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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
Design Controls
Radiology

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

Most discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves the manufact... more

YouTube

Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Ga... more

YouTube

Many early-stage medical device founders face a major dilemma: how do you prove regulatory maturity to investors and partners before you actually hold a final CE mark or FDA approval? Waiting until the end of a long development cycle creates signific... more

YouTube

In this episode, host Etienne Nichols sits down with Ali Samiian, founder and managing principal of Popular Access Advisors, to demystify the critical and often misunderstood world of MedTech reimbursement. Far too many early-stage medical device com... more

YouTube

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Recent Guests

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
Ali Samiian
Founder and managing principal of Popular Access Advisors
Popular Access Advisors
Episode: #465: Why Good Medical Devices Fail: Reimbursement Strategy with Ali Samiian
Liv Bullsides
Inventor and executive with experience in quality systems for major medical/device companies
Iaso Automated Medical Systems
Episode: #464: Why LLM Unpredictability is a Liability in MedTech
Tyler Harmon
CEO of Iaso Automated Medical Systems
Iaso Automated Medical Systems
Episode: #464: Why LLM Unpredictability is a Liability in MedTech
Sean Smith
Founder of MedTech Leading Voices
MedTech Leading Voices
Episode: #463: Finding MedTechs Leading Voices with Sean Smith
Michaela Kivett
Medical device consultant at Greenlight Guru
Greenlight Guru
Episode: #462: Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders
Mike Dolphin
CEO of GuideStar Medical Devices, developing epidural safety technology
GuideStar Medical Devices
Episode: #461: Why Manufacturing is Part of Product Development with Mike Dolphin

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 Kingdom8 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
    8 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.

Talking Points

Recent interactions between the hosts and their guests.

#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.
#464: Why LLM Unpredictability is a Liability in MedTech
Q: What governance structures are essential when embedding AI into a medical device company's processes?
Establish an AI mission statement, human-in-the-loop protocols, AI-specific SOPs, a dedicated AIMS within the QMS/ISMS, and ensure supplier relationships with model providers are tightly managed with clear licenses and revalidation plans.
#464: Why LLM Unpredictability is a Liability in MedTech
Q: How would you break down AI concepts for a general audience without losing the nuance?
A practical approach is to explain machine learning as moving between linear and non-linear problem spaces, using non-linear transformations to mimic human thinking, and highlighting the role of randomness as a driver of engagement but a risk when applied to safety-critical decisions.

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. Worklife with Molly Graham
3. Huberman Lab
4. Let's Talk Risk! Podcast
5. UnF*ck Your Brain: Feminist Self-Help for Everyone

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. Shawnnah Monterrey
2. James Fentress
3. Malte Knowles Schmidt
4. Ali Samiian
5. Liv Bullsides
6. Tyler Harmon
7. Sean Smith
8. Michaela Kivett

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