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
All episodes(55)
- StandardSummaries onlyLTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety
Published Jul 3, 2026
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 Agarwal brings together a panel of medtech safety and risk management leaders to discuss key takeaways from IMSC26 in Boston.The conversation highlights why the conference has become a unique gathering place for the medtech safety community: a forum where
- StandardSummaries onlyLTR 159: The Evolving Regulatory Landscape for AI in MedTech
Published Jun 26, 2026
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, regulatory workflows, post-market processes, and product development decisions.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
- StandardSummaries onlyCase Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions
Published Jun 19, 2026
Case StudyYou 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 tasks, labeling, training, post-market evidence, and design change control across the product lifecycle.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
- StandardSummaries onlyLTR 158: Three Questions To Keep Risk Connected to Decisions
Published Jun 12, 2026
Summary“Tools do not remove uncertainty”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 ac
- StandardSummaries onlyLTR 157: Why Risk Doesn't Get Heard and How to Change That
Published May 29, 2026
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 effectively to senior leaders.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 a
- StandardSummaries onlyLTR 156: Using AI as a Thinking Partner in Product Development Without Losing Control
Published May 22, 2026
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 control of risk, quality, or accountability.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
- StandardSummaries onlyLTR 155: Leverage VIP to Move from Compliance to Capability
Published May 15, 2026
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 toward true quality maturity.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,
- StandardSummaries onlyLTR 154: From Procedures to Judgment - Leading Through QMSR Inspections
Published May 8, 2026
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 observations under QMSR are already revealing: a clear shift from procedural compliance to evaluating how well companies actually make risk-based decisions across their quality systems.This conversation goes beyond clauses and documentation. It explores how FDA i
- StandardSummaries onlyLTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability
Published May 1, 2026
Summary“Just having a policy in place is one thing. Having a QMS that aligns to it is the next.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Sherita Black about one of the most challenging and often misunderstood topics in ISO 14971: creating a policy for risk acceptability. The conversation goes beyond the standard’s wording and gets into the practical questions that many teams struggle with: who top management really is, how to involve them, and how to turn policy int
- StandardSummaries onlyLTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems
Published Apr 24, 2026
Summary“FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?”In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits down with Dr. Omar Al Kalaa to talk about one of the most important emerging frontiers in MedTech: remotely controlled medical systems. From telesurgery to connected infusion therapy, these technologies are expanding what is possible in patient care—but they also introduce a very d
- StandardSummaries onlyLTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences
Published Apr 17, 2026
Summary“Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.”What happens when a highly regulated medical device depends on a tiny, single-sourced component buried deep in a fragile global supply chain?In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Dr. Sarai Pahla about why supply chain disruption is no longer just an operations problem. It is a real risk issue for life sciences companies.Sarai brings a rare perspective
- StandardSummaries onlyCase Study: How Patient Preference Data Rescued a High-Risk Device
Published Apr 10, 2026
Case StudyImagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury.If you are sitting in the regulatory or risk management seat, you are likely drafting the project’s post-mortem. In a traditional risk management paradigm, you are preparing to tell the executive team that the device failed to meet any traditional safety threshold.But what if the FDA didn
- StandardSummaries onlyLTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices
Published Apr 3, 2026
Summary“AI brings novel risks and addressing them will require a more creative approach to human factors engineering.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Jonathan Kendler, a seasoned medical device human factors and UI design consultant, about how artificial intelligence is changing the practice of usability engineering in MedTech. Jonathan brings a rare perspective to the discussion, blending decades of experience in user interface design, human factors, and m
- StandardSummaries onlyLTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
Published Mar 27, 2026
Summary“The clinical study is actually where your risk analysis is going to meet reality.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Lavanya Ramnath, Senior Regulatory Affairs Specialist at Insulet, about what it really takes to prepare for an IDE and why early-phase risk work is far more than a documentation exercise. Drawing on her experience in diabetes technology, SaMD, and closed-loop systems, Lavanya explains how regulatory, clinical, engineering, and usability
- StandardSummaries onlyLTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
Published Mar 20, 2026
Summary“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”Companion diagnostics (CDx) are inherently high-consequence because they can directly shape treatment decisions. That reality drives a higher bar for clarity: intended use boundaries, evidence expectations, and tight specificity in what the test is claiming and for whom.In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Chris Daly to discuss how
- StandardSummaries onlyLTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development
Published Mar 13, 2026
Summary“Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes benefits.”In this Let’s Talk Risk! conversation, Richard Matt shares a simple but uncomfortable observation: most organizations do risk “correctly” on paper, but too late to matter. By the time the DFMEA/PFMEA is polished, key architecture decisions are already locked, so risk management becomes cleanup, not guidance.His most valuable takeaway is
- StandardSummaries onlyLTR 146: Ganesh Sabat on Scaling MedTech Through Quality
Published Mar 6, 2026
Summary“A company can become world class the day the quality team decides.”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ganesh Sabat, former former CEO of Sahajanand Medical Technologies (SMT) and now Founder & Managing Partner of MedArtha Capital about a simple but hard truth: global scale in MedTech is earned through quality execution, not marketing narratives.Ganesh walks through SMT’s transformation from an innovative startup into a globally recognized cardiovascul
- StandardSummaries onlyLTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
Published Feb 27, 2026
Smart Quality PlanningSummary“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion persists across the MedTech industry. Is ISO 13485 certification enough? Does MDSAP cover everything? What exactly will FDA inspectors expect?In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits down with Holly Cotter to talk about what this transition really mean
- StandardSummaries onlyLTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management
Published Feb 20, 2026
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-u
- StandardSummaries onlyLTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era
Published Feb 13, 2026
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 cer
- StandardSummaries onlyLTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
Published Feb 6, 2026
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 f
- StandardSummaries onlyLTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR
Published Jan 30, 2026
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,
- StandardSummaries onlyLTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls
Published Jan 23, 2026
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 f
- StandardSummaries onlyLTR 139: Steve Silverman on FDA Readiness for QMSR
Published Jan 16, 2026
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 institu
- StandardSummaries onlyLTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
Published Jan 9, 2026
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 ho
- StandardSummaries onlyLTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
Published Dec 19, 2025
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 c
- StandardSummaries onlyLTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
Published Dec 12, 2025
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 focusi
- StandardSummaries onlyLTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech
Published Dec 5, 2025
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 m
- StandardSummaries onlyLTR 134: James Pink on Responsible AI and Future of MedTech Safety
Published Nov 28, 2025
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 safet
- StandardSummaries onlyLTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
Published Nov 21, 2025
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 dif
- StandardSummaries onlyLTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
Published Nov 14, 2025
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
- StandardSummaries onlyLTR 131: Rick Wedge on the Human Side of Safety Risk Management
Published Nov 7, 2025
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
- StandardSummaries onlyLTR 130: Hannah Walter on Human Factors and Inclusive Design in Medical Devices
Published Oct 31, 2025
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
- StandardSummaries onlyLTR 129: Viral Thakkar on breakthrough innovation and the Lungpacer story
Published Oct 24, 2025
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 t
- StandardSummaries onlyCase Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
Published Oct 20, 2025
Case StudyIn 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: Tex
- StandardSummaries onlyLTR 128: Edward Ball on AI, Vigilance and Future of MedTech Regulation
Published Oct 17, 2025
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+
- StandardSummaries onlyLTR 127: Ajay Dankar on Proactive AI Governance in MedTech
Published Oct 10, 2025
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 uncertai
- StandardSummaries onlyFDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
Published Oct 6, 2025
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
- StandardSummaries onlyLTR 126: Adam Foresman on Proactive Compliance and Future of MedTech
Published Oct 3, 2025
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 requireme
- StandardSummaries onlyLTR 125: Kevin Schawinski on Building Trustworthy AI and MedTech Readiness
Published Sep 26, 2025
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 i
- StandardSummaries onlyCase Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
Published Sep 22, 2025
Case StudyIn 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 gui
- StandardSummaries onlyLTR 124: Omar Al Kalaa on Wireless Coexistence and Risk in Connected Medical Devices
Published Sep 19, 2025
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 in
- StandardSummaries onlyLTR 123: Richard Matt on Effective Risk Communication
Published Sep 12, 2025
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
- StandardSummaries onlyCase Study: What AI/ML Device Recalls Reveal About Emerging Risks
Published Sep 8, 2025
Case StudyNote: this is an updated version of the original article first published on Sep 8. It has been corrected for an error in the number of AI/ML enabled medical devices cleared by the FDA mentioned in the original article.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: 1,247 FDA cleared AI/ML devices across 155 product codes; 38 recall events i
- StandardSummaries onlyLTR 122: Tibor Zechmeister on PSUR Best Practices
Published Sep 5, 2025
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
- StandardSummaries onlyLTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
Published Aug 29, 2025
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…
- StandardSummaries onlyCase Study: Contrasting U.S. and EU Approaches to AI Regulation
Published Aug 25, 2025
Case StudyIn 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
- StandardSummaries onlyLTR 120: Atty Chakraborty on India's Rising MedTech Sector
Published Aug 22, 2025
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
- StandardSummaries onlyLTR 119: AI, Risk and Regulatory Strategy with Dr. Jay Vaishnav
Published Aug 15, 2025
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…
- StandardSummaries onlyCase Study: When Clues to a Future Recall Hide in Plain Sight
Published Aug 11, 2025
Case StudyIn 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 patte
- StandardSummaries onlyLTR 118: Off-Label Use with Kristen Petersen
Published Aug 8, 2025
Kristen PetersenSummary“When reviewing clinical evidence for off-label use, come up with a plan to systematically address it and build these processes into your SOPs.”In this Let’s Talk Risk! conversation, host Naveen Agarwal and Kristen Petersen discuss the complexities of off-label use in clinical evaluation, emphasizing its significance in the medical device industry. They explore the definitions, examples, and regulatory considerations surrounding off-label use, as well as the importance of documentation an
- StandardSummaries onlyLTR 117: Queenita Fernandes on Smart Use of AI for Clinical Evaluation
Published Aug 1, 2025
Summary“You need to base your summary and conclusions based on facts, not assumptions. Work smarter, not harder.”In this Let’s Talk Risk! conversation, Dr. Queenita Fernandes shares her extensive experience in the healthcare industry, particularly in risk management and clinical evaluation. She emphasizes the importance of collaboration, leveraging technology, and the role of AI in enhancing clinical literature reviews and signal detection in adverse events. The discussion also highlights the ne
- StandardSummaries onlyA Quick Primer on FDA's Final Guidance for Cybersecurity in Medical Devices
Published Jul 28, 2025
FDA highlights the increasing relevance of cybersecurity in the context of medical device safety and effectiveness in the opening section of the final guidance issued on June 27, 2025:With the increasing integration of wireless, Internet- and network-connected capabilities, portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-related health information and other information, the need for robust cybersecurity controls to ensure medical device safety and effecti
- StandardSummaries onlyLTR 116: Priyanka Murawala on ISO 10993 Update, Biocompatibility, Learning from Recalls
Published Jul 25, 2025
Summary“A major change proposed in the draft of ISO 10993-1 revision is the focus on foreseeable misuse and effect of cumulative device use for biological safety. ”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Priyanka Murawala, an expert in biological evaluation of medical devices. They discuss the latest updates on ISO 10993-1, the differences in regulatory approaches between the EU and the US, challenges faced in biological evaluation, significant recalls related to
- StandardSummaries onlyLTR 115: Startup Lessons from EU MedTech Shark Tank
Published Jul 18, 2025
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“The EU MedTech Shark Tank helps bring new technology ideas on a roundtable, pitching in front of physicians and investors to support startups by creating a network.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal speaks with Dr. Michael Lichtenberg about the challenges and opportunities in bringing innovative medical devices…