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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
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

PublishesWeeklyEpisodes168Founded3 years ago
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Artwork for Let's Talk Risk! Podcast

Latest Episodes

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

YouTube

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

Summary

“Compliance alone does not drive quality”

In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Mike Cook about the the Voluntary Improvement Program (VIP), and how it can help MedTech leaders go beyond inspection readiness... more

YouTube

Summary

“FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.”

In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about what early FDA 483 observati... more

YouTube

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Recent Guests

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
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
Ganesh Sabat
Former CEO, Sahajanand Medical Technologies (SMT)
SMT
Episode: LTR 146: Ganesh Sabat on Scaling MedTech Through Quality
Holly Cotter
Co-founder of IndyMedTech and certified regulatory affairs professional with a biomedical engineering background.
IndyMedTech
Episode: LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning

Host

Naveen Agarwal
Host of Let's Talk Risk!

Chart Rankings

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

Apple Podcasts
#239
United Kingdom/Education/How To
Apple Podcasts
#8
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Apple Podcasts
#77
Sweden/Education/How To
Apple Podcasts
#83
Ireland/Education/How To
Apple Podcasts
#88
Taiwan/Education/How To
Apple Podcasts
#99
Singapore/Education/How To
Apple Podcasts
#136
Brazil/Education/How To
Apple Podcasts
#212
New Zealand/Education/How To

Talking Points

Recent interactions between the hosts and their guests.

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.
LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems
Q: What best practices can help prepare for FDA engagement and streamline development?
Do your homework on the ecosystem, bring the right partners to meetings, ask targeted questions the agency can answer, and present an organized risk-management argument rather than random data dumps.
LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems
Q: How should companies approach the regulatory pathway for telesurgery and distributed medical systems?
Regulators care about patient safety and end-to-end effectiveness; teams should map the entire system, define ownership across components, prepare robust evidence, and engage FDA early with a concrete plan that includes partnerships and clear responsibilities.

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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?

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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1. Medical Device made Easy Podcast
2. Global Medical Device Podcast powered by Greenlight Guru

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Let's Talk Risk! Podcast launched 3 years ago and published 168 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. David Grilli
2. Mike Cook
3. Sherita Black
4. Sarai Pahla
5. Jonathan Kendler
6. Lavanya Ramnath
7. Chris Daly
8. Ganesh Sabat

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