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PODCAST

Global Medical Device Podcast powered by Greenlight Guru

Greenlight Guru + Medical Device Entrepreneurs

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, direct from some of the world"s leading medical device experts and companies.

health & fitness medicine

All Episodes

45:42

#446: The Hidden Physics of the MedTech Life Cycle...

Global Medical Device Podcast powered by Greenlight Guru ·

2026/02/09

In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unpack the complexities of the medical device life cycle. The conversation centers on how manufacturers often overlook critical phases of a product’s journey, such as transportation, shelf life, and the decommissioning phase, focusing instead solely on the point of patient use.Dr. Katzenmeyer-Pleuss highlights the significance of the upcoming ISO 10993-1:2025

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37:49

#445: ISO 10993-1:2025: What Risk-Based...

Global Medical Device Podcast powered by Greenlight Guru ·

2026/02/02

In this episode, Etienne Nichols sits down with Thor Rollins, a leader at Nelson Labs and the convener of the committee revising ISO 10993-1. The conversation centers on the newest 2025 version of the standard, which represents a massive philosophical shift from a "checkbox" testing mentality to a rigorous, risk-based approach aligned with ISO 14971.Rollins explains that modern medical devices are far more complex than the metal and hard plastics of the past. With the rise of degradable materials,

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57:40

#444: Scaling Your QMS: What the FDA Really Expects...

Global Medical Device Podcast powered by Greenlight Guru ·

2026/01/30

This episode explores the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the foundational elements required for medical device compliance. Host Etienne Nichols and guest Mike Drues discuss the philosophy of building a usable system rather than a "museum of SOPs," emphasizing that the standard list of QMS sections should be viewed as a starting point rather than an exhaustive checklist.The conversation examines the critical differences

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44:59

#443: Generative AI in MedTech: Quality, Risks, and...

Global Medical Device Podcast powered by Greenlight Guru ·

2026/01/26

In this episode, host Etienne Nichols sits down with Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD). The conversation previews their upcoming session at MD&M West, focusing on the critical intersection of generative AI (GenAI) and quality assurance. While many AI applications exist in MedTech, GenAI presents unique challenges because it creates new data—text, code, or images—rather than simply classifying existing information.Ashkon breaks

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45:30

#442: MedTech Leadership: Vulnerability & The CEC...

Global Medical Device Podcast powered by Greenlight Guru ·

2026/01/19

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 the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional model of the "rigid, perfect leader" is no longer sustainable. She shares her personal journey—from being one of the first IVF babies in the U.S. to navigating life-threatening health complications—and how

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45:58

#441: ICYMI (In Case You Missed It!) How Artificial...

Global Medical Device Podcast powered by Greenlight Guru ·

2026/01/12

In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable health monitors to the future of surgical robots, they delve into how these technologies are reshaping healthcare. The discussion also touches on the challenges and opportunities in validating and regulating AI within MedTech, highlighting real-world applications and predicting future trends."Validation of AI tools in MedTech

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50:12

#440: ICYMI (In Case You Missed It!) Fundamentals of...

Global Medical Device Podcast powered by Greenlight Guru ·

2026/01/05

In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.Key Timestamps:[00:00:50] Introduction to Jennifer Mascioli-Tudor and

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42:41

#439: MedTech AI Trends 2025: Scaling Regulatory...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/12/29

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 the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality systems that keep the industry running.The conversation dives deep into the "Great Rewiring" of the

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19:07

#438: QMSR Mythbusters Episode

Global Medical Device Podcast powered by Greenlight Guru ·

2025/12/22

The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining, the change is mandatory, with an effective and fully enforceable date of February 2, 2026. The episode addresses industry complacency and details critical steps manufacturers must take immediately.The episode

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43:08

#437: MedTech Talent Reset: AI, Skills, and the...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/12/15

The MedTech talent landscape has undergone a significant "reset" in the two years since Elena Kyria, founder and CEO of Elemed, last joined the podcast. Driven by factors like the rise of AI, economic volatility, and post-pandemic shifts, the dynamic has swung from a "war for talent" (many jobs, few candidates) to a market flooded with applicants, often overwhelming internal recruitment teams. This shift, exacerbated by simple application processes like LinkedIn's Easy Apply, makes it challenging

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43:05

#436: Do ISO 13485's Production Controls apply to SaMD?

Global Medical Device Podcast powered by Greenlight Guru ·

2025/12/08

This episode tackles the complex challenge of applying the hardware-centric clauses of ISO 13485 to Software as a Medical Device (SaMD). Adnan Ashfaq, founder of Simply Medica, joins Etienne Nichols to dissect how traditional standards intended for physical manufacturing must be creatively interpreted for the virtual world of software development, where apps update weekly and cloud-based systems evolve in real-time. The conversation zeroes in on the often-muddy areas of production and service

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44:35

#435: ICYMI (In Case You Missed It!) Becoming a...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/12/01

In this episode of the Global Medical Device Podcast, Etienne Nichols is joined by Kavetha Ram, a seasoned expert in health and pharmaceutical sciences and the regulatory department leader at Spectra Medical Devices. Together, they delve into how new regulatory affairs professionals can get started in a career of medical device regulations and the shifting field of MedTech. The discussion offers a roadmap for professionals to navigate and thrive amidst these shifts. The episode is a treasure trove

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01:02:20

#434: ICYMI (In Case You Missed It!) Project...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/11/24

This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile practices, risk management, and the necessity for a patient-focused approach. The discussion sheds light on how companies can navigate regulatory landscapes,

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01:10:28

#433: ICYMI (In Case You Missed It!) Climbing the...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/11/17

In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding.Quotes"If you're not talking about the value that you add, how is anybody

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45:34

#432: China MedTech Compliance: Regulatory Risks,...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/11/10

This episode dives into the complex and often misunderstood MedTech market in China, featuring Elaine Tan, creator of MedTech Chopsticks, who translates the nation’s stringent regulatory language into actionable insights. Elaine and host Etienne Nichols discuss the substantial risks and rewards of bringing a medical device to China, highlighting the country's rapid execution, intense internal competition, and the shift from low-end manufacturing to a focus on high-level innovation. A key risk is

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26:07

#431: Meet Alex Naber: Insider Insights on Quality...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/11/03

This "Meet the Guru" episode introduces Alex Naber, a seasoned medical device consultant at Greenlight Guru, offering listeners a deep dive into his background and expertise. Alex shares his journey, beginning in bioengineering and progressing through roles in complaints, field action, design quality, and post-market quality management at a major orthopedic company (Zimmer Biomet). His experience highlights the crucial need for expert guidance in navigating complex MedTech regulations and quality

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32:49

#430: MedTech Language: Patient, Customer, or Partner?

Global Medical Device Podcast powered by Greenlight Guru ·

2025/10/27

In this episode, host Etienne Nichols and guest Dr. Allison Komiyama, CEO and Founder of Blue Stocking Health, dive into a fascinating dialogue about the language used in healthcare and MedTech, particularly the terms patient, customer, and user. They explore how these words influence the perception of care, service, and the entire medical device development process. The conversation touches on the friction and inefficiencies that arise when the relationship dynamic is unclear, highlighting the

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22:16

#429: MedTech Regulatory Risk: Navigating the FDA...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/10/20

This episode, hosted by Etienne Nichols, delves into the critical impact of a U.S. government shutdown on the medical device industry, specifically focusing on the Food and Drug Administration (FDA). Guest Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group and a former FDA Scientific Reviewer, offers an insider's perspective on which FDA functions halt and which remain active during a funding lapse. He clarifies that while the processing of new, user-fee-supported

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49:21

#428: Andragogy in MedTech: Why Adult Learning...

Global Medical Device Podcast powered by Greenlight Guru ·

2025/10/13

This episode of the Global Medical Device Podcast, hosted by Etienne Nichols with guest Shannon Decker, CEO of VBC1 and an expert in healthcare transformation, dives deep into the science of how adults learn, contrasting pedagogy (child-centered learning) with andragogy (adult-centered learning). The discussion reveals why traditional training methods, like handing new hires 40 SOPs to read, are often ineffective for experienced professionals in the MedTech industry.Shannon explains the core

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41:12

#427: Medical Device Reimbursement - Pitfalls to Avoid

Global Medical Device Podcast powered by Greenlight Guru ·

2025/10/06

This episode tackles the often-overlooked but critical topic of medical device reimbursement. Host Etienne Nichols speaks with Haley King, co-founder and CEO of Paxos Health, about why this process is just as vital as FDA approval for a device's commercial success. They explore the journey a medical device takes, highlighting the distinction between FDA approval and securing reimbursement from payers.Haley explains the three key pillars of reimbursement: coding, coverage, and payment. She delves

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440 results

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