Rephonic
Artwork for Let's Talk Risk! Podcast
Risk Management
Medical Devices
FDA
Artificial Intelligence
Cybersecurity
ISO 13485
AI and Machine Learning
Patient Safety
Quality Management System Regulation
Medical Device Industry
Regulatory Compliance
Regulatory Affairs
Medtech
Machine Learning
Quality Management
Clinical Evaluation
QMSR
Quality Assurance
Post-Market Surveillance
Medical Device Regulation

Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com

PublishesWeeklyEpisodes170Founded3 years ago
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Artwork for Let's Talk Risk! Podcast

Latest Episodes

You cannot reverse engineer your human factors regulatory strategy at the 11th hour.

FDA’s new human factors guidance is not just about what goes into a marketing submission. It changes the way teams need to think about use-related risk, critical ta... more

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Summary

“Tools do not remove uncertainty”

In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Vilma Nasteckiene, PhD, founder of Holistic Business Risk, about a broader and more human view of risk management. Vilma brings experie... more

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Summary

“Quality and risk people need to translate safety into business terms.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Eric Sugalski about how MedTech professionals can communicate safety, risk, and innovation more e... more

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Summary

“AI can be a powerful helper, but it should not be the decision-maker.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with David Grilli about how MedTech teams can use AI responsibly in product development without losing... more

YouTube

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Recent Guests

Vilma Nasteckiene
Founder of Holistic Business Risk
Holistic Business Risk
Episode: LTR 158: Three Questions To Keep Risk Connected to Decisions
David Grilli
Specialist in system safety engineering; senior engineering consultant and co-founder of North Star Haptics
North Star Haptics; former Abbott and Honeywell
Episode: LTR 156: Using AI as a Thinking Partner in Product Development Without Losing Control
Mike Cook
Strategic Account Executive for the VIP program
VIP Program, MDIC collaboration
Episode: LTR 155: Leverage VIP to Move from Compliance to Capability
Sherita Black
Risk Management Business Process Owner at Beckton-Dickinson
Beckton-Dickinson (BD)
Episode: LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability
Omar Al Kalaa
World-known expert at the intersection of medical devices and telecommunications; founder of Inovectrum
Inovectrum
Episode: LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems
Sarai Pahla
Medical doctor turned IT/medical writing professional
Self-employed / life sciences consultant
Episode: LTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences
Jonathan Kendler
Medical device human factors expert
Episode: LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices
Lavanya Ramnath
Senior Regulatory Affairs Specialist at Insulet
Insulet
Episode: LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
Chris Daly
Healthcare and life science executive
IronLine Consulting
Episode: LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach

Host

Naveen Agarwal
Host of Let's Talk Risk!, MedTech risk/quality discussions

Chart Rankings

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

Apple Podcasts
#62
South Korea/Education/How To
Apple Podcasts
#64
Sweden/Education/How To
Apple Podcasts
#146
Taiwan/Education/How To
Apple Podcasts
#161
Brazil/Education/How To
Apple Podcasts
#162
New Zealand/Education/How To
Apple Podcasts
#184
Singapore/Education/How To
Apple Podcasts
#197
Switzerland/Education/How To
Apple Podcasts
#250
Ireland/Education/How To

Talking Points

Recent interactions between the hosts and their guests.

LTR 158: Three Questions To Keep Risk Connected to Decisions
Q: What practical steps can teams take to keep risk connected to decisions as complexity grows?
Focus on cross-functional questions like what we are trying to achieve, what we rely on, and how it could fail, and use those prompts to guide leadership habits rather than over-reliance on procedural checks.
LTR 158: Three Questions To Keep Risk Connected to Decisions
Q: How does lifecycle thinking apply to risk management in growing companies?
Lifecycle thinking helps align risk with product and organizational maturity, avoiding silos by tying risk to ongoing decision-making and strategic planning rather than only to regulatory requirements.
LTR 155: Leverage VIP to Move from Compliance to Capability
Q: Why is it not broadly rolled out yet and what barriers exist to adoption?
The main barriers are the status quo and awareness. Many leaders are reactive and fixated on existing processes, while the program is relatively new (live since September 2023). There is also concern about FDA involvement, which is addressed by clarifying the safe, non-punitive nature of appraisals and the absence of pass/fail scoring.
LTR 155: Leverage VIP to Move from Compliance to Capability
Q: Nice. So give us a little bit of a history of the program.
Mike explains that the VIP program grew from the FDA Case for Quality study in 2012, which found no meaningful difference between compliant and non-compliant firms, leading to a focus on maturity, continuous improvement, and collaboration with MDIC as a joint public-private effort.
LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability
Q: What is the practical difference between a risk policy and a company's quality policy?
The policy for risk management focuses explicitly on safety, efficacy, and managing risk across the entire product lifecycle, while the quality policy covers the broader quality system; the risk policy is a focused extension embedded within the quality framework to ensure patient safety is explicitly prioritized.

Audience Metrics

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Frequently Asked Questions About Let's Talk Risk! Podcast

What is Let's Talk Risk! Podcast about and what kind of topics does it cover?

This show centers on risk, quality, and leadership in medical devices, with a strong focus on regulatory strategy, risk management, and the practicalities of bringing evidence-based MedTech products to market. Across episodes, listeners hear from engineers, regulatory professionals, and industry veterans who share actionable guidance on QMS implementation, FDA inspections, AI governance in regulated environments, and strategies to improve safety and efficiency throughout the product lifecycle. A standout trait is the guest mix—senior practitioners and consultants who connect real-world examples (from IDEs and QMSR to VIP programs and AI-enabled devices) to concrete decision-making, making it a practical resource for teams navigating complia... more

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Which podcasts are similar to Let's Talk Risk! Podcast?

These podcasts share a similar audience with Let's Talk Risk! Podcast:

1. Medical Device made Easy Podcast
2. Global Medical Device Podcast powered by Greenlight Guru
3. The Daily
4. دغدغه ایران
5. This Week in Cardiology

How many episodes of Let's Talk Risk! Podcast are there?

Let's Talk Risk! Podcast launched 3 years ago and published 170 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! Podcast?

Recent guests on Let's Talk Risk! Podcast include:

1. Vilma Nasteckiene
2. David Grilli
3. Mike Cook
4. Sherita Black
5. Omar Al Kalaa
6. Sarai Pahla
7. Jonathan Kendler
8. Lavanya Ramnath

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