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PODCAST

Let"s Talk Risk! Podcast

Where MedTech professionals gain clarity and confidence to navigate complex decisions.

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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All Episodes

27:52

LTR 132: Bijan Elahi on Future of MedTech Safety and...

Let"s Talk Risk! Podcast ·

2025/11/14

Summary“This conference is really by the community and for the community - a place where people passionate about MedTech safety can come together to share ideas, learn, and make a difference.”In this Let’s Talk Risk! conversation, host Dr. Naveen Agarwal welcomes back renowned safety risk management expert Bijan Elahi to discuss the upcoming International MedTech Safety Conference 2026 in Boston.Bijan shares the inspiring story of how a grassroots effort among passionate professionals has grown into

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30:55

LTR 131: Rick Wedge on the Human Side of Safety Risk...

Let"s Talk Risk! Podcast ·

2025/11/07

Summary“Be diligent, because one day, you might rely on the very device you helped design.”In this deeply personal and technically insightful episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Rick Wedge, a seasoned expert in risk management and design control for drug-device combination products.Rick shares his remarkable journey - from developing biosensors early in his career to depending on a glucose monitoring system to manage life without a pancreas. His story bridges the

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25:51

LTR 130: Hannah Walter on Human Factors and Inclusive...

Let"s Talk Risk! Podcast ·

2025/10/31

Summary“Talk to the people you are building the device for. Assumptions may speed development, but they often miss the human realities that determine whether a product succeeds or fails.”In this Let’s Talk Risk! conversation, host Dr. Naveen Agarwal sits down with Hannah Walter to explore the human side of medical technology. From robotic surgery consoles to AR/VR-assisted procedures, Hannah explains why human-machine interaction has become a critical design priority, and why early conversations

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26:58

LTR 129: Viral Thakkar on breakthrough innovation and...

Let"s Talk Risk! Podcast ·

2025/10/24

Summary“You can’t walk away from risk. If people did, no one would ever develop a product this complex. The key is learning how to manage risk intelligently through data and a structured process.”In this episode of the Let's Talk Risk Podcast, host Dr. Naveen Agarwal sits down with Viral Thakkar, Chief Operating Officer of Lungpacer Medical, Inc., to explore the inspiring story of a device that helps patients on mechanical ventilators recover their natural breathing ability. Viral recounts how the

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12:38

Case Study: The WATCHMAN TruSeal Recall and the...

Let"s Talk Risk! Podcast ·

2025/10/20

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.Key themes:* Procedural vs. device risk: How the true hazard emerged from workflow variation, not product failure.* Scale-driven exposure: Commercial success amplified rare risks as adoption expanded to community hospitals.* Narrative analytics: Text

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28:15

LTR 128: Edward Ball on AI, Vigilance and Future of...

Let"s Talk Risk! Podcast ·

2025/10/17

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 Naveen Agarwal welcomes Edward Ball, Manager of Intelligence and Strategic Execution at RQM+. Ed shares insights from his 20+ years in medical devices, including his unique perspective gained through roles at MHRA, ConvaTec, Fresenius Kabi, and now RQM+

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26:00

LTR 127: Ajay Dankar on Proactive AI Governance in...

Let"s Talk Risk! Podcast ·

2025/10/10

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 Ajay Dankar, Co-Founder of Trussed AI. Ajay shares insights from his career at Google, AWS, Adobe, and PayPal, and explains how generative and agentic AI are reshaping industries from healthcare to finance.Together, they explore the promise and uncertainty

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16:05

FDA CSA Debate: Streamlined Assurance or Audit...

Let"s Talk Risk! Podcast ·

2025/10/06

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 documentation, aligns validation with patient safety risk, and supports agile manufacturing.* Auditor’s view: CSA’s reliance on qualitative judgment, binary risk classification, and vendor dependence creates new challenges for audits, SOPs, and Part 11 compliance.Key

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26:48

LTR 126: Adam Foresman on Proactive Compliance and...

Let"s Talk Risk! Podcast ·

2025/10/03

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 Ryden Solutions, about building the first platform for continuous compliance gap analysis in the life sciences industry. Adam shares his journey from leading quality and regulatory affairs at a diagnostic AI startup, where he managed hundreds of requirements

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27:30

LTR 125: Kevin Schawinski on Building Trustworthy AI...

Let"s Talk Risk! Podcast ·

2025/09/26

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 black holes to building AI governance solutions, and explains how the EU AI Act is modeled after the EU Medical Device Regulation (MDR). He highlights the parallels between product safety regimes in MedTech and emerging AI regulation, offering practical

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16:22

Case Study: Comparing EU and FDA Cybersecurity...

Let"s Talk Risk! Podcast ·

2025/09/22

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, especially in areas like authentication, secure coding, network security, and resilience.Key points in this audio brief:* The biggest risks of connected medical devices and why cybersecurity is now inseparable from patient safety.* Where the EU and FDA

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28:12

LTR 124: Omar Al Kalaa on Wireless Coexistence and...

Let"s Talk Risk! Podcast ·

2025/09/19

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 challenges and opportunities of integrating wireless technology into medical devices. Omar shares his journey from academic research on wireless coexistence to leading FDA initiatives on 5G-enabled medical devices, offering a unique perspective at the

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25:48

LTR 123: Richard Matt on Effective Risk Communication

Let"s Talk Risk! Podcast ·

2025/09/12

Summary“Management listens when you connect patient risk to product requirements and business goals.”.In this Let’s Talk Risk! conversation, host Naveen Agarwal and Richard Matt delve into the complexities of communicating risk to senior executives. They explore the common challenges faced by risk practitioners in effectively conveying risks and the importance of framing these discussions in terms of both risks and benefits. Richard shares his experiences and insights on building trust, engaging

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16:10

Case Study: What AI/ML Device Recalls Reveal About...

Let"s Talk Risk! Podcast ·

2025/09/08

In this audio brief, we unpack recalls data on AI/ML enabled medical devices to gain insights on emerging vulnerabilities from a risk management point of view. Here are a few key highlights* The Landscape: 12,247 FDA cleared AI/ML devices across 155 product codes; 38 recall events identified for a deep dive.* Recall Severity: Mostly Class II recalls, no Class I recalls.* Leading Causes: * Software and algorithm errors (e.g., incorrect dose calculations).* Data integrity issues (e.g., misfiled or

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32:48

LTR 122: Tibor Zechmeister on PSUR Best Practices

Let"s Talk Risk! Podcast ·

2025/09/05

Summary“The PSUR should be a snapshot showing if your medical device is really safe, not just a 200-page report for auditors”.In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Tibor Zechmeister, Head of Quality and Regulatory at Flinn.ai, to unpack the complexities of the Periodic Safety Update Report (PSUR) under EU MDR. They discuss key takeaways from the RAPS Euroconvergence Conference, the real-world challenges of estimating device usage, and why PSUR must be treated as a

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1:09

LTR 121: Michelle Lott on Risk, CAPA and FDA...

Let"s Talk Risk! Podcast ·

2025/08/29

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day they walk through your door.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and Michelle Lott from Lean RAQA discuss the upcoming Quality Management System Regulation (QMSR) for medical devices, emphasizi…

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12:58

Case Study: Contrasting U.S. and EU Approaches to AI...

Let"s Talk Risk! Podcast ·

2025/08/25

In this audio brief, we unpack the rapidly evolving AI regulatory landscape in the U.S. and EU. While the U.S. emphasizes rapid innovation with lighter-touch oversight, the EU is implementing a strict, risk-based framework.Here are a few key highlights* U.S. AI Action Plan (July 2025): Prioritizes speed, innovation, and global leadership; promotes a “try first” culture; frames AI as a national security imperative.* FDA Guidance: Good Machine Learning Practices, predetermined change control plans,

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27:56

LTR 120: Atty Chakraborty on India's Rising MedTech...

Let"s Talk Risk! Podcast ·

2025/08/22

Summary“The opportunities in India’s MedTech sector are tremendous. Start networking, join incubators and get involved!”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Attrayee (Atty) Chakraborty, a quality systems engineer specializing in regulatory affairs. They discuss the rapidly evolving medical device landscape in India, the importance of networking for young professionals, and the comparison of Indian medical regulations with global standards. Atty shares insights on

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0:54

LTR 119: AI, Risk and Regulatory Strategy with Dr....

Let"s Talk Risk! Podcast ·

2025/08/15

This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“In this world that is changing really fast, your greatest superpower is your ability to learn new things.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and guest Dr. Jay Vaishnav discuss the dynamic regulatory landscape in the MedTech industry, particularly focusing on AI-powered medical devices. They explore the concept o…

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15:57

Case Study: When Clues to a Future Recall Hide in...

Let"s Talk Risk! Podcast ·

2025/08/11

In this audio brief, we unpack a recent Class I recall of Medtronic's Newport HT70 and HT70 Plus ventilators. These portable ventilators posed a grave risk—shutting down unexpectedly, potentially endangering patients on life support.But the story doesn't stop there.We take you inside the analytical process, examining over 2,000 adverse event reports from the FDA’s MAUDE database, and revealing early warning signals going back five years. Through deep narrative review, we uncover overlooked patterns

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