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Artwork for Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast powered by Greenlight Guru

Greenlight Guru + Medical Device Entrepreneurs
FDA
Medtech
Medical Device Industry
Medical Devices
Quality Management Systems
Regulatory Compliance
Risk Management
Patient Safety
Greenlight Guru
Quality Management System
Regulatory Affairs
Artificial Intelligence
Quality Assurance
FDA Regulations
Clinical Trials
ISO 13485
Project Management
Design Controls
Radiology
Software As a Medical Device

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.

PublishesWeeklyEpisodes350Founded11 years ago
Number of ListenersCategories
MedicineBusinessHealth & Fitness

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Artwork for Global Medical Device Podcast powered by Greenlight Guru

Latest Episodes

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 undere... more

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 avoidab... more

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 Medica... more

YouTube

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" perspect... more

YouTube

Key Facts

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Recent Guests

Ryan O'Mahoney
Commercial acceleration strategist; founder of Catalyst Ventures
Catalyst Ventures
Episode: #457: Exploring the MedTech Commercial Valley of Death with Ryan O'Mahoney
John Schindler
CEO of Liquet Medical
Liquet Medical
Episode: #455: MedTech Founder 101: Shifting from Corporate to Startup with John Schindler
Adam Saltman
Chief Medical Officer at Namsa
Namsa
Episode: #454: Bridging the Gap: Avoiding the MedTech Valley of Death with Dr. Adam Saltman
Lucas Pianegonda
Founder of Gradical; material scientist focusing on sustainable plastics for MedTech
Gradical
Episode: #453: Sustainable Material Selection in MedTech with Lucas Pianegonda
Staci Miller
Human factors and UX strategist at GenUX
GenUX
Episode: #450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling
Ivanny Franklin
Managing partner at MedSight Capital and former molecular biologist with extensive experience in MedTech and diagnostics
MedSight Capital
Episode: #448: MedTech Investment: Outcomes, Regulations, and the Shift to At-Home Care
Edwin Lindsay
MedTech operator and Quality Regulatory Leader who has taken products from concept to clearance.
Co-founder of SURE, Compliance Solutions
Episode: #447: Solving the Pediatric MedTech Gap with Edwin Lindsay
Dr. Kristy Katzenmeyer-Pleuss
President and Founder of KP Medical Device Consulting, with expertise spanning regulatory strategy, biocompatibility, sterilization, risk management, and clinical evaluation.
KP Medical Device Consulting
Episode: #446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss
Michelle Wu
Founder and CEO of Nyquist AI, recognized as a top woman in AI for 2025.
Nyquist AI
Episode: #439: MedTech AI Trends 2025: Scaling Regulatory Intelligence with Michelle Wu

Host

Etienne Nichols
Host of Global Medical Device Podcast, Greenlight Guru

Reviews

4.8 out of 5 stars from 201 ratings
  • The MedTech “How-To” Podcast: Practical Quality & Regulatory Lessons from the Global Medical Device

    Global Medical Device Podcast (Powered by Greenlight Guru) is a consistently practical MedTech show focused on what it takes to develop, regulate, and scale medical devices—quality systems, regulatory strategy, risk management, post-market, and operations. Hosted by Etienne Nichols, it leans into “how it actually works” discussions with practitioners and offers lots of transferable, day-to-day lessons for start-ups and established teams alike. The back catalogue is deep and topic coverage is bro... more

    Apple Podcasts
    5
    Dr.SRG76
    United Kingdom4 months ago
  • As an engineer in the medical device industry, this is a fantastic podcast for getting a bird's eye view of a wide range of regulatory topics that impact my daily design work.

    Podcast Addict
    5
    Trescanette
    5 months ago
  • Medical Device podcast is a Favorite of mine

    Always full of great resources, ideas, people. So helpful & motivating. Also, helps in keeping up with ever changing MedTech landscape. The most recent podcast #411 opened my eyes to local states issues I never considered. Always great guests & info.

    Apple Podcasts
    5
    Ttraveller
    United Statesa year ago
  • A Must for any Med Tech Professional

    Love the diverse range of topics covered in the show. The guests provide insights and advice which any medical device professional will find useful and actionable. I keep returning to previously listened shows, which speaks to the relevance and quality of the content.

    Apple Podcasts
    5
    HF Ian
    Ireland2 years ago
  • Stop bashing the FDA

    I think the podcast topics are great, but, I don’t appreciate the constant FDA bashing. There’s a reason innovation still happens first in the US.

    Apple Podcasts
    3
    giantshuskies
    United States2 years ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

High-quality guests and topics across regulation, lifecycle, and leadership in MedTech.
Strong production and host expertise, with deep industry insights and applicable frameworks.
Professional, practical medtech guidance with actionable takeaways for RA/QA and product teams.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Talking Points

Recent interactions between the hosts and their guests.

#453: Sustainable Material Selection in MedTech with Lucas Pianegonda
Q: Who does this really apply to first and then we can get into how?
Smaller players are often more agile and can implement changes faster, while larger companies face more complexity; the overall approach benefits everyone who can align on regulatory, customer, or competitive pressure.
#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling
Q: What is the definition of done for URA vs UFMEA and how can teams determine when to stop?
She outlines a method: define uses and use environments, identify users, map tasks, and ensure URA/UFMEA cover the critical tasks with mitigations and evidence; if post-market data or testing reveals new risks, revise; the process should be iterative and aligned with phase 0-4 development.
#450: Human Factors vs. Clinical Trials: Why Your MedTech Submission is Stalling
Q: Where does human factors actually fit in the regulatory pathways and why is it misunderstood?
Staci explains that HF sits within risk management and is focused on user interactions; the FDA guidance aligns with 14971 structure but requires clear definition of user groups and use environments, and URA/UFMEA should reflect this integration rather than treating HF as a stand-alone task.
#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss
Q: What are some of those early design decisions that you feel like maybe get overlooked?
Early design decisions regarding materials, cleaning methods, and supplier changes can have significant long-term impacts on regulatory burdens and testing requirements.
#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss
Q: Are there areas that you feel like companies really underestimate the risk?
Yes, companies often underestimate the risks associated with the device lifecycle, especially regarding FDA deficiencies that might arise later on.

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Frequently Asked Questions About This Podcast

What is This Podcast about and what kind of topics does it cover?

This show covers a broad swath of the medical device ecosystem, with deep dives into regulatory strategy, quality management, design controls, and post-market considerations. Episodes frequently explore practical pathways for bringing devices to market, scaling startups, and navigating cross-border regulatory landscapes, often featuring practitioners who share real-world lessons, templates, and frameworks that listeners can apply immediately. Notable angles include pediatric device challenges, AI in regulation and QA, and the evolving quality system landscape, all delivered through structured conversations with industry veterans and executives. The format tends to blend actionable guidance with thoughtful storytelling, making it a strong re... more

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These podcasts share a similar audience with this podcast:

1. The Rest Is History
2. Let's Talk Risk! Podcast
3. The Journal.
4. The Ezra Klein Show
5. Freakonomics Radio

How many episodes of this podcast are there?

this podcast launched 11 years ago and published 350 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on this podcast?

Recent guests on this podcast include:

1. Ryan O'Mahoney
2. John Schindler
3. Adam Saltman
4. Lucas Pianegonda
5. Staci Miller
6. Ivanny Franklin
7. Edwin Lindsay
8. Dr. Kristy Katzenmeyer-Pleuss

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