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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
Medical Devices
FDA
Greenlight Guru
AI
Regulatory Affairs
Healthcare
Medtech Career Advancement
Regulatory Compliance
FDA Submission Planning
510k
Quality Management System
Artificial Intelligence
AI In Medtech
Estar Program
Human Factors
Project Management
Design Controls
Quality Management Systems
Medtech Regulatory Affairs
Medical Device Industry

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
BusinessHealth & FitnessMedicine

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Artwork for Global Medical Device Podcast powered by Greenlight Guru

Latest Episodes

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 ... more

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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 ass... more

YouTube

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... more

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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 highl... more

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Key Facts

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Recent Guests

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
Adnan Ashfaq
Founder of Simply Medica with over 25 years in quality and regulatory validation work in medical technology
Simply Medica
Episode: #436: Do ISO 13485's Production Controls apply to SaMD?
Kavetha Ram
PhD of Health and Pharmaceutical Sciences, leading regulatory department at Spectra Medical Devices
Spectra Medical Devices
Episode: #435: ICYMI (In Case You Missed It!) Becoming a Regulatory Affairs Professional
Perry Parendo
Founder of Perry Solutions, recognized as a thought leader in project management for product development.
Perry Solutions
Episode: #434: ICYMI (In Case You Missed It!) Project Management In Medtech
Elaine Tan
Creator of MedTech Chopsticks, expert in navigating China's regulatory landscape.
MedTech Chopsticks
Episode: #432: China MedTech Compliance: Regulatory Risks, Rewards, & Strategy with Elaine Tan

Host

Etienne Nichols
Host of Global Medical Device Podcast, sharing insights on medical device regulations, quality assurance, and market trends.

Reviews

4.9 out of 5 stars from 199 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 Kingdom3 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
    3 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 States9 months 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
    Irelanda year 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.

There is a recurring praise for the depth and variety of topics covered, appealing to both veterans and newcomers in the industry.
Some feedback points out a perceived bias towards certain regulatory perspectives, suggesting a mixed reception to criticism of regulatory bodies, but overall, many find the content informative and valuable.
Listeners appreciate the actionable insights and practical advice shared throughout the episodes, noting a focus on real-world applications in the medical device industry.

Chart Rankings

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

Talking Points

Recent interactions between the hosts and their guests.

#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.
#446: The Hidden Physics of the MedTech Life Cycle with Dr. Kristy Katzenmeyer-Pleuss
Q: What is the definition in your mind of a medical device life cycle?
The medical device life cycle involves everything from the initial concept to the end where you're disposing or decommissioning the device, including all the steps in between.

Audience Metrics

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Frequently Asked Questions About This Podcast

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

This podcast focuses on critical insights and actionable knowledge within the medical device sector, emphasizing topics like regulatory compliance, quality assurance, and the overall lifecycle of medical products. It frequently features expert guests who share their experiences and strategies, providing listeners with practical lessons applicable to both startups and established companies. The conversations often address the complexities of medical device development, the implications of new regulations, and the integration of emerging technologies such as artificial intelligence within the industry. Unique elements include discussions on pediatric devices, the hiring landscape in MedTech, and the evolving terminology that influences patien... more

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Which podcasts are similar to this podcast?

These podcasts share a similar audience with this podcast:

1. Medical Device made Easy Podcast
2. Let's Talk Risk! with Dr. Naveen Agarwal
3. The Rest Is Science
4. Worklife with Adam Grant
5. Medtech Matters

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. Staci Miller
2. Ivanny Franklin
3. Edwin Lindsay
4. Dr. Kristy Katzenmeyer-Pleuss
5. Michelle Wu
6. Adnan Ashfaq
7. Kavetha Ram
8. Perry Parendo

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