics that are not discovered or something like this. So it's really nice. And also next step I decided, okay, I'm pretty aware like what are things with medical devices that contain hardware for instance, but how make this medical device life. Because it's really interesting and fascinating to see how their lives can be changed.
[00:05:45] So that's bring me to software in the medical devices. So software and firmware is something that could help to make medical devices live so they can be used in some analysis, predictions, and so on and so forth. And that's why I'm here in the medical device industry, really enjoying what I'm doing and understanding the medical device from different perspectives.
[00:06:10] Lindsey Dinneen: Yeah, that's wonderful. Thank you so much for sharing your background too. It's so fun for me to hear about how you go from so many different, yeah, because you're so multi talented, and you're so interested in so many things, and I love hearing that. I love hearing about your background in chemistry and then you went into R&D and now you're doing software and firmware. Oh my goodness, you are a lifelong learner!
[00:06:38] Marina Daineko: Yeah, I believe it's very important because we are living in book of world. It means that, there are a lot of changes around us. And additionally, for me, it's really interesting. I'm really fascinated to see is a medical device from different sites. Okay, we have compliance. Compliance means like this requirements, right? We have R&D and product quality and biological relations and those requirements may be applied, and when touching one topic, it's very interesting to see what is beyond this topic. For instance, as I said, okay, R&D requirements, design input, design verification activities, and so on, according to, for instance, ISO 13485 or CFR part 820. But what about regulatory, right? What about FERS?
[00:07:27] Moreover, it's also, yeah, one thing that I'm proud right now is that this year I took a very bold choice to become a student one more time and I selected a program that focused on the medical sterilization engineer. So I believe it helps me to understand medical device even deeper because biocompatibility and sterilization are things that lay near each other. So just to deep my knowledge in the sterilization and disinfection areas, I picked this program. So I'm a student again. It's a very nice feeling.
[00:08:09] Lindsey Dinneen: Oh good, yeah. I love how you said that, it's a nice feeling.
[00:08:15] Marina Daineko: Like back to school, yeah!
[00:08:17] Lindsey Dinneen: Yes, that is ,incredible though and it is so Interesting to hear how you just keep developing your skills, and like you said, you're a curious person, so you're going continue to explore different ways and help the industry move forward. So, good for you.
[00:08:35] Marina Daineko: New choices for industry,
[00:08:36] Lindsey Dinneen: Nice. Nice. Okay. So, I know that you also are an advocate for women in medtech, and I would love if you would share a little bit more about that and your involvement. How did all that get started, and what are you optimistic about with that?
[00:08:56] Marina Daineko: Oh yeah, it's great questions. Thank you very much for asking it. So it has started actually recently when I was invited to speak at Women in Tech conference. So I was really excited here because in my experience, I-- all right, some time ago, long, long time ago, I don't remember even how many years it was-- I tried to start a business as a woman and unfortunately, I have got quite a lot of pushbacks with said words, like for instance, "okay, you need to sit down at home and growing up children and I don't know, cooking," and for me it was like a question, "okay, I can do it truly, but I have like other perspective and other ambitions and willing motivation to grow like a professional, like an expert." So for me it's very important to show an example for other people, women said, "okay, we can, surely we can grow up children. Surely we can take care of some other people and cooking and cleaning, like this man."
[00:10:09] So it's very important to show an example that I can do it. So everyone can do it. Everyone has own voice and this voice shall be heard. It's very important. So it started quite innocent for me, just invitation to, to talk at the conference, but I was so proud of it. And I shared this news with my colleagues, with my family, friends like with everyone, I believe, and trying to support this.
[00:10:39] Moreover, recently I has been nominated for Women in Tech nomination. So, and I'm so excited of it because my presentation, I was talking about Internet of Medical Things actually, and compliance and risk aspects within IoMT. So, my, my talk as a speaker and I was congratulated with this nomination, so I'm so proud to, to show again other people that, "okay, look it start, it has started really innocently, but where I am now."
[00:11:13] I'm nominated and I am growing awareness regarding women in tech and asking for collaboration here as a women to join this network because I could see a lot of opportunities with it like to support each other, to help each other to grow together, because when we are sharing our expertise, when we are given advices, when we are providing areas for improvements, it is really also very important, actually, our points of growth here. So I believe it's very valuable network and really could see a lot of improvements while taking part in this Women Tech Network.
[00:11:54] Lindsey Dinneen: That's incredible. And first of all, congratulations on that nomination!
[00:11:59] Marina Daineko: Thank you. Thank you so much.
[00:12:01] Lindsey Dinneen: That's incredible. Yeah, I'm so excited to see where that leads, but in general, I
[00:12:06] Marina Daineko: Yeah.
[00:12:08] Lindsey Dinneen: Yeah! And you're like, oh my goodness, "yes, me too!" Ha Yeah, but I just I love the fact that, it started off with an ask of you do this talk, and then you just said, "okay, and I'm diving into this too." So,
[00:12:25] Marina Daineko: It's exactly how it works with me.
[00:12:26] Lindsey Dinneen: Okay. Excellent. Yeah. And, I know from being connected with you on LinkedIn that you are very passionate about helping to spread knowledge about the industry. Yeah, and so you do this Mondays, you do like a coffee chat or coffee talk. Yeah. Can you tell us a little bit more about that?
[00:12:50] Marina Daineko: Absolutely. So it's again interesting story because sometime ago, actually I have started to be pretty active on my LinkedIn, like just around the year or so. And how I, why I decided to be active and why, how it's actually started. It started because I felt like I'm so full of expertise, knowledge, advice that I can't just hold them with myself so I need to somehow to share them and I found LinkedIn platform very useful and comfortable for such knowledge sharing because here there is a community of different experts and that's why we can share opinions, advices, comments, because it's also valuable to see from some things from our perspective, right?
[00:13:43] And on Mondays, I'm doing like Monday news. And I remember when I'm using actually my own picture. I took this picture when I had a coffee and croissant, like dreaming, "okay, what would I like to read on Mondays?" And for me, it was kind of a digest of important things. And I usually connect in this important available things around biological evaluation, because I could see quite a lot of information regarding compliance, quality management system, risk management clinical evaluation, like really ocean of news and updates and knowledge sharing regarding clinical evaluation.
[00:14:24] But for some reasons, I saw that biological evaluation is kind of underestimated, meaning that-- and it's quite, it's not too easy to find some valuable information or clarify something or, to make it transparent and traceable why we need to go like this direction or this direction, and what are updates in the industry and so on so forth. And I know that quite a lot of people are too shy to ask directly or they simply don't know whom to ask, right? Because if you are known as a subject matter expert in this domain, nobody would ask you even if you are right.
[00:15:03] So, and it helped me to understand like, okay, maybe I could put myself in this niche and provide some updates like I'm doing here on Mondays, like taking one topic and provide small basic, maybe basic, maybe not too basic things, around this topic. Like for instance, biological evolution, but inside of biological evolution, we have a lot of things to talk. And to be honest, I can talk about a biocompatibility like all days and nights. It can be unstoppable. So, yeah.
[00:15:42] Lindsey Dinneen: Okay, so you have lots of things in the works and you're a student still. What is coming up for you? What is next that you're particularly excited about either personally or professionally or whatever you want to talk about.
[00:15:55] Excellent
[00:15:56] about
[00:15:56] marina_1_10-18-2023_190318: My God, I swear a lot of things, to be honest. Yeah. First of all, maybe from professional side, I'm really excited to take part in the MedTech Summit. Flying to the United States, and I'm really excited because there would be a lot of professionals and subject matter experts within the summit like from biological evaluation, as well as regulatory affairs. So I'm very interested to make like connection in real life, not only like online, looking at people's heads and that's it.
[00:16:34] Lindsey Dinneen: Right?
[00:16:37] Marina Daineko: So, I'm really excited of it. Also I will have panel session about post market surveillance. And it's very interesting, actually, format because it would be different experts here at this panel, like from regulatory, clinical, risk management. And I will represent biological evaluation aspect. So, and we would be talking about post market surveillance for medical devices. It's also hot topic and I'm excited because in such format is it, that would be my first time in such format with other experts, but I find it really valuable because this cross functional team usually, it's like kind of brainstorming, negotiation, discussion. So I expect like a vivid discussion around this topic and again I believe that would be very interesting insights here during this panel. Yeah.
[00:17:34] Lindsey Dinneen: Yeah. Yeah. And, speaking to that, when you are involved in these these panel discussions or conversations or things where you might, where like you said, you're going to be surrounded by experts and you have your area of expertise too and whatnot and you're sort of all collaborating, is there ever a moment where, does it ever feel overwhelming when you're just " oh, I don't know enough about this topic?" I'm just curious because I know sometimes we have those moments as humans. We go into this situation that's not 100 percent our realm, and I'm just curious how you handle those moments of " how can I contribute to this conversation?"
[00:18:13] Marina Daineko: Yeah, that's a great question because I wouldn't be honest if I say that I don't have such moments. Surely I have and as I'm quite active as a speaker in different conferences. So surely I have such moments in my life. And yeah, so, how I deal, I'm trying to be logical, first of all, and structured. Actually, I'm a super structured person. I have folder and folder, all the reminders and so on. Organized and structured. But, yeah, so I'm trying to think in this way, "Okay, here is the question. How can I decompose it for the parts that I can understand, right?", And I can provide some feedback, insight or advice, for instance, right? Because usually a person who is asking a question, this person usually has some background or circumstances or conditions why this question is asked. So I'm trying to decompose this question if it's still unclear. So I'm trying, I'm asking to ask maybe in a different way. It gives me additional time to think actually, so well, right?
[00:19:19] So, and in that for, I would say for 100% cases with this decomposition or, and for instance, asking to reward the question, I can answer it because it gives me time to think the decomposition can gives me the base, " okay, we are talking about XYZ or ABC or what we are talking about, right? What area from what perspective?" So all the things help me to answer, but usually, yeah decomposition and additional time to think helped me each time.
[00:19:57] Lindsey Dinneen: Yeah, and thank you for your honesty, because I really love listening to other people's strategies, because I think we all have those moments sometimes, right?
[00:20:04] Marina Daineko: Absolutely. It's very nice because I also can understand, okay, what are my weakness? What my, what are my areas for improvement? Maybe I need to dive deeper into this topic. But, I am, I consider myself brave enough to say, I don't know if I really don't know something, right? Not to, not to make a not proper conclusions, for instance, or advices and so on, so forth, because it's very important to, to say such things because we are talking about medical devices. Medical devices are used when people are in need some help. It might be even the question of life and death so it's very important to say if I don't know so I'm saying I don't know, please ask this I need additional time to investigate. So I need to so I need this additional time, right?
[00:20:56] And also what is very important for me as again as a woman and as immigrant, right? Not to be shy, but to talk, to speak up because yeah, I can be, I am an expert. And I need to show my expertise to others because others, other people can, for instance, they just simply maybe not aware that I'm expert, right? So it's very important to speak up and to be brave here.
[00:21:26] Lindsey Dinneen: Yes, a hundred percent. And I kept thinking about that when you've been telling us about your life and your trajectory and how curious you are. And I was going to say that bravery is such a strong theme. I, it really is though, because it is hard sometimes to be willing to speak up and say, "I don't know, or I let me go back and research or whatever." And so I really, I think that's really powerful what you said, and I appreciate your candor there. And I'm, I am also curious myself, so if, let's say that you are in a sort of mentorship position. What kind of advice would you give somebody, maybe especially a woman or, somebody who is coming from a different background who may not have the same access basically, how would you advise that person to participate and to keep moving forward with their own career, even if they're feeling a little uncertain or they don't fit in.
[00:22:30] Marina Daineko: Oh, yeah. No, I love this question. Thank you for asking it. So, I believe that we are living in such a world where hard skills shall be complemented with soft skills. And as far as I could see, listening is very important. Listening and communicating properly. And listening, I believe that listening to others is a part of communication. So, regarding listening, it's very important to listen,: like kind of correctly what I mean on this is for instance, not multitasking when someone is listening to another person, right? Because sometimes we are doing something and listening not attentively. And we, for instance, can mix up topics or don't understand something or just don't miss some part of, conversation. And that's why it's very important to, to listen attentively, really deep really diving into the topic and understanding what is going to be, like, what we are talking about, what is the topic, what is the ask. Maybe something is hidden between rows, so it's very important.
[00:23:44] Sometimes we are listening with a goal in mind. What it means? We have we are talking to each other, right? But I have my goal in, into my mind, so it doesn't matter actually what you are talking about. So. I have something and that's it. I don't care. So it doesn't work. It doesn't work actually. So especially for leadership, but not only for leadership, it's just for, for real life. It doesn't work. We need to listen and trying to understand what another person is trying to say here.
[00:24:20] And one more, maybe things that I noticed is judging. So when something, when someone is saying something, so we are judging. We are like, okay, there is just black and white and that's it. But fortunately, no, we have different colors, so like rainbow colors, there is no black and white, so we don't, we should, we shall not judge, we need to listen attentively, accurately, and trying to get rid of maybe some negativity when talking to a person, so it's very important because collaborating with different people may be challenging, especially in these cross functional teams because I could see more and more that we are working in remote world.
[00:25:08] So I'm from Poland, you're from the United States. Someone is from the United Kingdom, someone from Australia and it's really amazing and I love it. But people are from different cultures. People have different, I don't know, mood, time zones, different things in their private life. So it's very important to switch off this as, as much as possible, this emotional thing and don't judge, just take the information as it is. And actually it helps me also a lot when I'm doing internal audits. So as it's written, I could see, and I could just, yeah, ask for some evidence as it's written not judging here.
[00:25:50] And maybe one more topic here I would like to raise, it's about preparing your response. So when, for instance, my colleague is talking to me and I just codes the first sentence, for instance, right? And I'm answering to this sentence, not to whole speech or whole things that this person is trying to say, but to this sentence . Please don't prepare your response and improve your listening skills. I believe that this listening skills, first of all, when we are collaborating with other colleagues from other, I don't know, departments, for instance, like product quality or clinical affairs, regulatory affairs, R&D manufacturing, so it's very good, marketing, some other. So it's very important to listen and to listen to the messages because there are a lot of valuable information. It shall be filtered accordingly and taken into account for, taken for consideration.
[00:26:51] And when we have like good listening skills, we can proceed with improving our communication because I believe that communication is just powerful tools that can resolve any, simply any issue, challenge, whatever, if we can communicate effectively so it helps. It helps a lot in professional life, in not only professional , so it's very important to work on this.
[00:27:17] But coming back to your question, I believe that any person can entry medical device industry because there are a lot of directions here. This directions depends on people background. So here we need like mechanical engineers to be able to prepare drawings and actually work on new product development or modifications of existing medical devices, for instance, right? Someone with a chemistry, biology background needed for like specific things like biological evaluation, clinical evaluation, right?
[00:27:49] But even people without technical background, someone who is like a good communicator is very nice. It's very valuable person in the project because such person can help with communication between different departments, because someone needs to orchestrate all this work for medical device. So don't be afraid, listen carefully, and improve your communication skill. And I believe, yeah, it would help in any industry, including medical devices.
[00:28:21] Lindsey Dinneen: Yes, that's great advice and thank you for sharing that. I think you're right that in many aspects, so one of them,
[00:28:29] Marina Daineko: Thank
[00:28:30] Lindsey Dinneen: I just want to clarify, agree with you, one thing that stood out to me is, you said that it, It is definitely possible for people to come into the medical device industry. And I think you're absolutely right. There are lots of avenues within the industry. So if your background is in engineering, there's plenty of places for you to go, but if your background is in marketing and sales, I mean, people have to know your device exists in purchase it. So all of the roles are are useful. So I think you're absolutely right in finding the area where you fit in. But the industry is really friendly, is what I have, yeah.
[00:29:12] Marina Daineko: Absolutely. Because if I can, yeah, add here, for instance, for marketing and sales, so, I love these people because they help me a lot. Why? Because I am doing, for instance, biological evaluation, I need, this is my documentation, I need to explain other people from notified bodies who, for instance,. Can audit this documentation how this medical device works. And what happened here? Look, I need these people from notified bodies or like from like auditors, right? They can have really different background. They can have background in clinical or they may not have this background. They may just have, I don't know, absolutely different background, right? They are not familiar with this specific medical device.
[00:30:01] So, and within my biological evolution, I need to explain how this medical device works. And it's known fact that a lot of people can consume the information with their eyes. So it's visual. So it means that the information shall be visualized, and visualization is the best tool to explain some things to people. That's why I love marketing, people from marketing and sales, because they can prepare these great pictures of medical device, how it works, for instance, on YouTube, like video or whatever, right? As well as, yeah, to make it understandable for everyone. It's simple, not with all these tons of words. But usually it, it shall be described as well, right? But visualization as well. So, that's why, yeah, I triggered so much when you mentioned marketing and sales, because yeah, it's really important to explain complex things in pictures.
[00:31:02] Lindsey Dinneen: Yes. Indeed. Yes. And I'm glad to have an advocate for that.
[00:31:12] Marina Daineko: Absolutely. Yeah. Yeah.
[00:31:13] Lindsey Dinneen: Yeah, absolutely. Pivoting the conversation just a little for fun. Imagine you were to be offered a chance to teach a masterclass on any subject that you want to. You would be paid a million dollars to do so. It can be about your industry, but it doesn't have to be. What would you choose to teach and why?
[00:31:35] Marina Daineko: As I said, I can talk days and nights about biological evaluation. So maybe it would be the simplest answer because it really, it really works for me. I mean, like I can talk about biocompatibility a lot and I am more than happy to share some insight with people, especially taking into account that this buzz and noise regarding biological evaluation recently, and I could see a lot of people that are coming in this aspect, this domain, I mean, in biological evaluation in medical devices, so I would be more than happy even be paid properly for this.
[00:32:18] Lindsey Dinneen: There you go.
[00:32:20] Marina Daineko: Yeah.
[00:32:22] Lindsey Dinneen: You could put the million dollars to, your research or something fun, so.
[00:32:27] Marina Daineko: Yeah. No, absolutely. When I was younger, I had actually a dream to organize a kind of, research center and to have some equipment, to have some databases, and so on for scientists who can, for instance, like scientists, startups, and so on so forth who can actually try, say, ideas on this on this research center. So if you, for instance, I don't know, invented something, you can go to my research center and I, we can first of all, test it and also provide like scientific background if required to help with patents and so on and so forth. So I believe this million dollars can be used for this goal.
[00:33:12] Lindsey Dinneen: Ooh, I like it. Okay. Excellent. All right. And how do you wish to be remembered after you leave this world?
[00:33:24] Marina Daineko: This is important question and I'm thinking from time to time exactly on it. So, it's very personal for me because it's also a funny story. When I was a student at the university, I was, I have been providing kind of mentorship for people who would like to study chemistry. So, and usually I was working with, mentorship, blaming the fire for chemistry. So showing that chemistry is not just something boring, boring science, but also very interesting and it can be kind of fun. So, I had a case when one boy he needed he needed improve his knowledge for chemistry just for his marks because he intended to, to get in British College. And, we were having the studies with him. I was explaining things and providing real life examples where and how chemistry can be utilized and improved. And in the end, this boy decided to utilize chemistry in his life, so he switched from math as well as physics to chemistry and connected his life with chemistry.
[00:34:40] And for me, it was like, "Oh my God, it seems like I changed someone's life." And it was so, so inspiring for me that I decided for myself that I would like to proceed with it, that I like how I can make this connection to show people the beauty of different things, like for instance chemistry to this boy. And yeah, I believe that I'm pretty successful in such things, so I would say that I would like to be remembered as a person who can connect people with beautiful and inspiring things, changing lives in this matter.
[00:35:26] Lindsey Dinneen: Ooh, that is a beautiful goal. I love it. That just gave me chills.
[00:35:33] you
[00:35:34] Marina Daineko: Yeah, no, I feel the same, actually, because for me, this boy, it was like a changing moment for me. Yeah, it's very powerful. Even this even this memory is very powerful for me.
[00:35:47] Lindsey Dinneen: Yes. Thank you for sharing that story. It's a fantastic story, and I love that because it's so, that just speaks to you and your willingness to, to help somebody understand something that doesn't come naturally or maybe easily to them. And what a difference you made in that person's life, so, yes, I think that's incredible and a beautiful life goal of yours.
[00:36:11] Marina Daineko: Thank Thank you, Lindsey. Oh yeah. To explain like complex things into simple, understandable steps is my favorite entertainment, I would say
[00:36:21] Lindsey Dinneen: Ah, okay, I love it, alright. What is one thing that makes you smile every time you see or think about it?
[00:36:32] Marina Daineko: Oh, I believe it's my dog. I have pitbull, but she reminds me a cat, mostly, because, yeah, no, really, because, for instance, when I have a door opened to join other room, to go into other room, for instance, but when I close the door she needs to come back immediately. And it makes me smile because it's behavior of a cat and also yeah she's sleeping and she is snoring from time to time and when I have a meeting for instance with my colleagues So I am asked all the time "Marina, please don't sleep." Yeah. So, yeah it's funny and I adore her. I am working with her, actually, I like, I love walking like 10 kilometers or so. She's not happy with this distance, but she has just simply no choice with it. Yeah. So, yeah, no, believe useful for her heart, so that's my, yeah.
[00:37:35] Lindsey Dinneen: Mutually beneficial for both of you.
[00:37:37] Marina Daineko: Yeah.
[00:37:38] Lindsey Dinneen: Yeah. Very good. Oh my goodness. That's fantastic. Yeah. This has been so much fun. Thank you so very much for joining us today. I'm just so thrilled to have you and you're so inspirational. So thank you for doing what you're doing and how you're continuing to learn and evolve with the industry, but evolve your own skills too. Yeah. And we're,
[00:38:05] Marina Daineko: Thank you.
[00:38:06] Lindsey Dinneen: Of course. And we're so honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thank you for choosing that organization to ,support and we just wish you continued success as you work to change lives for a better world.
[00:38:30] Marina Daineko: Thank you. Thank you so much, Lindsey. It was a pleasure. I really enjoyed our conversation, a lot of, love and insight. So thank you very much for invitation and yeah I'm really happy to meet you.
[00:38:45] Lindsey Dinneen: You too. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
[00:38:58]
[00:38:59] Ben Trombold: The leading difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Ken Hoyme | Medical Device Cybersecurity Expert | The FDA's New Guidance, Safety-Critical Systems, & Pipe Organs
26 Oca· The Leading Difference
In this episode, Ken Hoyme, a semi-retired product security expert, talks in-depth about his 40-year career focusing on safety-critical systems, which spanned across commercial aviation, aerospace, and medical devices, with a particular focus on medical device security. Ken reflects on the personal impact of his work, and also talks about his continued involvement in the field through consulting, teaching, and volunteering post-retirement. He also discusses troubleshooting solutions, his pride for his family, and his passion for pipe organs.
Guest links: https://www.linkedin.com/in/kenhoyme/
Charity supported: Save the Children
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditing: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 022 - Ken Hoyme
[00:00:00] Lindsey Dinneen:
[00:00:01] Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:08] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:13] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:27] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:37] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:41] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
[00:00:47] Hello and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Ken Hoyme. Ken is the semi retired former Director of Product security at Boston Scientific. His 40 year career spanned commercial aviation and aerospace and medical devices with specific emphasis on medical device security. In retirement, Ken continues to consult, teach, and volunteer. Welcome, Ken. Thank you so much for joining us today. I'm so excited that you're here.
[00:01:20] Ken Hoyme: Thanks, Lindsey I'm happy to be here.
[00:01:22] Lindsey Dinneen: Wonderful. If you wouldn't mind just starting off by telling us a little bit about yourself and your background, I would love to hear more about you.
[00:01:31] Ken Hoyme: Sure, I'd be happy to. Being semi retired, I have had a career that spans close to 40 years, or actually I think I just passed 40 years about a month ago from when I started working. So I went to grad school, did four years of grad school at the same time my wife was in vet school, so four years of marriage that we were both studying like crazy. I never finished my dissertation on a PhD, so I'm the classic PhD, ADD person. Pretty much my entire career has been spent in safety critical, life critical systems, which has been a fascinating area. You gotta do the right job or people might die.
[00:02:08] I started, split 50 /50. My first 18 years was at Honeywell Corporate Research Labs, where I ended up working on various things between integrated circuit projects, but a lot of it was focused on control systems for commercial aircraft, and so building safety critical systems that made the pilot interface to the airplane was fascinating, tough, but interesting problems.
[00:02:32] Touched a bit on industrial controls and automotive controls, and then mid career, I got recruited away by former Honeywell folks who had gone to Guidant, medical device company at the time, that was later purchased by Boston Scientific, and where I ended up working initially on cardiac pacemakers and defibrillators and then shifted into remote patient monitoring, and that kind of evolved into more detailed interactions with how security can impact patient safety.
[00:03:02] So a large fraction of the last 12, 15 years has been in medical device cybersecurity. Did a brief stint, three and a half years, at a small R&D company doing research on medical device cybersecurity, and then returned to Boston Scientific in 2016 to lead the product security program at Boston Scientific, which is what I was doing when I officially retired.
[00:03:25] Lindsey Dinneen: Nice. Okay. So lots of cool twists and turns throughout your career. I wanted to touch on a couple things. The first is, you've actually talked about how one of the running themes was safety and safety critical systems and whatnot. And I'm curious, have you always had an interest or a passion in safety and security. Where did that come from?
[00:03:49] Ken Hoyme: Given some of my behavior as a kid, you wouldn't think so. I certainly did my share of foolish things as you grew up. My, my interest in grad school was in computer architecture, kind of a foot between hardware and software, though I was in electrical engineering as a degree. So as I ended up at Honeywell, Honeywell was at that time focused on control systems. And control systems are cyber physical systems, they are computers touching the real world physically. And almost all aspects of cyber physical systems-- which are pervasive and now what's viewed as US critical infrastructure-- there's a safety aspect of whether you're talking about nuclear power plants or oil refining and things that can explode to commercial aviation, automotive. All of those things, if they don't work correctly, the people that are interacting with them that run the risk of being harmed.
[00:04:44] So it really was that culture at the original research center of thinking about how you interact with the physical world. And so that really grew that interest. And that was the skill set in doing safety analysis that drew guidance to recruit me because it really was obviously another safety critical environment in cardiac devices. So it was a an early budding interest that was really nurtured by the projects and things that worked on for Honeywell.
[00:05:14] Lindsey Dinneen: Yeah, absolutely. And then you obviously continued to grow in your career, you continue to be involved in safety and security. And then you had your stint at Boston Scientific. And I wonder if you could share a little bit more about some of the projects that you worked on that were particularly impactful or just moments that stand out perhaps.
[00:05:36] Ken Hoyme: My first project, I knew nothing about things that bled. I had avoided them. In junior high, I had to dissect a frog, I really didn't like it. And so in high school, when you needed to have some science stuff, and I knew I was planning on going toward electrical engineering, I skipped biology and took chemistry and physics. And by working on cyber physical systems, aircraft and automotive and industrial controls, nothing bled, but I also had no pets growing up.
[00:06:09] And when I started dating my now wife of 44 years, she had a quarter horse, 4 Shetland ponies, a dog and two cats at a 10 acre hobby farm she had talked her parents into buying so that she could have horses. And as a veterinarian, everything in her life bled, so we really had this difference in backgrounds, but interest in learning from each other.
[00:06:35] And so when I first went to Guidant, the company recognized I didn't have that domain knowledge. And so I ended up being put on projects specifically with the goal of rapidly bringing me up to speed. I went to various classes on how the heart works, how you pace it, all the various different things. And I can tell you that the dinner conversation changed considerably as I was starting to learn these things and my wife knew these things. So it was kind of an exhilarating mid career change because of having to learn the domain.
[00:07:05] So, because of my safety background, Guidant was working on a new architecture for their pacemakers and defibrillators. And I got put on the redundant safety core, which was a redundant hardware pacemaker and defibrillator. If anything failed in the rest of the device, the hardware would kick in and keep the patient pink. And so I got to work on that, and I ended up with several patents.
[00:07:30] And so in 2006 or 7, I believe, my brother in law, my wife's brother, ended up with a viral cardiomyopathy and his ejection fraction was down at 15%. It's normally in a healthy human should be up around 70. He ended up getting a resynchronization defibrillator that I had worked on, as well as being put on the home patient monitor that I had been the lead system engineer in developing. And so that was that first family connection of recognizing that what you're doing is personal.
[00:08:04] And a few years back, my now 95 year old mother in law has a pacemaker in her and I have four patents on the technology. So you're recognizing that people that you love and care for are using these things. And the people who get these things are loved and cared for by somebody, so it really becomes a passion of building something that works correctly and is safe. Those kind of things stand out in terms of things that are meaningful.
[00:08:29] Lindsey Dinneen: Yeah, of course. Yeah, because when you are able to see the results in real time in real life, by people who you know personally who are affected by it, that's such a full circle moment of just recognizing that what you do isn't confined to this silo. It actually does impact lives. And that's a pretty cool thing to be a part of.
[00:08:52] Ken Hoyme: And I crossed over into security. I can recommend the devices that I was involved in developing because I am personally familiar with the level of detail that had been done in terms of securing them. So I don't have fears that my family members or others are going to have hackers going after them, which is a paranoia in the industry. The idea of hacking pacemakers became, as Dr. Kevin said, " sucks the oxygen out of the room." It's theoretically possible, but very difficult to do, compared to devices that might be connected to a hospital network, which are exposed to more.
[00:09:24] Lindsey Dinneen: And to that point, if you don't mind sharing a little bit more about how you were able to develop those skills and awareness of the importance of medical device security. I know that you are an expert in this field and there is a lot more education and knowledge these days, but it still seems like something every once in a while that you have to remind people, this is actually a critical thing. Do you mind speaking a bit to that?
[00:09:52] Ken Hoyme: I started out as an electrical engineer, but evolved to a systems engineer, particularly working in aviation. I worked on the design of the flight deck of the Boeing 777. And Boeing is the-- at least they used to be, they've lost some of the secret sauce-- but they were the premier system engineering organization in the world. And working on a critical system for an aircraft with the master of system engineering, you start learning the techniques. So my, my evolution into system engineering was very much on the job training, certainly a lot of reading and things that went on at the same time, but it was also interacting with experts.
[00:10:31] Similar thing happened when security came along is, I got recruited into Guident because of my safety skills. And then within the first year of being there, Guident was putting a remote patient management system together, which was a bedside monitor for every patient with the radio links to the device links up to a server that would analyze all the data for potential alerts that the physician should know.
[00:10:56] The system has more than a million patients on it. So it's a scalable protected health information, all of that. Program Manager on that project understood the importance of the various ilities that sit around system engineering and deal with the development. So he hired in a PhD psychologist to do human centered design and machine interface, he had been dealing with all of those issues. And in the medical device world, user interfaces also touch safety, because if you have confusion and a physician or patient makes a mistake in using something, harm can happen. So it's another branch of safety. And he recognized the security implications of what we were doing and hired in security experts.
[00:11:43] And so we had this old grizzled, bearded, absolutely canonical look of a computer geek that had been a chief architect at a company called Secure Computing and had been security. And he was titled our Security Curmudgeon and as Lead System Engineer, I worked with these various groups as we balance the design. And it really was interacting with real experts in this field who had no compunction about correcting me whenever I said anything that was inaccurate.
[00:12:15] In that environment, I started absorbing. The methods of doing security and the importance of it and what those kind of, so it really was one of those cool opportunities in your career where you get to a Vulcan mind meld with experts and absorb the information and integrate it with what you know.
[00:12:32] Lindsey Dinneen: Yeah, absolutely. And at the time of this recording the FDA has finalized their guidance and I'm curious to know what your thoughts are on that and how you feel it's going to affect everybody moving forward.
[00:12:50] Ken Hoyme: It's interesting because both the original pre market guidance and the post market guidance came out relatively quickly. The time between the draft pre market and the issuance of it, I think was just less than a year, which everyone who were involved with guidance has said was light speed for the FDA. And the post market was similar, but they've done a couple of iterations in 2018 and 2022 of drafts. And, was in a meeting earlier today where two of the FDA people who had been working on that were mentioning that in both cases, they got more than 100, 000 comments back to the FDA related to it.
[00:13:28] You know, the push by Congress to have it out by October 1st really pushed, I don't think anybody thought that it would be feasible to get it done. And yet they did it. It seems like they have clarified many of the concerns that were still in the 2022 draft, had some clear definitions about things like exploitability. So I think it really will anchor, and everyone is scrambling this week to read it and adapt to what's in there. But, the good news is it's not a giant leap from what they issued in 2022. So it's not going to have everyone doing a 90 or 180 degree turn on what they've already assumed it was heading for. So it's just good to have that out in its definitive form.
[00:14:14] Lindsey Dinneen: Yeah, absolutely. And it'll be exciting to see how the industry adapts.
[00:14:19] Ken Hoyme: As one example, the Health Sector Coordinating Council had published in 2018, I believe it was, their joint security plan, because the non formal standard, but kind of a guide, particularly helpful for smaller companies for what they need to do, incorporate cybersecurity into their quality system and their development. And a lot has changed, and so we have been working since middle of 2022, this is one of my retirement volunteer efforts that I'm involved in, to bring it up to date.
[00:14:54] And there was a real goal for the JSB version 2 to be out by the end of this year. And we were worried about the race condition with the FDA getting their final set pre market guidance out. And so one of the activities now is adapting what we've written in the joint security plan to make sure that it is in sync and in line with the finalized guidance. By getting it out now, we have time over the next couple of months to make whatever changes we need to based on that change. Which will be good, it means when that guide is updated, it will not be anchored in an old guidance, but will properly reflect the new update from the FDA. So it's really great to see them do that.
[00:15:38] Lindsey Dinneen: Yeah, absolutely. So circling back to something you mentioned, because I'm curious how you were able to overcome it. You mentioned you hadn't dealt early on in your career with anything blood related and you didn't necessarily want to go after that when you were in college. So how are you able to overcome that and say, "No, this is fine. I'm gonna, I'm gonna make it happen."
[00:16:05] Ken Hoyme: Thankfully, I didn't have to personally do any implants. Okay. I didn't have to handle a knife or deal with that and get flashbacks of my frog experience. When I left Honeywell, I thought I was going to retire out of the company. I was in an absolutely great position at the research center. I was invited to the strategic planning sessions for the entire aviation business as a technical expert. Honeywell was bought by Allied Signal, which was quite a culture shift. They were far more prescriptive. You're telling research center, here's what you're going to do rather than asking you to partner with the businesses, determine how to best apply the skills. And the other aspect is because I had become an expert in commercial aviation, I was not learning at the rate that you used to. It's like, you know, a lot of things, you're doing more mentoring than individual personal learning. So when I shifted domains and got hired in because I was a senior fellow at Honeywell, they hired me in at the top technical rank that Guidant had at the time to be competitive. I felt a huge obligation to learn the domain as quick as possible.
[00:17:19] I needed to feel like I was providing value. It's just not a good feeling to feel like you're taking a paycheck and not providing something for that. It's just not the way I was raised. And so I really took it on that I needed to learn this domain. And the reality, all kidding aside, is the work in understanding the physiology and the behavior of cardiac devices is really more about electrochemistry and how the muscles work and how arrhythmias occur and how they can be cleared. And so it was more of a learning a new technical domain than really dealing with the bleeding side of it.
[00:17:57] Yes, when I was at Honeywell, we had a program where if we were working in the commercial aviation side, we had, it was pre 9/ 11, we had jump seat privileges. So I got to be in the jump seat of aircraft so that you could see how the pilots who use the systems you develop, how they interact with them, just as an experience base. And one of my cool things, just as an aside to talk about, along with the family members using cardiac devices is, I got to jump seat a 777 from Dulles to Frankfort, and that's the aircraft that I did a fundamental invention to enable how the flight deck works. So that was cool to actually see the pilots interact with what you did.
[00:18:39] The same thing happened in the cardiac world is you got the opportunity to go and experience implants and see the doctors using and interacting with the devices. Again, part of that system's knowledge of how does the end person, the actual user, use those devices and how do you use that knowledge to get better. So the closest thing you get to bleeding is to watch somebody else do one but I never had to actually directly deal with blood.
[00:19:10] Lindsey Dinneen: Okay. That's fair. That's a really good hybrid situation right there. Well, nowadays I understand that you are quote unquote retired, however, you are still quite active. So I would love to hear about your current initiatives and frankly, if you don't mind sharing, why you're still so involved, obviously you care, but I'd love to hear it from your perspective.
[00:19:35] Ken Hoyme: So I've always been a bit of a workaholic. I gained a lot of my intellectual stimulation through the people I interact with. When I started a corperate research center, it was 25% PhDs, 50% master. It's a great learning environment because there were brilliant people are all around you.
[00:19:52] One of my career advices I've given to the young people is go to a place where you are not the smartest person in the room, surround yourself with people you can learn from. Now you want to have your niche. You want to have something that you feel is your area of expertise that you build, but being or thinking you're the best person in the room isn't necessarily a good learning experience. So, I've always enjoyed interacting with people at various stages in their career.
[00:20:20] So when I retired, I don't know how many different serious and semi serious reach outs I had from people asking what I was up to and what I was interested in. It was a dozen or something, but I had been interacting for several years at the company called MedCrypt out of San Diego, a company that focuses on initially tools to help secure medical devices, comes out of the medical device world and tools for software build of materials, things of that nature. And while I'm not a software engineer developing tools, they were also starting to build a service business to work with clients on how to improve their quality system.
[00:20:59] When I was at Adventium Labs, that three and a half year stint I did between my two Boston Scientific experiences, along with doing government funded research on medical device security, I also did consulting with companies, and so I had formed a reasonably strong opinion about how you can best organize cybersecurity into a quality management system in a medical device company. And so being able to apply those skills, very lightweight, I've tried to keep my consulting to no more than one day a week so that I still can do some retirement activities.
[00:21:36] And Mike Kijewski, who's the CEO of that, I've interacted with him for many years and he had been pursuing me before I retired. So they have some people on staff, two of them are ex FDA. One of their FDA people, Seth Carmody, had written the post market cybersecurity for the FDA and I think he did the first draft of the updated cybersecurity pre market. And then they have another gentleman, Axel Wirth, who I've interacted with for a decade and has written textbooks in the space. And so it was a way to continue where you got to really work with smart people and continue to have that intellectual stimulation that watching TV or picking up whittling doesn't give you.
[00:22:16] Lindsey Dinneen: Fair, but those two activities on occasion could be good for your mental health, which we were talking about. So you can have both. You can have both.
[00:22:26] Ken Hoyme: So my eldest daughter, when she was going through undergrad, wanted to take a class. She went to Luther College in Iowa, which was a very Scandinavian Norwegian school, and there was a class on Scandinavian whittling. And she really wanted to take it, and she did, but she was going into dental school, and so there was this paranoia about her slicing something important in her hand when she was whittling. She whittled with Kevlar gloves on!
[00:22:54] Lindsey Dinneen: Oh!
[00:22:55] Ken Hoyme: So there's a certain amount of connection, potentially, between whittling as a hobby and that blood thing that I didn't like, so that hasn't necessarily attracted me retirement hobby.
[00:23:04] Lindsey Dinneen: That's a fantastic story. I love that. I wonder, you know, with her whittling skills, did those help her in her dental practice?
[00:23:12] Ken Hoyme: She stopped it after undergrad. She also no longer plays the oboe, though she had an oboe scholarship along with her sciences because the finger stretching on the oboe ,she has all of the finger exercises she gets at work and doesn't really think she should be taking the risk of fatiguing it more. And so yeah, being safe in that environment has been important. So I think the thing that actually did the best for her is playing video games. She played things like Mario World, where you're having to constantly in your brain translate going around sphere things and jumping. And that's when you're looking through a mirror and drilling in the back of the mouth, you're constantly doing these translations. And so I'm convinced that all the video games she played growing up really gave her the spatial skills that help, particularly as she took the exams to get in, they do try to assess whether somebody is capable of that before you get into dental school, because you don't want to get in there and start getting into drilling and having somebody who just can't make their brain do that.
[00:24:17] Lindsey Dinneen: Thank goodness.
[00:24:19] Ken Hoyme: Exactly.
[00:24:20] Lindsey Dinneen: That's fantastic.
[00:24:21] Ken Hoyme: No wonder why people are afraid of the dentist. Maybe they had one of the bad ones.
[00:24:25] Lindsey Dinneen: Right. Yeah, exactly. Oh, my goodness. Oh.
[00:24:28] Ken Hoyme: And then I had already alluded to the fact that I'm, I'm doing volunteer work at HSCC on the joint security plan. And then the other thing that I did this last winter, and we'll be repeating this, is I had developed and taught a master's level class in medical device cybersecurity through the University of Minnesota's Technological Leadership Institute. And so after giving it once, they decided to make it a core curriculum for their medical device innovation. So it will be scheduled to be given annually. Things like the FDA keep coming out with new guidances, even while we were giving it last winter, one of the things that would happen each week is, this week, this got replaced. It's kind of this constantly changing environment that happens in this space.
[00:25:13] Lindsey Dinneen: It keeps you on your toes and it keeps you learning and growing. I guess that's a great thing.
[00:25:18] Ken Hoyme: I can't claim I've been bored.
[00:25:22] Lindsey Dinneen: Brilliant. All right. Pivoting just for fun. Imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your industry, but it doesn't have to be. What would you choose to teach and why?
[00:25:37] Ken Hoyme: My first thought might be a master class in how to hide out with somebody's million dollars and not get caught. Being realistic, if I was teaching in my domain, I would probably want to expand out things related to security and safety and how that really is my technical expertise. If I was going to jump out of domain, you know, just something that, might seem off the wall would be a masterclass on the design and physics of the pipe organ.
[00:26:09] Lindsey Dinneen: Oh, tell me more.
[00:26:12] Ken Hoyme: When I was growing up, I studied the classical organ and sang in choir, was in the all state choir in high school and came out of high school thinking, music major, engineering, music, and I ultimately decided I could do music on an engineer's salary a lot easier than the other way around. And so I had twice been on pipe organ projects at churches I've attended where they brought in and bid and had a pipe organ builder install. So I've been close to that process. When I've been over in Europe, I seek organ recitals. So I've gotten to hear many instruments in Europe that are older than the United States.
[00:27:00] And so, yeah, that's always been a passion and fascination of mine because there's such a engineering aspect of that and yet so much of it is musicality. And I've learned a lot interacting and talking with these builders. If I had a million bucks, I would be able to dive deeply into the topic and try to flesh out something that would actually be more comprehensive.
[00:27:23] Lindsey Dinneen: Amazing. Okay. So I have to ask you, since you are a pipe organ enthusiast, how do you feel about the fact that there's quite a lot in pop culture of, it's being a vilified instrument, you know, you have the Phantom of the Opera, and there's like a Disney something that has a pipe organ that's a bad character. And how do you feel about the fact that pipe organs are used as villains?
[00:27:48] Ken Hoyme: It's always an interesting thing when popular culture adapts something that is so much deeper. As a totally different but slight example, the accordion has always made fun of it. I don't remember how I tripped across it, but there is a very famous organ work by Olivier Messiaen, a French composer, which is-- I think it translates from French to English, "The Epiphany of the Lord." It is a multi-part work related to the Christmas story, and it is incredibly complex, somewhat challenging to listen to, you have to be quite into it. But there is a movement called Du Parmanu, which is, " God Descends and Becomes Us." And it is one of the most bombastic, just these big, huge chords. It's just exciting to hear.
[00:28:40] And back 20 years ago, I heard or saw something about a Russian woman who had recorded the entire suite on accordion. And here in the Twin Cities, and it's nationally distributed, but I don't know how many different places, there's a gentleman by the name of Michael Barone who works for Minnesota Public Radio, who for 30 years plus has produced a weekly radio program called Pipe Dreams, all about the pipe organ and that.
[00:29:10] So I ended up ordering, because I had a friend who was Russian and was only available on a Russian Amazon kind of equivalent, copies of it and sent a copy to Michael Barone and he actually played an excerpt. I think he did the Du Parmenu section on his radio program. And it's in countries like Russia, the accordion is treated very much differently than in Western countries, where it's more of a polka accompaniment. And so it's different instruments have the different faces, depending on how they're viewed and who's viewing them. So I just tend to look at the mass media view of it as the unwashed heathen.
[00:29:48] That said, there is a woman who is bursting onto the scene, she's 26, I think, British, name is Anna Hapwood, and she has been making TikTok videos of her playing the organ, including at the, the Albert Great Hall that they do the BBC proms, and she is popularizing the instrument through her TikTok videos. I think it was CBS Sunday Morning, I saw her interviewed about how she's popularizing the instrument. You never know with the modern media and music distribution, how somebody might reinvigorate interest in something that was viewed as old fashioned before.
[00:30:26] Lindsey Dinneen: Yeah, I love that. I love that. And I think it always depends on context. All sorts of instruments, for instance, could be used to be very light hearted and fun or very serious and mysterious. And part of it is just, yeah, are you playing in the major or minor keys? And, all the things that go into it. But anyway, it's just funny because pipe organ, I feel is one of those instruments that is a little polarizing
[00:30:50] Ken Hoyme: I understand that. I was warped as a child and the interesting merging there is my father was a serial hobbyist. And when he went into a hobby, he went in 110%. And when I was growing up in my formative years, he was into gardening and breeding his own Asiatic lily types. And we had flowers everywhere and garden clubs would come through and tour the garden.
[00:31:23] Then he went cold turkey on it and decided to build him an electronic organ in the basement and he built it from initially a kit and then through other designs that he did. And so I was in fifth or sixth grade with the soldering iron in my hand, helping build this electronic organ. And it was, part of what I view, my dad, his dad died in the Great Depression. He came out of World War II and really had to support his mother and sister, and never really had the money for college-- he would have been a great engineer-- but instead he manipulated my brother and I to both become electrical engineers, and part of it was by these, so part of my interest in organ was also my father's manipulation of getting my brother and I both interested in electrical engineering.
[00:32:11] Lindsey Dinneen: Hey, it worked out. I love it. Okay.
[00:32:14] Ken Hoyme: My brother has a church organ in his basement, so it took a little heavier with him than it did with me. I enjoy it being played but I don't play it myself anymore
[00:32:22] Lindsey Dinneen: Ah, understandable. Well, what is one thing you wish to be remembered for after you leave this world?
[00:32:24] Ken Hoyme: Number one would be that I didn't overstay my welcome. I would hope to be remembered that I made lives better, I made lives safer. That attention to detail matter and I worked on things that were significant, that actually had meaning for people's lives. When I moved from Honeywell to Guidant, I said, I used to be worrying on things that if they failed, people might die, 375 people at a time. And then you get into medical devices and now you're working to save their lives, one at a time. I would hope to be remembered that I worked to make a difference and had positive impact on people's lives.
[00:33:03] Lindsey Dinneen: Yeah. Of course. Yeah. And then final question, what is one thing that makes you smile every time you see or think about it?
[00:33:14] Ken Hoyme: I would have to say my children. Yep. I'm incredibly proud of them. They're both, both professionals, a dentist and an audiologist, they have remarkably snarky sense of humor that I presume they got from their mother. My story on that one was, I was telling my eldest one time, she said something snarky and I said, "Kirsten, you are the queen of snark." And her instant response was, "Yep, broke it, you bought it." But yeah, as you think about what you leave behind in the world, and I'm incredibly proud of them and the things that they've learned. They both secure, use individual passwords on every website and deal with the internet with the sufficient paranoia that they should, so I'm proud of that as well, but yeah.
[00:33:57] Lindsey Dinneen: Excellent. Well, It sounds like you raised them right.
[00:34:01] Ken Hoyme: They're great kids. They had to live with growing up with their dad being an engineer.
[00:34:06] Lindsey Dinneen: Yeah. But it looks like it all worked out beautifully. So I'm very glad to hear all that. Ken, this has been so much fun. I really appreciate you joining me today. It was great to hear about your background and your advice, and I loved especially hearing about some of the little nuances that I wouldn't have gotten to otherwise, like pipe organ interests. So that's fantastic. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thanks so much for choosing that organization to support. And we just wish you continued success as you work to change lives for a better world.
[00:34:54] Ken Hoyme: Thanks, Lindsey. I really enjoyed chatting with you.
[00:34:57] Lindsey Dinneen: Yeah, same. And thank you so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time.
[00:35:10] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
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Dr. Kenneth Brown | Atrantil | Gut Health, Brain Health, & the Advantages of Being a Generalist
29 Ara 2023· The Leading Difference
Dr. Kenneth Brown is a private gastroenterologist with a clinical research division at Atrantil. Dr. Brown shares his journey from traditional medicine to a more holistic approach, blending natural therapeutics with traditional methods to treat gastrointestinal issues. He also discusses the advantages of being a generalist, how to care for your microbiome, and the need for more education about the link between gut health, brain health, and overall wellbeing.
Guest links: https://www.linkedin.com/in/kennethbrownmd/| https://atrantil.com/
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
EPISODE TRANSCRIPT
Episode 021 - Kenneth Brown
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome to The Leading Difference Podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Dr. Kenneth Brown. Dr. Brown is a private gastroenterologist with a clinical research division. In his practice, Dr. Brown uses a mix of traditional medicine and natural therapeutics to treat patients suffering from gastrointestinal issues. He hosts the Gut Check Project podcast where he and his team address topics surrounding gut health, healthcare economy, patient safety, nutrition, and more. Thank you so much Dr. Brown for joining me today. I am so excited that you're here and welcome.
Dr. Kenneth Brown: Thank you so much, Lindsey. I'm super excited getting to be a guest on The Leading Difference podcast. Awesome. I typically am always asked to do medical stuff, so this is a little bit out of my scope, but very exciting nonetheless.
Lindsey Dinneen: Great. No I'm very excited to have you and talk with you, and I would love if you would start by just telling us a little bit about yourself and your background and how you got to where you are today.
Dr. Kenneth Brown: Yeah, absolutely. So I'll take you way back. I was in medicals, I basically raised in Omaha, Nebraska. I was in medical school scraping ice off my car and realized one day, "I don't have to do this." And so I immediately drove down to Texas as quickly as I could, did my residency and fellowship, and became a gastroenterologist and still residing in Texas. I seemed to like the warm a little bit more than that scraping ice off cars.
So I started my practice about 20 years ago. Initially, I started doing clinical research specifically for the pharmaceutical industry. And I was helping launch some small biotech firms that were developing products. We were doing research for them, and in that time I realized there was this unmet need. In other words, no drug was being developed, or no drug existed for this big space called irritable bowel syndrome. I started to do research for the first drug that was trying to address this when I was in training. IBS, Irritable Bowel Syndrome, was considered more of a psychological diagnosis and literally I was taught that if you do tests on people and everything is normal, then more than likely, it is a psychological thing.
We used to think the same thing about ulcer disease. Whenever it was 50 years ago, if you got an ulcer, it was because you were too stressed. You need to back off work, do something like that. Then we found out that it was probably due to a bacteria called Helicobacter, H Pylori. And the person that discovered that got a Nobel Prize. That same massive paradigm shift was starting to take place when I was doing this research about 15 years ago. And that was that a doctor had shown that irritable bowel syndrome is actually caused by bacteria growing where it shouldn't be. And that's called small intestinal bacterial overgrowth. So it's just that bacteria growing where it shouldn't be.
And I was doing the clinical trial for them to look at treating people that had irritable bowel with diarrhea and in passing, I was having a conversation with the lead investigator and he said, unfortunately we'll never be able to help the bloated person with constipation because the type of bacteria that is causing it is a very old, ancient type called archaebacteria, and no modern antibiotics affect it." And that was kind of interesting. And and he said, "the issue is that this type of bacteria produces a gas called methane."
So I'm writing on my whiteboard in my office, "archaebacteria methane." And I start thinking, I started the story in the very beginning, 'cause I said I was raised in Nebraska and I scraped ice off my car to come down in Nebraska, the prime export would be agriculture. And what they were trying to do is mandate that these ranchers and farmers give different feed products to the cattle to decrease methane production that they're admitting for the Greenhouse Effect.
And I looked at that and I just went, "they've been trying to do this in Nebraska for a really long time. What is it that they're giving these cattle and can it be transferable to humans?" And so that sort of started the "aha!" moment of a bloated cow producing methane could be something eventually that might help the millions of people, and I mean millions, like 20% of the US population suffers from some form of irritable bowel syndrome and many more suffer from bloating and have never been diagnosed.
So I spent the next several years, me and my research manager, and we were looking at all the data in animals, and then we came across this combination of three large polyphenols, which are the molecules that make vegetables and fruits colorful. And realized that one of the major ones in there is something called Quebracho Colorado that had never been used in a supplement before, but it is used in wine making and beer making and many other things that humans are already consuming.
Went through some trouble of trying to get some Quebracho. This is in the like, weird things that happen with entrepreneurs. The only place that it is being developed is Argentina. And I happen to be half Argentinian, so I'm emailing, I'm calling, I'm trying to do anything to get hold of somebody to get me some of this product up just so I can do a clinical trial on it. And nothing was happening, I'm getting no response.
And so I actually called a cousin who's a physician in Argentina. She physically drove to the manufacturing facility, walked in an office and said, "there's a doctor in Dallas that's needs your product. He thinks he found a reason to give it to humans." And so that started this whole domino effect. And then eventually I get this shady bag of material sent to my office and I had to spend a lot of money to have analyzed and everything because they're used to working in the agricultural business where they would just send bags of stuff.
And so I was able to get this analyzed and all this other stuff, and then we encapsulated it and then put it with a few other things, and then ultimately did two clinical trials and found that it was remarkably successful in this patient population. And, we were able to launch this company called Atrantil. And that was about seven years ago that we were able to actually launch the company. And we have just been learning more and more about the science of all of this.
I've been fortunate enough to do this at the exact time where you and I were talking off air about where there seems to be this push for more awareness about nutrition, more awareness about doing things naturally, and not always relying on drugs to do everything. So I feel like I'm very fortunate to be in this great space, learning a ton. And being able to help millions of people at the same time. So that's where we're at now.
Lindsey Dinneen: Yeah. I love your story. Thank you for sharing that. There's a few different things that really stood out. First of all, I'm curious, did you always want to be a doctor? Is that something that was always a bit of a goal for you, or what made you decide to go into the medical field?
Dr. Kenneth Brown: I don't know how detailed you want to get into this, but I will tell you another quick story since this is, that one's very specific because, when I was in eighth grade, summer of eighth grade, my childhood friend got severely burned when he was on vacation with his mom. Third degree burns, ICU, whole nine yards, both him and his mom. And I get a call, you know, I was in touch with him, this is back before cell phones, so it's landlines. I get a call from him and he goes, "they say that I need to get outta the hospital because, mom needs to stay in here a little bit longer." Like they were in the ICU for a long time, so he had skin grafts and everything.
And I said, " just come live with us." And didn't even ask my parents and I just said, "Junior's gonna come live with us." And so he came and ended up spending a year living in our house and I was changing his bandages and all this other stuff. One night, at like 8:00 PM at night, doorbell rings and it's a guy-- introduced himself, his name was Leonard Woods. He said, I'm a physical therapist. I hear you have a young man who could use little help. I'd like to volunteer my services.
So he just basically rehabbed and then we all became friends, all of us. And of course I'm watching this guy that comes over and volunteers his time and I for sure am gonna be a physical therapist now. And I'm like in ninth grade, go through high school, always kinda shadowing and then during college doing some internships and stuff. And this guy saves my friend and he's this super cool dude and this is what I'm gonna do. And then he pulled me aside and he just said, "Hey, I know that you think this is what you should do, but I really think your calling is to be a doctor and I think you need to apply for medical school."
So I went, "okay." I just, at this point, I'm gonna do something in healthcare, just to help people. And the fact that your hero slash mentor is telling you to not do the job he's doing that he loves, I'm like, "okay, I guess I'll apply to med school." And then I ended up graduating college early, so I got a chance to spend a year, and I worked officially for him and he knew I was going to med school and then he spent that year teaching me how to manage employees, teaching me how to manage patients, how to run a busy clinic.
And he just said, " dovetail me so that you can see how the business side of this stuff works." And I was fortunate enough to go to medical school already having some idea of how I would do this and then I thought I would be a surgeon and then quickly realized that's a horrible lifestyle. I think I need to shift gears and was internal medicine. And then found gastroenterology and that fit me like a glove. So a gastroenterologist is an internal medicine trained doctor, so they already have a predisposition for a little bit of intellectual curiosity, but you get to do procedures. So you get to get in and immediately fix or help or prevent various diseases.
And so as a gastroenterologist, you basically are treating things from the esophagus to the anus. So I got into fellowship to be a gastroenterologist. I'm loving it. And then that's when I started realizing, "wait a minute, all health begins and ends in the gut." I was seeing all these people, they had gut issues years before they had something else. Everybody would complain that they had something else, and so, when I started private practice, that's how come I was drawn immediately after just a few years, I started the first research division of our company and I did research for about 10 years and it was just this beautiful sequence of events that led up to that point where I'm thinking about a bloated cow.
I mean, it took a really nice physical therapist to show up and then physical therapist to tell me to do something different-- possibly more, depending how you look at it-- and me to realize that all health begins and ends in the gut. And I basically continued that with that complete curiosity. And I'm continuing to learn all the time as everyone else is, as we're all learning that the gut is probably the root of disease and health.
Lindsey Dinneen: Yeah. Thank you for going to that story. I love hearing the why, what prompted somebody's interest or passion in what they're doing, and it really struck me-- both kind of stories you've shared with me so far about how synergistic from an outsider's perspective your life has been in a few different ways where like, seemingly no connection. So grew up in, in Nebraska and just you didn't like the snow, which I totally relate to by the way, side note. And then drawing from that experience is what helped you translate that into your work more recently. And that, that seems so disjointed, but it actually was this synergistic connection. And then you also have something like, you mentioned the one random place in Argentina and you had the connections, and I just love those stories when what's meant to be comes together in such a way that you could never predict.
Dr. Kenneth Brown: For sure. And the other thing about it, you say the story, but I look back and it was months and months of just radio silence. But I knew that we had something there. So it was me asking around, call my mom, "do we have anybody in this part of Argentina?" And so it took that continual pursuit of doing that. It wasn't just, oh, dumb luck. It's there, but it's the knowledge that it's there and it's the knowledge that you have an angle and it's the knowledge to utilize your network to try and get there.
The story sounds like it just kind of fell in place, but I think with every entrepreneur that you speak with, there's that classic line, "it only took 10 years to be an overnight success." There's so much more that happens back over here. And I look at this and I realized that some of these decisions that were made-- I don't know if you gave me another shot at this. Do you ever think about this?
I mean, you have this incredible dualistic career of being a ballerina and then being in the medtech, entrepreneur space and marketing and it's funny 'cause you love your life and you've got this great situation that you have going, when people say, "would you ever do it again?" I'm like, "no, no way. 'cause I don't know if I would make the right decisions, even though I know what decisions I made. I don't know if I would make the right decision to get exactly where I'm at right now, 'cause I kind of feel like I'm just beginning about where we can go with all this."
Lindsey Dinneen: Yeah. But that's the fun part, right? So it is kind of an interesting exercise to look back and think about the "what ifs." And if you were to redo it, would you make the same decisions? I've thought about that many times with different aspects where I chose between two seemingly really good options, but I'm so thankful I went with the one I did because that got me to where I am now. But you know, I was chuckling about your overnight sensation comment and I have thought about that so many times where, agree-- from an outside perspective it always looks different-- but I've always appreciated the quote, something like, "the harder I work, the more luck I have," or something like that,
Dr. Kenneth Brown: Exactly.
Lindsey Dinneen: I also think there's something to be said-- you talked about drawing on your network and the months of work that it did take. But I do think that there is something to be said to being open to possibilities that you wouldn't ordinarily pursue, or opportunities that you wouldn't ordinarily consider, because sometimes those, again, seemingly random, disconnected moments, somehow do all come together. And it might not be this overnight thing, but...
Dr. Kenneth Brown: Have you heard of a book called "Range" by David Epstein?
Lindsey Dinneen: Nope, but I'm writing it down.
Dr. Kenneth Brown: So the book is called "Range: Why Generalists Triumph In a Specialized World." It's really interesting because it's an analysis-- who's looking like business leaders and things like that, and generalists that learn a little bit-- it's always thought like in medicine it's " jack of all trades, but master of none." So it's that whole thing of jack of all trades, but master of none. And so in my field, you wanna become the most specialized of subspecialists that just, you're the expert. And I think because of my path coming in, there was never this devotion to this one thing immediately or I'm gonna be the experts' expert. I'm a generalist in life and I eventually end up in this space of a specialized world. But I seem to be better off 'cause I was a generalist.
And what I mean by that is in his book, what he describes is that when you have lots of life experiences-- if you've been in marketing for a little bit, and then of course you did have that, brief minor in accounting during college, and then you dabbled into sales over here-- and what he showed is that if you are adept at looking at this and you're still passionate about everything, you make the neural connections between these different experiences so you can see a connection between something where others are not. And almost by definition, that's kind of what genius is, where you can continually see things and go, "yes, this idea over here relates to that article that I read five years ago."
I see where this happens, and that's how you end up having an electric car company and a rocket company and a whatever that Elon Musk does, right? He's just pooling from all this knowledge and forming something. So I think that is probably the most important thing, and I'm, and I say all this because my massively transformative goal for the rest of my life is to cure something that to me is the, like, the worst thing that can happen, which is robbing you of your memories.
So dementia, it's an epidemic and it continues to go on, and I feel like what you lose when you have any type of brain trauma, even minor trauma, CTE, when you have toxins, when you start developing Alzheimer's and things, you lose the dendritic, meaning the connections between the neurons that allow that use of prior knowledge to now be integrated with new knowledge. And so that's why I think it's so important to protect the brain through the gut. Is any of that making sense? I feel like it just went down a rabbit hole.
Lindsey Dinneen: No, I love rabbit holes, first of all, so that's great. But also I think that is such a fantastic goal and it's so important and actually very encouraging to hear people working on these kinds of things, and the losing your memories and not being able to recognize people you love but realizing that maybe there are ways to slow that process or reverse or cure, that's a wonderful, hopeful thing.
Dr. Kenneth Brown: So that's the thing. Nobody's talking about that, but there's so much evidence out there. So one of my most frustrating things being in this space-- so what's happened since the-- I did, traditionally trained gastroenterologists, and then I'm doing pharmaceutical research and then I figure out that there's this space where maybe natural products can start filling the void, and that has really just shifted me to what I would consider myself more of a functional gastroenterologist. I still do traditional gastroenterology stuff, but I sure would like to find a more natural solution before we just knee-jerk and put you on drugs.
And one of my most frustrating things when talking to colleagues is, and I'm not throwing any individual under the bus here, but I start talking about, "oh, did you see this?" For instance, "hey, I just read a great article on the neuromodulatory effects of flavonoids, polyphenols, my world and gut microbiota through the gut brain access and how we can ultimately start healing our brains by having the right microbiome plus flavonoids. So that's an article. Just reviewed it. Super cool. Neat." And discussing that amongst my colleagues would be like there's no data on that.
And I went to a meeting recently and I was preparing to give a talk on, if you keep your microbiome young, you'll stay young. And, and it's all about manipulating your microbiome. And there's evidence to show that our supercentenarians, the ones that live past 95 or whatever, they actually have a microbiome, the microbiome is the collection of bacteria in your body, the collection of bacteria primarily in your colon that they have their own genome. You and I have a 99% identical genome, but we could have a 90% different genome in our microbiome, which may be one of the reasons why I age quick and you don't, one of the reasons why I get cancer and you don't, got it? The microbiome, it's the collection of the bacteria in our body.
So I was in a meeting, so I'm already preparing for this talk about the microbiome. And so I'm going to Croatia to give it. So I'm like really excited and it's, it's motivating 'cause I'm learning and everything. And I go to a meeting where a professor emeritus is gonna give a talk on probiotics and he gets up and the actual title of the talk was the "Probiotic Guide to the Gastroenterologist in 2023." And he said, "I think we can finally agree to this," and this is his words, "that the data does not support the use of traditional probiotics and we need to move away from this, and this is data. So some people do well in probiotics, but the data really is showing that probably traditional probiotics don't survive the digestive tract." And he said, "but what we really need to start thinking is we need to work on our microbiomes, but unfortunately, there's no data out there."
I'm in the audience and I have a folder of about 200 articles and a Mendeley. Mendeley is a journal repository on my computer of like another 300, and I'm like, "no data out there?" And it just got me thinking. I'm like, unless you have a specific desire to go look at something, the data that you're referring to is when a drug rep shows up at your office and gives you a detail piece 'cause that's how we're being reminded that there's new research. Here's the new drug, not are there any new, because this is like bench research that's going on all over the world.
Now we live in unprecedented times. I can find an article that hasn't even been translated in English yet, translate it from some postdoc candidate in Thailand doing crazy work on the stuff that I'm working on. And this is a true story. This is exactly what happened, and it's helping me develop more products because I'm like, "Oh, this person did do the heavy lifting already." And it was done 10 years ago and nobody's probably even heard of this. It's out there. It's just, do you have the motivation and the time to go look for things? Right now doctors are super busy and the time that they have is the five minutes they get with the person that brings them lunch.
Lindsey Dinneen: Wow. Yeah. So pivoting just slightly. I'm so thankful again that there are people like you doing this research and analyzing this data and helping us live healthier, fuller lives. So first of all, just thank you for that. I am curious if there are any moments that stand out to you throughout your career as really affirming that this was the right career path for you.
Dr. Kenneth Brown: Yeah. There was a-- I can't call it "aha moment" or anything. It is a, " you cannot not do this" moment, is what it came down to. So I'm an adult doctor and a woman who quit her job brought her 18 year old, severely autistic son in to see me. And I don't have any particular specialty in autism or anything like that. And what she said to me is, she goes, "I need help, 'cause he's now a young man. He's big and he's strong." And she said, "Nobody will take him. Like nobody will babysit him because he can be aggressive. And he's getting much worse with his autism and things are very rough on me, I had to quit my job. I have to spend all my time with him at home."
And I said, "I'm just curious, why here?" Now this is years ago, so it isn't like I was really deep into the functional medicine yet. And she said, "I've noticed one thing. I've noticed that when he eats, he's much more combative, and he's non-verbal so his communication is just really limited." And she said, "There has to be something with his gut if it's doing this." it didn't take very long to realize that he was getting super bloated after he ate and his belly hurt and he couldn't say, "I'm hurt, I'm hurting."
And so now we're in my wheelhouse. I started doing some research real quick and it's very evident that people on the autism spectrum disorder can have dysmotility or changes in the motility of their intestines, which can predispose to developing bacterial overgrowth, which is exactly my space now. And so we treated him and we treated him with both an antibiotic and my product and then changes diet. Changed lifestyle, change his diet, just made some changes. No processed foods. Don't open a bag. It's whole foods.
I personally, with the way that we grow our crop, I really try and get patients to avoid gluten as well. I think it's very neuroinflammatory. And so she came back three months later and she was crying. And she was so happy. And this young man was calm. He was talking. She's like, "he can eat." She's like, "I haven't seen him like this in 10 years since he was like a little kid."
And I'm like, "Okay, this is the n-of-1 that tells you, the brain and gut are connected and you have to keep pursuing that." And so that was oof, I dunno, six, seven years ago or guess well, like shortly after we launched. So I guess about, yeah, I dunno, six years ago or so. Yeah. So when you say that, I always think about that, if that's ever a case. I've heard that many other times since then and I don't think it's just the product or the antibiotics, I think it's the lifestyle change as well.
Lindsey Dinneen: Yeah. And how it all comes together to support Oh my word. Wow. Thank you for sharing that story. That is really powerful and I can see why it would be such a moment that would make you say, "yeah, this is what I'm meant to do, this is the impact I can potentially have on changing someone's life." There's nothing quite like that.
Dr. Kenneth Brown: Yeah. And then the more that you get into it, it just more reaffirming. So then it just becomes all consuming. You're like, you have to do this. And I think everybody that owns a business or is an entrepreneur-- I'm the visionary. We need an implementer to make things run at the company and all this. So if I had all the time and all the money in the world, it would just be 24/7 trying things out, looking at these natural products.
The beauty is we're learning that the modulation of the microbiome, the gut microbiota, the thing that seems to positively affect them the most are these large, stable polyphenols. And it's these large, stable polyphenols that get broken down into smaller phenolic compounds that work in an anti-inflammatory way and can cross the blood brain barrier, which is what I think is happening. Just go ahead and name any neuro-inflammatory disease from anxiety, A D H D, dementia, autism spectrum. There's different neurologic mechanisms primarily excitability and overactivity due to inflammation, creating all of it.
So knowing that's the root cause, where does most of the inflammation come from? It actually can start in the gut. So knowing that, how do we stop that inflammation? And then how do we improve the microbiome to produce anti-inflammatory aspects that then heal the brain? And the science is mapping out there. I think the traditional scientists will say that we don't know enough about it.
And that's true, 'cause you can't manipulate it in a way that people wanna manipulate it, but, I'm kind of taking that functional approach. Let Mother Nature figure it out. Just give your body what it wants, give it the foundation. Make sure you have a good sleep. Make sure that you socialize. Make sure that you exercise a little and make sure that you eat the right foods and all of it will sort of work itself out If you have your foundation right.
Lindsey Dinneen: Yeah. So last year, I had the opportunity to spend a little bit of time in Puerto Rico and there was this beautiful rainforest that we did a hike in. And it was really interesting, our guide was telling us that with the hurricane that they had just a few years back, had destroyed like, I wanna say maybe 80%, it was a very high percentage of the flora and fauna of the rainforest. And when we were there, there was no way we would've known that had she not pointed it out. And it really struck me how resilient living things are.
I think about this with humans as well. And when you intentionally try to nurture and cultivate and take care of yourself or other living things, how much we can bounce back from and how much we can heal and regenerate and make new, and I just thought of that when you were talking about the possibilities that if we can heal our gut, maybe we can heal our brain and heal some of these other things that come from, from that inflammation.
Dr. Kenneth Brown: Yeah, for sure. So let's use that same analogy with the hurricane, because what we do to our microbiome is a tropical forest. Exactly what you are walking through. There's trillions of bacteria. There's thousands of species. The more diverse it is, the healthier it is. Just like the rainforest you were walking through. Now you take antibiotics, you eat a highly processed diet, you do something to disrupt it. That's equivalent to that hurricane disrupting the rainforest.
The difference is we continue to do that and what we try to do is, we try to take control of it and take drugs or take different things to try and say, "oh, I'm gonna heal it with this." So the equivalent would be, when the rainforest was knocked down, somebody comes in and goes, "the rainforest was destroyed, but what I'm gonna do is I'm going to plant anything, name it, corn. I'm gonna plant grass, anything."
And so now you have a big lush field of grass. Now on the one side is just grass, and on the other side is a dense tropical forest. The dense tropical forest is the healthier version. We tend to focus on one bacterial species. That's where the science is. It's like, how do we grow more of this? How do we do more of this when it's the diversity that has to happen? They left the rainforest alone and it figured it out. And grew back quickly. The more that they would intervene with that, the slower that process would be.
Lindsey Dinneen: Yeah. Thank you for taking my own thoughts and putting it in, into exactly what we're talking about 'cause I appreciate that. Okay, so I am gonna take the conversation slightly differently, so just for fun, imagine you were to be offered a million dollars to teach a masterclass on anything you want. It could be in your industry, could be related to your work, but it doesn't have to be. What would you choose to teach and why?
Dr. Kenneth Brown: Oh my goodness, it's gonna be so boring 'cause it's, I mean, the masterclass would be this exact same topic. It's, you can protect your brain through your gut, would be what it is just because there's too much evidence that so little people are talking about it. And would it be a masterclass, 'cause I'm still learning? You'd pay me a million dollars and we would have to share it, 'cause it would be a group learning session. That's what it would be like. Everybody that attends, we all teach each other and share the million.
Lindsey Dinneen: There you go. You can use part of it to further your work because you were saying, if you had unlimited resources, how much more could you do? So, we can share the love.
Dr. Kenneth Brown: Yeah, I just, immediately was thinking, "my ego would not allow me to accept a million dollars to give a class". I'm like, "oh my gosh." What kind of a, like, there's my PowerPoint. Could never be that good deserving a million.
Lindsey Dinneen: Oh, yeah. Like We'll just give it to your organization and I'm sure you could find good ways to use it. I'm sure that would be a worthwhile masterclass to take, and it would be just a good learning experience for everyone. So, good answer. What is the one thing you wish to be remembered for after you leave this world?
Dr. Kenneth Brown: I wanna be remembered as a curious and kind person.
Lindsey Dinneen: Yeah. I like that. And then final question, what's one thing that makes you smile every time you see or think about it?
Dr. Kenneth Brown: Dude, I'm so boring on these questions. Like my knee jerk is like, oh, my family. I want to give something cooler than that. Oh my gosh. I try to practice some mindfulness type things. Have you heard of neurolinguistic programming? NLP? And so you know how there's an anchoring technique so that you can get yourself excited or happy? I will say that my happy memories would be, I took my family to Spain and we went to a Michelin star restaurant and had a chef's tasting menu there. And just thinking about that is my, anchoring to be happy. And then this summer, we went to Portugal and did the exact same thing, except the kids are older and all this other stuff. And so something that makes me smile immediately. Alright, there we go. It doesn't even have to be me. Something that makes me smile immediately is when people are loving and caring and they're breaking bread with each other over a nice Mediterranean meal.
Lindsey Dinneen: That is a great answer. Yes. I would have to say that I, I can fully support that. I love both Spain and Portugal, and some of my fondest food memories would have to be there too. So see this.
Dr. Kenneth Brown: It's just that feeling of, just openness and enjoying and discussing. There's something primal about breaking bread with other humans in a way that is, I don't know. And of course, it's a chef's tasting menu, so you don't know what's coming. There's that dopamine anticipation, and then it gets put down and it's like nine courses. It's just stuff like that that's awesome.
Lindsey Dinneen: Oh, I love it. That's amazing. Thank you so very much for joining me today. This has been such a great conversation, and I learned a lot. I'm very thankful for the work that you do and just all the ways that you finding to help people live their best lives. I just wanna, again, say thank you for your time and as just a small token of that, we're honored to be making a donation on your behalf to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. And we just appreciate again, your time, your efforts, and we just wish you continued success as you work to change lives for a better world.
Dr. Kenneth Brown: Thank you so much, Lindsey. Thank you so much for having me on. And I really enjoyed this and I enjoyed our 10 minute off the record banter and I feel like you would be a great guest on the Gut Check Project, my podcast, and we can talk about the ballerina days and all that. Let's do it.
Lindsey Dinneen: That sounds amazing. Alright, well, thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two and we will catch you next time.
The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
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Visit velentium.com to explore your next step in medical device development.
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Allison London Brown | CEO of LUMINELLE 360 | Femtech Innovation, Fundraising, & Personal Missions
15 Ara 2023· The Leading Difference
Allison London Brown is the CEO of LUMINELLE 360, a company focused on improving women's health through innovative medical technologies. In this episode, she discusses the challenges of fundraising, particularly for startups and women-led organizations, and the importance of personal mission and storytelling in leading a company and securing financial backing. Allison also emphasizes her commitment to changing diagnostic practices for women's health, particularly uterine biopsies, by developing a device through LUMINELLE 360 that enables physicians to perform these procedures more effectively.
Guest links: https://www.linkedin.com/in/allisonlondonbrown/ | https://www.luminelle360.com/
Charity supported: Tunnel to Towers
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenProduction: Marketing WiseProducer: Velentium
EPISODE TRANSCRIPT
Episode 020 - Allison London Brown
[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
[00:00:10] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
[00:00:39] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
[00:00:43] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to The Leading Difference Podcast. I'm your host, Lindsey, and I am so excited to introduce you to my guest today, Allison London Brown. Allison is the CEO of LUMINELLE 360. She is a visionary leader with a passion for changing the lives of patients, providers, and caregivers and inspiring teams to achieve their full potential. She has experience working with startups, venture backed organizations, global partnerships and corporations, as well as associations, NGOs, and global government agencies. Thank you so much for being here. I'm so excited to talk with you.
[00:01:28] Allison London Brown: I'm excited to be here. It's, it's great to meet you, Lindsey, and to talk to your audience, and I look forward to it.
[00:01:35] Lindsey Dinneen: Wonderful. Well, I'd love if you wouldn't mind starting off by telling us a little bit about yourself and your background.
[00:01:43] Allison London Brown: Yeah, so I am currently the co-founder and CEO of a company called Luminelle. And we in essence are a company that's focused in women's health. And we do that using our insights into what happens for women in diagnosis, especially in the office place. And we have a proprietary visualization system that physicians can use in their office. I wouldn't say it's just my job. It's actually a mission for me.
[00:02:17] So a little bit about me. I am a recovering scientist. I started in chemistry and engineering, so I still have a little bit of that, I'm a nerd, whatever, and I was with J&J for a lot of years in GE and some really great, amazing companies and was trained in both the medical device and as well as in the consumer and pharma world. So I've had some really spectacular experiences with tremendous people and great physicians and their patients. And, I've been in the women's health industry for a really long time.
[00:02:53] And in the company I'm in now, a few years ago, some physicians came to us and started talking about a problem that they were having and I had to say, I really didn't understand or believe it because I've been, again, been doing this for forever, and they were telling me that the difficulties of something as simple as getting a uterine biopsy. What we started looking into is that the failure rate for uterine biopsies is 50%. And that just seems really unacceptable, right?
[00:03:29] And so then the more I dug into it, the more I was learning about uterine cancer and how it's the fastest growing mortality rate. And that African American women, if they're diagnosed with uterine cancer, they have a 90% mortality rate. Hispanics have a six times mortality rate.
[00:03:50] So, just doesn't make sense, right? What is going on? And really what I discovered was that the way we do endometrial biopsy is they do it blind. So it's like this little straw that goes in to, to try to take a sample and you're not taking the right spot and you're not taking enough tissue. And so we get these really high failure rates. And the reason I'm saying all this about that is it was shocking to me, A: as a woman and B: as a person who felt like I was extremely knowledgeable and had been doing this for forever. So I was honestly shamed, that I didn't realize that this is such a major but small, a simple problem, right?
[00:04:40] So we've shifted all of our efforts really into creating this new device that we are going to launch any minute now which is allowing physicians to do very easy sampling. And I will tell people it's the most meaningful thing I've ever done in my career. And again, had great opportunities to work on major launches, but this is, I feel like is kind of that legacy moment, people talk about that legacy moment and I feel like that's this for me.
[00:05:10] Lindsey Dinneen: Oh, I love that. Yeah. You talk so much about it being so important and underrepresented and can't believe that there's this gap, and you know, that seems to be coming out more and more. There's so much more awareness, there's chatter, there's emphasis on women's health. However, there's also, it feels like there's still such a barrier to progress. Yeah, and I was wondering if you could touch on that, because obviously you're at the forefront of this. You are the one who is paving the way, but it is tough.
[00:05:45] Allison London Brown: Yeah, so people always ask me this question about, oh, as a CEO, my job is 99% of the time I'm raising money. Right? That's what you do when you're in a startup. You're raising money. You can never have enough money. You're always raising money. And so the question inevitably is talking about all of the statistics about how women founders don't get cash and the VCs don't fund us, and blah, blah, blah, blah, blah.
[00:06:11] Yes. Okay. So all of that may be true, but I do think that the bigger challenge is not 'cause I'm a woman, but because of the fact that I'm dealing in women's health. And, it's difficult. I've worked in a lot of different male down there care issues, and I have difficulty understanding all of it. And I'm sure that for investors ,who are predominantly male, are also struggling to understand why this is so impactful. I think the other thing is there's been so much legality in the United States around women's health. There's, lawsuits left and right, and so it does make some investors a bit wary. So on a positive side, we are seeing some significant wins when it comes to reimbursement. And so doctors are actually getting paid for their work. I think we're seeing some innovation come. But it's a whole lot too late maybe. I dunno, can I say that?
[00:07:15] Lindsey Dinneen: Yeah, that's fine. . Yeah. But now you have a bit of a unique fundraising experience if I ascertained correctly through some of your posts, and one thing that really stood out to me is there was a comment at one point where you said something to the effect of, if you're not comfortable raising money or asking for money or whatnot, then maybe you need to find a different occupation or different job title. Yeah. Yeah. I love the boldness of that. I was wondering if you could elaborate a little bit on that, because obviously, like you said, that's a huge component of what you have to do.
[00:07:54] Allison London Brown: Yeah, I mean, I think. The essence of all that anybody does really is we're all storytellers, right? We should all be telling a story. If you want someone to buy into what you're doing, whether it's to write you a check or to join your team, or to stay on your team, we talk about leadership and loyalty and recruiting and all these things, but in essence, all of those things really go down to, you gotta tell a good story. You gotta believe your story. And I don't mean like making up a story, I mean, you're sharing this common experience with somebody, or you're sharing how you've come to something with somebody.
[00:08:28] And so I think the challenge is it's easy for some people to ask for a sale, right? I'm selling you a product, I'm selling you a widget, I'm selling you a contract, whatever that is. But when you are raising funds for your company, you're kind of selling yourself. You are saying to an investor, trust me. Trust my team. Trust that I am going to take care of your money. I'm a good steward of your money and that I will not waste your money. And not only that, but that I will give you a good return.
[00:09:09] And I think when I talk to a lot of younger, newer entrepreneurs, the idea of selling yourself in a way and then getting the close on the deal, getting that check right? You gotta close the deal for whatever reason is very troubling for some people. And I mean, that's the whole point, "I'm telling you my story so you can understand why am I doing this, why I know I can be successful, why my team can be successful, and write me a check. Show me the money."
[00:09:46] Lindsey Dinneen: Yeah. And now you have approached it in, well, my perspective, a little bit of a unique way, and that is that you mentioned at one point that you raise a lot of capital through your own networks and through maybe not just Angel Investors or VCs or whatnot, but that you have been able to draw on your own social network, and so I was wondering if you could share a little bit about that process and if it's still an option, what opportunities still exist for people to invest in your company?
[00:10:18] Allison London Brown: Well you're welcome to invest, of course I'm always raising money, so, yes, thank you for asking. So the first part of that question, though it's kind of personal and I think people talk about doing like a friends and family round. That's not what I'm talking about here. The way that I have approached our fundraising, done a lot of Angel Funds, we've done a lot of high net worth individuals. We've been very judicious in our spend. We've been very fortunate. I mean, raised very little money, and have four or five, 10Ks, five patents, we're commercial, we've got contracts.
[00:10:55] But we are now at that stage that so many startups find themselves in, which is, I hate this word, but it's the "valley of death" where you finally have got everything ready to go and you run outta cash. A lot of us are in that boat. This has been a horrific year for raising money. So I, earlier in the year really tapped into my network. But I raised actually a little bit over a half a million dollars in two weeks, and most of it was from people in my church and their contacts.
[00:11:28] Lindsey Dinneen: Wow.
[00:11:29] Allison London Brown: So when I talk about it being personal, when we say this is missional, it is missional on a mental, emotional level, but for us it's also on a spiritual level that we really believe in what we're doing and we believe that kind of, for such a time as this, is why we're doing it. There's a reason why this idea came to us at this time with this group of people, with these physicians, with the technology that's available today. And honestly, that's not lost on a lot of people who know me personally, they understand why we are doing what we're doing. We will not quit. we will do whatever it takes to keep us going. And so in terms of fundraising, yes, we are still fundraising. We have a note that's out. We are opening up a seed round in the first quarter. And we have some very big plans for how we are going to launch this product. Not expensive plans, but big plans. Anybody who's interested, you can find me on LinkedIn. I think I'm on the only last name, London Brown. So easy to find.
[00:12:46] Lindsey Dinneen: Amazing. Yeah. I love what you said, and you've now said it a couple of times, of being so mission focused. Like this is not just a job to you, it's not just a company to you. This is a life's work and I love that. And I'm wondering if you can speak a little bit to, you've found this purpose, you've found this goal, and this mission to orient around and then how are you able to, like you said, story tell and express that to people who may not have experience or concern?
[00:13:21] Allison London Brown: The organ! They, they don't have a uterus! That's OK.
[00:13:25] Lindsey Dinneen: Exactly so, so, right, or people who might think, oh well, "I'm healthy, I'm fine." But that doesn't necessarily mean anything. So I just love to hear how do you share that heart and that passion and really help people care and understand like you do.
[00:13:39] Allison London Brown: Yeah, I mean, it does depend on the audience and everybody will say that, " it depends," but it does. I mean, you have to know kind of who you're speaking to and what's gonna matter for them, what's gonna get them to a, yes. Typically when I'm meeting with a group of, especially let's just say older gentlemen, it's easier for people to think about, "oh, have you had a colonoscopy?" Right? "Have you had a skin biopsy?" Have you had, all these different things that we kind of take for granted, right?
[00:14:08] These wonderful abilities to do diagnoses, and it's all driven by the ability to see. My business development manager, Jamie Harding, she goes on rant all the time about how sight is one of the most critical things in medicine, and yet here we are doing something blind. And, for a typical biopsy, the failure rate is 2%. So I think for a lot of guys they can get their head around, "oh, can you imagine no anesthesia, and the doctor starts just using some probe, and no camera, and it's just like digging around to try to figure if you have a problem." Okay.
[00:14:56] Or, you know, it's hard sometimes, but it's like getting a root canal without anesthesia and he's not looking. I mean, it's, there's a lot of different ways could say this, but at the bottom of this, it's like you gotta be able to see, right? So that's not a hard thing, I think for a lot of them to understand. Many times I'll spend more time talking about the technology, or I'll talk about the dollars, the actual economics of the situation versus the problem itself, because that can be, again, it can be a little bit distressing for some audiences.
[00:15:30] But, get 'em in the mindset of what if this was happening to you, and then what if this was your mother or your sister or your daughter or your granddaughter, you know? And she goes in, she has this horrific experience. It's extremely painful. And then. You wait a couple weeks and the doctor says, "oh well, either we didn't find anything or we are not really sure because it was Inconclusive." Inconclusive! That is the word that nobody wants to hear, right?
[00:16:05] Lindsey Dinneen: Yeah. Yes.
[00:16:06] Allison London Brown: Inconclusive. What does that mean? You can't tell me what's wrong with me. So yeah.
[00:16:13] Lindsey Dinneen: Yeah, so part of it definitely is sort of putting it into almost like, like you gave some great examples of putting it into terms where it's like, yeah, "can you imagine if you had a root canal where the dentist wasn't looking at you , and you had no anesthesia, what would that feel like?" That's ridiculous , and there's a solution for that.
[00:16:35] Allison London Brown: The other one is, I like this one, is a skin biopsy. You go in, you have something on your arm, you can see it, it's on your arm. Everybody can see it. It looks weird. Your wife has said to you, "you need to go get that thing checked. You need to go get that thing looked at," as we would say in the south. You go into your doctor, the doctor sees it, the doctor gets out a tool, then the doctor turns off the light and then tries to find where it was. I mean, it's kind of that same thing. Things you don't do blind. This is like a whole, like if I had a bazillion dollars, I'd be doing commercials about things you don't do blind, right?
[00:17:10] Lindsey Dinneen: Yes. Oh, I love that though. . I'm already starting to think of so many great ideas with that particular...
[00:17:17] Allison London Brown: Exactly.
[00:17:19] Lindsey Dinneen: You know, looking back, let's say years ago, and I recognize this as a little bit of a, a newer venture, although you've been very involved in med tech and science your whole life, did you always have an interest in science and healthcare from an early age? Is this something that you thought you might ever do or was this sort of a, an evolution over time?
[00:17:39] Allison London Brown: I can tell you the exact time where I decided this is what I wanted to do. So in high school, I thought I was gonna be a musician. I actually had a full scholarship in music and piano, voice and drama and really thought, that was my journey. And I took a chemistry class. I had put it off until my senior year. And fell in love with chemistry. I mean, I always liked math and then, at the time there were all these really interesting things going on around genetics and just so many different breakthroughs in medicine and I just felt like that was my path. So I started studying in chemistry. I started looking at the different careers in chemistry. I knew I didn't really wanna be in the lab, I didn't wanna be like a bench top scientist or anything like that.
[00:18:37] But medicine was so intriguing, I kind of thought that I was gonna go be a researcher at like NIH or National Cancer Institute or something like that. Some big, huge impact on the world. And, over time, I just, I found myself feeling more and more drawn to really understanding another form of science, which is understanding, "why do people make the decisions they make and why do they buy the way they buy?" Which, you know, behavioral decision making. And so marketing and sales was very intriguing to me. So I think I've I just leveraged a different part of my brain on the commercial side to really figure out how do you get someone, again, you get somebody to that yes.
[00:19:26] Lindsey Dinneen: Yeah. So very multi-passionate and multi gifted. Do you still do anything with music, voice, or drama, out of curiosity?
[00:19:36] Allison London Brown: I don't do drama anymore. I mean, well, ask my friends-- might tell you I'm dramatic all the time. I don't, I dunno that I am, but don't like drama. Let's just that way. I try to avoid drama in my life. Look, I'm very comfortable in front of an audience, and think all that upbringing of being on the stage, and I had the opportunity to sing at the Grand Ole Opry, so it wasn't a foreign concept to be in front of a large audience. I think that's very helpful. I'm in a band at church and I do that kind of stuff, but I don't have time anymore. I, you know, I'm trying to raise money. Right. I don't have time for that.
[00:20:12] Lindsey Dinneen: Right. But I love how that performer background may have helped contribute a little bit to your comfort on stage and giving presentation, being in front of people because that would be a very useful skill that, that, would intimidate some other people sometimes if they're suddenly in this role where, oh my gosh, now I have to be the face of the company, which means I have to do Y, and Z.
[00:20:34] Allison London Brown: Yeah. Right. Isn't that like the number one fear I think people have is speak in front of a crowd?
[00:20:39] Lindsey Dinneen: Yeah, . So there you go, you already had a little bit of an edge there 'cause you had that comfort, that's amazing. .
[00:20:46] Allison London Brown: Yeah, I mean, I think that's helpful, but and I tell people this all the time, again, if you cannot communicate your ideas or your story, then it is gonna be very difficult for anybody to buy in. I may have been a scientist, but again, that training in drama I think helped because a lot of people in science, they have a hard time articulating their ideas at a level that if you're not a PhD, you can't understand it. I am not a PhD. There are many brilliant people around me all the time and I'm like, "can you please dumb it down for me." Like I can't communicate it back to you in a way that makes sense, it's not gonna stick with anybody.
[00:21:29] Lindsey Dinneen: Yeah. And speaking of not having time anymore, you are a board member of multiple other organizations. Can you share a little bit about that? And also, do you get a chance to sleep or...
[00:21:43] Allison London Brown: Yeah. Yeah, I've actually had to back off some of my work. I've been involved with CED, which is the Council for Entrepreneurial Development here in Raleigh, for a long time. I guess 10 years. And this year I've had to really back off of that work, even though it's a passion of mine to help other entrepreneurs. I do sit on the board of Clayco Therapeutics. I really believe in what they're doing. They're working on a new biologic for necrotizing enterocolitis, and I know that's a big word, right? Basically it's when babies are low birth weight or premature, we talk a lot about like lung development, right? They can't breathe well or whatever. A lot of times their gut doesn't work, so their stomach doesn't work, and there's not a good diagnosis for it at all. And there's also a really not a great therapy for it. There's not like a drug. Some of these kids end up having multiple surgeries, it can lead to slow development, it can cause, just a myriad of other really horrific things for kids. And so they have a product that we believe is gonna be able to literally reset the gut, and allow the children to be able to feed properly. So I mean, these are like itty bitty little babies, right? So it's, I guess, adjacent to the women's health world, but it's, I just think it's a fascinating area of medicine, which is biologics, using natural substances to heal our bodies.
[00:23:15] Lindsey Dinneen: Yeah.
[00:23:16] Allison London Brown: Not synthetic things. And its a great mission, yes, I do get to sleep.
[00:23:20] Lindsey Dinneen: Okay, good.
[00:23:22] Allison London Brown: I do get to sleep. But I do try to get involved in things that, A) where I think I can add value. I try to get involved in things where I really know make a difference or help the entrepreneur, and it's something I, I believe in.
[00:23:34] Lindsey Dinneen: Yeah. Oh, I love that. Yes. And paying it forward is such a wonderful thing. So what are you looking forward to, as the company continues to move forward, either personally, professionally, what are some things that you're looking forward to?
[00:23:48] Allison London Brown: I'm looking forward to a vacation I don't, dunnah know if that's a good thing to say, but I'm looking forward a good, a vacation, that would be nice. We did not do a vacation this year 'cause it's just been one of those years. No, so in terms of the company, I have this vision in my head of having a building and having 20-30 people and 10 to 15 sales reps and just this humming, working, hive of people all focused in the same direction, working and aligned on the same outcomes, and just this community of believers that have come together to really make a difference. So I kind of have this idea of that place where we are all together doing something. And I think that could happen for us this year. So I'm extremely excited about that and giving people jobs, right, and giving people an opportunity to join with us in this mission. So that's exciting for me.
[00:24:53] Lindsey Dinneen: Absolutely, are there any moments in particular that stand out to you, that really solidified for you, "yes, this is why I'm here doing what I'm doing"? Because of something that happened that just was such a reinforcement of, "yes, I'm in the right place at the right time."
[00:25:13] Allison London Brown: Yes, I have. Two things. The first thing is we were doing research around this new biopsy tool and listening to physicians talk about what they're doing today, how they're doing it today, and hearing. doctor, after doctor say, "what I'm doing today is just fine, not good, not great, just fine." And I thought, "you gotta be kidding me." Like, how is that an acceptable answer? And not trying to diss the doctors, please. That's not at all what I'm trying to say. To me that just sounded like they have acquiesced or they don't feel like anybody's gonna pay attention to them or their plight or their concerns. And so why bother? And it felt very defeatist. Again, for people who-- my friends who know me, like, give me a challenge. Like, just go ahead, tell me, "no." let's see where that goes. So that was one thing.
[00:26:20] The second thing is much more personal. And in my prayer time, in my devotional time, in my, crying out to God to ask him is "Is this really real? Is this really gonna happen? I'm running outta money." All those fun things that we think about as entrepreneurs, "what am I supposed to do?" kind of at your wit's end and just having this huge sense of, " yes, move forward. Yes, go forward. Yes, I'm here with you. Yes, I'm in it." And I know that sounds kind of kooky, for people who are not maybe into that kind of thing, but a few years ago I would've said, "that's crazy." But I will tell you, it was extremely meaningful event for me and it stays with me. It keeps us going because I just, I believe in us. I have faith that this is what we're supposed to be doing.
[00:27:19] Lindsey Dinneen: Thank you for sharing those stories. Those are both very meaningful and it is encouraging because feeling that belief and that reassurance that "yes, you're in the right place, doing the right thing at the right time" is so important because it's not easy. Nothing about what you're doing is easy , so you have come back to that.
[00:27:40] Allison London Brown: Yeah, and I feel extremely blessed that I do have that, because I, a lot of my friends are thinking through what is their purpose? What should I be doing? How blah, blah, blah, it's tough when you are seeking for something that's meaningful, right? And I do believe that we've been given that opportunity.
[00:28:00] Lindsey Dinneen: Oh. I love that. I, yeah, absolutely love that. Pivoting just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything that you want. It can be in your industry, does not have to be. What would you choose to teach and why?
[00:28:20] Allison London Brown: Yeah. There's a lot of things I think I would like to teach people. It's something my girlfriends and I have been talking about quite a bit lately, which is, as a woman-- and it's probably not a masterclass, it may be more of discussion group-- but it's, how do you move through those different periods of your life physically, emotionally, mentally, all of those things and still be true to yourself. And I think, I look back on my twenties and my thirties and I think "well, wow, was that really who I was? Did I have to evolve through that to get to where I am?" And if there's a way to impart any knowledge to someone to say, here are some skills you can use, here are ways to leverage your brain or deal with hormonal issues, or deal with the fact that you're having to take care of your family or whatever it is. I feel like we chunk it up a lot. We talk about, oh, mothers in the workplace, or we talk about now the big thing is menopause in the workplace, which I think is hilarious. But it's great that we're talking about all these things, but there's not a kind of path, how do you go from being an 18 year old to a 22 year old, to a 30 year old, to a whatever year old, right? So to me it's really sitting down and thinking through how do you go through each stage of your life. That would be one thing that may sound kooky, but...
[00:29:50] Lindsey Dinneen: Nope. I would sign up for that Masterclass. No, I love that. And because that's not something that is really talked about and like you said, each stage is different and it brings its own unique sets of excitement and challenges and considerations and you don't really hear enough people saying, "Hey, here's some things to think about. Here's some things to watch out for." So, yep. I'm on board.
[00:30:16] Allison London Brown: Yeah, I have a friend that she's in her thirties and she listens to a group of us talk and she's like, "oh, so this is what I have to look forward to." And I'm like, "oh, yes."
[00:30:25] Lindsey Dinneen: Yes. Indeed. Indeed. Yeah. So, what do you wish to be remembered for after you leave this world?
[00:30:35] Allison London Brown: Well, besides what we're doing here at Luminelle, I certainly would love to have that as a legacy as something that really impacted how, maybe not just how women were diagnosed, but how physicians started thinking about diagnosis differently. But, I guess I would like to be thought of as somebody who liked to have fun and laugh and brought joy to other people.
[00:30:56] Lindsey Dinneen: I love that. I love that answer. That's a wonderful thing, . And then final question, what is one thing that makes you smile every time you see or think about it?
[00:31:08] Allison London Brown: I probably should say my husband's face. I get points for being a good wife to say that. And it's true. It's true. It's not-- I'm not making it up. It's true. I'm a sucker for I really am a sucker for the movie "Elf."
[00:31:23] Lindsey Dinneen: I love that movie.
[00:31:26] Allison London Brown: I have three movies I watch every holiday, " Elf," " Scrooged" with Bill Murray and "Die Hard." And I'm not allowed to get those movies out until after Thanksgiving.
[00:31:41] Lindsey Dinneen: Oh, So what works for, what works for our family is my husband and I have a tradition of always on Thanksgiving Eve, so to speak, we break bread to get it ready for stuffing so it can, kind of dry out overnight. And we spend the evening watching "Elf," and that's like the start of our holiday season. It's like a really fun tradition, do you think you could get away with that?
[00:32:06] Allison London Brown: I don't know, because I will watch it like 500 times during the holidays.
[00:32:12] Lindsey Dinneen: Fair enough.
[00:32:13] Allison London Brown: I am a sucker for like --not stupid comedy, so I'm not, I don't like slapstick or anything like that, but I just think "Elf" is such, I mean, it's a great story. It's got great songs. It's got Will Ferrell's hilarious. It's got a great ending. It's kind of that. It's, it, I just, and I love James Kahn. Let's just, okay, sorry, but love me some James Conn. I think he's amazing.
[00:32:39] Lindsey Dinneen: That is a fabulous answer. Definitely, that goes to the top of the most unique and that is so fun. I'm so glad you enjoyed that. Oh, my word, Allison, this has been such a fun conversation. I'm really inspired by what you're doing and by your focus on mission and impact and the way that you are working so diligently, even when it's tough and it's gonna be tough to share your story, to bring this to market, to change lives.
[00:33:10] And we are so excited to be making a donation on your behalf Today to the Tunnel to Towers Foundation, which since 9/11 has been helping America's heroes by providing mortgage-free Homes to Gold Star and fallen first responder families with young children, and by building specially adapted smart homes for catastrophic injured veterans and first responders. They are also committed to eradicating veteran homelessness and helping America to never forget September 11th, 2001. So, thank you so much for choosing that organization to support. And we just really appreciate your time.
[00:33:47] Allison London Brown: Thank you. I really appreciate it. And I hope that if one person hears this one post, one mention can sometimes change a life. And so if you're a woman out there, and if you've had abnormal uterine bleeding. That is your warning sign. And so go get checked. Don't wait. Do not pass go. Do not collect $200. Go to your physician and do not accept a subpar answer.
[00:34:17] Lindsey Dinneen: Yeah.
[00:34:18] Allison London Brown: So I think if I can get, just as important as it is to get physicians doing the right thing is for us to be asking for the right thing and being our own advocate. And write me a check. while y'oure at it, write me a check, I'm not sure I'm actually allowed to say that. There's probably some like SEC violation I just did. But
[00:34:40] Lindsey Dinneen: Write the company a check. It's important.
[00:34:42] Allison London Brown: Yes. Write the company a check if an accredited investor, please. Yes, no, I'm happy to talk to anybody who would like to know more.
[00:34:51] Lindsey Dinneen: I love that. Well, thank you again. I just wish you the most continued success as you work to change lives for a better world and thank you also to everyone who has listened to this episode, and if you're feeling as inspired as I am, I would love if you would share this -episode with a colleague or two, and we will catch you next time.
[00:35:11] The Leading Difference podcast is brought to you by Velentium.
[00:35:17] Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
[00:35:32] Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
[00:35:49] Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
[00:35:56] Visit velentium.com to explore your next step in medical device development.
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Joe Landolina | CEO of Cresilon | Vetigel, Entrepreneurship, & Saving Lives
1 Ara 2023· The Leading Difference
Joe Landolina is the co-founder and CEO of Cresilon, a biotech company that developed a plant-based gel technology to stop bleeding within seconds. Joe shares his unique journey from inventing this groundbreaking technology at the age of 17 to building a manufacturing facility in the heart of New York City. The gel, known as Vetigel, has saved numerous animal lives and recently received FDA clearance for human use. Joe discusses the challenges of building the company, the importance of community support, and his passion for helping the next generation of entrepreneurs.
Guest links: https://cresilon.com/| https://www.linkedin.com/company/cresilon/
Charity supported: ASPCA
Interested in being a guest on the show or have feedback to share? Email us at [email protected].
PRODUCTION CREDITSHost: Lindsey DinneenEditor: Tim OliphantProducer: Velentium
EPISODE TRANSCRIPT
Episode 019 - Joe Landolina
Joe Landolina
Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world.
Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.
Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.
Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.
Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.
Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.
Hello, and welcome to The Leading Difference podcast. I'm your host, Lindsey, and I am excited to introduce you to my guest today, Joe Landolina. Joe is the co founder and CEO of Cresilon, a Brooklyn based biotech company developing and manufacturing a plant based gel technology that stops bleeding in seconds. The revolutionary technology, which was created by Joe, recently received its first FDA clearance in human use. Well, welcome, Joe. Thank you so much for being here. I'm so excited to talk with you.
Joe Landolina: Definitely, Lindsey. Thank you so much for having me on.
Lindsey Dinneen: Of course. I would love if you don't mind by just starting by telling us a little bit about yourself and your background and how you ended up in medtech.
Joe Landolina: Sure. So I have a bit of a unique story coming into medtech because I got a really early start. But to start from the basics, I'm a chemical engineer by training. I did both my undergrad and my graduate work at NYU in New York. I'm a New Yorker, born and raised. And my grandfather was a Hoffman LaRoche executive, that in retirement, started a vineyard. And he also learned lab safety in the sixties. And so that meant the day I learned how to walk, I was taken into a chemistry lab with my grandfather and told, "Mix some things together, don't kill yourself, kid." And so, from a very early age, I got an intro into lab research.
And so that led to me inventing the technology that Cresilon was based on at the age of 17 when I was a freshman at NYU. And over the last 13 years, I've taken that passion and that invention and turned it into what Cresilon is today, which is a biotech company that has sold our products in 30 countries outside of the US. And we do all of our manufacturing and are headquartered here in Brooklyn, New York.
Lindsey Dinneen: Wow. Oh my goodness. Well, first of all, the fact that you started off in a lab and we're just kind of told, "Go have fun." Okay. So what are some of your first memories of experimentation?
Joe Landolina: So, I'm not sure if I can tell all of the first memories on a podcast as upstanding as this one. But what I can say is that my, my first several experiments created such fear and anger in my parents that they cut me a deal, and the deal was I had to go learn how to do lab research the right way, anywhere, please, quickly. And so, the end result of that was at the age of 13 or 14 years old, I did a summer research program at Columbia University in tissue engineering. And that program really opened my eyes up to the field of medtech, because at that time, I had a simple worldview where career paths were either doctor, lawyer, accountant, and so on. And so realizing that there were so many other shades of possibility within this industry was something that, that I realized thankfully at that age, and it started this path of really falling in love with this type of research and I dove headfirst into it.
Lindsey Dinneen: Yeah, absolutely. It sounds like in general that you've had a passion for basically what you're doing now from a very young age. So how did Columbia help you narrow down this passion into a more specific area of focus?
Joe Landolina: Definitely. And so let me talk a bit specifically about what I was working on at Columbia, because there was a lab there that was using plant based scaffolding. Meaning polymers that come from plant based materials to grow stem cells that come out of a human patient and have them differentiated into a target tissue. And this lab was working specifically on chondrocytes or cartilage. And so it was just amazing for me to see this material taken completely from nature that was able to be repurposed to take a patient's own stem cells and turn them back into cartilage that could potentially be put back into that same patient.
And so it set me down this path where at the time I only had access to-- the internet was good for a lot of things, but not really finding information yet at that point. And so if you wanted to learn, you had to go to a library, you had to, whether it was a public library or a university library. And so I surrounded myself with Eastern medicine books, and books that looked at how pharmaceuticals derived from nature around us, because the one thing that I had, I grew up on a vineyard. And so I was able to grow anything or collect anything that I wanted to. And so I had a real interest in finding solutions to the experiments that I was trying to run in nature.
And I got fairly good at identifying these sources of material, because again, no one would sell a winery lab or a 13, 14, 15, 16, 17 year old, agents to do these types of experiments. So, I had to get creative. And so that was really my entry point into that and Columbia opened my eyes that that was being done at the highest levels.
Lindsey Dinneen: Wow. Okay. So nature based solutions. And as you have continued to go down this path and then of course develop your company and your products, can you tell me a little bit about the origin story of the company? Because, gosh, doing this at 17 years old, that must've been a remarkable breakthrough. I'd love to hear more about that.
Joe Landolina: Sure. So, to start with, I was running this experiment in the winery lab where I was trying to make a plant based scaffold to effectively replicate some of the stuff that I had seen at Columbia. And that experiment went terribly because instead of having a multimillion dollar university funded lab, I had a winery lab, which you can interpret that as effectively a glorified kitchen counter with a bunch of equipment that was "borrowed" from Roche in the late 70s when my grandfather retired. And so it wasn't very fancy by any means. And so I didn't get the result that I wanted.
But what I did get was this material that was this mess that came out of algae that would form a gel that would simply stick to skin and wouldn't let go until you wanted it to. And I had this idea, which was, what if you could take a material like that, inject it into a bullet wound, and at least plug up that bullet wound from bleeding so you can get a patient and move them from point A to point B without them bleeding out. And at around the same time, as a freshman, this was my first week of school, there was a poster in the engineering quad at NYU that said "best business plan idea $75,000 top prize."
And what really drew my eye was that they would give free MBA classes to anyone who got into the quarterfinals. And I thought, you know what? There's no way I win, but I wanted to be a doctor and I was an engineer's engineer and I was really looking for things that were around me on my resume. And I thought that this stuff isn't going to work and it's not going to become a company, but I may as well join this competition. And worst case scenario, maybe I can talk my way into getting some free business classes and get me an internship over the summer. And so I met my co founder, Isaac, who was a student at the business school at NYU at the time, and we entered the competition and we ended up taking first place at the engineering school, and second place at the business school where he was at, and and the rest was history.
Lindsey Dinneen: Wow. Oh my word. Well, congratulations. That's a fantastic origin story. And I love the fact that you just went into it with this mindset of, even if we don't necessarily win, we're still going to see the benefits from this other education. And I think that's so important to have a lot of cross experiences that eventually help lead into the success, and sometimes you don't see how they all interrelate, but eventually they do. I love that that's how you approached it. What a great mindset.
Joe Landolina: Thank you.
Lindsey Dinneen: Yeah. Well, so, okay. how many years have you been in business?
Joe Landolina: 13 years later.
Lindsey Dinneen: 13 years later. Okay. So 13 years later and you have now gone through several rounds of funding. And so I'm curious how that process has gone for you, 'cause that's a whole other kind of learning curve as well. How has that been for you?
Joe Landolina: So we've been very unorthodox in a number of ways here at Cresilon. And the way that we raised funding was was no exception to that rule. And so we've done over a hundred million dollars in funding to date across several rounds of funding. Our first round was in 2013. So our seed run was raised from angel investors, high net worth individuals that read about us in social media. We were lucky in those early years, we had a lot of press coverage, both because of my age and really just because this technology is unlike anything else that I've seen in that you can, in a 20 second video, understand exactly what it does and what the value is.
And we had this video of a steak that I cut and we pump blood through it and it's this massive bleed. You put the product on it, it stops instantly. And that video had over 140 million views on it, all in all, so we get a lot of attention in the beginning there. But then, those investors that we brought in to raise a couple million dollars in our seed round, ended up reinvesting time and time again, just all the way through the company's history, and so those same investors-- along with some other investors that we collected along the way-- ended up being the bulk of the funding that we brought in.
And that's incredibly rare in this industry, especially in biotech, where there are usually different VC funds that come in at each stage, it's not like we don't have venture investing or investment here at Cresilon, but primarily our largest investors and the average investor is a private individual. And that's very rare for this type of funding, but it's allowed us to build a cohort of investors that primarily are end users. We have a number of surgeons and doctors and veterinarians who have used the product and who were very vocal in helping us design the product in the very beginning, and it allowed for this healthy conversation where if there's an investor who has money behind something, that they're not going to pull their punches when they tell us what they like. And then more importantly, what they don't like about the product. And it allowed us to get really raw, involved feedback from day one effectively.
Lindsey Dinneen: Yeah. Which is so important and what an interesting funding experience you've had, like you said, it's definitely unique. Now looking back over the last 13 years: what has been one of the biggest challenges in either starting or building the company. What has been either unexpected or the largest obstacle to overcome so far?
Joe Landolina: So I think that the biggest obstacle by far has been the middle phase of the business. And so when I say the middle phase, from the end of 2015 until the end of 2020. And so if we look at the business in sort of five year packets of time, from, 2010, which is when we founded the company and had the idea, to 2015, we were building a product that worked.
And so at the end of 2015, we had Vetigel. We knew Vetigel would work and we were able to manufacture it. But we realized that the market demand far exceeded our ability to manufacture. And in fact, we were too reliant on third parties. And so, in 2015, the goal was to effectively outsource everything that we could.
And unfortunately, when you make a highly novel product like this, we were finding that we were unable to find partners that could outsource. So in fact, there was not a single manufacturer that could manufacture Vetigel gel. We had to do everything ourselves, but there weren't even labs that could do the testing that we needed. And so we were getting false positives and false negatives.
And so in 2015, we were ready to launch and I made one of the hardest decisions that I ever had to make. I pulled the plug on the whole thing. I went back to our investors and told them, "Look, if we can't do this the right way, if we can't ensure the safety of our product, we're not launching." And we raised 10 times the amount of money that we'd raised up to that point, just to build brick and mortar manufacturing. We brought in individuals who had built quality labs and done this at scale for large vaccine manufacturers.
And Cresilon at that point became the very first or the very only sterile manufacturer in the five boroughs of New York, something that we're proud of. But it took us five years, and that was a very hard, onerous time where, frankly, we didn't know if it was perfectly possible or completely possible to do what we needed to do. And so the entire time we were working on perfecting, on validating, on standing up this factory where we had to design all of the equipment from scratch.
Our product is like the consistency of hummus. So it's not incredibly viscous and there are lots of machines and manufacturers that make vaccines and lots of machines that manufactures and make hummus, but no one dumb enough to do it together. And so, we were lucky enough to be the first and we had to figure out a way to get it done. And so we had to design clean rooms. We were one of the first production clean rooms that had to be made in New York City under New York building code. So we had to even custom design things like sprinkler heads to comply with FDNY regulations, but also maintain the sterility of our clean rooms.
And so it was literally nuts to bolts. Like every test that's run on a syringe today was designed by a Cresilon employee and something we're proud of, but it was hard. We were going effectively month to month where we couldn't sell. We couldn't make revenue until we got these pieces put together. I mean, obviously when you're doe eyed and naive, you think it's an 18 month process to stand up a factory, but it took all of five years and it culminated with launching in the very best time to launch a new product to a direct customer in an operating room, which is at the height of the COVID pandemic in October of 2020.
Lindsey Dinneen: Oh, my goodness. Yeah. All those years of just waiting and planning and executing, but not, not quite being there. Oh, my word. Your patience and your stress. Good for you to have gotten through that. I would love to hear about what you consider your biggest win, but I recently read something that I wonder if we'll be on the same page here with that, but tell me what your biggest win is so far to date.
Joe Landolina: So frankly, Cresilon's mission is saving life lives and the biggest win still to this date, right, it's saving our first animal life, right. I'm, my guess is that you're going to mention that the recent FDA approval for humans, but what I tell my team is it's not about the paperwork. It's not about the regulations and that's an amazing accomplishment that I don't want to minimize by any means. It's about what we do for our patients and what we do for our clinicians. And so, you know, for me, I'm an engineer by training, and so that means I'm a natural pessimist. And so I always look for flaws in products because I like to fix flaws.
And the thing that you can't argue with is when you take a patient that would have not survived a procedure and translate that into a successful outcome. And we've now done that over 45,000 times on the Vetigel product line. And what I'll say is that excitement doesn't diminish. And we're now ever closer to being able to do it for the first time in a human patient. And that's something we're looking forward to. But we still have some some ways to go before we can achieve that.
Lindsey Dinneen: Yeah. First of all, that's incredible how many lives you've already impacted through what you're doing. And I love your mission statement. I think you're so right to get back to the heart of it. But also I do want to say congratulations for the FDA approval, because I know that was no easy feat. That's really exciting that you're there now too. So on both ends, lots of lives being saved. Thank you for what you're doing.
Joe Landolina: Yeah, thank you so much. It was a journey and a half to get to that point. It takes a lot, especially for the first time on a new technology to get it through. But I can take no credit for it, it was all my team. And they were the ones who put in the countless hours and overnights to get it done. But for now, that means we can start growing.
Lindsey Dinneen: Yeah, absolutely. Is there any specific instance or memory that stands out to you as reinforcing the idea that you were in the right place at the right time? Like, this is your field, what you're doing, your specific path. Did you have a moment that was just like this affirmation of, "Yes, I'm in the right place."
Joe Landolina: I'd say that's a really good question. What I'll say is that we've been very lucky throughout the entire journey. I think that the silver bullet that allowed us to stand up our factory was something that was only invented itself in the same year that we implemented it, meaning that if we had gotten there, even a year earlier after developing the technology, the thing that allowed us to solve our problems wouldn't have been there. And to get it back to, to what I was mentioning earlier, I think that there are definitely cases where surgeons that we've just trained have a case come in that day, where on a Monday, we teach them about the product and on Tuesday morning, they have a dog that's been hit by a car that would have been unsavable a couple days before without our product. And, and there are countless cases like that that we hear about and it just shows that the world keeps turning whether or not our products are out there, but the fact that we can be there and make a difference and truly save lives is something that, that just is validation enough.
Lindsey Dinneen: Yeah, Oh, absolutely. Speaking about being able to use this product with animals, I noticed on LinkedIn that you seem very passionate about animals and especially shared some really heartwarming rescue stories and whatnot. So I have to ask, have you always loved animals? Is this always been a passion of yours?
Joe Landolina: So I grew up on a vineyard with a bunch of property and I always joked that my parents had a menagerie at home and so we always had everything from dogs and cats to llamas and alpacas and ducks and they're interesting animals going around and and so I've always been a lover of animals. It's hard living in Brooklyn now. My wife and I recently took a plunge last year. We adopted a German shepherd puppy who very quickly grew to 85 pounds. She keeps me fit. We do 10 miles a day together. So she's adapted well to the Brooklyn lifestyle. But it's it's definitely nice to be able to do that in the city because I went for years without having a pet of my own.
Lindsey Dinneen: Oh, yeah, and dogs are just such great companions. It's hard to not fall in love with them. So what's next for you and for your company and what are you excited about coming up?
Joe Landolina: So on the back of this FDA clearance of of our technology, what's next is translating that into our first human life saved. And there's a lot of work that still needs to be done. We still have to scale everything up and get ready for that launch to do it the right way. But it's coming; it's scheduled for next year. And it's something that, that we're looking forward to is it just allows us to extend and expand our mission beyond what we've already been doing.
And then on the Vetigel front, we've been seeing really amazing results in indications that frankly, when I came into this market, I never thought that we would be doing surgery. And so Vetigel is being used today in brain surgery, is being used in spine surgery to help dogs that were paralyzed that now can walk again because their surgery time is short enough that they're no longer at risk of of going under that procedure.
And so really amazing things that are coming out of that market that we've been working with commercial partners to make sure that we're able to get that in the hands of any vet that is able to use Vetigel, or willing to use Vetigel. And so a lot of growth is ahead of us and it's just trying to put our heads down and come back to mission which is making sure that we can save lives.
Lindsey Dinneen: Yeah, I love that. So is the plan to continue for both animals, and now because you'll have the opportunity to test with humans as well. So is the goal to always have both things going simultaneously?
Joe Landolina: Definitely. And because we're in the human market, it doesn't mean that animal becomes an afterthought in any way. And so our team in animal health-- we have a direct sales force here in the US, the partners that we have abroad are still staying. And so we're still growing those teams pretty substantially. It just means that, for better or for worse, we have a lot of hiring to do. We have like 45 open positions right now as we start to beef up the human commercial side of our business.
Lindsey Dinneen: Wow. Well, that's exciting. So anyone listening could potentially go to your website and learn more about working with y'all.
Joe Landolina: Exactly. We have a careers page on Cresilon.com and if anyone interested checks that out, we have a number of roles open for for people who are interested and willing to join our team.
Lindsey Dinneen: Awesome. So one thing that I noticed also on LinkedIn was I saw a couple of different posts about various speaking or resources that you seem very passionate about helping the next generation of professionals in the field to level up their skills, feel comfortable, gain the experience and the knowledge. Would you want to speak anything to that and in terms of your interest in helping the next generation? I really appreciated seeing that.
Joe Landolina: Definitely. I think that I'm not the only one by far that's doing this, but it's just, founder resources are tricky because there's a level of healthy competition that happens in startups. And so something that's been very near and dear to my heart is just talking openly about sharing of resources, talking openly about mental health challenges that the founders go through, and being there for the communities that I'm a part of, and that may mean the New York community, that may mean the NYU community, or that may just be the larger entrepreneurship community as a whole, but in my opinion, this only works if the community comes together and supports one another.
And I think that I've gone through this journey and there were resources that I had that were amazing, and there were resources that I didn't have, and what I'm trying to do is if there are entrepreneurs out there that don't have the same resources that I did have or that are looking for something that I also couldn't find, if I can be a little part in helping alleviate something, then I'm all for it.
Lindsey Dinneen: Yeah. Yeah. Well, I love that. Thank you for paying it forward. I think that's really important and it's very encouraging to continue to see people speak out about various struggles and obstacles. And when you're real and honest and transparent with those kinds of things, you can really help somebody else who might be going through similar challenges. So thank you. I appreciate what you're doing.
Joe Landolina: Definitely. Yeah, it's been a lot of fun. And in fact, I have much younger siblings. So my parents, when I was in high school, wanted to try for a daughter and ended up getting triplets, two boys and a girl. And one of the triplets who turned 18 last week has just founded his first company. And so it's it's nice to see it run in the family.
Lindsey Dinneen: Oh my goodness. Yes. Congratulations. That's pretty cool. All right. Well, pivoting and just for fun, imagine someone were to offer you a million dollars to teach a masterclass on anything you want. It can be in your field or industry, but it doesn't have to be. What would you choose to teach and why?
Joe Landolina: I think, negotiation would be what I talk about . Because it leans into entrepreneurship, right? And what I find is both in young entrepreneurs and in candidates that come to work for us, or members of my team, or even myself, people don't realize that the way to affect change, whether it's in, in their personal lives, in, in their work or as they're starting a company, it all comes down to how you position it and what you ask for.
And so I think that it's something that people realize maybe too late on average that if you want something, all you have to do is ask for it. And one of the best learnings I had early on was that the beauty of New York is that there's so many resources just around us and at our fingertips. And if you want something, most people, their tendency is to say, "I'm going to keep that hidden. And I'm not going to, I'm not going to tell anyone else that I want this thing, but the worst you can get is 'no'."
And if you ask enough people, odds are, you'll find someone who will say "yes" at the end of the day, right. And that's how we got our first lab space. That's how we got our first checks. That's how we started putting the pieces together to build the business. And so understanding how to do that is just such a great launch pad. And maybe I'm not the best professor or teacher of that in myself, but it's been a skill set that I find has helped me greatly and that people, on average, don't seem to realize that, that it's a possibility in pretty much in any circumstance.
Lindsey Dinneen: Yes. Great. Great answer. And I would definitely attend that masterclass. I'm really passionate about this topic too. I think there's so much hidden power in just asking. And like you said, the worst someone can say "no". And a lot of times that "no" is "not yet". So if you've got a great idea, if you have something you need or want and you do put it out there, there are so many people that are willing to help. So yeah. I love that. What's one thing that you wish to be remembered for after you leave this world?
Joe Landolina: I think that I feel bad giving the same answer, but it's true. So I so I'm going to say it again, but it's just-- if there is one patient that had their life or had a family member affected because of technology that we put out, that's enough. And so the way that I view what we do, right, I want to have made a difference in someone's life. I want to have made a product that swings the needle in, in, in the direction of good, rather than worse.
Lindsey Dinneen: Yeah. And just think of all of those animals already. That alone to me is very cool as well. And this is just the beginning. So yeah, that's exciting. And final question: what is one thing that makes you smile every time you see or think about it?
Joe Landolina: I'm going to say my German shepherd. Yeah. She's been a a massive positive influence in my life. So I think doing what I do, it's hard to stay grounded and stay present. And having a dog forces you to be grounded and present at least for a good part of your day. And there's something here that relies on you. And so she, she makes my day every day.
Lindsey Dinneen: I love that. Well, thank you so much for joining us today, Joe. This was so much fun. I'm so excited about the work that you and your company are doing. Obviously you're making a huge difference in people's lives, you're living out your mission, and I just commend you for that. Thank you for contributing so positively to the world. We're honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. So thanks for picking that organization to support and we just wish you continued success as you work to change lives for a better world.
Joe Landolina: Definitely. Well, thank you so much, Lindsey, for having me on. This was an absolute pleasure.
Lindsey Dinneen: Wonderful. And thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time.
The Leading Difference podcast is brought to you by Velentium.
Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications.
Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems.
Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies.
Visit velentium.com to explore your next step in medical device development.
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