Global Medical Device Podcast powered by Greenlight Guru
The Global Medical Device Podcast, powered by Greenlight Guru, provides insider knowledge and actionable insights for the medical device industry. Hosted by Greenlight Guru and medical device entrepreneurs, it features interviews with leading experts and companies. Topics include regulatory affairs, quality management, innovation, and best practices in medical device development.
Episodes
#475: Rethinking FDA Guidance: Why Non-Binding Documents Define Your Regulatory Strategy
In this episode of the Global Medical Device Podcast, host Etienne Nichols and regulatory consultant Mike Drues dive deep into the world of FDA guidance documents. They unpack what these documents truly represent—the agency's current thinking rather than binding law—and explore how manufacturers can navigate them effectively. The discussion covers the distinction between regulations in the Code of
#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Nikhil Mangale, Vice President of Quality at Kapstone Medical, to discuss the real-world impact of the FDA's Quality Management System Regulation (QMSR). Seven months post-implementation, the industry is seeing actual inspection data that shifts the focus away from superficial documentation updates and direct
#473: The MedTech Odyssey: Bridging Academic Science to Series A Success
The transition from academic research to commercial MedTech entrepreneurship requires a strategic mindset shift, particularly when navigating high-risk vascular innovations. Jordi Martorell, CEO and co-founder of Aortyx, shares his journey from mapping arterial blood flow at the Harvard-MIT Biomedical Engineering Center to developing bioresorbable endovascular patches for aortic dissection. Driven
#472: Cost Containment: Right-Sizing Medical Device Cybersecurity with Chris Gates
Medical device cybersecurity is no longer an optional feature or a last-minute checkbox prior to market entry. Hosted by Etienne Nichols, this episode features Chris Gates, founder and CEO of arsMedSecurity, who delivers a practical, engineering-first perspective on embedding security directly into the development lifecycle. Gates highlights that deferring cybersecurity efforts until the end of de
#471: From AI Visuals to FDA Approval: Fixing MedTech’s Design-to-Market Gap
Many MedTech startups and innovators focus heavily on core technology development, often assuming physical product design is simple polishing once a working concept exists. Michael Sprauve explains that this approach frequently creates a gap between brilliant engineering and a market-ready, commercially viable medical device. Succeeding in hardware requires looking past the technology to consider
#470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova
Building a medical device rarely follows the smooth, predictable trajectory presented in investor pitch decks. While regulatory consultants often default to "it depends," medical device teams require concrete figures regarding engineering hours, calendar timelines, and budget allocations to bring a concept to market safely and effectively.Lisa Voronkova, co-founder of OVA Solutions, draws on a dat
#469: Why Market Strategy Comes First in MedTech Development
Medical device startups frequently fall into the trap of developing complex technology first, only to struggle downstream with clinical adoption, regulatory hurdles, and reimbursement. In this episode, host Etienne Nichols sits down with Shai Policker, Managing Partner at Edge Medical Ventures, to explore why reversing this traditional paradigm leads to sustainable, category-defining products.Poli
A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology
Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transformation of the spine industry by making outcomes and technologies standardized and reproducible.In this episode of the Global Medical Device Podcast Jon Speer talks to Carlton Weatherby, Vice President and General Manager of Spine and Biologics at Medtronic. Listen to Carlton discuss recent developm
Developing a Regulatory Strategy
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru.Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, phar
#365: Medical Device Reporting: The Do's and Don'ts
In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up robust reporting processes and explains how manufac
#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 10993-1. 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
#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-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, hig
#346: FDAs eSTAR Program
This episode of the Global Medical Device Podcast delves into the world of FDA submissions, specifically focusing on the eSTAR program. Host Etienne Nichols leads an insightful discussion exploring the intricacies, benefits, and strategies for using eSTAR effectively in medical device regulatory submissions.To discuss this topic, we brought in the following experts:Patrick Axtell, Ph.D., the Senio
#345: Using AI In MedTech
In this episode, we delve into the burgeoning world of artificial intelligence in MedTech. Listen as we discuss the skepticism and opportunities associated with AI, the revolutionary impact on product development, and provide practical advice for professionals looking to harness AI's potential. Wade Schroeder, Medical Device Guru for Greenlight Guru, shares his expertise on MedTechs AI-powered too
#327 Understanding the ROI of an eQMS
In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Some of the topics we explore are:3rd- party study by Hobson & CO that reveals significant reductions in setup time, full-time employee requirements, time spent on development and documentation, training time, and audit preparation
#323 The Combination Products Handbook
Combination products are a difficult niche because they combine so many different elements. However, today’s guest literally wrote the book on the topic, and she’s joining the podcast to share her insights. In today’s episode, Susan Neadle and I spoke on the topic of Combination Products, and specifically how she recently wrote the Handbook on this topic, with many co-authors from FDA.Susan is a r
Avoiding Potential Issues with your 510(k) Submission
When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it.Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the presi
Most Common Problems Found During FDA Inspections in 2022
Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections.Recurring guest Mike Drues is the President of Vascular Sciences where he works to educate the industry and offers help to b
Part 2: The Theranos Loophole & Lab Developed Tests
In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today’s episode, he begins by reviewing some of the information in Part 1 of this discussion. He dis
Part 1: The Theranos Loophole & Lab Developed Tests
What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the re
UDI: 101
What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode, you’ll hear from two guests with UDI experience. You’ll learn a lot about UDI and learn where to find some fantastic resources that can increase your knowledge.Laura Maher and Brittani Smith are both Medical Device Gurus and Greenlight
Quality Myths and Lessons Learned
What words cause the most problems in MedTech, and what situations should you be ready to handle when you work in Quality? Today’s guest wrote about these issues in his book and will be talking more about them in today’s interview.Kevin Becker has a bachelor’s degree in Mechanical Engineering from the University of Minnesota and a Master's degree in Reliability Engineering from the University of M
What "Exempt" Means with Respect to Medical Devices & Regulatory
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed?This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting
The Future of Reprocessed Used Medical Equipment
What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we spoke with Scott Carson on the future of buying and selling used medical devices.Scott has been in healthcare marketing, business development, sales, and management experience for more than 30 years. He was on the team that built the eB
Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry
Are you a medical device professional or company seeking suppliers? Or, are you a supplier yourself? There’s a supplier management solution that will make your job a whole lot easier.In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-owner of QUNIQUE, a quality and regulatory consultancy. Previously, Bassil worked with the notified body, TÜV SÜD.Bassi
How Being Strategic During A Career Transition Can Yield The Best Opportunities
There is a spectrum of feelings someone may experience in the midst of a career transition. For some, however, being laid off can turn out to be one of the best things to ever happen to them.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Aaron Moncur, owner of Pipeline Design & Engineering and host of the Being an Engineer podcast, as they both reflect on the twists
Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers
Are you a medical provider or caregiver unable to find facemasks as PPE for COVID-19? Get one for free.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Sanjay Vakil and Devon Campbell from MasksOn.org to discuss the impactful efforts being made through the MasksOn initiative that’s providing personal protective equipment and relief at no cost during the coronavirus pande
What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?
The FDA announced another new pilot program to improve the consistency and efficiency of its 510(k) review process. It’s called, eSTAR, or electronic Submission Template And Resource.
Today’s guest is Mike Drues of Vascular Sciences. Together, we discuss the details of the eSTAR Pilot Program to help you understand what you need to know and do as medical device professionals.
Some of the highli
How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory
Regulatory is a big deal for medical device companies. Whether it’s a startup or established business, a strong understanding of regulations and regulatory strategy is vital for product success in the marketplace.
Today’s guest is Isabella Schmitt, regulatory affairs consultant at Proxima Clinical Research where she specializes in quality and regulatory business advice. Isabella shares how medic
Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?
Superbugs.
Reprocessing.
The White House.
And Design Controls.
Probably not a combo of topics you see grouped together very often.
But we have them all for you on today’s Global Medical Device Podcast.
This is the 2nd edition in our series focused on Design Controls and related topics within the Medical Device Industry.
During this episode, we’ll surface some interesting and potentially c
#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment
Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), to unpack the structural differences and hidden pitfalls when medical device and pharmaceutical worlds collide. They dis
#459: The Purolea Warning Letter & Validating AI in Medical Devices - What FDA Actually Requires
The MedTech industry widely misread the FDA's recent warning letter to Purolea Cosmetics Lab as a direct crackdown on Artificial Intelligence (AI). Host Etienne Nichols challenges this narrative, explaining that viewing the event strictly through an AI lens causes medical device manufacturers to miss the actual compliance lesson. At its core, the Purolea situation is not a story of bad software, b
#462: Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders
In this episode, host Etienne Nichols sits down with Michaela Kivett, a seasoned medical device consultant at Greenlight Guru, to break down the complexities of implementing an electronic Quality Management System (eQMS). Drawing from her background in orthopedic implant contract manufacturing and pharmaceutical process engineering, Michaela shares firsthand accounts of the critical inefficiencies
#454: Bridging the Gap: Avoiding the MedTech Valley of Death with Dr. Adam Saltman
In this episode, host Etienne Nichols sits down with Dr. Adam Saltman, Chief Medical Officer at NAMSA, to explore the treacherous "valley of death" that exists between a medical device prototype and the patient. With a unique "triple threat" perspective as a cardiothoracic surgeon, former FDA official, and industry consultant, Dr. Saltman reveals why technical brilliance often fails in the face of
#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 looking to transition into MedTech. Drawing from his own experience moving from aerospace to medical devices, Etienne demystifies the industry’s high barriers to entry and explains why your existing skills are more valuable than you might think.The conversation
#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 molecular biology and her decade-long tenure at NAMSA. The conversation centers on the shifting paradigms of medical device investment, specifically how the industry is moving away from service-based models toward a focus on clinical outcomes.Etienne and Ivanny expl
#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 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 c
#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 challenges facing the pediatric medical device market. Following a personal experience in a neonatal ward, Edwin highlights the stark reality that many pediatric treatments rely on adult devices adapted off-label, often leading to safety risks and clinical inefficienc
#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 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 sta
#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 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
#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 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
#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 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
#426: Software as a Medical Device: Securing Your Digital Future
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
#422: ISO 14971 and the Road to Risk Management with Edwin Bills
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
#417: Evaluating EQMS: A Crucial Step for Medtech Success
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
#414: Why Global Certification is the Future of Clinical Research in Latin America
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
#415: Neurotech: Accelerating Innovation in a Complex Medical Device Vertical
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
#409: How Iterative Management Transforms MedTech Teams: Faster Execution, Smarter Decisions
In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate, to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded in over 70 years of research. With real-world anal
#406: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 2
In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC). This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions.
#404: MedTech 101: What You Need to Know About the Medical Device Industry
Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass. They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually co
#403: Global Perspective on Medical Device Reimbursement
In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets. From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies
#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity
In this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development. They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape c
#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions
In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions. Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-w
#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. They unpack the upcoming revisions to the fourth edition of IEC 60601, focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the fu
#394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances o
#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, culture over mandate, redundancy over duplication, and
#387: The case for Real World Evidence Studies
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation. Simon breaks down NEST's critical role in catalyzing the use of RWE to streamline submissions, accelerate time-to-market, and
#388: Elements of an Effective CAPA Program
In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems. Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions that not only ensure compliance but also drive me
#386: The Danger of In-Home Use Medical Devices, Pt. 2
In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these devices, increasingly used by non-healthcare profe
#383: What Standards Apply to My Device?
In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuring product safety and regulatory compliance. They
#380: Navigating the Complex World of Combination Products with Subhi Saadeh
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products. They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth. Subhi shares his personal journey in podcasting, the i
#377: Designing a Medical Device for a Global User
In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design courses and discusses the importance of global and contextual perspectives in medical device innovati
#373: Creative Clinical Recruitment
In this episode of the Global Medical Device Podcast, host Etienne Nichols, along with part-time co-host Stephanie Hinton, dives into the art of clinical trial recruitment with Dr. Kelly Palmer, Assistant Professor at the University of Arizona. Dr. Palmer shares her extensive experience and innovative strategies for overcoming recruitment challenges, emphasizing the importance of community engagem
#371: Achieving ISO 13485 Certification
In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru’s eQMS software. Listeners will gain valuable insights into maintaini
#355: Mastering the Pitch: MedTech Innovations from Concept to Market
In this episode of the Global Medical Device Podcast, host Etienne Nichols dives into the art of pitching to medical device investors with Blythe Karow, COO at Neurogeneces. Blythe shares her wealth of experience, from her early days as a marketer to leading significant product launches and achieving FDA breakthrough designations. The conversation revolves around crafting compelling pitches, under
#354: Advice for MedTech Regulatory Affairs Professionals
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
#347: Human-Centered Design in Medical Devices
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols engages with Morven Shearlaw, co-founder of Fearsome, in a thought-provoking discussion on the essence of human-centered design in medical devices.Delve into the importance of understanding user needs beyond surface-level assumptions and learn how Fearsome's approach to product development is setting new standard
#343: Recent FDA Draft Guidances
Description:In this episode, we discuss with with regulatory expert Mike Drues to dissect the evolving landscape of FDA medical device regulations. These discussions provide a comprehensive overview of the historical context and current implications of FDA guidances, with a particular focus on 510K predicate selection, clinical data requirements, and the nuances of permanent implants. The conversa
#340: LDTs & the FDAs Proposed Ruling
Description:In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory Developed Tests (LDTs) and In Vitro Diagnostic products (IVDs). Shannon breaks down the past and present regulatory landscapes of LDTs, the differences between IVDs and LDTs, and what the FDA's changes could mean. They
#341: What NOT to say to FDA
Description:Dive into the enlightening world of FDA inspections with Etienne Nichols and Mike Drues. In this comprehensive episode, the duo decodes the essence of effective communication, the importance of managing expectations, and the art of proactive dialogue with the FDA. They reveal insights that every MedTech professional must know, breaking down the philosophy, challenges, and expectations
#339: UDI and the State of EUDAMED
Description:In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device Regulation. While the EUMDR may have been published in 2017, many companies are still unsure how to handle the submission of their UDI (Unique Device Identification) data.Joining us to discuss this topic is Richard
#336: From Academia to FDA Clearance (True Quality Roadshow - Boston)
Description:In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance. T
#332: Regulatory Strategy and the Advantage of Diversity in MedTech
Description:In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in t
#331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues
Description:During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Dan tells the story of how his company weathered the early days of startup life, and how the pandemic - which took so many companies down - turned out to be the springboard that tested the culture that Dan and his co
#326 CSA vs. CSV: Modern Validation for Modern MedTech
In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. She discusses the FDA's draft guidance from September 2022, the industry's response, and the practical applications of it all. The conversation also covers the evolution of software validation processes, the
Leaning into Lean Documentation
What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s conversation, documentation. Steve Gompertz is a partner at QRX Partners and has led initiatives in project management, engineering automation, configuration management, audit, and software development.During today’s episode,
Cybersecurity and the Future of MedTech
The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food and Drug Cosmetic Act has expanded the scope of the FDA beyond just "safety and efficacy" to include the cybersecurity of medical devices. This amendment resembles a watered-down version of the PATCH Act, which failed to pass
Ad Promo and The Difference in Regulatory & Legal
What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to regulatory affairs professionals and regulatory affairs attorneys? Those are just a few of the items covered in today’s live discussion with Mark DuVal.Mark is the founder and president of Duval & Associates. He’s been in he
Systematic Literature Review for EU MDR
What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps? In today’s episode, you’ll hear from Co-Founder and Operating Partner of CiteMed, Ethan Drower, on the topic of Systematic Literature Reviews for EU MDR Clinical Evaluation Reporting.In today’s conversation, we covered topics like where information for the literature review comes from, t
How Communication Affects the Outcomes of Quality Activities
Why do quality professionals struggle with clear communication in writing? What’s the problem with jargon? These are some of the questions explored in today’s podcast.Joining the show this episode is Lesley Worthington. Lesley has 20 years of quality and regulatory experience in medical devices, and she uses that experience to work with individuals and teams to fine-tune their quality conversation
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Learn 50 English Phrases While You Sleep | Everyday English Phrases & Vocabulary
