Rephonic
Artwork for Let's Talk Risk!
Risk Management
Medical Devices
FDA
Cybersecurity
In Vitro Diagnostics
Medical Device Industry
Quality Management
Artificial Intelligence
Product Change Control Processes
Machine Learning
IEC 62366-2
Usability Engineering
Healthcare Delivery
Ecosystem
ISO 13485
Regulatory Compliance
Augmented Reality
Patient Safety
Data Diversity
Quality Assurance

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

PublishesTwice weeklyEpisodes150Founded2 years ago
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Artwork for Let's Talk Risk!

Latest Episodes

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

YouTube

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

YouTube

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

YouTube

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Recent Guests

Michelle Lott
Executive Advisor for Regulatory Affairs at Lean RAQA
Lean RAQA
Episode: LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
Priya Setty
Regulatory affairs manager at Ologic with a background in occupational therapy and hospital administration.
Ologic
Episode: LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
Adam Isaacs Rae
Managing Director of Quality and Regulatory at The Other Consultants
The Other Consultants
Episode: LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
Allison Komiyama
Regulatory affairs professional with a PhD in neuroscience from Stanford.
Episode: LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech
James Pink
A leading voice in medical device safety and risk management with extensive experience in the field
Episode: LTR 134: James Pink on Responsible AI and Future of MedTech Safety
Megan Kane
Regulatory and Quality consultant with extensive experience in MedTech startups.
Rellia
Episode: LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
Bijan Elahi
Globally recognized authority in safety risk management, lecturer, and training consultant.
Episode: LTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
Rick Wedge
Technical expert in risk management and personal experience living with diabetes
Leading manufacturer of pharmaceutical products
Episode: LTR 131: Rick Wedge on the Human Side of Safety Risk Management
Hannah Walter
Expert in human factors with experience in both academia and industry, specializing in usability in medical devices.
Episode: LTR 130: Hannah Walter on Human Factors and Inclusive Design in Medical Devices

Host

Dr. Naveen Agarwal
Host and expert in risk management within the medical device industry, leading discussions with various industry professionals.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts
#148
Sweden/Technology

Talking Points

Recent interactions between the hosts and their guests.

LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
Q: What are your thoughts about treating competence as a broader topic from a leadership point of view?
Megan agrees that merely checking training boxes is insufficient and emphasizes the need for deeper, more practical engagement in training.
LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
Q: What do you think might be happening right now as leaders and colleagues in these companies start to prepare for the QMSR transition?
Megan highlights that there is significant discussion within the quality and regulatory field, with some companies making changes early, while others may wait until the last minute.
LTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
Q: How does one quantitatively address risk, residual risk, utilizing clinical data?
Post-market data is used for quantitative analysis, while pre-market data involves prediction.
LTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
Q: Which criteria will you use to select abstracts for the conference?
Abstracts will be selected based on their relevance to safety and risk management in MedTech, practicality and applicability, originality, and the speaker's experience.
LTR 131: Rick Wedge on the Human Side of Safety Risk Management
Q: How did you process this enormous change in your life?
I'm still processing it, to be honest with you. It was very difficult. It was life-changing, you know. I'm still in therapy for it. I have sort of mild PTSD, I was told.

Audience Metrics

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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!?

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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 150 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. Michelle Lott
2. Priya Setty
3. Adam Isaacs Rae
4. Allison Komiyama
5. James Pink
6. Megan Kane
7. Bijan Elahi
8. Rick Wedge

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