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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
Project Management
Design Controls
Human Factors
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.

PublishesWeeklyEpisodes350Founded10 years ago
Number of ListenersCategories
MedicineBusinessHealth & Fitness

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Artwork for Global Medical Device Podcast powered by Greenlight Guru

Latest Episodes

In this episode, Etienne Nichols sits down with Dr. Kristy Katzenmeyer-Pleuss, President and Founder of KP Medical Device Consulting, to unpack the complexities of the medical device life cycle. The conversation centers on how manufacturers often ove... more

YouTube

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 philosophica... more

YouTube

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 t... more

YouTube

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 inter... more

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Key Facts

Accepts Guests
Accepts Sponsors
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Podcast Host
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Find out how many people listen to this podcast per episode and each month.

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Let's Talk Risk! with Dr. Naveen Agarwal
Let's Talk Risk! with Dr. Naveen AgarwalCasual and informal conversations about practical aspects of medical device risk management.

Recent Guests

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?
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
Alex Naber
Medical device consultant at Greenlight Guru
Greenlight Guru
Episode: #431: Meet Alex Naber: Insider Insights on Quality Systems, Design Quality, and MedTech's Patient-First Ethos
Dr. Allison Komiyama
CEO and founder of Blue Stocking Health, focused on medical technologies
Blue Stocking Health
Episode: #430: MedTech Language: Patient, Customer, or Partner?
Shannon Decker
CEO of Healthcare Clinical Performance Operations at VBC1
VBC1
Episode: #428: Andragogy in MedTech: Why Adult Learning Principles Beat Traditional Training
Haley King
Co-founder and CEO of Paxos Health
Paxos Health
Episode: #427: Medical Device Reimbursement - Pitfalls to Avoid
Jose Borges
Helps MedTech companies build secure compliance software and leads cybersecurity services at CyberMed.
CyberMed
Episode: #426: Software as a Medical Device: Securing Your Digital Future

Host

Etienne Nichols
Host of the Global Medical Device Podcast. Etienne engages with industry leaders to bring vital insights and expert knowledge to medical device professionals.

Reviews

4.9 out of 5 stars from 198 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 Kingdoma month 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
    2 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 States8 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 Statesa year ago

Listeners Say

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

The podcast is seen as an essential resource for medtech professionals looking to stay informed in a rapidly evolving field.
Overall, users commend the show's production quality, engaging interviews, and the diverse range of subjects that cater to various roles in the medtech industry.
Some feedback indicates a desire for less criticism towards regulatory bodies, particularly the FDA.
Listeners appreciate the depth and relevance of topics covered, highlighting the actionable insights offered by industry experts.

Chart Rankings

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

Talking Points

Recent interactions between the hosts and their guests.

#442: MedTech Leadership: Vulnerability & The CEC Framework with Dr. Jenny Hoffmann
Q: How can leaders effectively balance vulnerability and professionalism?
It's about sharing relevant stories that relate to others while being mindful of oversharing.
#442: MedTech Leadership: Vulnerability & The CEC Framework with Dr. Jenny Hoffmann
Q: What motivated you to write a book?
I felt that my stories and experiences could help others fulfill their purpose and have an impact.
#440: ICYMI (In Case You Missed It!) Fundamentals of Quality & Regulatory
Q: What advice would you give to budding professionals in quality and regulatory?
You need to be proactive in seeking information, and not just passively waiting for it to come to you.
#436: Do ISO 13485's Production Controls apply to SaMD?
Q: How do you recommend companies approach the potential clash of Agile development and ISO 13485?
Documentation plays a crucial role in ensuring compliance, particularly in version control and risk assessments, to avoid non-conformances during audits.
#436: Do ISO 13485's Production Controls apply to SaMD?
Q: What actually counts as production under ISO 13485 for software that updates continuously?
You need to consider any bugs and patches, revision histories, and changes in design when evaluating production for continuously updating software.

Audience Metrics

Listeners, social reach, demographics and more for this podcast.

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Frequently Asked Questions About This Podcast

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

The focus of this podcast is on the medical device industry, where industry leaders and experts share valuable insights and knowledge designed to help professionals navigate the complexities of medical technology. Topics discussed range from regulatory compliance, quality management, and innovation in product development, to reimbursement strategies and the nuances of global market entry. Listeners can expect engaging conversations that not only address current trends and regulations but also delve into practical advice aimed at improving operations within the medtech sector. With a mix of expert interviews and relevant discussions, the content seeks to empower listeners to advance their careers and elevate their organizations' strategies i... 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 Readout Loud
4. TED Talks Daily
5. What Now? with Trevor Noah

How many episodes of this podcast are there?

this podcast launched 10 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. Michelle Wu
2. Adnan Ashfaq
3. Perry Parendo
4. Elaine Tan
5. Alex Naber
6. Dr. Allison Komiyama
7. Shannon Decker
8. Haley King

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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