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 | 159 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | EducationHow ToTechnology | |||
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Latest Episodes
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
Summary
“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”
Companion diagnostics (CDx) are inherently high-consequence because they can directly shape treatment decisions. That... more
Summary
“Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes benefits.”
In this Let’s Talk Risk! conversation, Richard Matt shares a simple but uncomfortable... more
Summary
“A company can become world class the day the quality team decides.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ganesh Sabat, former former CEO of Sahajanand Medical Technologies (SMT) and now Founder & Managing... more
Summary
“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”
As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion persists across the MedTech in... more
Summary
“Risks occur. They happen but they don’t exist… hazards do.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal sits with Jean Blom, a QMS & Audit Specialist and risk management trainer with deep experience across ISO 13485 auditing... more
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
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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
How many episodes of Let's Talk Risk! are there?
Let's Talk Risk! launched 2 years ago and published 159 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. Chris Daly
2. Richard Matt
3. Ganesh Sabat
4. Holly Cotter
5. Jean Blom
6. Jennifer Mascioli-Tudor
7. Florian Tolkmitt
8. Ashkon Rasooli
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