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 | 162 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | How ToEducationTechnology | |||
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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
Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury.
If you are sitting in the regulatory ... more
Summary
“AI brings novel risks and addressing them will require a more creative approach to human factors engineering.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Jonathan Kendler, a seasoned medical device human factors... more
Summary
“The clinical study is actually where your risk analysis is going to meet reality.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Lavanya Ramnath, Senior Regulatory Affairs Specialist at Insulet, about what it reall... more
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Apple Podcasts | #150 |  South Korea/Technology |
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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?
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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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
3. Let's Combinate - Drugs + Devices
4. The Diary Of A CEO with Steven Bartlett
5. Mon Psy Part En Live
How many episodes of Let's Talk Risk! are there?
Let's Talk Risk! launched 2 years ago and published 162 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. Jonathan Kendler
2. Lavanya Ramnath
3. Chris Daly
4. Richard Matt
5. Ganesh Sabat
6. Holly Cotter
7. Jean Blom
8. Jennifer Mascioli-Tudor
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