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In this episode, the discussion centers around the crucial role of advisory boards in guiding company strategies, product development, and business initiatives within the medical device sector. Featuring insights from Paul Hickey, CEO of ReShape Life Sciences, the conversation delves into best practices for forming and managing advisory boards, emphasizing the importance of team involvement and maintaining high-quality standards. Paul shares his extensive career journey across different companies, detailing how advisory boards have provided key insights and contributed to successful product innovations. The episode also explores the fight against obesity and how ReShape is working to deliver effective solutions. Key takeaways include the strategic formation of advisory boards, the need for cross-functional collaboration, and the pursuit of unarticulated customer needs for innovation.
Paul Hickey LinkedIn https://www.linkedin.com/in/paul-f-h-4955a78/ReShape Lifesciences https://www.reshapelifesciences.com/
00:00 Welcome and Introduction to Advisory Boards
01:15 Meet Paul Hickey: Career Journey and Insights
02:17 Transitioning from Aerospace to Medical Devices
09:41 The Importance of Quality in Medical Devices
17:17 Forming and Managing Effective Advisory Boards
40:06 Reshape Life Sciences: Tackling Obesity
47:13 Career Advice and Final Thoughts
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Joe Steele is Head of Commercialization at Hemosonics, where they are providing point-of-care solutions to help clinicians make more informed decisions on blood product usage. In this episode Joe shares why moving up the ladder too fast may not be the best way to go, why experiencing failure will help in the long-run, how to use wisdom from past experiences and apply it to new situations, the challenges of hiring, training and managing a group of hard-charging people, getting into the C suite, and how Hemosonics is helping doctors make blood product usage decisions quicker and better.
Joe Steele LinkedIn https://www.linkedin.com/in/janthonysteele/Hemosonics https://hemosonics.com/
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Stuart Simpson is CEO of Think Surgical. During his stellar 24-year career at Stryker he led an orthopedic industry transformation that established surgical robotic joint replacement as a standard of care, beginning with the acquisition of Mako Surgical in 2013. In this episode he shares his roots in medical device and how orthopedics became his passion, how competition is deeply imbedded in him, the challenges surgeons and hospitals face with the proliferation of robotics in the OR, how Think Surgical is trying to solve clinical, logistical and monetary issues, and his thoughts on how you can become a stronger leader.
Stuart Simpson LinkedIn https://www.linkedin.com/in/stuart-f-simpson/Think Surgical https://thinksurgical.com/
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Dave Rosa is CEO of NeuroOne Medical Technologies, a company that has developed high-definition, minimally invasive diagnostic and treatment devices based on a unique thin film electrode technology, with an initial focus on epilepsy and the fast-growing neurostimulation market. In this episode he shares some times when tough feedback helped him grow as a leader, why taking the stretch assignment was the better choice, structuring a marketing group, key criteria when evaluating distribution options in a start-up company, and how NeuroOne is providing technology helpful to patients and clinicians.
Dave Rosa LinkedIn https://www.linkedin.com/in/daverosa/NeuroOne Medical Technologies https://nmtc1.com/
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Ken Riordan, Regulatory Affairs Project Manager at Telos Partners, brings a unique but essential perspective to his clients having worked in both the public and private sector. He was a lead reviewer for the FDA where he conducted scientific and engineering reviews of pre-market applications for cardiovascular devices. Ken’s broad experience in the private sector with Bayer Pharmaceuticals, Philips Respironics and others enables him to apply creative and effective solutions to his clients. In this episode Ken shares what it was like to work at FDA, how reviewers are chosen, how collaboration within the agency works, what you should know about the three new Guidance’s on the 510(k) process that were recently released, and how Telos Partners helps medical device companies.
Ken Riordan LinkedIn https://www.linkedin.com/in/ken-riordan/Telos Partners https://www.telospartnersllc.com/
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Scott Wolf, MD is the Founder & Chief Medical Officer of Aerin Medical, where they are providing products to bring relief from nasal airway obstruction and chronic rhinitis. Scott is a prolific medical device entrepreneur across a broad range of therapeutic areas, and has also been a venture capitalist. In this episode we discuss how he identifies ideas, what criteria he uses to select ideas to work on, how VC’s evaluate opportunities, what entrepreneurs should know before they meet with investors, the problems Aerin is addressing, and how they are serving the ENT community.
Scott Wolf, MD LinkedIn https://www.linkedin.com/in/sjwolf/Aerin Medical https://aerinmedical.com/
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Rollie Calrson is the CEO of Immunexpress, a company that is pioneering technology that can rapidly detect sepsis. Rollie contributed to the success of Abbott Laboratories for 20 years, starting off in R&D, then transitioning to leadership positions in global businesses and start-up ventures. His attraction to start-ups led him to become CEO of Asuragen and then WaferGen Biosystems. In this episode we discuss how he prepared for new opportunities, the benefits of extreme ownership, balancing company vision and mission, alignment of everyone in a company, why sepsis is such a big problem, and what Immunexpress is doing to help clinicians better manage sepsis patients.
Rollie Carlson LinkedIn https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/Immunexpress https://immunexpress.com/
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Weronika Michaluk is Digital Health Principal and SaMD Lead at HTD Health, a company dedicated to planning, designing and developing custom healthcare software. Weronika is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. In this episode she shares the differences between the waterfall and agile methodologies, what sprints and scrums are, controlling scope creep, working with a company that does not have agile experience, assuring regulatory compliance, and the tools and tech stack that are used in today’s software development environment.
Weronika Michaluk LinkedIn https://www.linkedin.com/in/weronika-michaluk-mba-43811698HTD Health https://htdhealth.com
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Keith Smith is President of Vonco Products, a medical device contract manufacturer that works with some of the largest companies in the industry. In the first part of this episode Keith shares why companies decide to use contract manufacturers, what they look for when choosing one, the importance of transparency, and how Vonco transitioned from a job-shop serving many industries to focusing on high value industries, like medical device. The second half of the conversation goes deep into his personal story about the cost of going all-in on business, what he learned and how he has reprioritized his life, while maintaining a strong growth mindset in business.
Keith Smith LinkedIn https://www.linkedin.com/in/keith-smith-725508bVonco Products https://www.vonco.com
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Milton Yarberry is Director of Project Management at Integrated Computer Solutions. Milton has developed or managed software development for Motorola, Lucent, Cognex, Inktomi, and FEI, before moving into the medical software sector in 2006 with Foliage, Ivenix and now ICS. In this episode he shares about the Protecting and Transforming Cyber Health Care, or Patch Act, which FDA implemented in October 2023, including what software is impacted, the key take-aways from this regulation, if this effects legacy devices, and how medical device companies will be impacted.
Milton Yarberry LinkedIn https://www.linkedin.com/in/milton-yarberry-06a2311/Integrated Computer Solutions https://www.ics.com
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Rich Walsh is CEO of Corvent, a company that is focused on providing solutions in the ventilator market. Rich has a long history in sales and sales management, and has transitioned from sales to become a first-time CEO. At the same time, Rich and the team are transitioning from providing a ventilator for COVID, to a full-featured product. In this episode Rich shares about the foundation of his career and the importance of discipline, openness and leader engagement, how direct feedback can make or break a career, locating a company in a non-traditional city and state, building an internship program that benefits the company and interns, and leadership lessons learned from legends in our industry.
Rich Walsh LinkedIn https://www.linkedin.com/in/richardswalsh/Corvent Medical https://www.corventmedical.com
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Joe Landolina is CEO of Cresilon, a company that has developed a technology and product intended to stop bleeding quickly and reliably. In this episode Joe shares how he began his journey at age 17, how a short project has turned into more than a decade of hard work, the impact pivots made on his team and investors, why open communication is best for the team and the well-being of the founder, and the importance of doing things the right way - even if it means delays and more investment.
Joe Landolina LinkedIn https://www.linkedin.com/in/jlandolina/Cresilon https://cresilon.com/
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Jordan Griffin is a Field Clinical Specialist at Boston Scientific. Jordan’s no stranger to the medical device field, as her dad owns a distributorship focused on spinal implants. In this episode she shares what it was like to be a daughter of a busy, successful surgical distributor, product and sales education and how it differs in direct and distributor companies, managing a rural territory, how a clinical specialist differs from a sales rep, and what it’s like to interview and break into a large company.
Jordan Griffin LinkedIn https://www.linkedin.com/in/jordan-griffin-685b97209/Boston Scientific https://www.bostonscientific.com
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Marty Gauvin is CEO of Fertilis, a company focused on helping prospective parents have a better experience with in-vitro fertilization. Marty is a serial entrepreneur and Fertilis is his first in medical device. In this episode Marty shares his views on entrepreneurship, where ideas come from, the differences and similarities between industries, what we can learn from outside medical device, and how the Fertilis products are aiming to increase the chance of people becoming parents.
Marty Gauvin LinkedIn https://www.linkedin.com/in/martygauvin/Fertilis https://new.fertil.is/
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Zach Champeau is Sr. Director of Operations at Saleytics, an inside sales organization that has a program focused on DTC strategy. In this episode he shares the objectives companies have with DTC, where DTC activities have the most influence, types of programs that can help with lead generation, the main reasons why patients who need care drop out before receiving it, and how to measure the success of your program.
Zach Champeau LinkedIn https://www.linkedin.com/in/zach-champeau-50441264/Saleytics https://www.salelytics.com/
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Johannes Schaeferhoff is CEO of ROPCA, a company focused on an autonomous robotic solution to aid in the diagnosis and monitoring of Rheumatoid Arthritis. In this episode, Johannes shares some of the cultural differences in the countries he has lived in and what he learned, trends in medicine that led their team to develop their innovative solution, how efficiency in medicine can be as important as efficacy, and how the ROPCA system may help solve issues with patient access and the timely and accurate diagnosis and monitoring of patients with Rheumatoid Arthritis.
Johannes Schaeferhoff LinkedIn https://www.linkedin.com/in/johannes-schaeferhoff/ROPCA https://ropca.com/
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Zach Selch is CEO of Global Sales Mentor, and has decades of experience selling medical products in over 135 countries. He has authored books on international sales and has some great free resources that you can access from his website. In this episode he shares why you should consider international sales, whether direct or a distributor model is preferred, key buying influences in different countries, setting up a distributor for success, contract considerations, and managing a distributor sales process.
Zach Selch LinkedIn https://www.linkedin.com/in/international-sales-growth/Global Sales Mentor https://www.globalsalesmentor.com/
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Dr. Jay Shah is Chief Medical Officer at Aktii, where they are developing technology focused on identifying and monitoring hypertension. Dr. Shah is a practicing Cardiologist who pivoted his career from strictly patent care, to becoming the CMO of a start-up. In this episode he shares his thoughts on career pivots, how he researched options that were the right fit for him, what it is like to be a CMO in a start-up, what hypertension is and the difficulty of diagnosis, and how wearables can change the way hypertension is managed.
Jay Shah, MD LinkedIn https://www.linkedin.com/in/jshahmd/Aktiia https://aktiia.com/
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Steve Gielda is President and Co-founder of Ignite Selling, a global sales training, simulation and consulting organization. He’s co-authored two books – Ignite Your Sales Strategy: A Field Guide to Accelerating Your Pipeline, and Premeditated Selling: Tools for Developing the Right Strategy for Every Opportunity. In this episode we discuss the changing medical device environment, why strategic planning is vital in today’s environment, what a sales simulation is and how it clarifies strategy and aligns your internal resources, tips for managers to make them more effective with their reps, and considerations in hiring your sales team.
Steve Gielda LinkedIn https://www.linkedin.com/in/sgielda/Ignite Selling https://igniteselling.com/
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Lucas Piandegonda is Managing Director of Gradical, which provides specialized expertise to companies that need help with plastic evaluation, material compliance and testing, and training. In this episode he shares the challenge and opportunity of becoming a consultant, considerations in choosing a plastic, how additives and manufacturing processes changes plastics, the importance of supplier choice and management, and options for making our devices more sustainable.
Lucas Pianegonda LinkedIn https://www.linkedin.com/in/lucas-r-pianegonda-81142b110/Gradical https://gradical.ch/
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