Let's Talk Risk! Podcast
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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Deep Dive: FDA's RWE Guidance
<p>Real-world data does not become regulatory evidence simply because it is large, current, or readily available.</p><p>FDA’s December 2025 final guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, supersedes the 2017 guidance and provides a more detailed framework for determining when real-world data can generate evidence suitable for a medical device regulatory decision.</p><p>One important change is FDA’s recognition that a sponsor’s inability to obtain participant-level data does not automatically prevent the Agency from evaluating the evidence. But this flexibility does not lower the evidentiary bar. Sponsors must explain the limits...
LTR 161: AI Governance by Design
<p>Summary</p><p>“Let’s treat AI governance by design as the connective tissue of a product lifecycle ecosystem.”</p><p>AI governance is often introduced as another layer of oversight—more procedures, approvals, documentation, and checklists. Ankita Mishra offers a different way to think about it: governance should be designed into the digital health product lifecycle from the beginning.</p><p>In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal and Ankita Mishra explore how systems thinking and risk-based decision-making can help organizations innovate responsibly without applying the same level of rigor to every product or...
Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations
<p>You cannot bolt cybersecurity onto a medical device at the end of development.</p><p>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 software-enabled devices, it is not enough to show that the software works as intended. Manufacturers also need to show how cybersecurity risks were identified, controlled, verified, traced to patient harm, and managed after release.</p><p>In this audio summary, we walk through why FDA’s expectations go beyond submission documentation and why QA/RA teams need...
LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety
<p>Summary</p><p>“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.”</p><p>In this special episode of the Let’s Talk Risk! conversation, host Naveen Agarwal brings together a panel of medtech safety and risk management leaders to discuss key takeaways from IMSC26 in Boston.</p><p>The conversation highlights why the conference has become a unique gathering place for the medtech safety community: a forum where risk, quality, regulatory, clinical, and engineering professionals can speak a shared language and challe...
LTR 159: The Evolving Regulatory Landscape for AI in MedTech
<p>Summary</p><p>“Stop thinking of AI as replacing humans. Think about humans staying in charge while AI is placed in the loop”</p><p>Artificial intelligence is no longer a future concept in MedTech. It is already inside medical devices, quality systems, regulatory workflows, post-market processes, and product development decisions.</p><p>In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits down with Priya Setty and Atty Chakraborty for a wide-ranging discussion on how AI is changing medical device regulation and quality practice.</p><p>Priya frames AI through a human lens: like a chil...
Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions
<p>You cannot reverse engineer your human factors regulatory strategy at the 11th hour.</p><p>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 tasks, labeling, training, post-market evidence, and design change control across the product lifecycle.</p><p>In this audio case study, we walk through why Category 3 human factors validation may become the default concern when critical tasks are introduced or impacted and why Decision Point D is not a shortcut, but an evidence-based exception that depends on hi...
LTR 158: Three Questions To Keep Risk Connected to Decisions
<p>Summary</p><p>“Tools do not remove uncertainty”</p><p>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 experience from banking, fintech, operational excellence, consulting, research, and business transformation. Her work focuses on reconnecting risk management with the real habits, decisions, tensions, and accountability practices that shape how organizations actually operate.</p><p>This conversation moves beyond medical device risk management in the narrow technical sense. Instead, it explores risk as a business discipline: how compan...
LTR 157: Why Risk Doesn't Get Heard and How to Change That
<p>Summary</p><p>“Quality and risk people need to translate safety into business terms.”</p><p>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 effectively to senior leaders.</p><p>Eric brings a broad product-development perspective across engineering, manufacturing, regulatory strategy, commercialization, and early-stage MedTech leadership. He discusses why innovation and safety should not be treated as separate conversations, why risk professionals need to get involved earlier, and how safety-led thinking can reduce rework, improve alignment, and strengthen business outcomes.</p><p>The co...
LTR 156: Using AI as a Thinking Partner in Product Development Without Losing Control
<p>Summary</p><p>“AI can be a powerful helper, but it should not be the decision-maker.”</p><p>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 control of risk, quality, or accountability.</p><p>David brings experience across medical device risk management, system safety, reliability engineering, and regulated product development. He shares practical examples of where AI may help—such as requirements development, software troubleshooting, and early discovery—while emphasizing the need for clear boundaries, human judgment, validation, and leadership oversight...
LTR 155: Leverage VIP to Move from Compliance to Capability
<p>Summary</p><p>“Compliance alone does not drive quality”</p><p>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 toward true quality maturity.</p><p>Mike explains how VIP grew out of FDA’s Case for Quality initiative, why the program uses a maturity-appraisal model rather than a traditional audit model, and how organizations can use it to surface operational weaknesses, strengthen quality culture, and translate quality improvement into business language.</p><p>The conversation also exp...
