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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.

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

Links from this episode:

• Paul Hickey LinkedIn https://www.linkedin.com/in/paul-f-h-4955a78/
• ReShape Lifesciences https://www.reshapelifesciences.com/

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Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

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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.

Links from this episode:

• Joe Steele LinkedIn https://www.linkedin.com/in/janthonysteele/
• Hemosonics https://hemosonics.com/

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Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

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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.

Links from this episode:

• Stuart Simpson LinkedIn https://www.linkedin.com/in/stuart-f-simpson/
• Think Surgical https://thinksurgical.com/

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Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

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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.

Links from this episode:

• Dave Rosa LinkedIn https://www.linkedin.com/in/daverosa/
• NeuroOne Medical Technologies https://nmtc1.com/

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Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

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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.

Links from this episode:

• Ken Riordan LinkedIn https://www.linkedin.com/in/ken-riordan/
• Telos Partners https://www.telospartnersllc.com/

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Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

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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.

Links from this episode:

• Scott Wolf, MD LinkedIn https://www.linkedin.com/in/sjwolf/
• Aerin Medical https://aerinmedical.com/

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Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

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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.

Links from this episode:

• Rollie Carlson LinkedIn https://www.linkedin.com/in/rollie-carlson-ph-d-059074a/
• Immunexpress https://immunexpress.com/

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Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

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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.

Links from this episode:

• Weronika Michaluk LinkedIn https://www.linkedin.com/in/weronika-michaluk-mba-43811698
• HTD Health https://htdhealth.com

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Connect with Mastering Medical Device:

• Website: https://www.masteringmedicaldevice.com
• LinkedIn: https://www.linkedin.com/company/mastering-medical-device
• Patrick Kothe LinkedIn: https://www.linkedin.com/in/patrick-kothe
• Patrick Kothe Twitter: https://twitter.com/patrickkothe

Support the show for as little as $3/month: https://www.buzzsprout.com/1286645/support

Thanks for listening!