Global Medical Device Podcast powered by Greenlight Guru

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 ad...

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. Thi...

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...

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...

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 pat...

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 net...

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 com...

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...

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 t...

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 re...

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 o...

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 pay...

In this episode, host Etienne Nichols sits down with Jose Bohorquez and Mohamad Foustok from CyberMed to dissect the complex world of Software as a Medical Device (SaMD) and cybersecurity. They emphasize that SaMD is first and foremost a medical device and should be treated as such from the very beginning of the development process. The conversation highlights the most common mistakes companies ma...

This episode with Stuart Grant of Archetype MedTech demystifies the "front end of innovation," a critical yet often overlooked phase of medical device development. Stuart, a seasoned MedTech veteran with over two decades of experience at Johnson & Johnson, shares insights from his doctoral research on this topic. He breaks down the process, defining the front end as the crucial period between...

In this episode, host Etienne Nichols sits down with seasoned MedTech entrepreneur Steve Bell to discuss the critical lessons for starting and scaling a medical device company. With over 30 years of global experience, Steve shares insights from his work with major corporations like Johnson & Johnson and his role in building Europe’s largest MedTech unicorn. He reveals how a conversation with h...

In this episode, host Etienne Nichols sits down with Josh Eckelberry, Principal at Solas BioVentures, for an illuminating conversation about venture capital in the MedTech and life sciences sectors. Josh shares his journey from a medical background to a career in venture capital, driven by a passion for creating "leveraged change" by helping innovative technologies reach a broader patient populati...

This episode takes an unexpected journey with Edwin Bills, a lead expert in medical device risk management and a key contributor to the development of ISO 14971. Edwin shares stories from his diverse career, beginning with his time as a submariner and electronics technician in the Navy, where he worked on early GPS technology and helped build missile subs from the ground up. This unique hands-on e...

In this episode, host Etienne Nichols sits down with Lesley Worthington, an executive coach with a background in psychology, law, and over 20 years in quality and regulatory affairs. They explore the critical, yet often overlooked, role of communication in building a robust culture of quality. Lesley explains that while quality professionals possess deep technical knowledge, they often struggle to...

In this episode, host Etienne Nichols sits down with MedTech quality expert Beth Waring to explore the often-overlooked but crucial relationship between project managers and quality professionals. They tackle the common friction points and misunderstandings that arise when these two roles intersect, and discuss why this relationship is so vital for building a successful and compliant quality manag...

In this episode, host Etienne Nichols speaks with Greenlight Guru's Christine Wilbert, an expert in Electronic Data Capture (EDC) systems for Clinical Research Organizations (CROs). They discuss the critical factors CROs must consider when selecting an EDC solution. Christine highlights that the biggest mistake is a lack of due diligence and not planning for future needs beyond a single study. She...

This episode offers a "biocompatibility brief" with guest Marina Daineko, a MedTech expert and chemist specializing in biological evaluations. Marina shares her perspective on the critical role of chemistry and critical thinking in assessing the safety of medical devices. The discussion highlights the need to look beyond simple pass/fail tests and delve into the nuances of raw data analysis, mater...

This episode features host Etienne Nichols and guest Andy Rogantino, who discuss the critical timing and process for evaluating and implementing an Electronic Quality Management System (EQMS). They challenge the common "wait until something breaks" approach, emphasizing that the most effective MedTech teams integrate an EQMS early in the product lifecycle. The conversation covers the strategic and...

In this insightful episode, Mike Drues joins host Etienne Nichols to dissect the FDA's most frequently cited compliance issues, challenging the notion that many are strictly "pre-market" concerns. They delve into the nuances of software changes, design creep, and off-label marketing, providing a critical look at how companies can avoid common pitfalls. This discussion is vital for MedTech professi...

In this episode, Etienne Nichols and Matt Stratton, Director and Principal Consultant at Coalition, delve into the dynamic and complex world of neurotechnology. They discuss the expansive definition of neurotech, the significant challenges in accelerating innovation—particularly concerning regulatory frameworks and cross-functional collaboration—and how a united industry voice can overcome these h...

As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America. They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Am...