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

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.

PublishesTwice weeklyEpisodes357Founded11 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 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 ... more

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, cale... more

YouTube

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 ... more

YouTube

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 mappi... more

YouTube

Key Facts

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Recent Guests

Lisa Voronkova
Co-founder of OVA Solutions, engineering leader
OVA Solutions
Episode: #470: The Real Cost of MedTech Innovation: From Idea to Pre-Production with Lisa Voronkova
Jordi Martorell
CEO and co-founder of Aortyx
Aortyx
Episode: #473: The MedTech Odyssey: Bridging Academic Science to Series A Success
Chris Gates
Founder and CEO of ArsMed Security
ArsMed Security
Episode: #472: Cost Containment: Right-Sizing Medical Device Cybersecurity with Chris Gates
Nikhil Mangale
Vice President of Quality at Kapstone Medical
Kapstone Medical
Episode: #474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls
Michael Sprauve
President of Spec Design, a firm building hardware since 1996
Spec Design
Episode: #471: From AI Visuals to FDA Approval: Fixing MedTech’s Design-to-Market Gap
Shai Policker
Managing Partner at Edge Medical Ventures; CEO of Endostem
Edge Medical Ventures / Endostem
Episode: #469: Why Market Strategy Comes First in MedTech Development
Shawnnah Monterrey
Beanstalk Ventures founder; FDA accredited third-party reviewer
Beanstalk Ventures / Beanstalk Consulting
Episode: #468: SaMD Issues, Defects & Detection | Shawnnah Monterrey
James Fentress
Director of Regulatory Affairs
Galero (a Santa Group company)
Episode: #467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment
Malte Knowles Schmidt
Head of regulatory and product strategy at TÜV Süd (guest on episode)
TÜV Süd
Episode: #466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth

Host

Etienne Nichols
Host of the Global Medical Device Podcast powered by Greenlight Guru

Reviews

4.9 out of 5 stars from 204 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 Kingdom9 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
    9 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.

Great guest diversity and deep-dive topics across regulatory and commercialization.
Consistently practical MedTech show with actionable lessons for QA/RA and product teams.
High-signal content and steady production, though sponsor mentions are noticeable.
Excellent resource for staying current on regulatory trends and AI in MedTech.

Chart Rankings

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

Apple Podcasts
#180
India/Business

Talking Points

Recent interactions between the hosts and their guests.

#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls
Q: How should a small company approach QMSR preparation differently from a larger organization?
Small companies should tailor a true, lean quality system that reflects actual practices, start with risk management as the foundation, then address design and development, document control, and supplier controls. Avoid boilerplate templates; focus on practical processes and a risk-based plan with prioritized actions.
#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls
Q: What are the five top FDA citations under QMSR and why do they appear so often?
They are risk management, supplier controls, complaint handling, UDI, and corrective actions. They appear frequently because inspectors focus on how information flows among these areas and whether risk is actively managed across the product lifecycle, rather than just on documented files.
#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment
Q: How does PMOA influence how a combination product is regulated in the US?
PMOA determines which center leads the review (CDRH for device or CDER for drug), and in many cases the Office of Combination Products designates the path, sometimes resulting in a lead center that coordinates the overall regulatory strategy.
#465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian
Q: For an early-stage founder, what should be prioritized in market access in the first couple of years?
Start with a landscape assessment to identify potential codes and payment levels, then plan payer-relevant endpoints in the clinical studies to reduce post-FDA data needs. Early alignment with payers and regulators like the TAP and RAPID programs can facilitate faster access and reduce investor risk.
#465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian
Q: What are the common mistakes you see that derail a device's path to market from a reimbursement standpoint?
Two key mistakes: assuming FDA clearance alone guarantees reimbursement and racing to be first to FDA approval without considering the broader regulatory pathways and their reimbursement implications; and designing trials without payer-relevant endpoints, leading to long, costly data generation that may not satisfy payers.

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?

The show focuses on the medical device industry, frequently hosting regulatory, quality, and go-to-market experts to unpack real-world pathways for bringing devices to market. Episodes often dissect regulatory strategy, QMS alignment, reimbursement, and practical product development challenges, with guests from leading testing bodies, manufacturers, and advisory firms. A standout aspect is the practical, practitioner-oriented lens—guests share actionable guidance, actionable frameworks, and cautionary tales from hands-on industry experience. This makes it valuable for professionals seeking concrete steps to navigate complex compliance, safety, and commercialization landscape, including startup founders, RA/QA specialists, and product leader... more

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These podcasts share a similar audience with this podcast:

1. Medical Device made Easy Podcast
2. The Journal.
3. HBR IdeaCast
4. Coaching Real Leaders
5. Apple News Today

How many episodes of this podcast are there?

this podcast launched 11 years ago and published 357 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. Lisa Voronkova
2. Jordi Martorell
3. Chris Gates
4. Nikhil Mangale
5. Michael Sprauve
6. Shai Policker
7. Shawnnah Monterrey
8. James Fentress

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