Let's Talk Risk! Podcast
Where MedTech professionals gain clarity and confidence to navigate complex decisions.Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com
| Publishes | Weekly | Episodes | 165 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | How ToEducationBusiness | |||
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Latest Episodes
Summary
“FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.”
In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about what early FDA 483 observati... more
Summary
“Just having a policy in place is one thing. Having a QMS that aligns to it is the next.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Sherita Black about one of the most challenging and often misunderstood topics ... more
Summary
“FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?”
In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits down with Dr. Omar Al Kalaa ... more
Summary
“Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.”
What happens when a highly regulated medical device depends on a tiny, single-sourced component buried deep in a fragile global suppl... more
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Apple Podcasts | #24 |  South Korea/Education/How To |
Apple Podcasts | #92 |  Brazil/Education/How To |
Apple Podcasts | #109 |  New Zealand/Education/How To |
Apple Podcasts | #134 |  Taiwan/Education/How To |
Apple Podcasts | #151 |  Sweden/Education/How To |
Apple Podcasts | #225 |  Saudi Arabia/Education/How To |
Talking Points
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Audience Metrics
Listeners, social reach, demographics and more for this podcast.
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Frequently Asked Questions About Let's Talk Risk! Podcast
What is Let's Talk Risk! Podcast about and what kind of topics does it cover?
A practical, practitioner-focused discussion space for risk, quality, and regulatory challenges in the medical device space. Episodes repeatedly center on how to implement risk management, navigate evolving standards (including QMSR and ISO 13485), and prepare for FDA inspections without stifling innovation. Guests typically bring hands-on expertise in regulatory affairs, quality assurance, clinical evaluation, and safety risk management, often sharing concrete frameworks (like hazard-first thinking, proactive quality planning, and agile approaches) that listeners can apply to startups, growing medtech companies, or teams navigating complex compliance journeys. The show often highlights real-world challenges, future regulatory shifts, and t... more
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How many listeners does Let's Talk Risk! Podcast get?
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What are the audience demographics for Let's Talk Risk! Podcast?
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How many subscribers and views does Let's Talk Risk! Podcast have?
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Which podcasts are similar to Let's Talk Risk! Podcast?
These podcasts share a similar audience with Let's Talk Risk! Podcast:
1. Medical Device made Easy Podcast
2. Global Medical Device Podcast powered by Greenlight Guru
3. The Med Device Cyber Podcast
4. Sternstunde Philosophie
How many episodes of Let's Talk Risk! Podcast are there?
Let's Talk Risk! Podcast launched 2 years ago and published 165 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
How do I contact Let's Talk Risk! Podcast?
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What guests have appeared on Let's Talk Risk! Podcast?
Recent guests on Let's Talk Risk! Podcast include:
1. Sherita Black
2. Sarai Pahla
3. Jonathan Kendler
4. Lavanya Ramnath
5. Chris Daly
6. Ganesh Sabat
7. Holly Cotter
8. Jean Blom
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.