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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
Medtech
Medical Device Industry
Regulatory Compliance
Regulatory Affairs
Machine Learning
QMSR
Quality Management
Clinical Evaluation
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

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Artwork for Let's Talk Risk! Podcast

Latest Episodes

You cannot bolt cybersecurity onto a medical device at the end of development.

FDA’s cybersecurity guidance makes a clear shift: cyber risk is now a quality system issue, a patient safety issue, and a lifecycle management issue. For connected and so... more

Summary

“The biggest takeaway was realizing that our perspectives on risk and safety are not isolated. They are shared, validated, and strengthened by others in the field.”

In this special episode of the Let’s Talk Risk! conversation, host Naveen A... more

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Summary

“Stop thinking of AI as replacing humans. Think about humans staying in charge while AI is placed in the loop”

Artificial intelligence is no longer a future concept in MedTech. It is already inside medical devices, quality systems, regulato... more

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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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Recent Guests

Olaf Hedrich
Chief Medical Safety Officer
Medtronic
Episode: LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety
Aaron Joseph
Principal consultant
Sunstone Pilot
Episode: LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety
Atty Chakraborty
Senior Quality Systems Engineer at Analog Devices in the Medical Products Division
Analog Devices
Episode: LTR 159: The Evolving Regulatory Landscape for AI in MedTech
Vilma Nasteckiene
Founder of Holistic Business Risk
Holistic Business Risk
Episode: LTR 158: Three Questions To Keep Risk Connected to Decisions
Erick Sugalski
President of Tangram Medtech; founder and CEO of Ampulis
Tangram Medtech; Ampulis
Episode: LTR 157: Why Risk Doesn't Get Heard and How to Change That
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

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
#68
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Apple Podcasts
#21
South Korea/Education/How To
Apple Podcasts
#63
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Apple Podcasts
#68
New Zealand/Education/How To
Apple Podcasts
#91
Sweden/Education/How To
Apple Podcasts
#104
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Apple Podcasts
#132
Taiwan/Education/How To
Apple Podcasts
#147
Spain/Education/How To
Apple Podcasts
#188
Brazil/Education/How To
Apple Podcasts
#214
Singapore/Education/How To

Talking Points

Recent interactions between the hosts and their guests.

LTR 157: Why Risk Doesn't Get Heard and How to Change That
Q: Eric, can you share how you communicate major issues or opportunities to senior executives and any insights that help elevate safety and risk on the agenda?
Communication needs to translate risk into business implications, showing how inaction could affect manufacturing, time-to-market, or revenue, and positioning safety as a driver of competitive advantage rather than a checkbox.
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.

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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1. Global Medical Device Podcast powered by Greenlight Guru

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

Let's Talk Risk! Podcast launched 3 years ago and published 173 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. Olaf Hedrich
2. Aaron Joseph
3. Atty Chakraborty
4. Vilma Nasteckiene
5. Erick Sugalski
6. David Grilli
7. Mike Cook
8. Sherita Black

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