Let's Talk Risk! with Dr. Naveen Agarwal
Casual and informal conversations about practical aspects of medical device risk management.Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management proces... more
| Publishes | Weekly | Episodes | 153 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | How ToEducationTechnology | |||
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Latest Episodes
Summary
“Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.”
In this episode of the Let’s Talk Risk Podcast, Naveen Agarwal sits down with Jennifer Mascioli-Tudor, an exper... more
Summary
“For years, clinical evaluations were mostly a story. What was missing were clearly defined outcome parameters, something measurable that connects the state of the art to benefit–risk conclusions.”
In this Let’s Talk Risk! conversation, hos... more
Summary
“Delaying a product that is adequately safe and effective is itself a risk, one we rarely acknowledge in our quality systems.”
In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Ashkon Rasooli, a seasoned SaMD a... more
Summary
“Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Pujitha Gourabathini,... more
Summary
“QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.”
In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Steve Silverman to explore a qu... more
Summary
“The industry is aware of QMSR, but they’re not moving. Many are still holding their breath, hoping something will change.”
In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Michelle Lott for a deep and practi... more
Summary
“FDA isn’t asking whether you followed the procedure. They are asking whether your system can assure consistent outcomes in the real world.”
In this episode of the Let's Talk Risk Podcast, Priya Setty joins host Naveen Agarwal to unpack why... more
Summary
“Under QMSR, FDA will still be FDA, but they’ll finally have broader authority to cite what they’ve always cared about.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Adam Isaacs Rae to unpack one of the most mis... more
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Frequently Asked Questions About Let's Talk Risk!
What is Let's Talk Risk! about and what kind of topics does it cover?
The content centers around risk management within the highly regulated medical device industry, where conversations frequently address the intricate balance between compliance, innovation, and practical application. Topics discussed encompass a range of challenges, from adapting to new regulatory frameworks like the Quality Management System Regulation (QMSR) to exploring the role of artificial intelligence in ensuring patient safety and enhancing medical device efficacy. The narrative emphasizes collaboration among industry professionals to share best practices and insights, covering themes such as benefit-risk evaluation, human factors in device design, and proactive compliance strategies as core areas of focus. A noteworthy aspect of thi... more
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Which podcasts are similar to Let's Talk Risk!?
These podcasts share a similar audience with Let's Talk Risk!:
1. Medical Device made Easy Podcast
2. Global Medical Device Podcast powered by Greenlight Guru
How many episodes of Let's Talk Risk! are there?
Let's Talk Risk! launched 2 years ago and published 153 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 Let's Talk Risk!?
Recent guests on Let's Talk Risk! include:
1. Pujitha Gourabathini
2. Michelle Lott
3. Priya Setty
4. Adam Isaacs Rae
5. Allison Komiyama
6. James Pink
7. Megan Kane
8. Bijan Elahi
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.