258 episodes listed below
Regulatory clarity for medtech’s hard decisions.
Global Medical Device Podcast treats medical device development as a chain of real regulatory choices, not a checklist. Episodes move through QMS timing, human factors evidence, ISO 10993-1, FDA submissions, pediatric devices, and international expansion with a steady, practitioner-first lens.
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Global Medical Device Podcast sits squarely in the operational reality of medical device development. It treats regulation as a living design constraint, not as paperwork added after the product is finished. The episodes are interview-led and often start with a simple practical problem. Then they slow down. A question about human factors becomes a distinction between simulated use, clinical trial data, design inputs, and design outputs. A conversation about entering the U.S. market turns into a warning about assuming that standards, evidence, and prior approvals travel cleanly across jurisdictions. The show is most useful when the guest is drawing lines between concepts that teams often blur. QMS work, for example, is discussed as something that should run in parallel with development rather than appear at design freeze. ISO 10993-1 is treated not as a test menu, but as a risk-based framework tied to materials, human contact, foreseeable misuse, biological safety, and end-of-life thinking. Investment conversations stay close to evidence, reimbursement, regulatory path, clinical utility, and whether a founding team can actually execute. Pediatric medtech gets a similarly pragmatic treatment, with attention to small markets, adult-level quality expectations, hospitals, investors, and adoption barriers. The show also follows the full life cycle of a device, from early concept through market entry, post-market, and pulling a device off the market. Its tone is professional but not sterile. There are occasional flubbed intros, small interruptions, and dry conversational turns, which make the technical material feel worked through rather than recited. The value is in the friction. Guests and host circle back, restate terms, test assumptions, and keep asking what changes for a team trying to get a device cleared, funded, built, or used. The result is a specialist show for people who already know that medtech compliance has consequences. It does not flatten the field into generic innovation talk. It stays with the hard parts: standards recognition, FDA expectations, international regulatory strategy, 510(k) versus PMA assumptions, OTC versus prescription pathways, clinical evidence, biocompatibility, design controls, audits, and risk-based QARA. For listeners inside medical device companies, that specificity is the point.
Made for: Built for medtech founders, regulatory affairs teams, quality leaders, device teams, clinical leaders, and investors who need practical context around device development and market entry. It assumes the listener cares about submissions, audits, standards, evidence, and commercialization details.
What sets it apart: The show stands out by staying close to the exact misunderstandings that stall regulated device teams: human factors versus clinical trials, design inputs versus outputs, standards versus guidance, and strategy versus sequencing. Its interviews favor applied judgment over polished futurism.
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.
Based on 6 episodes we listened to · September 2026
Medtech strategy becomes legible through detailed conversations about regulation, product development, investment diligence, and the choices that determine market entry.
Etienne Nichols turns the business of medical devices into a series of practical operating questions. Guest conversations focus on decisions that can delay a submission, complicate expansion, or weaken an investment case, with regulation treated as part of building and…
This is where your medtech shortcut gets politely escorted back to the risk file.
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Short reviews from the PlayNext desk, based on the episodes we processed.
A clear medtech review of why clinical-trial data does not replace human-factors evidence.
The episode draws a clean line between two kinds of evidence that medtech teams can too easily blur: clinical-trial data and human-factors work. Clinical evidence can include observations about users, but its main job is to support efficacy.
A practical episode on why U.S. medtech expansion needs earlier, more deliberate regulatory planning.
Taking a medtech company from Europe or Asia into the United States is less a late-stage filing task than a regulatory strategy decision, and this episode frames that shift in practical terms.
A grounded look at how medtech investors test regulatory and reimbursement claims before backing a company.
Medtech investing gets a practical stress test here: can a founding team make its regulatory and reimbursement story hold up after funding is on the table?
A standards revision becomes a practical question of evidence, risk, and how much time a medtech team can afford to lose.
ISO 10993-1 lands at the point where medical-device safety has to meet practical judgment. Etienne Nichols talks with Thor Rollins of Nelson Labs, who also convenes the committee revising ISO 10993-1, about why the standard is changing and how teams can avoid spending months…
A practical look at scaling QMS work before design freeze and FDA scrutiny.
Global Medical Device Podcast turns quality management into an operating decision, not just a compliance checkbox. Host Etienne Nichols and Mike Drews, president of Vascular Solutions, look at when a team really needs a full QMS, what can reasonably scale later, and what the FDA…
Why quality controls make more sense as objectives firm up, and why small monthly upkeep matters before it becomes a major milestone.
Quality management does not have to mean following procedures for their own sake. Ashkan Rasooli draws a useful line between compliance and understanding what each process is meant to achieve.
A grounded forecast of specialized AI copilots becoming everyday tools in medtech quality and regulatory work.
Etienne Nichols and Nyquist AI founder and CEO Michelle Wu look at how AI copilots could change quality and regulatory work in medtech. Wu expects specialized copilots to emerge for particular roles and tasks, such as regulatory strategy, regulatory intelligence, quality…
Medtech strategy, straight from the people running it.
Medical technology, explained from problem to market.
Orthopedic surgeons and researchers on putting weight-bearing CT to work
Medical technology safety, explained by the people doing the work.
Host Etienne Nichols interviews Michelle Wu, founder of Nyquist AI, about AI trends in medtech regulatory and quality for 2025.
Ashkan Rasooli discusses building effective quality management systems for medical device companies from startup to scale.
Host Etienne Nichols interviews Edwin Bills, a leading expert with 35+ years of experience, about ISO 14971 and risk management for medical devices.
Dr.
Human factors is not clinical trial data.
Crossing into the U.S.
A discussion on medtech investment trends, focusing on outcomes over services, regulatory shifts, and the move to at-home care.
This episode explores the challenges and solutions for bringing pediatric medical devices to market, featuring insights from medtech operator Edwin Lindsay.
Dr.
Thor Rollins of Nelson Labs says ISO 10993-1:2025 moves biocompatibility away from "checkboxing" and toward risk estimation tied to ISO 14971.
Mike Drews says copy-and-paste QMS language fails because a QMS must fit your device, not someone else's.
This episode discusses the regulatory requirements for switching a medical device from prescription to over-the-counter status, focusing on 510k cleared devices.
This episode introduces a two-part series comparing over-the-counter and prescription medical devices, with host Etienne Nichols and Dr.
Etienne Nichols interviews Kirk Petyo about attracting and hiring top talent in the medical device industry.