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 | Twice weekly | Episodes | 138 | Founded | 2 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | How ToTechnologyEducation | |||
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Latest Episodes
In this audio brief, we unpack a recent Class I recalls of the Boston Scientific Watchman TruSeal Access System. What began as a rare but catastrophic risk of air embolism evolved into a global procedural-safety lesson for the entire MedTech industry... more
Summary
“Risk management is nothing without asking questions. And just as important, we need to create a culture where people aren’t afraid to ask them, because without that, everything grinds to a halt.”
In this Let’s Talk Risk! conversation, host... more
Summary
“Ethical and compliant AI adoption isn’t a barrier to innovation. It makes your business stronger and more resilient.”
In this Let’s Talk Risk! conversation, host Naveen Agarwal reconnects with longtime friend and Silicon Valley tech leader... more
In this audio brief, we unpack the practical implications of the FDA’s Final Guidance on Computer Software Assurance (CSA), issued September 2025.
The debate highlights two perspectives:
* Quality professional’s view: CSA cuts unnecessary documenta... more
Summary
“Compliance can’t just be a once-per-year audit anymore. It has to be continuous, proactive, and built into the way we work every day.”
In this Let’s Talk Risk! conversation, Naveen Agarwal speaks with Adam Foresman, Co-Founder and CEO of R... more
Summary
“EU MDR is the spiritual ancestor of the EU AI Act”.
In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes Kevin Schawinski, astrophysicist turned AI entrepreneur and CEO of Modulos AG. Kevin shares his journey from studying b... more
In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against international best practices. Both documents cover the basics, but each leaves troubling gaps, especi... more
Summary
“Wireless coexistence is not a checkbox. It’s a risk management approach”.
In this Let’s Talk Risk! conversation, Dr. Naveen Agarwal sits down with Omar Al Kalaa, PhD, Founder of Inovectrum and former FDA wireless scientist, to explore the ... 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?
Focusing on the complexities and challenges of risk management in the highly regulated medical device industry, the conversations highlight how practitioners navigate evolving regulatory landscapes. Various topics discussed include the implications of AI regulation, compliance best practices, effective risk communication, and cybersecurity challenges related to connected devices. Each episode features insights from industry experts, emphasizing the importance of collaboration and shared learning for developing effective risk management strategies. This series likely appeals to professionals looking to deepen their understanding of regulatory compliance and practical solutions in an ever-changing environment.
Where can I find podcast stats for Let's Talk Risk!?
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What are the audience demographics for Let's Talk Risk!?
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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. Global Medical Device Podcast powered by Greenlight Guru
2. Medical Device made Easy Podcast
How many episodes of Let's Talk Risk! are there?
Let's Talk Risk! launched 2 years ago and published 138 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. Edward Ball
2. Ajay Dankar
3. Adam Foresman
4. Kevin Schawinski
5. Omar Al Kalaa
6. Richard Matt
7. Tibor Zechmeister
8. Michelle Lott
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.