#452: Switching Careers to MedTech: A Practical Guide for Engineers and Professionals
In this episode, host Etienne Nichols speaks directly to professionals in industries like automotive, aerospace, and manufacturing who are l...
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Global Medical Device Podcast powered by greenlight.guru
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Listen to Global Medical Device Podcast powered by greenlight.guru, a Business podcast by Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory. Stream 350 episodes in English, follow new audio stories, and play episodes online on Radio and Podcast.
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20 of 350 episodes#451: Building a MedTech Powerhouse: The 5 Stages of Founder Success
In this deep-dive episode, host Etienne Nichols shifts away from the "inspiring" fluff of entrepreneurship to deliver a gritty, practical ma...
#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling
In this episode, Etienne Nichols sits down with Staci Miller , a Human Factors and UX Strategist at GenUX , to demystify the role of human f...
#449: 7 Pitfalls of International MedTech Expansion
In this episode, Etienne Nichols sits down with regulatory expert Mike Drues, President of Vascular Sciences, to discuss the "culture shock"...
#448: MedTech Investment: Outcomes, Regulations, and the Shift to At-Home Care
This episode features Ivanny Franklin , Managing Partner at MedSight Capital, who brings a wealth of experience from her background in molec...
#447: Solving the Pediatric MedTech Gap with Edwin Lindsay
In this episode, Etienne Nichols sits down with Edwin Lindsay, a seasoned MedTech operator and QARA leader, to discuss the systemic challeng...
#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss
In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unp...
#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech
In this episode, Etienne Nichols sits down with Thor Rollins , a leader at Nelson Labs and the convener of the committee revising ISO 10993-...
#444: Scaling Your QMS: What the FDA Really Expects for MedTech Startups
This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the fou...
#443: Generative AI in MedTech: Quality, Risks, and the Autonomy Scale with Ashkon Rasooli
In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medica...
#442: MedTech Leadership: Vulnerability & The CEC Framework with Dr. Jenny Hoffmann
Dr. Jenny Hoffmann, MedTech executive and author of Open Up: Step Into the Leader You Are Meant to Be, joins host Etienne Nichols to discuss...
#441: ICYMI (In Case You Missed It!) How Artificial Intelligence is Impacting the MedTech Industry
In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-dr...
#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory
In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed...
#439: MedTech AI Trends 2025: Scaling Regulatory Intelligence with Michelle Wu
In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss th...
#438: QMSR Mythbusters Episode
The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporat...
#437: MedTech Talent Reset: AI, Skills, and the Hidden Job Market
The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined...
#436: Do ISO 13485's Production Controls apply to SaMD?
This episode tackles the complex challenge of applying the hardware-centric clauses of ISO 13485 to Software as a Medical Device (SaMD) . Ad...
#435: ICYMI (In Case You Missed It!) Becoming a Regulatory Affairs Professional
In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutic...
#434: ICYMI (In Case You Missed It!) Project Management In Medtech
This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product develo...
#433: ICYMI (In Case You Missed It!) Climbing the Medtech Ladder - How to Get to the Top
In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena...
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