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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
Greenlight Guru
Patient Safety
Artificial Intelligence
Quality Management System
Regulatory Affairs
Quality Assurance
FDA Regulations
Clinical Trials
ISO 13485
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
Health & FitnessBusinessMedicine

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Artwork for Global Medical Device Podcast powered by Greenlight Guru

Latest Episodes

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

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Artificial intelligence has officially entered the mainstream cultural zeitgeist, creating a wave of excitement—and a fair share of fatigue—across the medical device industry. In this episode, host Etienne Nichols sits down with Tyler Harmon, biomedi... more

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The medical device industry functions as a highly complex ecosystem where diverse niches—including regulatory affairs, quality assurance, marketing, and reimbursement—must seamlessly interconnect to bring life-saving technologies to life. In this epi... more

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In this episode, host Etienne Nichols sits down with Michaela Kivett, a seasoned medical device consultant at Greenlight Guru, to break down the complexities of implementing an electronic Quality Management System (eQMS). Drawing from her background ... more

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Recent Guests

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
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

Host

Etienne Nichols
Host of Global Medical Device Podcast, Greenlight Guru

Reviews

4.9 out of 5 stars from 203 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 Kingdom6 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
    7 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.

#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.
#463: Finding MedTechs Leading Voices with Sean Smith
Q: What is the advice you have for MedTech vendors or service providers when it comes to getting visibility and acquiring new clients?
Start by building an advisory committee, engage with the cool kids, focus on not pitching but interviewing and asking questions, and let your network and the people you surround yourself with do the selling for you. Consistency, authenticity, and delivering value over time are key; document your unique experiences and turn them into durable, shareable content like newsletters or community-driven resources.

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 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. Medical Device made Easy Podcast
2. Success Story with Scott D. Clary
3. Let's Talk Risk! Podcast
4. Morning Brew Daily
5. Hidden Brain

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. Ali Samiian
2. Liv Bullsides
3. Tyler Harmon
4. Sean Smith
5. Michaela Kivett
6. Mike Dolphin
7. Ryan O'Mahoney
8. John Schindler

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