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Global Medical Device Podcast powered by greenlight.guru

Greenlight Guru's Jon Speer + Medical Device Entrepreneurs, Executives, Inventors & Consultants; R&D, Quality, Regulatory

The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, dir...

Episodes

20 of 350 episodes

#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...

26:52Mar 23, 2026

#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...

30:42Mar 16, 2026

#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...

53:27Mar 9, 2026

#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"...

48:31Mar 2, 2026

#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...

01:00:37Feb 23, 2026

#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...

43:21Feb 16, 2026

#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...

45:42Feb 9, 2026

#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-...

37:49Feb 2, 2026

#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...

57:40Jan 30, 2026

#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...

44:59Jan 26, 2026

#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...

45:30Jan 19, 2026

#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...

45:58Jan 12, 2026

#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...

50:12Jan 5, 2026

#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...

42:41Dec 29, 2025

#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...

19:07Dec 22, 2025

#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...

43:08Dec 15, 2025

#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...

43:05Dec 8, 2025

#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...

44:35Dec 1, 2025

#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...

01:02:20Nov 24, 2025

#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...

01:10:28Nov 17, 2025