Episodes
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Juliana Elstad is the President, CEO of Vibrato Medical. She is a global executive with significant experience identifying opportunities for growth and delivering success in start-ups to multi-billion-dollar companies, and has led innovative medical companies through compelling vision, strategy, and growth. She has worked both in start-ups and Fortune 500 corporations in the U.S. and Emerging Markets and has worn many leadership “hats” in the medical device business. She serves as a board member of AdvaMed Accel, the world’s largest trade association representing medical device and diagnostics manufacturers. AdvaMed Accel is the division within AdvaMed dedicated to addressing the needs and challenges of smaller innovative medical device and diagnostics manufacturers – the lifeblood of the medical technology industry. Advamed is powering the MedTech Conference in Anaheim, California, October 9-11, 2023. Featuring world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology, this forum for transformational ideas is a can’t-miss event for the industry’s prominent and most promising companies. Learn more at: https://themedtechconference.com/
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MedTech startups found themselves flush with cash a couple of years ago for quite obvious reasons. Pandemic-fuelled investment pushed VC funding for medtech and health-focused companies to unforeseen heights. But times have certainly changed. The medical device industry now finds itself reckoning from the banking crisis and VCs shifting priorities (and funds) towards other opportunities. That shift has caused funding for early-stage medtech companies to decline significantly, with numbers sliding by the billions across the board for digital health projects. Entrepreneurs and developers in MedTech will have to shift their focus on projects that either address the most common pain points in healthcare or projects that bridge different industries to create innovative healthcare solutions. What are the best strategies to do this during times like these?
Today's guest is the CEO of Single Pass, Bill Colone. He is an experienced medical device executive with expertise in investor presentations, fund raising, building teams, product development, operations management, Class II and Class III Medical Device clinical trials, start-up organizations, and hands-on experience with peripheral cardiovascular devices from concept through commercialization. He is a seasoned entrepreneur, and MedTech executive who has held past roles as General Partner of Quantum Fund, CEO of Spinal Singularity, VP of R&D at Direct Flow Medical, Director of R&D at Endologix, and President and CEO of Arizona Heart Innovative Technologies. Join us for a lively discussion on the life lessons he's learned as a MedTech entrepreneur, the most important aspects of creating a start-up team, the best strategies for emerging MedTech companies in challenging economic times, and what Orange County needs to do to become a global medical device leader. -
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In an ideal world, no one would have a catheter, but the reality is that 100M patients worldwide rely on an indwelling urinary catheter. Catheterized patients often experience problems, such as catheter-associated urinary tract infections (CAUTI), catheter blockages, leaking and bladder spasms. FLUME estimates the healthcare burden of Foley catheter complications to be equivalent to $80 on average, for each of the 28m placed annually in the US - a total burden of around $2.2bn - and close to $60 even for short term placement.
Join Co-Founder & Chief Executive at The Flume Catheter Company Limited Roger Holmes, and DeviceAlliance MedTech Radio Host Scott Johnson as they discuss.... - The catheter problem impacting 100M people - The 2.2B burden in the U.S.
- Flume Catheter's goal to impact millions for a philanthropic purpose
- Roger's life lessons in entrepreneurship -
It's been almost a year since Anthony Klotz, a psychologist and professor of business administration at Texas A&M University, coined a famous phrase when he said “the great resignation is coming” in an interview with Bloomberg Businessweek. The popular phrase refers to the elevated level in early 2022 coming off a year in which almost 48 million people quit their jobs, an annual record. As one can imagine, this revolution of sorts has caused quite a stir amongst the HR Community, with experts scrambling to understand the "why" behind this mass exodus…and work out what it is that employees actually want. Join us as we discuss the misconceptions of the Great Resignation from the employee and employer perspective, the mistakes that companies are making to address employee engagement, best shared practices adapting to our new norms, and the strategic considerations for small to large scale MedTech companies building their workforce.
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Today we speak with CEO of Diality, Osman Khawar. Diality is a privately held medical device company currently in development of a versatile hemodialysis machine useable at home or in a variety of care settings, including nursing homes, hospitals, transitional care facilities and dialysis centers*. Committed to helping build a future where all patients and partners can control kidney disease, Diality is focused on developing solutions that help care providers improve the care and lives of patients with kidney disease while giving physicians the flexibility to prescribe personalized dialysis treatments regardless of delivery setting.
Join us as we discuss the current status of dialysis treatment, the burdens of treatments, the evolution toward consumer centric dialysis, and how the opportunity for innovation can improve the distinct needs of dialysis providers across all segments of the market. -
Ramin Mousavi is the CEO, President, and Board of Directors for Cathworks; a medical technology company focused on applying its advanced computational science platform to optimize Coronary Artery Disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians. Ramin has executive leadership and operational experience
Join us as we discuss the unmet clinical needs for coronary artery disease, Cathworks journey to understanding the physician perspective, Ramin's personal leadership journey, the advancement of computational science, the economic benefits for patients and payers, the evolution of innovation, and much more!
in general management, marketing, strategy, product development, and commercialization across multiple market segments and was responsible for developing the clinical and commercial strategy for CathWorks. He helped with the regulatory clearance of the product in Europe, United States and Japan. He also led the company’s Global Health Economic & Reimbursement strategy where the company was successful in receiving reimbursements in the US and Japan. He is leading the way in building an innovative and community-based organization with a mission to provide clinicians with objective data, so they can make the best decisions for their patients. -
Your Medtech brand is not something an agency gives to you. Nor is it something you buy. Your brand is defined by the relationship you have with your customers, and it’s shaped by the messages you send and the response those messages elicit. Getting the attention of busy physicians and hospital executives is more challenging than ever for medical device manufacturers across the globe. Doctors are busier and have less time to see patients, let alone talk to a sales representative. Successful medical device marketers have learned how to harness the power of digital to achieve their key objectives.
In this episode of DeviceAlliance’s Medtech Radio, we speak with Chief Operating Officer of TMG360 Media, Kristy Kennedy. TMG360 Media is a Medtech media company focusing on exclusive editorial coverage to influence mainstream media, policymakers, emerging companies, strategics, investors, payers and providers, clinicians, and consumers. Join us as we discuss
- The biggest changes medical device companies must consider for their marketing strategies
- The new outlook on social media
- How the empowered patient will impact consumerization of Medtech
- Adding value beyond the device
- How upstream and downstream marketing has impacted sales And much more! -
Irvine is home to over 15,000 businesses, and life sciences and medical device companies constitute one of the fastest-growing sectors. With a global focus on the Medtech industry, the need to build an infrastructure that can support the explosive forecasted growth is more crucial than ever. A well-educated, job-ready workforce, world-renowned R&D facilities and community initiatives all conspire to make Irvine a magnet for Medtech success. So how is Irvine executing on their 50-year plan coming out of the pandemic, to ensure our medical device community is not only a hub of talent and innovation for California, but for the world?
In this episode of DeviceAlliance’s Medtech Radio, we speak with the President and CEO at Greater Irvine Chamber of Commerce, Destination Irvine and Irvine Economic Development, Bryan Starr. Join us as we discuss the efforts the Irvine Chamber is making to support the medical device community, their initiatives to attract foreign medical device companies to relocate to Irvine, as how we as a community can engage in local efforts to ensure the thriving success of medical device industry.
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You’ve got a great idea for a medical device! Now what?
Join us for this Live-Recorded Podcast Event "Proving Your Device Works in The Real World" as we discuss... - Consideration for the problem you are trying to solve
Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is absolutely crucial for clinical trial success. With the explosion of Medtech opportunities for startups, what are the current best standards for ensuring the success of your design and clinical trials?
- Big Questions to answer for Clinical Literature, IP Landscape, Stakeholder and Value Proposition, What is relevant today
- Pre-clinical / Clinical Testing Feasibility
- Planning the Clinical Trial Design – Tactical and Strategic Considerations
- Regulatory Pathway & Business Strategy
- Design Approach and policy level considerations - The External Environment (Legislative, Healthcare Economics, Orange County Talent, Reimbursement and Market Adoption Expert Panelists Include: Dr. Michael Drues - President of Vascular Sciences & FDA Consultant
Jeremy Koehler - Director Of Engineering at NXT Biomedical
Vinny Podichetty - VP Clinical & Medical Affairs at JenaValve Technology, Inc. Anand S. Patel, MD - Chief of Interventional Radiology at Providence Little Company of Mary, Torrance Free Opinion Disclaimer
The views and opinions expressed at this event are those of the panelists and do not necessarily reflect the official policy or position of their respective organizations. Any content provided by our panelists are of their opinion and are not intended to malign any organization, company, individual or any entity. -
What is leadership, anyway?
Such a simple question, and yet it continues to vex popular consultants and laypeople alike. Leadership is a process of social influence, which maximizes the efforts of others, towards the achievement of a goal. In this episode of DeviceAlliance’s Medtech Radio, we speak with the President of Bioplatte, Thomas Hopson. Thomas Hopson is an accomplished business executive with over 30 years of experience in the medical device industry. Thomas has provided leadership to multi-million-dollar business enterprises in Europe, Asia, and the United States, and he has successfully transformed multiple struggling organizations into healthy and thriving businesses. He joined Bioplate as President in 2018, bringing with him an extensive background in sales, business development, organizational learning, and product commercialization. Before joining Bioplate, Thomas served as the Director, Global Talent Management & Learning at Edwards Life Sciences. Prior to Edwards, Thomas held various leadership positions at St. Jude Medical. Join us as we discuss his life's journey into leadership, his most valuables mistakes, keeping teams motivated in times of crisis, how to handle making unpopular decisions, and key trends in key trends in the global craniofacial fixation market. -
What are Contract Research Organizations? For any Medtech company, working with CRO’s allow them to outsource work that would otherwise require significant capital to do internally. CRO's let you avoid buying expensive equipment and hiring or training staff for a short-term project. Having independent oversight is critical to ensuring compliance, keeping your clinical research trial on track and bringing your device to market faster. For this reason, many companies hire a clinical research organization (CRO) to monitor, audit, and even manage their trial. Medical device trials in particular bring complex compliance challenges, so having a CRO with specific expertise in this area can be tremendously beneficial. How can you be sure you hire a medical device CRO that is committed to ensuring compliance and is as invested in your success as you are? In this episode of DeviceAlliance’s Medtech Radio, we speak with the Director of Regulatory Affairs at Inari Medical, Sarah Boundy Wong and Vice President Clinical Affairs & Market Dev. at JenaValve Technology, Inc., Vinny Podichetty. Join us as we discuss the best-shared practices and methodologies for selecting a medical device CRO, where does one find CROs, the biggest selection considerations, and lessons learned from both of their professional experiences.
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COVID-19 has put the MedTech industry at center stage with unparalleled demand for diagnostic tests, personal protective equipment (PPE), ventilators, and other critical medical supplies. In addition to the extraordinary measures underway to rapidly ramp up manufacturing capacity and capabilities, MedTtech companies are also looking outside their normal sector boundaries to explore creative solutions to strategize how they will supplement capacity, open-source equipment design, and address deployment of medically trained employees to support public-health needs. Forward-thinking firms will need data to respond with new products, services, and operating models that can optimize the shifting landscape of healthcare and Medtech development. Join us as talk with the CEO & Founder of LSI, Scott Pantel. In this episode, we discuss the challenges of living in an era of an overabundance of MedTech data and how unique market insights remain an industry challenge. We explore why it's more important than ever for startups and large corporations to make their key strategic decisions based on unique and timely insights. Learn about covid's impact permanently changing the MedTech landscape, and the new considerations the industry must face to address unmet clinical needs.
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For medical device companies, the consumerization of Medtech represents a new paradigm. In the past, medical devices were more targeted toward healthcare providers and payers – now there is a demand for direct-to-consumer products. People are demanding to have more control over their healthcare and they want the ability to proactively manage it. The connected health and wellness devices market is expected to reach $612 billion by 2024, according to a report by Grand View Research Inc. and the wearable medical device market alone is projected to reach $14.41 billion by 2022, according to Markets&Markets Inc. As Medtech explores opportunities within this business model, this consumerization will forever change how healthcare is delivered and medical device evolve. In this episode of DeviceAlliance’s Medtech Radio, we speak with the FDA Consultant and President of Vascular Sciences, Dr. Michael Drues. Join us as we discuss the consumerization of Medtech, defining what is a medical device vs. wellness device with respect to regulation, the "essence" of these distinctions, interpretation of words, and one's ability to defend them in regulation, "Class 0" devices, and wellness devices impact on the evolution of medical devices.
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Before one begins any new project, it’s important to understand where you fit into the grand scheme of things. While you may be the person who had the brilliant idea in the first place, that doesn’t mean you know how to lead a company, or build a team, or build a prototype. You can’t be all things to all people. One needs to know what you’re good at, and then you need to know how to hire the best people to fill the positions that you can’t cover. The very first question you should ask is, am I the person who should lead my new company, or do I need to hire a leader who can take my idea and run with it?
In this episode of DeviceAlliance’s Medtech Radio, we speak with the Chief Technology Officer at Balt, Dave Ferrera. He also serves as a member of the Board of Advisors to Spinal Singularity, a member of Sage Executive Group, and Chair Orange County American Heart Association Heart & Stroke Ball 2020. Join us as we discuss his upcoming book Innovation in Translation, the critical lessons learned through his early startups, and what it takes to build a team of "A players".
Follow the great work Dave and team are doing at Quantum Fund OC.
Connect with Dave on LinkedIn
Dave's Book Recommendation - Iacocca: An Autobiography by Lee Iacocca
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