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PODCAST

Let"s Talk Risk! with Dr. Naveen Agarwal

Casual and informal conversations about practical aspects of medical device risk management.

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 process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a

technology how to

All Episodes

28:17

LTR 144: Jean Blom on How Hazard-First Thinking...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2026/02/20

Summary“Risks occur. They happen but they don’t exist… hazards do.”In this Let’s Talk Risk! conversation, host Naveen Agarwal sits with Jean Blom, a QMS & Audit Specialist and risk management trainer with deep experience across ISO 13485 auditing, ISO 14971 risk management (including usability), and certification/accreditation perspectives.Our conversation is deliberately informal and highly practical. We explore why many teams get stuck in the mechanics of risk tools (especially large, bottom-up

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30:32

LTR 143: Jennifer Mascioli-Tudor on Leading Proactive...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2026/02/13

Summary“Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.”In this episode of the Let’s Talk Risk Podcast, Naveen Agarwal sits down with Jennifer Mascioli-Tudor, an experienced Quality and Regulatory leader, to unpack what QMSR readiness really means in practice.Jennifer shares what she’s seeing across the industry, from companies that are fully prepared to those that haven’t started, and explains why being ISO 13485

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27:51

LTR 142: Florian Tolkmitt on Clinical Evaluation,...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2026/02/06

Summary“For years, clinical evaluations were mostly a story. What was missing were clearly defined outcome parameters, something measurable that connects the state of the art to benefit–risk conclusions.”In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes back Florian Tolkmitt, Managing Director of Pro-Liance Global Solutions, for a timely and highly practical discussion on clinical evaluation for medical devices.The conversation centers on the newly released draft ISO standard for

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27:54

LTR 141: Ashkon Rasooli on Applying an Agile Mindset...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2026/01/30

Summary“Delaying a product that is adequately safe and effective is itself a risk, one we rarely acknowledge in our quality systems.”In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Ashkon Rasooli, a seasoned SaMD and AI/ML quality strategist, about what QMSR readiness really means for software-heavy medical device organizations.Ashkon explains why traditional hardware-centric quality thinking breaks down in software environments, where failures are deterministic,

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26:12

LTR 140: Pujitha Gourabathini on Connecting Risk...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2026/01/23

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, Quality Assurance and Risk Management leader at Becton Dickinson, to explore one of the most persistent challenges in MedTech: effectively integrating risk management with design controls.Pujitha shares practical, experience-based insights on why risk files

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32:12

LTR 139: Steve Silverman on FDA Readiness for QMSR

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2026/01/16

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 question that’s often left unspoken: Is the FDA ready for QMSR?Drawing on his experience as a former FDA leader and industry policy expert, Steve acknowledges that the current environment inside the agency is marked by workforce reductions, loss of

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29:43

LTR 138: Michelle Lott on QMSR Readiness, Risk-Based...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2026/01/09

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 practical discussion on QMSR readiness as FDA’s February 2026 deadline rapidly approaches. Michelle shares a sobering view of where the medical device industry truly stands, highlighting a dangerous gap between awareness and action.The conversation explores how

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31:44

LTR 137: Priya Setty on QMSR, Risk-Based Assurance,...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/12/19

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 QMSR represents more than a procedural update; it’s a mindset shift toward assurance, credibility, and risk-based decision making across the entire product lifecycle. Priya shares how the FDA’s alignment with ISO 13485 elevates expectations for design

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27:27

LTR 136: Adam Isaacs Rae on What QMSR Really Changes...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/12/12

Summary“Under QMSR, FDA will still be FDA, but they’ll finally have broader authority to cite what they’ve always cared about.”In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Adam Isaacs Rae to unpack one of the most misunderstood aspects of FDA’s new QMSR rule: the parts that aren’t changing.Adam brings a unique dual-lens perspective as both a medical device consultant and a lead auditor for certification bodies. With trademark clarity and humor, he explains why focusing

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32:05

LTR 135: Allison Komiyama on Rethinking Benefit-Risk...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/12/05

Summary“We talk about risk all the time, but we forget to talk about the benefit. FDA’s job is to protect and promote public health, and benefit–risk is how those two missions meet.”In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal sits down with Dr. Allison Komiyama, neuroscientist, former FDA reviewer, regulatory strategist, and founder of Bluestocking Health. Known for her ability to make complex FDA topics understandable and fun, Allison brings fresh clarity to one of the most

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29:11

LTR 134: James Pink on Responsible AI and Future of...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/11/28

Summary“With great power comes great responsibility. The innovation in AI is incredible, but our assurance models must catch up if we’re to keep patients safe”In this thought provoking Let’s Talk Risk! conversation, host Dr. Naveen Agarwal welcomes James Pink, a global leader in medical device safety, risk, and regulatory strategy. James shares his deeply personal journey, from clinical engineering and auditing, to his life-altering health experience that reinforced his passion for patient

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28:42

LTR 133: Megan Kane on Leading QMSR Readiness in...

Let"s Talk Risk! with Dr. Naveen Agarwal ·

2025/11/21

Summary“If you’re a small company and feel stuck in the QMSR transition, use that startup energy. Get creative, tap your network, and find the experts who can help you get unstuck.”In this episode of the Let's Talk Risk Podcast, Megan Kane joins host Dr. Naveen Agarwal to unpack what the FDA’s new Quality Management System Regulation (QMSR) means for startups and small MedTech companies. She explains how the shift from checklist compliance to process-based assurance challenges teams to think

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27:52

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

Let"s Talk Risk! with Dr. Naveen Agarwal ·

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! with Dr. Naveen Agarwal ·

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! with Dr. Naveen Agarwal ·

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! with Dr. Naveen Agarwal ·

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! with Dr. Naveen Agarwal ·

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! with Dr. Naveen Agarwal ·

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! with Dr. Naveen Agarwal ·

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! with Dr. Naveen Agarwal ·

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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