PODCAST · business
MedTech True Quality Stories
by Powered by Greenlight Guru with host Jon Speer + Medical Device Leaders
This is MedTech True Quality Stories, hosted by Jon Speer, founder and VP of QA/RA at Greenlight Guru.Each week, we embark on a new storytelling journey with different MedTech executives as they share real-world, actionable best practices for medical device leaders. Listeners will gain invaluable insights into how these industry pioneers are successfully imagining, implementing, and improving True Quality medical devices.
Episodes
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#476: Part 2: FDA Guidance: What We Should Expect in 2027
In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory consultant Michael Drues, Ph.D., to examine the FDA's Center for Devices and Radiological Health (CDRH) guidance document priorities for fiscal year 2027. The discussion kicks off...
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#475: Part 1: 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...
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#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…
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#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...
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#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...
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#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…
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#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,...
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#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…
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#468: SaMD Issues, Defects & Detection | Shawnnah Monterrey
Most discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves the manufacturing floor. In this episode of the Global...
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#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...
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#466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth
Many early-stage medical device founders face a major dilemma: how do you prove regulatory maturity to investors and partners before you actually hold a final CE mark or FDA approval? Waiting until the end of a long development cycle creates significant commercial risk. By treating regulatory...
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#465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian
In this episode, host Etienne Nichols sits down with Ali Samiian, founder and managing principal of Popular Access Advisors, to demystify the critical and often misunderstood world of MedTech reimbursement. Far too many early-stage medical device companies treat reimbursement as a secondary,...
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#463: Finding MedTechs Leading Voices with Sean Smith
The medical device industry functions as a highly complex ecosystem where diverse niches—including regulatory affairs, quality assurance, marketing, and reimbursement—must seamlessly interconnect to bring life-saving technologies to life. In this episode, host Etienne Nichols sits down with Sean...
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#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…
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#461: Why Manufacturing is Part of Product Development with Mike Dolphin
The traditional approach to medical device commercialization often treats manufacturing as a distinct, isolated step executed after the design phase is completed. In this episode, Mike Dolphin, CEO of GuideStar Medical Devices, challenges this linear mindset by arguing that manufacturing process...
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Improving the Colon Cancer Screening Experience
Preparation for a colonoscopy is not a pleasant or positive experience. From laxatives to the invasiveness and sedation involved, preparing for a colonoscopy is something most patients dread and try to avoid. Fortunately, clinicians and patients can look forward to colonoscopy and colon cancer...
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#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...
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#458: What the FDA Actually Says About AI in Medical Devices
The medical device industry is undergoing a paradigm shift as Artificial Intelligence (AI) and Machine Learning (ML) transition from novelties into heavily regulated realities. The turning point arrived when the FDA integrated its own internal AI tool, Elsa, into its scientific review and...
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#457: Exploring the MedTech Commercial Valley of Death with Ryan O'Mahoney
The transition from a cleared medical device to a commercialized product is one of the most perilous phases for a MedTech startup. While founders frequently anticipate the technical and regulatory hurdles of early-stage development, they often underestimate the "commercial valley of death."…
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#456: What You Don’t Know Can Hurt You: 483 Pitfalls and Regulatory Accountability
In this episode, host Etienne Nichols sits down with industry veteran Mike Drues to explore a critical theme in modern MedTech: the danger of "not knowing what you don't know." The conversation centers on the growing trend of companies making avoidable, "boneheaded" mistakes despite a robust...
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#455: MedTech Founder 101: Shifting from Corporate to Startup with John Schindler
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with John Schindler, CEO of Liquet Medical, for a "MedTech Founder 101" masterclass. With over 25 years of experience at industry giants like Atrium and Merit Medical, Schindler shares the "painful reality…
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#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...
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#453: Sustainable Material Selection in MedTech with Lucas Pianegonda
Sustainability in the medical device industry is far more complex than simple material substitution. It involves a rigorous balancing act between biocompatibility, regulatory requirements, and supply chain logistics. Etienne Nichols sits down with Lucas Pianegonda, founder of Gradical, to explore...
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#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...
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#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 factors (HF) in the medical device regulatory pathway. Staci explains that many companies mistakenly treat HF as a "box-checking" exercise late in development,...
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#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" international medical device companies face when entering the U.S. market. They challenge the traditional assumption that a device should always launch...
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#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…
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#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...
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#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…
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#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…
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#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...
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#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 the evolution of leadership in the medical device industry. Drawing from her experience as a bioengineer and CEO, Dr. Hoffmann explains why the traditional...
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#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…
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#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 incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining…
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#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,...
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#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). Adnan Ashfaq, founder of Simply Medica, joins Etienne Nichols to dissect how traditional standards intended for physical manufacturing must be creatively...
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#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…
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#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...
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#432: China MedTech Compliance: Regulatory Risks, Rewards, & Strategy with Elaine Tan
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…
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#431: Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First Ethos
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...
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#430: MedTech Language: Patient, Customer, or Partner?
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...
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#428: Andragogy in MedTech: Why Adult Learning Principles Beat Traditional Training
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)....
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#427: Medical Device Reimbursement - Pitfalls to Avoid
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...
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#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...
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#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...
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#420: MedTech Synergy: The Project Manager and Quality Professional Relationship
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...
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#418: Biocompatibility Brief - What Medical Device Companies Need to Know
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…
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#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...
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#416: Unpacking Common FDA Compliance Gaps: Pre-Market vs. Post-Market Realities
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...
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#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...
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ABOUT THIS SHOW
This is MedTech True Quality Stories, hosted by Jon Speer, founder and VP of QA/RA at Greenlight Guru.Each week, we embark on a new storytelling journey with different MedTech executives as they share real-world, actionable best practices for medical device leaders. Listeners will gain invaluable insights into how these industry pioneers are successfully imagining, implementing, and improving True Quality medical devices.
HOSTED BY
Powered by Greenlight Guru with host Jon Speer + Medical Device Leaders
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How many episodes does MedTech True Quality Stories have?
MedTech True Quality Stories currently has 50 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
What is MedTech True Quality Stories about?
This is MedTech True Quality Stories, hosted by Jon Speer, founder and VP of QA/RA at Greenlight Guru.Each week, we embark on a new storytelling journey with different MedTech executives as they share real-world, actionable best practices for medical device leaders. Listeners will gain invaluable...
How often does MedTech True Quality Stories release new episodes?
MedTech True Quality Stories has 50 episodes. Check the episode list to see recent publication dates and frequency.
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You can listen to MedTech True Quality Stories on PodParley by clicking any episode. We provide an embedded audio player for direct listening, and you can also subscribe via your preferred podcast app using the RSS feed.
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MedTech True Quality Stories is created and hosted by Powered by Greenlight Guru with host Jon Speer + Medical Device Leaders.
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