Let's Talk Risk! with Dr. Naveen Agarwal

Imagine 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’t just approve this device, but approved it specifically because the sponsors mathematically proved that patients were willing to tolerate a higher level or risk to gain access to this device?This scenario completely dismantles the way the MedTech industry has historically viewed safety and effectiveness. As professionals, we are trained to treat clinical thresholds as objective, immutable laws of physics—a line in the sand where an adverse event rate either passes or fails. However, with the FDA’s finalized guidance issued on March 30, 2026, safety is no longer just a raw numerical threshold; it is now a quantifiable variable relative to the validated preference of the end user.So, how does a manufacturer mathematically prove that a severe safety profile is acceptable, and how does the FDA reconcile approving it?🎧Click Play above to listen to a brief audio summary about this case and lessons QA/RA and Clinical professionals can apply in practice using the newly released FDA Guidance.In this episode, we discuss:* The fundamental difference between Patient Reported Outcomes (PROs) and Patient Preference Information (PPI)—and why conflating the two leads to flawed regulatory submissions.* The exact mechanics of how a rigorously designed Discrete Choice Experiment (DCE) rescued the alfapump system from regulatory rejection.* How to utilize the Q-submission program to negotiate mathematical models with the FDA before collecting a single data point.* Strategic traps to avoid, including the “subpopulation matching problem” that can engineer a massive off-label use issue for your pipeline.Thanks for reading Let's Talk Risk!. If you liked this post, share with others.Note:The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here are a few key resources used for this analysis:* FDA Guidance: Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling (Issued March 30, 2026).* P230044, Sequana Medical N.V., alfapump® System, Approved December 2024. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 medical device development.The conversation explores a central tension facing the industry today: while AI introduces new interaction patterns, trust challenges, and potential safety risks, the core responsibility remains unchanged - understand the user, understand the context of use, and design for safe, effective human interaction. Jonathan also shares where he sees real promise, including AI-supported training, surgical planning, and stronger cross-functional collaboration across risk, quality, regulatory, engineering, and human factors teams.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Introduction02:53 Why AI changes the environment, but not the fundamentals of human factors05:46 Transparency, over-reliance, and helping clinicians stay vigilant09:36 AI-strengthened training and the shift from training to competence13:19 Promising AI use cases, especially in surgical planning and clinician support15:38 The future of human factors: creativity, collaboration, and new evaluation methods23:30 Jonathan’s upcoming workshop on advanced human factors and use-related risk26:45 Final takeaways: stay grounded in the user, fundamentals, and teamworkIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Start Treating Human Factors as Science, Not Art.LTR: Understanding Human Factors for AR/VR Applications in MedTech.LTR: LTR Risk Coach - AI-Powered Decision Support Tool.Key Takeaways* AI-enabled devices do not eliminate the need for strong human factors fundamentals; they make them more important.* One of the biggest emerging risks is lack of transparency around what the AI is doing and how users should interpret its output.* Accuracy alone is not enough; teams must design for the reality that AI can fail and users must remain appropriately vigilant.* AI may create meaningful opportunities to improve training, making it more interactive, adaptive, and competence-focused.* Some of the most promising applications of AI are those that strengthen clinician judgment rather than replace it.* Human factors professionals will need more creativity to anticipate novel use errors, misuse, and complex real-world interactions.* Conventional usability testing may not be enough for AI-enabled systems, especially when risks like habituation emerge over time.* The best outcomes will come from closer collaboration across human factors, engineering, risk management, quality, regulatory, and safety teams.KeywordsHuman factors, usability engineering, AI in medical devices, machine learning, transparency, clinician vigilance, use-related risk, AI training, competence, surgical planning, usability testing, cross-functional collaborationAbout Jonathan KendlerJonathan Kendler is a medical device human factors and UI design consultant with more than 20 years of experience supporting the development of healthcare products, including dialysis machines, infusion pumps, glucose monitors, and patient monitoring systems. He is Principal Consultant at Curiolis and previously co-founded Wiklund Research & Design, which was later acquired by UL.Jonathan has authored numerous articles on usability engineering and co-authored Usability Testing of Medical Devices and Designing for Safe Use. He has also taught graduate-level courses in user interface design at Tufts University and delivered workshops and lectures on usability engineering across North America, Europe, and Asia.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every other Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 thinking must come together long before a device ever reaches a patient.The conversation also goes deeper than process. Lavanya shares the personal connection that drew her into MedTech, how family experiences with diabetes and cardiac disease shaped her career, and why she approaches device development with a simple principle: build as if it were intended for your own family. From significant-risk judgments and feasibility studies to alarm design, human factors, and mentorship, this episode is a thoughtful reminder that good regulatory work is ultimately about real people, real uncertainty, and real consequences.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Introduction03:23 The personal story behind Lavanya’s commitment to MedTech05:01 What an IDE is and why it matters07:53 When companies decide they need an IDE09:08 Significant vs. non-significant risk in early clinical development12:36 In silico testing, risk analysis, and the three buckets of risk work16:07 Human factors, usability, and improving confidence in risk judgments19:00 Alarm design, patient preference, standards, and practical tradeoffs20:49 Learning regulatory on the job and the role of mentorship25:40 Final takeaways: patient focus, study design, and risk as strategyIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Decoding Privacy Laws in Clinical Research.LTR: A Patient Centric Approach to Medical Device R&D.LTR: A 90-Day Plan to Review QMSR Readiness.Key Takeaways* An IDE is not a marketing authorization. It is the permission to study a device in humans, and it often begins much earlier in development than many teams expect.* Early risk work is a judgment exercise under uncertainty. Teams must assess whether a device could cause serious harm even before every failure mode is fully known.* Risk analysis should not stop at a table. Lavanya frames it as a broader strategy spanning system hazards, component-level failure analysis, and an overall residual-risk rationale.* Clinical studies are where risk analysis meets reality. They help confirm whether residual risk is truly acceptable in real-world use.* Human factors matters directly to safety. User behavior, interface design, age, familiarity with technology, and real-use conditions all shape risk.* Good design requires balancing competing needs. The insulin pump alarm example shows the tension between patient preference, safety urgency, and standards compliance.* Regulatory growth happens through cross-functional learning. Lavanya emphasizes partnering with other functions, asking questions, and staying open to how the full product puzzle fits together.* Mentorship can accelerate confidence and visibility. The episode closes with a strong message about seeking mentors, giving back, and finding your voice in the profession.KeywordsIDE, Investigational Device Exemption, clinical trials, risk management, ISO 14971, human factors, IEC 62366, usability engineering, insulin pumps, SaMD, digital health, regulatory affairs, benefit-risk, design controls, mentorshipAbout Lavanya RamnathLavanya Ramnath is a Senior Regulatory Affairs Specialist at Insulet, where she supports U.S. new product development for SaMD and closed-loop insulin delivery systems, including feasibility and pivotal clinical studies, IDE submissions, and FDA interactions. She has also contributed to indication expansion work for Omnipod 5 and supports broader regulatory documentation, process improvement, and global compliance activities.Previously, Lavanya held regulatory roles at Abbott, CR Bard, and Medtronic, building experience across the full device lifecycle for both low- and high-risk devices in U.S., EU, and international markets. A biomedical engineer by training, she is especially passionate about helping bring safe, effective, and innovative devices to patients worldwide — a mission shaped by personal family experiences with diabetes and cardiac disease.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every other Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were cre

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 AI is transforming the MedTech landscape, including CDx, and how FDA’s expectations are evolving in this area. Chris emphasizes anchoring on the clinical question, using AI as a tool (not a vague strategy), and making uncertainty explicit: not “can we explain everything,” but “how much uncertainty is acceptable for this intended use?”Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 2026 context: uncertainty is rising; fundamentals matter 05:00 CDx basics: why CDx is different (and higher-stakes) 07:05 AI/ML + diagnostics: define the question, bound the tool 09:40 Explainability vs uncertainty: “how much confidence is enough?” 14:10 The human factor: vigilance and better questions 18:10 FDA and CDx: what “evolving approach” may signal 21:30 Dataset boundaries, bias, and representativeness as safety issues 25:40 Closing: adapting to rapid AI rise through discipline + alignment If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Three Pillars for Defining Your IVD Risk Management Strategy.LTR: Responsible AI and Future of MedTech Safety.FDA: Companion Diagnostics.Key Takeaways* CDx is high-stakes by design. If the test can steer therapy, FDA (and clinicians) will demand tighter specificity on intended use, population, and claims.* The real compliance challenge is uncertainty, not buzzwords. Move the discussion from “can you explain it?” to “how confident are we, and what uncertainty are we accepting for this use?”* Adjusting to AI’s rise means upgrading the team’s habits. Better questions, tougher validation, and active skepticism are the guardrails, especially when outputs can be wrong or misleading.* Your training data defines your safety boundary. If the dataset doesn’t represent the real population/use context, we should not be surprised by bias and performance gaps in the real world.* FDA’s CDx posture is evolving, but rigor isn’t going away. Reclassification signals pathway experimentation, * AI readiness is cross-functional risk governance. The winners align science, quality, regulatory, and commercial goals around shared definitions, shared uncertainty, and shared decision logic.KeywordsCompanion diagnostics (CDx), AI/ML diagnostics, FDA CDx policy, reclassification, intended use, uncertainty, explainability, bias, lifecycle control, vigilance.About Chris DalyChris Daly is a healthcare and life science executive and Principal at IronLine Consulting, where he helps emerging medical device manufacturers build regulatory and commercialization strategies for diagnostic products, especially companion diagnostics (CDx) and AI/ML-enabled solutions. He has supported FDA submissions, including successful clearances in infectious disease and software-as-a-medical-device (SaMD), and works with teams on quality system development across device companies, diagnostic labs, and independent diagnostic testing facilities. Before IronLine, Chris served as Chief Operating Officer of Total Child Health (CHADIS), a web-based screening and clinical management platform that uses pre-visit questionnaires to help clinicians streamline care and improve diagnosis and management of pediatric health, emotional, and behavioral concerns.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every other Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 the shift upstream: start with the treatment plan, write down the expected benefits and plausible risks early, and iterate them as the design evolves. When benefits are made explicit, you stop treating risk as a single independent variable and start using benefit–risk as a practical decision engine for design tradeoffs.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Welcome and Introduction01:04 Risk focus in QMSR04:50 Risk as an input to design05:33 Why FMEA alone is not sufficient10:33 Consider both benefits and risks early in design20:43 Audience questions24:30 Closing remarksIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Allison Komiyama on Rethinking Benefit-Risk in MedTech.LTR: Benefit-Risk Evaluation of an AI/ML Enabled Device.LTR: An Ideal Medical Device.Key Takeaways* Use benefit–risk early, not as an afterthought. Start at the treatment-plan/concept phase so benefit and harm shape architecture decisions before they’re hard to change.* Make “benefit” explicit and usable. If you only optimize against harm, you can unintentionally degrade clinical value; benefit must be part of the design tradeoff logic from day one.* FMEA is necessary, but often too late to drive architecture. Treat it as confirmation and refinement—not the first time risk influences design.* Replace ad hoc early risk with a lightweight upstream method. A simple evolving list of benefits, risks, and the design choices they drove can outperform a “perfect” late-stage file.* QMSR will expose weak integration between risk and design controls. The compliance work is not the hard part—the hard part is showing risk actually shaped the design.KeywordsQMSR, ISO 13485, ISO 14971, design controls, risk-based thinking, DFMEA/PFMEA limits, hazards & hazardous situations, benefit–risk, early design inputs, architecture decisions, process validation (OQ/PQ), iterative development.About Richard MattRichard Matt is Principal Consultant at Aspen Medical Risk Consulting, with over 30 years of experience in product development, quality engineering, and risk management. He specializes in innovative methods for benefit–risk assessment, FMEA, and integrated product development, helping medical device companies strengthen compliance and improve patient safety.He is also the inventor of a patented “risk algebra” approach that enables clear, defensible comparisons of benefit and risk, a breakthrough with wide implications for devices, biologics, and combination products.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every other Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 cardiovascular device company, then zooms out to India’s broader MedTech ambition. We unpack what’s missing (talent depth, shared learning, true design ownership), what’s emerging (incubation + device parks + incentives), and why quality leaders are the real “make-or-break” force behind India’s credibility on the world stage.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Welcome and Introduction02:09 SMT story: from “innovative startup” to global scale04:54 The turning point: why Ganesh bet on quality as the growth lever06:13 What investors demanded: proof, discipline, and scalable systems08:39 India ecosystem reality: pharma-quality mindset vs device-grade rigor11:22 “Quality as a system”: building defect prevention into process + design15:21 Building the ecosystem: why shared learning + capability depth matter18:58 Challenges and opportunities for MedTech startup21:02 Achieving global success not through low-cost but high quality24:25 Closing remarksIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: What QA/RA Professionals Need to Know About MedTech in India.LTR: Navigating the Regulatory Landscape for SaMD in India.LTR: Atty Chakraborty on India’s Rising MedTech Sector.Key Takeaways* Quality isn’t a checkpoint at the end. It’s a design-and-system discipline built upstream.* SMT’s scaling story is framed as “investing in quality,” then validating it through clinical proof and execution rigor.* Customer trust and investor confidence converge on the same requirement: consistent, reliable quality (and safety) at global standards.* India’s MedTech ecosystem is growing rapidly, but limited depth of specialized quality talent slows the curve.* Moving from pharma-style quality to device-grade quality requires engineering capability, process ownership, and design mastery.* Many early-stage companies need more than capital. They need experienced, operator-led “corridor finding” through regulatory + commercialization complexity.* Device parks and incentives can accelerate manufacturing and scale, but credibility still hinges on execution discipline.* Ganesh’s closing challenge is direct: quality teams hold the leverage to make companies—and countries—world class.KeywordsQuality culture; design controls; engineering-led quality; global scale-up; cardiovascular devices; stents; clinical evidence; India MedTech; regulatory rigor; manufacturing excellence.About Ganesh SabatGanesh Sabat is is the Founder & Managing Partner of MedArtha Capital, an visionary investment platform backing MedTech, medical device, and digital healthcare companies emerging from India and scaling globally.Previously, Ganesh spent ~15+ years as a senior executive, most recently as CEO of Sahajanand Medical Technologies (SMT), where he helped scale a highly regulated cardiovascular medical device business across innovation, manufacturing, quality, regulatory pathways, and international markets, building presence across 80+ countries and driving sustained growth.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every other Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

Summary“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 means for manufacturers, especially startups and U.S.-only companies.Holly brings a rare perspective: biomedical engineer, hands-on clinical experience, global regulatory consultant, and community builder. Together, we unpack not just regulatory changes — but the leadership opportunity QMSR presents for quality and regulatory professionals.Chapters00:00 Introduction and QMSR transition02:25 Explicit vs. implied changes under QMSR06:00 Risk beyond design validation: FDA’s broader lens09:30 Inspection uncertainty: Q-SIT, guidance gaps, and readiness11:35 MDSAP alignment: what it covers — and what it doesn’t14:00 The Quality Plan: your most practical readiness tool20:10 Dangerous assumptions about ISO 13485 certification25:40 indieMedTech: building community in MedTechIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:* LTR: QMSR Readiness, Risk-Based Assurance and FDA Expectations.* LTR: 90-Day QMSR Readiness Action Pan for Leaders.* LTR: FDA Readiness for QMSR.Key Takeaways* ISO 13485 certification ≠ automatic QMSR compliance* Risk-based thinking must extend across the entire quality system* Internal audits and management reviews will face deeper FDA scrutiny* MDSAP is helpful, but not sufficient* A simple, well-structured Quality Plan demonstrates leadership and readiness* QMSR presents a strategic opportunity for QARA professionalsKeywordsQMSR, FDA Quality System Regulation, ISO 13485, Risk-Based Thinking, MDSAP, FDA Inspection Readiness, Quality Plan, CAPA, Supplier Controls, MedTech LeadershipAbout Holly CotterHolly Cotter is a a biomedical engineer turned regulatory strategist with hands-on clinical roots and global MedTech experience. She has led regulatory, quality, and clinical initiatives across startups, large manufacturers, and consulting environments, with deep expertise in EU MDR, post-market surveillance, PMCF strategy, and FDA compliance.Holly is also the Co-Founder of indieMedTech, a growing professional platform dedicated to connecting and empowering MedTech leaders. Through her consulting work and community building, she is helping companies navigate complex regulatory transitions - including the shift to QMSR - with clarity, structure, and risk-based thinking.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 FMEAs), and how a shift toward hazard-first thinking can make risk management more tangible, especially for startups, early-career professionals, and teams working on diagnostic and software-driven devices.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:01 Introduction to Jean’s start in risk management02:45 Linear standards vs. real-world complexity05:20 Indirect harm in diagnostic and AI devices07:10 Risk management for start up and early career professionals10:30 Risks don’t exist, hazards do 13:20 Role of examples in risk management16:45 Risk information outside of risk management team 18:00 Why FMEAs fail at the executive view20:20 Risk management competence development21:00 Seek to be understood 23:40 Teaching risk without jargon26:40 From getting it right to not getting it wrongIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Why FMEA Alone is Not Sufficient for Risk Analysis.LTR: Three Pillars for Defining Your IVD Risk Management Strategy.LTR: Focus on Intended Use for IVD Risk Management.Key Takeaways* When just starting with risk management, begin with hazards: they are tangible and controllable; “risk” is an outcome.* Standards provide structure, but real-world risk is non-linear and contextual.* Diagnostic and AI devices shift risk focus from physical harm to information.* The instructions for many legacy risk tools (like FMEA) were built for projects and missions, not full lifecycle thinking.* Large FMEAs, even summarized, do not provide meaningful executive insight.* Jargon blocks learning; effective training must be adapted to experience level.* Risk capability evolves: from first learning to get it right, to continue training to not being able to get it wrong.KeywordsHazards, Hazardous Situations, ISO 14971, ISO 13485, Risk Management Training, FMEA Limitations, Diagnostic Device Risk, Usability Engineering, ISO 62366-1, Systems Thinking, Benefit–Risk, Risk Communication, Startup QMSAbout Jean BlomJean Blom is Netherlands-based QMS & Audit Specialist and Quality Manager (Medical Devices) with extensive experience guiding teams through ISO 13485 quality systems, auditing (ISO 19011), and ISO 14971 risk management, including usability. He has served as a Technical Assessor/Technical Expert for ISO 17021-1 accreditation activities related to ISO 13485 certification bodies and has supported global QMS compliance across multiple markets and device types.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 certified is not enough. The conversation dives deep into FDA inspection behavior, closed-loop risk management, management review as a leadership tool (not a formality), and the very real consequences of reactive quality systems.This episode is a must-listen for quality, regulatory, and executive leaders who want to move beyond compliance and build proactive, inspection-ready organizations.Chapters00:00 Welcome and Introduction02:20 ISO 13485 vs FDA inspections: where assumptions break down03:40 Closed-loop risk management across the total product lifecycle05:40 How FDA uses complaints, CAPA, and trends to escalate inspections09:35 Leadership mindset shift: from reactive fixes to proactive quality11:35 Management review as a strategic decision-making forum20:25 Inspection readiness as culture, practice, and people, not paperworkIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:* LTR: QMSR Readiness, Risk-Based Assurance and FDA Expectations.* LTR: 90-Day QMSR Readiness Action Pan for Leaders.* LTR: FDA Readiness for QMSR.Key Takeaways* Don’t wait for FDA to expose your gaps, identify and document them yourself* Treat QMSR as a strategic initiative, not a quality department project* Use management review to drive real discussion, decisions, and accountability* Focus on the critical few metrics, not dozens of unprioritized indicators* Train SMEs and cross-functional leaders to speak confidently about risk* Practice inspection scenarios before FDA shows up, not during the inspectionKeywordsQMSR, FDA inspection readiness, closed-loop risk management, ISO 13485, management review, risk-based decision making, proactive quality, trend escalation, cross-functional accountability, total product lifecycleAbout Jennifer Mascioli-TudorJennifer Mascioli-Tudor is currently the Founder and Principal Consultant at JMT Compliance Consulting offering consultant services to MedTech organizations in business, regulatory and quality management strategy. She is also an instructor at UC San Diego where she teaches regulatory fundamentals and design controls. Her industry experience includes leadership roles at J&J, Boston Scientific, Medtronic, and GE Healthcare. She holds a BSc from Eastern Michigan University, an MBA in Global Management, and is an ASQ Certified Quality Auditor.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 clinical evaluation (ISO/DIS 18969), why it was developed, and what problem it is trying to solve. Florian shares first-hand insight from his role in the ISO working group, highlighting common industry misunderstandings, especially around outcome parameters, state of the art, and the linkage between clinical evaluation and ISO 14971 risk management.Together, Naveen and Florian unpack new terminology such as clinical risk, clinical outcome parameters, and available knowledge, clarifying how these concepts are meant to sharpen focus on patient-relevant benefit–risk decisions without overloading clinical evaluation with non-clinical risk data. The episode closes with practical reflections on how manufacturers, especially those struggling with EU MDR expectations, can use this process standard to strengthen their clinical evaluation approach.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Welcome and introduction to the topic of clinical evaluation01:25 What companies still get wrong about clinical evaluation03:10 Overview of the new ISO/DIS 18969 draft standard05:30 Why the standard is process-focused, not regulatory06:20 ISO 14971 as a normative reference and the idea of “clinical risk”10:20 State of the art vs. “available knowledge”17:40 Clinical outcome parameters and measurable benefit–risk25:00 Why this standard matters and who will benefit mostIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Clinical Evaluation Now More Important Than Ever Under EU-MDR.LTR: Smart Use of AI for Clinical Evaluation.LTR: Clinical Evaluation a Lifecycle Process Not a One Time Activity.Key Takeaways* Clinical evaluation is not a narrative exercise, it must be outcome-driven.* Not all risks belong in clinical evaluation; patient-relevant risks do.* Outcome parameters should be derived from state of the art, not after the fact.* The new ISO draft aims to harmonize global practice without reinventing regulations.* A strong clinical evaluation process improves both regulatory confidence and decision quality.KeywordsClinical Evaluation, ISO/DIS 18969, Risk Management, ISO 14971, EU MDR, Clinical Risk, Benefit–Risk Assessment, State of the Art, Post-Market Surveillance, Medical Device RegulationAbout Florian TolkmittFlorian Tolkmitt is the founder and owner of PRO-LIANCE GLOBAL SOLUTIONS GmbH providing consulting services in all aspects of clinical evaluation, regulatory affairs, risk and quality management. He is an expert in clinical evaluation, post-market clinical follow up and post-market reporting compliance. As a co-founder and board member of RAPS Deutschland e.V., he is very active in the regulatory community sharing his expertise and mentoring industry colleagues.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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, complexity is effectively infinite, and rapid iteration is the norm. He challenges the industry’s fixation on “bug-free” software and over-proceduralized QMS, arguing instead for quality systems that emphasize risk-based decision-making, shared ownership, and real-world practice.The conversation explores how QMSR’s deeper integration of ISO 13485 and risk management will reshape inspections, elevate expectations around cybersecurity and supplier oversight, and require QA/RA leaders to rethink their role—from compliance enforcers to system designers and collaborators.Chapters00:00 Welcome and introduction01:00 Fundamental differences between software and hardware risk04:50 Agile development vs. quality system control: where conflict arises07:40 Why “move fast and break things” fails in medical devices09:10 Bringing agility and ISO 13485 together through risk-based thinking12:05 QMSR’s implications for SaMD, cybersecurity, and supplier management16:20 Moving beyond procedures: practicing risk, not just documenting it20:20 Treating the QMS as a product with internal customers24:30 Delayed innovation as an overlooked form of patient riskSuggested links:* LTR: QMSR Readiness, Risk-Based Assurance and FDA Expectations. * LTR: 90-Day QMSR Readiness Action Pan for Leaders. * LTR: FDA Readiness for QMSR.Key Takeaways* Software risk is deterministic, not statistical: bugs fail 100% of the time once triggered.* Chasing “bug-free” software can delay safe, effective products and deny patients timely access.* Agile and quality are not opposites, but they must be reconciled through risk-based discipline, not speed alone.* Under QMSR, risk expands beyond safety to include cybersecurity, data integrity, and system reliability.* FDA inspections may increasingly link observations directly to deficiencies in risk-based decision-making.* A mature QMS must be practiced, not just documented; procedures alone won’t demonstrate control.* QA/RA leaders must treat the QMS itself as a product with internal users and continuously improve it.* Future quality leaders need enough technical fluency to engage engineering as partners, not adversaries.KeywordsQMSR, FDA readiness, ISO 13485, MDSAP, FDA inspections, quality system regulation, risk-based quality, CAPA, post-market surveillance, QA/RA leadershipAbout Ashkon RasooliAshkon Rasooli, is a medical device Quality Management Systems strategist specializing in SaMD, SiMD, and AI/ML-enabled technologies. He brings over a decade of experience across engineering, product management, regulatory, and quality roles, spanning large MedTech firms, big-tech environments, and VC-backed startups. Ashkon is the founder of EnGenius Solutions and is known for his pragmatic, “non-BS” approach to building quality systems that protect patients without stalling innovation.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 often become disconnected from design inputs, verification strategies, and sustaining engineering changes. Drawing on real-world examples, she explains how “like-for-like” assumptions, tight timelines, and limited cross-functional engagement can quietly erode patient safety if risk is not continuously reassessed.The conversation goes beyond procedures to focus on culture, highlighting the importance of collaboration, early engagement, and continuous improvement to ensure risk truly governs design decisions. As QMSR approaches, this episode offers timely guidance for QA/RA and engineering leaders looking to move from checkbox compliance to lifecycle risk assurance.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Welcome and introduction01:00 Pujitha’s path into quality and risk management03:40 Where risk and design controls disconnect in practice05:20 Sustaining engineering: the most overlooked risk blind spot06:40 “Like-for-like” changes and dangerous hidden assumptions09:00 Proactive risk reassessment through continuous improvement11:10 Organizational barriers: timelines, awareness, and ownership25:05 Closing takeaways: culture, collaboration, and QMSR readinessIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Managing Post-Market Design Changes.LTR: Building Safety by Design.LTR: Beyond Compliance - Building Good Practices Under QMSR.Key Takeaways* Risk management must actively inform design inputs, outputs, and verification, not exist as a standalone file* Sample sizes and verification strategies should be scaled to patient impact, not convenience* Sustaining engineering changes often carry hidden risk and deserve the same rigor as new product development* “Like-for-like” component changes can invalidate prior risk analyses if assumptions go unchallenged* Continuous improvement programs work best when risk awareness extends beyond Quality into engineering and project management* Early collaboration reduces rework, delays, and late-stage risk discoveries* QMSR raises expectations for closed-loop feedback between design, risk, and post-market dataKeywordsRisk management, design controls, QMSR, sustaining engineering, ISO 14971, patient safety, verification strategy, continuous improvement, safety culture, lifecycle riskAbout Pujitha GourabathiniPujitha Gourabathini is a Quality Assurance and Risk Management leader in the medical device industry with deep expertise in lifecycle risk integration, design controls, and post-market safety. She currently serves as a Quality Assurance Manager focused on risk management, where she leads cross-functional efforts to embed patient safety into both new product development and sustaining engineering activities.With hands-on experience across ISO 14971, FDA QSR/QMSR, EU MDR, and safety assurance practices, Pujitha is passionate about moving risk management beyond documentation toward practical, decision-driven application. She is an active contributor to industry discussions through writing, mentoring, and knowledge sharing—advocating for stronger safety culture, continuous improvement, and proactive risk ownership across organizations.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 institutional knowledge, and political disruption. But he also emphasizes that QMSR activation on February 2, 2026, is still very much on track. He cautions companies against “waiting it out” and explains why hoping for delays or informal grace periods is a risky strategy.The conversation dives into practical implications for manufacturers, including how FDA is preparing its inspectors, what the absence of updated QSIT guidance really means, why MDSAP certification is helpful but not sufficient, and how FDA is signaling stronger expectations around risk-based quality systems, especially in premarket reviews. The episode closes with clear advice for QA/RA leaders on how to frame QMSR readiness as a business risk and strategic opportunity, not just a regulatory exercise.Chapters00:00 Why FDA readiness for QMSR matters as much as industry readiness02:00 Inside FDA: disruption, workforce loss, and institutional impact04:12 Will QMSR really go live in February 2026?06:14 Lessons from MDSAP and parallels to QMSR rollout10:40 How FDA prepares inspectors for a new regulatory framework15:14 Why MDSAP certification is not a free pass under QMSR19:14 What FDA inspections may look like in early 202627:58 How QA/RA leaders should explain QMSR to the C-suiteSuggested links:* LTR: Communicating Effectively with Senior Executives. * LTR: 90-Day QMSR Readiness Action Pan for Leaders. * Steve’s Substack: What the FDA?.Key Takeaways* QMSR will activate on February 2, 2026, companies should not expect delays or extensions.* FDA has experienced significant disruption, including workforce reductions and loss of expertise, but core regulatory work continues.* Waiting to see how FDA “handles” QMSR is a high-risk strategy for manufacturers.* FDA inspectors are being trained internally to transition from QSR to QMSR, even without updated QSIT guidance.* MDSAP certification can ease the transition but does not replace FDA inspections or guarantee QMSR compliance.* FDA will continue enforcing recall and adverse event reporting requirements alongside QMSR.* Firms that demonstrate good-faith progress and a clear quality plan are likely to encounter a more collaborative FDA posture.* QMSR explicitly elevates risk as a lifecycle concept, spanning premarket, post-market, and business decision-making.* Leaders should assess their real exposure using post-market data and not assume compliance equals safety.* QA/RA leaders must translate QMSR work into business risk, market impact, and strategic value for executives.KeywordsQMSR, FDA readiness, ISO 13485, MDSAP, FDA inspections, quality system regulation, risk-based quality, CAPA, post-market surveillance, QA/RA leadershipAbout Steve SilvermanSteve Silverman, is the President of The Silverman Group. Steve spent more than a decade at FDA in leadership positions across the Agency. He adds private-sector expertise from consulting and representing industry members. Steve develops strategies that satisfy regulators and promote business needs. He holds a Bachelor’s degree in English Literature, and a JD in Law.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 FDA is signaling its expectations well before inspections begin, particularly through new draft guidance for pre-market submissions. Together, Naveen and Michelle unpack what “risk-based approach” really means under QMSR, not just for design and development, but across supplier controls, CAPA, complaints, data analysis, and management review.They also examine one of the most consequential shifts under QMSR: FDA’s expanded authority to review management responsibility and system-level effectiveness. The episode closes on a forward-looking note, emphasizing the opportunity for QA/RA leaders to reposition themselves, not as compliance enforcers, but as strategic partners in prevention, assurance, and sustainable patient safety.Chapters00:00 Why QMSR readiness matters now01:00 Industry complacency and false hope for delays05:00 FDA signals through pre-market guidance09:00 Compliance vs. assurance: what FDA really wants11:00 What “risk-based” means beyond ISO 1497114:00 Where companies should prioritize immediately17:00 Management review and executive accountability26:00 The opportunity for QA/RA leadership under QMSRSuggested links:* LTR: Risk, CAPA and FDA Inspections under QMSR. * Lean RAQA: RAQA Services, Resources and Courses. * FDA: Voluntary Improvement Program (VIP).Key Takeaways* Many companies are aware of QMSR, but are still not acting with urgency.* ISO 13485 alignment significantly reduces compliance risk, but does not eliminate it.* FDA has already committed to inspecting against QMSR beginning February 3, 2026 and there is no grace period coming.* New PMA draft guidance signals FDA’s shift from compliance evidence to assurance of sustained safety and effectiveness.* “Risk-based approach” under QMSR applies across the entire QMS, not just ISO 14971 hazard analyses.* Management review is no longer protected territory; FDA can now assess how leadership identifies and responds to systemic risk.* The five chronic FDA pain points: CAPA, complaints, design controls, supplier controls, and nonconforming product, will matter even more under QMSR.* Strong QA/RA leaders can use QMSR as a platform to become prevention partners, not procedural gatekeepers.KeywordsQMSR readiness, FDA QMSR, ISO 13485, risk-based approach, risk-based assurance, compliance vs assurance, FDA inspections, management review accountability, CAPA effectiveness, supplier controls, quality system maturity, QA/RA leadershipAbout Michelle LottMichelle Lott is the founder of Lean RAQA, where she provides fractional RA/QA leadership, audit prep, quality system design, and regulatory strategy for MedTech startups and small companies. With 20+ years of experience and an RAC certification, Michelle has helped hundreds of firms navigate FDA submissions and ISO compliance, bringing clarity and efficiency to even the most complex regulatory challenges. DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 controls, risk integration, software assurance, and role-specific competence.Drawing on her clinical roots, global regulatory experience, and work in regulatory intelligence, Priya discusses how RA/QA professionals can prepare for future expectations through deeper understanding of risk, building strong feedback loops, developing competence beyond training, and embracing leadership roles that shape culture, not just documentation.Chapters00:00 Why QMSR is a shift from compliance to assurance.01:00 Priya’s unconventional journey from occupational therapy to regulatory affairs.04:00 How FDA expects QMSR readiness to show up in pre-market submissions.07:00 Compliance vs. assurance: Priya’s analogy for FDA’s mindset shift.09:30 Software assurance, least burdensome validation, and risk-based thinking.13:00 Why QMSR requires more than documentation—evidence of decision-making maturity.17:00 The future of inspections: competence, culture, and systemic vulnerabilities.22:00 Priya’s advice on preparing for QMSR and building a future-ready RA/QA career.Suggested links:* FDA: Draft Guidance - QMS Information for PMA Reviews. * LTR: Megan Kane on Leading QMSR Readiness in a Startup. * LTR: A 90-Day QMSR Readiness Action Plan for Leaders.Key Takeaways* QMSR represents a mindset shift: from proving compliance through procedures to demonstrating assurance through real-world performance and decision-making maturity.* FDA now expects integrated, lifecycle risk management, not isolated risk files; risk thinking must visibly connect design, verification/validation, manufacturing, and post-market actions.* Pre-market submissions will reflect QMSR readiness by showing how risk management drives design decisions, supplier oversight, and verification strategies.* Software assurance is now explicitly risk-based, requiring validation proportional to intended use and potential impact, reflecting the “least burdensome” approach.* Competence, not just training, will be scrutinized, and systemic gaps may escalate into management responsibility findings under QMSR.* Culture becomes a quality system indicator, especially how organizations make decisions, close feedback loops, and connect signals to design controls.* QMSR transition challenges differ by maturity: ISO 13485–certified companies refine and align; non-certified companies must build foundational structures.* RA/QA professionals must evolve into cross-functional leaders, shaping risk-informed culture, strengthening feedback systems, and developing deeper expertise in standards and regulatory philosophy.* Personal career growth principles - curiosity, networking, boldness, persistence - remain essential, especially as AI and digital technologies reshape regulatory practice.KeywordsQMSR, Quality Management System Regulation, ISO 13485, Regulatory Affairs, Risk Management, Assurance Mindset, FDA Inspections, Software Assurance, Competence vs. Training, Regulatory Intelligence, Medical Devices, Digital Health.About Priya SettyGeethapriya (Priya) Setty is a regulatory affairs strategist and systems builder with over eight years in global regulatory affairs and more than twenty years in healthcare. Starting her career as a pediatric occupational therapist, Priya brings a unique blend of clinical insight and policy expertise to the evolving world of medical technology. She leads regulatory intelligence and digital transformation initiatives at a global medical device company, specializing in global regulatory strategy, regulatory intelligence, and digital health/AI compliance for high-risk devices. Priya is adept at navigating complex regulations such as the EU AI Act and FDA guidance, ensuring compliance is embedded in every innovation.A certified PMP, RAC (Devices), and ISO 13485 lead auditor, Priya is known for demystifying complex regulations and building systems that keep teams ahead of industry changes. Guided by her mantra, “make a choice, and make it happen,” she is dedicated to leadership, mentorship, and simplifying healthcare through curiosity and purpose-driven action.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.Let's Talk Risk! is a reader-suppor

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 only on “closing gaps” misses the real risk. The conversation dives into places where FDA will continue to operate exactly as before such as design control expectations, CAPA rigor, complaint handling scrutiny, and the agency’s ability to dig deeper under the broader ISO 13485 framework.Across thirty minutes, Naveen and Adam explore how QMSR will shift the conversation from timeliness to effectiveness, from dashboards to real risk thinking, and from procedural compliance to deliberate regulatory strategy in complex multi-market environments.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Introduction and welcome00:53 The story behind “The Other Consultants”02:22 Why QMSR prep must go beyond gap assessments03:12 What QMSR won’t change and why it matters04:59 Design control complexity under QMSR08:00 FDA’s deeper reach into complaints and risk13:41 CAPA becomes CA + PA and effectiveness takes center stage23:07 Key takeaways and closing remarksIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: 90-Day Action Plan to Review QMSR Readiness.LTR: Beyond Compliance - Building Good Practices Under QMSR.ACHIEVE Workshop: Using ChatGPT to Analyze Recalls and Adverse Events. Key Takeaways* QMSR changes the requirements, not FDA’s inspection philosophy. The agency will still probe deeply and expect strong evidence of safety and effectiveness.* Design control complexity will increase. Especially for manufacturers managing the same device across the US, EU, and UK under a unified system.* Risk integration becomes unavoidable. Under ISO 13485, FDA can now cite weaknesses in risk-linked processes more explicitly.* Complaint handling scrutiny will intensify. Inspectors can now ask for “your highest-risk complaints”, and expect a defensible rationale.* CAPA becomes CA + PA. Terminology harmonizes with ISO, but FDA’s expectations for root cause depth and recurrence prevention remain unchanged.* Effectiveness will take center stage. FDA will look beyond timeliness KPIs and challenge the thinking behind effectiveness criteria.* Effectiveness must be defined up front. Not after the corrective actions are completed, a common failure mode in CAPA systems.* Recurrence and escapes remain FDA’s biggest red flags. QMSR simply gives them broader grounds to write findings.* Manufacturers must rethink regulatory strategy. Reliance sounds attractive, but differing market routes require clear separation and intentional planning.* The biggest risks come from what QMSR doesn’t change. These unchanged legacy expectations can “sting” manufacturers who assume harmonization means simplification.KeywordsQMSR, ISO 13485, FDA inspections, design controls, CAPA, corrective action, preventive action, effectiveness criteria, complaint handling, risk-based quality, regulatory strategy, post-market surveillanceAbout Adam Isaacs RaeAdam Isaacs Rae is a medical device quality and regulatory leader and Managing Director of The Other Consultants and The Other Auditors. With over a decade of experience across global medical device manufacturers, regulatory bodies, and certification audits, Adam brings a rare dual perspective as both consultant and lead auditor for ISO 13485. He specializes in pragmatic, risk-based compliance strategies that balance regulatory rigor with business realities, and is known for his clear, conversational approach to complex topics like QMSR, CAPA, and international market access.Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 misunderstood areas in risk management: benefit–risk evaluation.Together, they explore why benefit–risk thinking goes far beyond premarket submissions, how companies can use it to guide post-market decisions, and why QA/RA professionals have a massive leadership opportunity as technology accelerates faster than regulations can keep up. Allison also shares the inspiration behind her new venture, Bluestocking Health, and her mission to spark more accessible, joyful conversations about medical technologies.Chapters01:20 Introducing Allison Komiyama03:40 How FDA thinks about benefit and risk08:10 Why benefits must be evidence-based, not marketing claims10:45 The missing benefit–risk conversation in 510(k) submissions13:45 Reverse-engineering FDA’s benefit–risk guidance for real devices14:30 How AI/ML challenges traditional benefit–risk evaluation17:00 Why intended use and indications are the foundation18:40 Bringing marketing, clinical, and reimbursement into early conversations20:05 QA/RA as strategic leaders, not gatekeepers24:30 How the patient voice reframes quality and purpose26:00 The mission behind Bluestocking Health30:15 Final message for QA/RA professionals: “Keep talking to each other.”Suggested links:* FDA: Benefit-Risk Case Study for an AI/ML Device. * LTR: An Ideal Medical Device. * FDA: Benefit-Risk Guidance for 510(k) Submissions.Key Takeaways* Benefit–risk is fundamental to safety and effectiveness but there is no cookie-cutter formula. * FDA reviewers weigh benefit just as heavily as risk, but industry often forgets the benefit side.* Many devices enter the market via 510(k), where benefit–risk is rarely discussed, despite being essential.* FDA does provide benefit–risk guidance for substantial equivalence, a tool few companies actually use.* Post-market benefit–risk evaluation is critical; clearance is the starting line, not the finish line.* For AI/ML devices, understanding good machine-learning practices and PCCPs helps establish safe guardrails.* Intended use and indications are the anchor for any meaningful benefit–risk assessment.* QA/RA professionals can play a strategic leadership role by connecting benefit–risk to business, clinical, and patient perspectives.* Cross-functional conversations among engineering, marketing, reimbursement, clinical must start early, not at the end.* The patient voice remains the most powerful unifying force in developing safe, beneficial technology.KeywordsBenefit–risk evaluation, FDA submissions, 510(k)/De Novo/PMA, post-market safety, AI/ML devices, regulatory strategy, quality leadership, Bluestocking Health, patient-centric design, MedTech innovation.About Allison KomiyamaAllison Komiyama is the Founder & CEO of Bluestocking Health, a new platform dedicated to elevating conversations around medical technologies and helping patients, caregivers, and innovators better understand the devices that shape healthcare. A former FDA reviewer at CDRH, Allison has spent more than a decade supporting hundreds of submissions across the full product lifecycle, spanning startups to global enterprises. DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 safety.Together they unpack how artificial intelligence is transforming healthcare innovation, the gaps in current assurance models, and the urgent need for literacy, accountability, and human-in-the-loop oversight.The discussion highlights contrasts between EU and U.S. regulatory approaches, the concept of AI assurance, and why quality professionals must evolve from compliance guardians to informed custodians of safety in an AI-enabled world.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Welcome & Introduction 02:00 A Personal Story 05:00 AI’s Transformative Power 07:00 Regulatory Divergence 11:30 Understanding AI Assurance 15:00 Raising AI Literacy 18:00 The Human-in-the-Loop Imperative 23:00 Guardrails & Accountability 26:00 Key Takeaways & ClosingIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Building Trustworthy AI and MedTech Readiness.LTR: Proactive AI Governance in MedTech.ACHIEVE Workshop: Using ChatGPT to Analyze Recalls and Adverse Events. Key Takeaways* Patient-safety passion often begins with personal experience — and sustains professional purpose.* AI innovation is racing ahead of our assurance and measurement systems.* The EU and U.S. regulatory models reveal opposite extremes; balance and shared responsibility are essential.* “AI literacy” should become a core competency for all QA/RA professionals.* Assurance in AI demands new tools, standards (e.g., ISO 42001, 22989), and human judgment.* Human oversight is indispensable: vigilance prevents overreliance and hubris.* Safety frameworks must evolve as fast as the technologies they govern.* Communities like the AI Safety Officer Network will drive the next era of responsible innovation.KeywordsAI safety, medical device risk management, patient safety, regulatory strategy, ISO 42001, human-in-the-loop, responsible innovation, AI assurance, EU AI Act, risk literacyAbout James PinkJames Pink is a leading voice in medical device safety and risk management with over 25 years of global experience spanning clinical engineering, notified bodies, and regulatory consulting.He is the Managing Partner at James Pink Advisory Services and Module Leader for Data Management and Digitalisation in Regulatory Affairs at TOPRA.A respected educator and expert witness, James has trained thousands of professionals worldwide and previously held senior leadership roles at Element Materials Technology and NSF International. He also founded the Medical Device Safety Risk Management and AI Safety Officer groups on LinkedIn, fostering global collaboration on responsible innovation and patient safety.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 differently - embedding risk management early, strengthening design controls, and elevating competence beyond routine training.Drawing from her diverse experience across AI-enabled SaMD, diagnostics, and implantables, Megan shares how agile organizations can turn regulatory change into an advantage. She discusses building risk-based quality systems, tapping external expertise through fractional leadership, and fostering a culture of continuous learning where expertise grows with every project.Chapters00:00 Why QMSR matters now02:00 Inside the startup mindset: energy, agility, and chaos04:30 From checklists to connected processes06:45 How FDA’s expectations are evolving09:50 Integrating risk management with design controls13:30 Competence vs. training: what QMSR really demands15:30 Startups and global thinking: harmonization as opportunity18:00 Leveraging networks and external expertise22:00 Building courage and translating skills to new domains24:00 Overcoming imposter syndrome and redefining expertise26:30 Final takeaways and Megan’s vision for ReliaSuggested links:* LTR: A 90-day plan to review QMSR readiness. * LTR: Risk, CAPA and FDA inspections under QMSR. * LTR: QMSR QuickTake #1: From compliance to assurance.Key Takeaways* The QMSR transition signals a shift from procedural compliance to process-based assurance.* Startups have a unique advantage. Their speed and adaptability can drive faster QMSR readiness.* The new regulation demands earlier integration of risk management into design and development.* FDA reviewers are already expecting deeper risk-to-design traceability, even premarket.* Competence, not just training, will define readiness under QMSR.* Leadership must create cultures that encourage learning and vulnerability, not perfection.* “Experts” aren’t the goal; continuous growth and shared learning are.* For startups, external networks and fractional leadership can fill critical capability gaps.* Global harmonization is coming; QMSR is the first step toward a unified framework.* Success depends on collaboration across the quality community, not isolated effort.KeywordsQMSR, ISO 13485, FDA, risk management, competence, startups, leadership, regulatory strategy, AI/ML, medical devicesAbout Megan KaneMegan Kane is a fractional regulatory and quality executive with expertise spanning medical devices, digital health, and AI-enabled SaMD. As Founder and Executive Director of Rellia, she helps early-stage MedTech companies navigate global regulatory pathways and develop practical, risk-based quality systems. Her career spans startups, global corporations, and contract manufacturing, giving her a unique lens on how to simplify complex regulations into sustainable systems. Rellia is an incubator for digital health startups, helping the next generation of healthcare innovators.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 a global movement for advancing safety risk management in medical devices. From its beginnings at Medtronic headquarters to a sold-out conference in Amsterdam, this event has become a central hub for knowledge exchange between industry, academia, and regulators, including keynote participation from FDA CDRH Director Dr. Michelle Tarver.Together, Naveen and Bijan explore emerging themes shaping MedTech risk management today - AI and machine learning, combination products, and proactive safety by design - and highlight the many ways professionals can get involved in shaping the future of safety science.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:00 Introduction and welcome01:40 Emerging themes in MedTech risk: AI and combination products03:30 Why Bijan created the MedTech Safety Conference05:00 From Medtronic to Amsterdam: a 400% growth story06:45 The 2026 theme: Proactive Safety by Design08:30 Academic and regulatory collaboration (Northeastern, MIT, FDA)10:00 QMSR and the growing role of risk-based assurance12:00 Conference structure: workshops, keynotes, collaboration day15:00 How to participate: speak, teach, or lead a discussion18:00 Abstract selection and deadlines21:00 New ISO documents on AI/ML and combination devices23:00 Early-bird registration and next steps25:00 Closing thoughts and key takeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:Conference Website: Program, Abstract Submission, Early Bird Pricing.LTR: Tips for Improving Collaboration in Risk Management.ACHIEVE Workshop: Using ChatGPT to Analyze Recalls and Adverse Events. Key Takeaways* The MedTech Safety Conference 2026 will be held at Boston at Northeastern University, from June 2-5, 2026.* The conference theme: “Proactive Safety - From Clinic to Home” emphasizes the focus on building safety into devices from concept.* The event has grown 400% since its first year, proving global momentum.* Dr. Michelle Tarver (FDA CDRH) is an invited speaker to deliver a keynote, highlighting the importance of safety in medical devices.* New ISO guidance documents 24971-2 (AI/ML) and 24971-3 (Combination Devices) are expected to launch just before the event.* The conference includes an expanded four-day program includes workshops, keynotes, and a “Day of Collaboration.”* It brings together industry, academia, and regulators in one shared forum.* AI and combination products are today’s top emerging risk themes.* Abstracts open through Dec 31, 2025; early-bird registration at medsafety.net.* This conference is a grassroots, non-commercial movement: by the community, for the community.KeywordsMedTech Safety Conference 2026, Proactive Safety by Design, Risk Management, QMSR Readiness, AI/ML in Medical Devices, Combination Products, ISO 24971-2, ISO 24971-3, FDA CDRH, Medical Device SafetyAbout Bijan ElahiBijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. Bijan is a technical fellow, and an affiliate professor at Drexel University, USA. Bijan is also a lecturer at Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. He is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He has trained over 10,000 people worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 technical and human sides of medical innovation, revealing how living with diabetes transformed his understanding of patient experience, vigilance, and empathy in risk-based decision-making.Together, Naveen and Rick explore:* The evolution of continuous glucose monitoring (CGM) technology* What held back CGMs for decades, and what finally made them viable* How real-world data and device reliability shape patient trust* Why risk management must include emotional and psychological dimensions of user experience* The leadership challenge of turning “patient-centricity” from a slogan into a daily practiceThis conversation reminds every MedTech professional that behind every risk file is a real human story—and sometimes, that story could be our own.Chapters00:00 – Introduction: The human side of risk and living with diabetes02:00 – Rick’s medical journey and sudden onset of diabetes06:00 – Emotional and psychological recovery after surgery10:30 – From biosensors to combination products: a full-circle career13:30 – The rise of CGM technology and what made it possible18:00 – Data overload, trust, and the benefit-risk balance24:00 – Failures, vigilance, and lessons for risk professionals26:00 – Empathy as a leadership skill in risk management29:00 – Closing reflections: patient-centricity as personal missionSuggested links:* LTR: Why risk practitioners must build the empathy muscle. * LTR: The most important question - who is taking the risk?.* FDA: Dexcom G6 De Novo database entry.Key Takeaways* Risk is personal: The devices we design may one day keep us alive.* Empathy is technical: Design controls must reflect real human experience.* Patient-centricity needs proof: It’s shown in practice, not posters.* Data empowers, and overwhelms: More information isn’t always better.* Reliability builds trust: Every sensor failure is a lesson in vigilance.* Benefit-risk is dynamic: Even mature devices demand continuous balance.* Innovation carries responsibility: Breakthroughs require humility and care.* Experience changes perspective: Living the risk reshapes professional judgment.* Leadership starts with listening: Empathy drives safer, smarter teams.* Technology evolves, so must we: Staying curious sustains both progress and safety.KeywordsRisk management, design control, combination products, empathy, patient experience, diabetes, continuous glucose monitoring, benefit-risk, medical devices, leadershipAbout Rick WedgeRick Wedge is a risk management and design control leader with extensive experience in drug-device combination products. Over more than two decades in MedTech and pharma, he has led global initiatives in quality systems, design controls, and risk management aligned with ISO 13485, ISO 14971, and FDA 21 CFR Part 820.A trained scientist with a Ph.D. background in electrochemical biosensors, Rick began his career developing glucose sensors - technology that later became essential to his own health journey. Today, he combines deep technical expertise with a passion for patient-centric design and regulatory excellence, inspiring professionals to view risk management through both a technical and human lens.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 about inclusivity can make or break product safety and adoption.They discuss how differences in motion sickness between male and female users, or colorblindness among technicians, can introduce hidden usability risks if overlooked. Hannah emphasizes the value of partnering with universities, learning from real users, and fostering open feedback loops between engineers and healthcare professionals.Her message is clear: by recognizing human variability, building empathy into design, and communicating early, teams can create safer, more effective medical devices, and avoid costly human factors failures that derail regulatory approval.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:30 Introducing Hannah Walter02:39 Human Factors in Emerging Technologies05:25 Behavioral Adaptation in Virtual Environments07:50 Motion Sickness and Gender Differences10:45 Inclusive Design and Colorblindness13:32 Design Evolution and Adaptation17:18 Early Human Factors Conversations19:54 Practical Strategies for Inclusivity20:59 Standards, Guidance, and Research24:31 Key Takeaways and Closing ReflectionsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Think of human factors for AI as levels of automation.LTR: Understanding human factors aspect of AR applications in MedTech.LTR: Medical device recalls deep dive series - Part 1.Key Takeaways* Human factors must be integrated early, not treated as a final test.* Inclusivity isn’t optional - gender, color perception, and physical comfort all affect usability and safety.* Failure examples (e.g., color-blind-unfriendly devices) can be powerful motivators for change.* Academic partnerships can extend research beyond product-development constraints.* AR/VR environments highlight motion-sickness differences that designers must account for.* The FDA cites human-factors issues as a leading reason for product-clearance delays.* Iconography, feedback cues, and adaptive interfaces reduce user error.* Open dialogue with nurses, lab techs, and other users drives innovation.* Human-centered design is also business-centered - better usability means fewer recalls and more adoption.* “Don’t forget the human in human factors.”KeywordsHuman factors, inclusive design, usability engineering, AR/VR, motion sickness, robotic surgery, colorblindness, medical devices, human-machine interface, user experience, ergonomics, product development, safety, innovation, FDA guidanceAbout Hannah Walter, Ph.D.Hannah Walter is a Senior Human Factors Engineer specializing in usability engineering, cognitive and physical ergonomics, and accessibility in medical devices. She has extensive experience supporting the full product development lifecycle - from early user research and formative usability testing to validation, risk analysis, and regulatory submissions.Hannah earned her Ph.D. in Kinesiology (Human Movement Science) from the University of Minnesota, where her research explored motion sickness, postural adaptation, and human interaction in virtual environments. Before transitioning to industry, she served as an adjunct professor at the University of Minnesota, teaching courses on motor development and human perception.Her passion lies in advancing inclusive, human-centered design practices that bridge research, engineering, and user experience to make technology safer and more intuitive for everyone. Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 idea to stimulate the phrenic nerves trans-venously evolved from a university lab concept into a first-in-kind, FDA-approved technology. He explains how early investment in quality and risk management systems enabled Lungpacer to navigate three clinical trials, to achieve Breakthrough Device Designation, Emergency Use Authorization during COVID-19, and ultimately PMA approval.The conversation dives into how risk-based decision-making shaped each phase of development - from material selection trade-offs to parallel-path prototyping - and how transparent communication with regulators and investors built confidence in a novel approach to respiratory care. Viral also reflects on leadership lessons from his transition from engineer to executive: balancing innovation with safety, thinking strategically as a QA/RA professional, and having the courage to stay the course through uncertainty. The episode closes with a glimpse into Lungpacer’s future - preventing diaphragm atrophy before it begins through next-generation technology.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:42 Introducing Viral Thakkar01:30 Origins of Lungpacer and early development hurdles04:30 Understanding ventilator-induced diaphragm atrophy06:30 Clinical results and patient impact08:00 How the device works and when it’s used10:15 The EUA experience during COVID-1912:00 Making risk-based trade-offs in materials and design15:15 Communicating risk strategy to management17:37 Strategic role of QA/RA professionals in startups21:13 Career evolution from engineer to executive24:00 Personal story and lessons learned25:00 Future direction and closing commentsSuggested links:* LTR - Collaboration that drives innovation, not delays. * LTR: Understanding risk-based thinking.* LTR: Leadership in the age of AI.Key Takeaways* Mechanical ventilation saves lives but causes rapid diaphragm atrophy and lung injury.* Lungpacer helps recover diaphragm strength to activate the natural breathing pathway via phrenic-nerve stimulation.* Early implementation of quality and risk systems accelerates innovation safely.* FDA granted Breakthrough Device Designation in 2016 and PMA approval in 2024.* COVID-19 EUA demonstrated safety and efficacy under crisis conditions.* Parallel development reduced risk while maintaining speed to clinic.* Data-driven, structured decision-making earns management and regulatory trust.* Cross-functional teamwork and communication are vital for success.* Courage, patience, and strategic thinking define MedTech leadership.* The next frontier: using stimulation proactively to prevent ventilator-induced injury.KeywordsMedTech innovation, breakthrough device, risk-based decision making, regulatory strategy, leadership in startups, quality, risk management, patient safety, strategic decision making, medical device development, transformative healthcare technologyAbout Viral ThakkarViral Thakkar PEng, is Chief Operating Officer at Lungpacer Medical Inc., a company dedicated to developing therapeutic solutions for patients requiring mechanical ventilation.He has over 20 years of experience in the medical device industry, specializing in the design and development of innovative medical technologies. Viral has led the development of critical care, cardiovascular, robotic surgery, respiratory, and neurostimulation devices. He has been instrumental in bringing to market first-of-their-kind products, including power-actuated surgical stapling devices, cardiovascular and peripheral stents, stent delivery systems, embolic protection devices, and catheter-based intra-vascular temperature management devices. He has successfully led the concept-to-commercialization of seven regulated Class II and III medical devices.With over 100 global patents his extensive experience includes leadership roles at ZOLL Medical Corporation, Boston Scientific Corporation, Radiant Medical, SMTPL, and Power Medical Interventions.Viral’s commitment to innovation has contributed to the advancement of the medical device industry, helping improve patient outcomes.DisclaimerInformation and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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 mining of MAUDE reports uncovered 43 % of events that structured codes missed - a three-to-four-month early warning.* Regulatory blind spot: Substantial-equivalence pathways preserved untested procedural assumptions.* Strategic mitigation: Boston Scientific chose updating information for safety as the appropriate risk control measure and not product removal.* Industry-wide signal: Similar Abbott access-system recalls revealed a shared procedural vulnerability, highlighting the need for peer vigilance.* Evolving vigilance: Turning post-market surveillance from a compliance task into strategic intelligence.Actionable takeaways for QA/RA leaders:* Integrate narrative analytics to detect weak procedural signals early.* Bridge verification gaps with proactive human-factors and workflow validation.* Adopt cross-manufacturer vigilance: treat competitor recalls as intelligence triggers, not isolated events.* Align risk management with growth: ensure vigilance capacity scales with commercial expansion.* Reframe safety as a value driver: invest in foresight tools before crisis forces the case.🎧Listen to the audio brief above for an overview of this case and lessons learned. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* WATCHMAN TruSeal Access System Class 1 Recall, FDA recalls database entry. * Boston Scientific Urgent Field Safety Notice, Issued 29 July 2025. * Boston Scientific WATCHMAN TruSeal Recall Analysis, Unpublished reportThe text summary was created using ChatGPT-5 (October 2025) with expert review. It distills publicly available information on the Boston Scientific WATCHMAN TruSeal Access System recall and related regulatory insights. While reviewed for accuracy and relevance, it does not constitute legal, regulatory, or medical advice. Medical-device safety and vigilance practices continue to evolve, and details may change after publication.We encourage listeners to interpret these findings in the context of these constraints. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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+. The conversation dives into his role in monitoring regulatory intelligence, supporting clients in navigating evolving global requirements, and making sense of the shifting landscape of risk and compliance.Ed and Naveen explore key themes from the recent RAPS Euroconvergence Conference, including the growing influence of AI in regulatory processes, the importance of standardized IMDRF coding for vigilance and trending, and the need to bridge gaps between post-market surveillance, risk management, and complaints handling. They also reflect on how language and interpretation such as “indicators,” “benefit-risk ratio,” and “state of the art” are shaping our understanding and regulatory expectations. Ed closes with a reminder that asking the right questions, building systems that deliver actionable answers, and fostering a culture of curiosity are essential to effective risk management.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters* 00:10 – Introducing Edward Ball* 02:41 – Insights from the RAPS Euroconvergence Conference* 04:41 – AI in MedTech regulation and FDA’s use of AI tools* 07:00 – AI for vigilance reporting and trending of adverse events* 09:00 – Importance of IMDRF coding and challenges with standardization* 12:00 – Disconnect between vigilance, complaints, and risk management files* 16:20 – Indicators vs. thresholds in post-market surveillance* 18:30 – Misinterpretations of “benefit-risk ratio” and “state of the art”* 22:00 – Regulatory expectations vs. manufacturer practices* 23:47 – Announcements, Key takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Defining state of the art can be challenging - here are a few tips.LTR: AI use cases in MedTech regulatory applications.ACHIEVE: PMS Workshop.Key Takeaways* AI is increasingly used by regulators for trending and vigilance, but its outputs are only as reliable as the inputs.* Standardized IMDRF coding is critical for consistent vigilance reporting and meaningful trend analysis.* Many companies still struggle to align internal complaints data with standardized codes, creating disconnects in risk management.* Post-market surveillance (PMS) is not new, but it must be integrated into the quality and risk management system, not treated as a silo.* “Indicators” in PMS are not always numeric; a single new signal or case can be just as important as statistical thresholds.* Misinterpretation of terms like “benefit-risk ratio” or “state of the art” can cause regulatory confusion and misaligned expectations.* Regulators, notified bodies, and manufacturers often use different definitions, underscoring the need for clearer common language.* Building PMS systems around the questions you need to answer ensures data is actionable for patients, regulators, and companies.* A culture of curiosity where people feel safe asking questions is essential for effective risk management.* Continuous learning and diverse perspectives strengthen both regulatory understanding and organizational decision-making.KeywordsAI in MedTech, Vigilance reporting, IMDRF coding, Post-market surveillance (PMS), Risk management, Regulatory intelligence, Benefit-risk ratio, State of the art, Trend reporting, Complaints handling, Patient safetyAbout Edward BallEdward Ball is a seasoned medical device specialist with over 20 years of experience spanning regulatory compliance, risk management, product safety, quality systems, and post-market surveillance. He has held leadership roles at RQM+, Fresenius Kabi, ConvaTec, and the UK’s MHRA, where he led complex investigations, vigilance reporting, and technical reviews of medical devices.With a strong foundation in medical engineering (MSc, University of Liverpool), Edward brings deep expertise in design controls, incident investigation, and CAPA systems, helping organizations navigate evolving global regulatory frameworks and ensure patient safety.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated conte

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 of AI adoption, and how regulations like the EU AI Act and America’s new AI Action Plan will shape compliance, why trust and governance are central to enterprise deployment, and what skills QA and RA professionals need to thrive in an AI-driven world. Ajay emphasizes that ethical and proactive AI governance isn’t a barrier to innovation, rather a pathway to building better, more resilient businesses.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters* 00:26 – Introducing Ajay Dankar* 01:12 – How AI is Shaping Everything We Do* 03:32 – Generative vs. Agentic AI* 06:02 – Regulations and the U.S. AI Action Plan* 10:13 – What Senior Executives are Asking* 16:17– Opportunities for QA/RA Professionals* 23:32 – Announcements, Key Takeaways and Closing ThoughtsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Kevin Schawinski on Building Trustworthy AI and MedTech Readiness.LTR: Contrasting US and EU approaches to AI regulation.ACHIEVE: PMS Workshop.Key Takeaways* AI is fundamentally reshaping how work gets done across industries.* Generative AI creates new content, while agentic AI aims for autonomous decision-making.* The U.S. AI Action Plan offers a blueprint for compliance, innovation, and governance.* Regulations will require proactive integration of AI governance into development pipelines.* Trust is a central challenge. Enterprises must ensure compliance, transparency, and reliability.* Most organizations have moved past AI pilots and now face execution and scaling challenges.* QA and RA professionals have a unique opportunity to lead enterprise-level AI governance.* Skills in AI literacy and critical thinking are essential for future career growth.* Compliance is no longer a “checkpoint”; it must be embedded into workflows from the start.* Ethical, well-governed AI adoption strengthens business resilience and customer trust.KeywordsAI governance, generative AI, agentic AI, compliance, trust, regulatory landscape, medtech, enterprise adoption, ethical AI, proactive governanceAbout Ajay DankarAjay Dankar is a seasoned product and engineering leader with deep expertise in cloud infrastructure, enterprise-grade platforms, and AI-driven innovation. Currently the Co-Founder of Trussed AI, he is focused on making generative and agentic AI trusted and enterprise-ready. Ajay has held senior leadership roles at Google, Amazon Web Services, Adobe, Aviatrix, and PayPal, where he drove large-scale product strategies, cloud transformations, and SaaS platform development.An entrepreneur and innovator at heart, Ajay has co-founded multiple startups, authored four U.S. patents in multi-factor authentication, and successfully built Finsphere—a fintech company acquired by Visa. With a proven track record of leading multi-geo teams, mentoring talent, and aligning technology with customer needs, he brings a rare blend of business acumen, technical depth, and customer empathy. Ajay holds degrees in Electrical Engineering from the Indian Institute of Technology, Delhi, and the University of Florida.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 themes include:* The distinction between CSA process risk vs. ISO 14971 medical device risk.* The binary “high vs. not high process risk” classification and its audit implications.* Use of unscripted testing (exploratory, scenario, error guessing) and the challenge of proving rigor.* Vendor accountability in cloud/SaaS environments and continuous deployment.* The cultural shift required for manufacturers to define and defend “profound judgment” in risk decisions.Ultimately, CSA is framed as both an opportunity for efficiency and a test of organizational maturity in risk-based quality management.🎧Listen to the audio brief above for an overview of the AI/ML device recalls, emerging vulnerabilities and trends to watch. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* Computer Software Assurance for Production and Quality System Software, Final Guidance issued on September 24, 2025. This summary was created using ChatGPT-5 with expert review. It distills publicly available information on the FDA’s Final Guidance on Computer Software Assurance (CSA). While reviewed for accuracy and relevance, it does not constitute legal, regulatory, or medical advice. Software assurance practices in healthcare are rapidly evolving, and details may change after publication.We encourage listeners to interpret these findings in the context of these constraints. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 as a department of one, to envisioning a “virtual FDA inspector” that continuously highlights QMS health and compliance gaps. The discussion explores how regulatory bodies like FDA and EU notified bodies are already deploying AI to review submissions, why trust and validation remain critical for adoption, and how companies can prepare their culture and QMS for this shift. Adam emphasizes that while AI can streamline audits, inspections, and submissions, Quality professionals must remain vigilant, collaborative, and open to continuous improvement. The message is clear: proactive compliance, powered by AI, is quickly becoming the new standard for life sciences organizations.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:08 – Introducing Adam Foresman01:00 – From Quality Leader to Startup Founder02:56– What Proactive Compliance Really Means04:23 – AI Agents for Regulatory Gap Assessments07:21 – Trust and Validation in AI Systems13:00 – Real-World Use Cases and Benefits19:06 – Preparing for an AI-Enabled Future22:16 – Standardization, Culture Shift & Key TakeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Databases and automation tools for clinical evaluation.LTR: Contrasting US and EU approaches to AI regulation.ACHIEVE: PMS Workshop.Key Takeaways* Proactive compliance shifts QMS from periodic audits to continuous monitoring.* A “virtual FDA inspector” can highlight compliance gaps in real time.* Seamless EQMS integration is critical for adoption and user trust.* AI-driven platforms must be validated with rigorous accuracy testing.* Regulators like FDA and EU notified bodies are already using AI for submissions.* Trust in AI systems depends on transparency, validation, and human oversight.* Real-world use cases show benefits in inspections, audits, and onboarding.* False positives are manageable if systems allow human review and override.* Culture shift toward openness and continuous improvement is essential.* Quality professionals should focus on collaboration and adaptability in an AI-driven future.KeywordsProactive Compliance, Continuous Auditing, QMS, Regulatory Affairs, FDA, EU MDR, AI in Quality, Gap Analysis, EQMS Integration, Trust in AIAbout Adam ForesmanAdam Foresman is Co-Founder and CEO of Ryden Solutions, a platform that automates compliance gap analysis and audits for life science companies. He has led global quality and regulatory affairs at VideaHealth, driving approvals and compliance for AI/ML diagnostics, and held senior roles at Midmark Corporation, Dentsply, and Hollister. Adam holds engineering degrees from Purdue University, an MBA from Indiana University’s Kelley School of Business, and multiple ASQ certifications, including Six Sigma Black Belt.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 insights for organizations preparing for compliance.The conversation explores ISO 42001 as a baseline AI management system standard, the implications of fine-tuning large models, and why medical device professionals may actually be better prepared than most industries to navigate AI regulation. Kevin emphasizes the importance of responsible deployment across culture, processes, and technology, and leaves listeners with a clear message: MedTech organizations already have the tools and mindset to take a leadership role in shaping trustworthy AI.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:10 Introducing Kevin Schawinski - From Black Holes to AI03:29 How EU AI Act Parallels EU MDR07:00 MedTech Readiness for AI Compliance11:00 Defining and Building Responsible AI20:13 Managing Risks Across Supply Chain23:19 Announcements and Key TakeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Contrasting US and EU Approaches to AI Regulation.LTR: Eight Practical Actions to Future-Proof Your AI Enabled Medical Devices.ACHIEVE: PMS Workshop.Key Takeaways* The EU AI Act mirrors MDR’s risk-tiered framework.* MedTech pros are better prepared than most for AI rules.* ISO 42001 is the new baseline for AI management.* 42001 helps, but doesn’t ensure AI Act compliance.* Fine-tuning AI models shifts full responsibility to you.* Responsible AI needs culture, process, and tech alignment.* EU and U.S. AI laws are moving fast but differ in approach.* U.S. states push ahead, driving calls for federal law.* AI supply chains create hidden liability risks.* MedTech can lead in trustworthy AI using existing practices.KeywordsEU AI Act, MDR, Risk-tiering, ISO 42001, Compliance, Liability, Fine-tuning, Responsible AI, Trustworthy AI, Supply chain, MedTech, GovernanceAbout Kevin SchawinskiKevin Schawinski is the Co-Founder & CEO of Modulos AG, where he leads the development of AI governance solutions that align with global standards such as the EU AI Act and the U.S. NIST AI Risk Management Framework. An astrophysicist turned entrepreneur, he previously served as an assistant professor at ETH Zurich, published in leading journals like Nature and Science, and pioneered the use of machine learning in astrophysics. Today, Kevin contributes to international AI policy efforts with NIST and the European Commission, advocating for responsible and trustworthy AI innovation.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 guidance converge, and where they diverge.* Thematic gaps: authentication, cryptography, secure coding (EU) vs. network security and resilience (FDA).* Why existing vulnerabilities often stem from implementation failures, not policy gaps.* A proposed structural fix: separating high-level principles from device-specific technical guidance.* How stronger enforcement or penalties could change manufacturer behavior.For professionals in regulatory affairs, risk management, and MedTech development, this conversation highlights where guidance is falling short, and what’s needed to drive consistent, secure practices across the industry.🎧Listen to the audio brief above for an overview of the AI/ML device recalls, emerging vulnerabilities and trends to watch. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* Cybersecurity requirements for medical devices in the EU and US - A comparison and gap analysis of the MDCG 2019–16 and FDA premarket cybersecurity guidance, Research Letter | Computational and Structural Biotechnology Journal, July 2025.This summary was created using ChatGPT-5 (September 2025) with expert review. It distills publicly available information on EU and FDA cybersecurity guidance for medical devices. While reviewed for accuracy and relevance, it does not constitute legal, regulatory, or medical advice. Cybersecurity in healthcare is a rapidly evolving field, and details may change after publication.We encourage listeners to interpret these findings in the context of these constraints. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 intersection of MedTech, telecom, and regulatory science.The conversation covers key issues manufacturers face when adopting wireless connectivity, such as defining quality of service, assessing risk categories, and ensuring coexistence in crowded spectrum environments. Omar explains why medical devices must be viewed as connected systems rather than standalone products, highlighting risks from Bluetooth- and Wi-Fi-enabled devices, lessons from real-world recalls, and the growing need to integrate safety, cybersecurity, and interoperability into design. His takeaways emphasize a holistic, systems-based approach to innovation and evaluation in connected healthcare.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters01:00 Omar’s Journey - From Academia to FDA to Entrepreneurship03:35 Understanding First Principles of Wireless in MedTech06:14 Risk Categories for Wireless Functions08:16 Understanding Wireless Coexistence13:00 Thinking in Systems, Not a Stand Alone Device15:35 Real-World Recall Example19:17 Wireless Immunity and 5G24:42 Announcements, Key Takeaways and Closing ThoughtsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: A new paradigm for building connected medical devices.LTR: FDA guidance on interoperable devices.ACHIEVE: PMS Workshop.Key Takeaways* The FDA wireless guidance is crucial for incorporating wireless technology.* Understanding the risk category for wireless functions is essential.* Wireless coexistence is a risk management approach, not just a checkbox.* Medical devices should be viewed as interconnected systems.* Cybersecurity must be considered alongside other technical aspects.* Evaluating the end-to-end system is vital for safety and performance.* Device manufacturers should consult relevant technical documents for guidance.* The introduction of new technologies requires updated evaluation standards.* Communication between devices can impact performance and safety.* A holistic approach is necessary for effective risk management.KeywordsMedical devices, wireless technology, risk management, FDA guidelines, wireless coexistence, medical systems, cybersecurity, connectivity, healthcare innovation, regulatory complianceAbout Omar Al KalaaOmar Al Kalaa is the Founder and Principal of Inovectrum, a technology practice bridging MedTech and telecom through wireless innovation. He helps companies design and deploy high-performance connectivity solutions for medical devices, clinical environments, and digital health systems.Before founding Inovectrum, Omar spent over eight years at the FDA, where he led regulatory science initiatives on 5G-enabled medical devices, developed wireless coexistence standards, and guided industry on complex compliance challenges. With a PhD in Electrical and Computer Engineering from the University of Oklahoma, he combines deep technical expertise with regulatory insight to advance future-ready connected health technologies.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 middle management, and the evolving definitions of benefits in risk management. The discussion emphasizes the need for clear communication, prioritization of patient safety, and the integration of project and patient risks to foster better decision-making and collaboration within organizations.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:10 Introducing Richard Matt02:01 Understanding the Communication Breakdown05:02 Connecting Technical and Management Perspectives06:16 Effective Communication Strategies in Risk Management09:12 Navigating Middle Management Dynamics15:50 The Importance of Framing Risks and Benefits17:07 Expanding the Definition of Benefits in Risk Management20:31 Authority and Credibility in Risk Management23:05 Announcements, Key Takeaways and ConclusionIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Communicate to facilitate collaboration, not to impose opinions.LTR Webinar: Benefit-risk evaluation of an AI/ML enabled device.ACHIEVE: FMEA workshop.Key Takeaways* Communication with management about risks is crucial.* Integrating project risks with patient risks enhances understanding.* Building trust is essential for effective collaboration.* Early communication prevents crises from escalating.* Understanding leadership concerns helps frame discussions.* Middle management dynamics can complicate risk communication.* Framing risks in terms of benefits is vital for engagement.* Simplifying risk management practices can improve efficiency.* Authority in risk management comes from expertise, not just position.* Listening to customer complaints provides valuable insights.KeywordsRisk communication, senior executives, risk management, patient safety, project management, collaboration, trust, benefits, medical devices, leadershipAbout Richard MattRichard Matt is Principal Consultant at Aspen Medical Risk Consulting, with over 30 years of experience in product development, quality engineering, and risk management. He specializes in innovative methods for benefit–risk assessment, FMEA, and integrated product development, helping medical device companies strengthen compliance and improve patient safety.He is also the inventor of a patented “risk algebra” approach that enables clear, defensible comparisons of benefit and risk, a breakthrough with wide implications for devices, biologics, and combination products.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

Note: 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 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 missing images).* Hardware failures (e.g., loose CT table bolts).* Labeling & approval lapses (e.g., unapproved software versions).Four-tier, risk-based system; stringent requirements for high-risk systems (including many medical devices); compliance timelines of 1–3 years.* Trends to Watch: * High rate of recalls within 12 months of clearance.* Devices without clinical validation face more, and larger, recalls.* Public companies account for nearly all recalled units, suggesting market pressures for faster launches without adequate clinical validation. * Takeaways for stakeholders: * Manufacturers: Strengthen lifecycle controls, prioritize pre-market validation, enhance post-market vigilance.* Regulators: Consider time-limited approvals and stronger oversight of high-volume AI devices.* Clinicians: Validate AI results with clinical judgment—trust but verify.* Patients: Benefit from innovation but remain vulnerable; safety must remain paramount.AI in MedTech is transformative but not without risk. The challenge is moving from compliance - driven recall response to active risk mitigation for robust safety and effectiveness. 🎧Listen to the audio brief above for an overview of the AI/ML device recalls, emerging vulnerabilities and trends to watch. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* JAMA: Early Recalls and Clinical Validation Gaps in Artificial Intelligence - Enabled Medical Devices, Research Letter | AI in Health Policy, August 2025.* AI/ML Recalls Analysis - Unpublished report, created using ChatGPT. This summary was created using ChatGPT-5 (September 2025) with expert review. It distills publicly available information on FDA-cleared AI/ML-enabled devices and related recall patterns. While reviewed for accuracy and relevance, it does not constitute legal, regulatory, or medical advice. AI in healthcare is a rapidly evolving area, and details may change after publication.We encourage listeners to interpret these findings in the context of these constraints. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 living process tied to risk management. Tibor also shares common audit pitfalls, best practices for compliance, and how automation tools - and even AI - are reshaping the future of PSUR reporting.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing Tibor Zechmeister01:05 Insights from RAPS Euroconvergence Conference03:17 Understanding PSUR Requirements in MDR05:40 Challenges in Estimating Device Usage10:18 The Role of Software in Medical Devices13:43 Regulatory Intent Behind PSUR Requirements17:16 Common Audit Findings in PSUR Compliance21:01 Best Practices for Integrating PSUR with Risk Management23:45 Automation Tools for PSUR Development28:02 Announcements, Key Takeaways and ConclusionIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Databases and Automation Tools for Clinical Evaluation.MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745, updated as of December 2022..ACHIEVE: Post-Market Surveillance Workshop.Key Takeaways* The PSUR is a snapshot to assess device safety.* MDCG guidance should be followed for best practices.* PSUR should be a continuous, interrelated process.* Collaboration among industry stakeholders is essential.* Understanding the regulatory intent behind PSUR is crucial.* Estimation of device usage can be challenging.* Software as a medical device requires careful tracking.* Automation tools can enhance PSUR development efficiency.* PSUR is not just a regulatory requirement, but a safety measure.* Effective communication with regulatory bodies is key.KeywordsPSUR, MDR, medical device regulation, risk management, post-market surveillance, compliance, software as a medical device, regulatory challenges, best practices, automation toolsAbout Tibor ZechmeisterTibor Zechmeister is Head of Regulatory and Quality at Flinn.ai and a MedTech entrepreneur with nearly 15 years of experience spanning medical devices, software, and regulatory compliance. He has founded multiple companies, advised startups, and serves as a Notified Body auditor across Europe. At Flinn.ai, he helps manufacturers harness AI and automation to simplify regulatory processes and improve patient safety. With a background in biomedical engineering and an MBA, Tibor brings a rare mix of technical depth, regulatory expertise, and entrepreneurial vision to the future of MedTech.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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…

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, and lifecycle management for adaptive AI in medical devices.* EU AI Act: Four-tier, risk-based system; stringent requirements for high-risk systems (including many medical devices); compliance timelines of 1–3 years.* Strategic Impact: Global companies must navigate divergent compliance pathways — innovation speed vs. upfront safety guarantees.* Professional Development Tips: Stay informed, understand AI fundamentals, think globally, and develop AI-specific quality, regulatory, and risk management skills.The regulatory choices made today will shape not only innovation timelines but also how safely and ethically AI integrates into healthcare. Professionals who understand both U.S. and EU approaches will be best positioned to navigate and influence the future.🎧Listen to the audio brief above for an overview of the contrasting visions and strategies in the U.S. and EU for AI regulation.Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* The White House: Americas AI Action Plan, issued July 2025.* US Congress: Regulating Artificial Intelligence: U.S. and International Approaches and Considerations for Congress, Report number R48555, issued June 2025. * FDA: Artificial Intelligence in Software as a Medical Device, website accessed on August 10, 2025. * Future of Life Institute: High-level summary of the AI Act, Issued February 2024.The text summary was created using ChatGPT-4o (May 2024) with expert review. It summarizes publicly available sources on emerging U.S. and EU AI regulation approaches. While reviewed for accuracy and relevance, it is not legal or regulatory advice. AI regulation is rapidly evolving, and details may change after publication. We encourage listeners to interpret these findings in the context of these constraints. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 domestic innovation, government support, and the role of AI in healthcare, providing valuable advice for students and early career professionals looking to enter the medical sector.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:22 Introducing Attrayee (Atty) Chakraborty03:42 The Evolving Landscape of Medical Devices in India05:58 Domestic Innovation and Government Support09:04 Career Opportunities for Young Professionals in India14:45 Comparing Indian Regulations with Global Standards18:02 The Role of AI in India's Medical Sector21:55 Advice for Students and Early Career Professionals24:50 Closing Comments, Announcements and Key TakeawaysIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: What QA/Ra Professionals Need to Know About Rapidly Growing MedTech in India. ABLE: Association of Biotechnology Led Enterprises.ACHIEVE: Post-Market Surveillance Workshop.Key Takeaways* The medical device industry in India is evolving rapidly.* Networking is crucial for career advancement in regulatory affairs.* Government support is fostering innovation in the medical device sector.* AI is becoming increasingly important in India's healthcare landscape.* Young professionals should seek out incubators and accelerators for support.* Understanding global regulations can enhance credibility in the industry.* Simplicity and cost-effectiveness are key in Indian medical devices.* Engaging with startups can provide unique insights into problem-solving.* Participating in conferences can expand professional networks.* Taking initiative is essential for career growth in the medical field.KeywordsMedical devices, regulatory affairs, India, innovation, career guidance, AI in healthcare, quality management, healthcare regulations, startups, networkingAbout Attrayee ChakrabortyAttrayee Chakraborty is a quality and regulatory leader specializing in digital health and AI-enabled medical devices. At Analog Devices, she drives QMS development, risk management, and AI governance to meet global regulatory standards. Recognized as Quality Magazine’s 2025 “Rookie of the Year” and a 2025 RAPS Rising Star, Attrayee has delivered talks at major industry events including RAPS, MDM West, and ISPE. She also serves on working groups with IEEE, RAPS, and SQA, shaping the future of healthcare AI compliance. Passionate about empowering early-career professionals, she bridges the gap between regulatory rigor and real-world innovation. Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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…

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 of patient harm and compare this event with a similar capacitor-related recall involving Medtronic’s Puritan Bennett 980 (PB980) ICU ventilator.This 15-minute episode covers:* 🚨 The critical failure mode and what made it so impactful* 🕵️‍♂️ How injury signals were buried in "malfunction" codes* 🔍 Comparative insights between HT70 and PB980 ventilator recalls* 🧠 Organizational decisions and how strategic priorities influenced recall actions* 💡 Key takeaways for quality, regulatory, and risk professionals: including how to better use narrative data, monitor slow-developing risks, and conduct cross-device analysisThis case study challenges us to think beyond checkboxes—to look at what data truly reveals, how companies respond differently to similar failures, and how we as professionals can improve surveillance and advocacy for patient safety.🎧Listen to a brief audio summary of this case above and lessons QA/RA and Risk professionals can apply in practice. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:This audio brief is the result of a retrospective analysis conducted using ChatGPT-4o (May 2024 version) in close collaboration with a human expert. The analysis combined structured MAUDE data with deep narrative review across more than a decade of adverse event reports. Our approach followed a phased, hypothesis-driven process to identify early safety signals, quantify underreported harm, and evaluate differences in organizational response across two Medtronic ventilator recalls (HT70 and PB980).The insights presented were generated through iterative refinement with ChatGPT and were critically reviewed by a human expert for clinical relevance, methodological soundness, and editorial integrity. Key limitations—such as underreporting in the FDA’s MAUDE database and lack of access to internal company data—are acknowledged within the audio. We encourage listeners to interpret these findings in the context of these constraints.Specifically, the audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used in our analysis:* FDA: Class I recall event 96774, Posted Date June 9, 2025, Newport HT70 and HT70 Plus Ventilators, accessed on 25 July 2025. * FDA: Class I recall event 76891, Posted Date April 10, 2017, Newport HT70 and HT70 Plus Ventilators, accessed on 25 July 2025.* FDA: Class I recall event 88987, Posted Date April 10, 2017, Puritan Bennett 980 Series Ventilator, accessed on 25 July 2025.* FDA: Newport HT70 Ventilator, K111146 summary, Issued December 1, 2011, accessed on 24 July 2025.* FDA: Puritan Bennett 980 Series Ventilator System, K131252 summary, Issued Feb 24, 2014, accessed on 24 July 2025. * Orca1.ai: MAUDE data extract for HT70 ventilators, 2013-2025, extracted on 24 July 2025.* Orca1.ai: MAUDE data extract for all ventilators, FDA Product Code CBK, 2019-2024, extracted on 24 July 2025.* Medtronic press releases, annual reports and other media coverage during 2020 - 2025 timeframe* Analyst Report (Unpublished): Iterative data analysis, insights and lessons learned, prepared with assistance from OpenAI ChatGPT-4o, guided by human expert, 24 July 2025. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

Summary“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 and collaboration among teams. The discussion highlights the potential benefits of off-label use for patient care while also addressing the need for risk management and monitoring to ensure safety and compliance.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing to Kristen Petersen02:25 Understanding Off-Label Use: Definitions and Examples07:33 Understanding Off-Label Use in the Context of ISO 1497111:23 Opportunities and Challenges of Off-Label Use13:526 Documenting Off-Label Use in Clinical Evaluation Reports18:25 Reasons Behind Off-Label Use by Healthcare Professionals21:59 Regulatory Considerations for Off-Label Use23:45 Announcements, Key Takeaways and Closing RemarksIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Understanding the notified body perspective on clinical evaluation. Team NB: Data generated from ‘Off-Label’ Use of a device under the EU Medical Device Regulation 2017/745.ACHIEVE: Post-Market Surveillance Workshop.Key Takeaways* Off-label use is when a device is used outside its intended use.* Understanding off-label use is crucial for regulatory compliance.* Risk management plays a key role in addressing off-label use.* Collaboration among teams is essential for effective monitoring.* Documentation of off-label use should be integrated into clinical evaluation reports.* Off-label use can provide opportunities for expanding indications.* Healthcare professionals sometimes use devices in unapproved and off-label ways to solve patient issues.* Regulatory bodies are increasingly recognizing the importance of monitoring and reporting off-label device use.* Ambiguous labeling can lead to unintentional off-label use.* Continuous monitoring of literature and adverse events is necessary.KeywordsOff-label use, clinical evaluation, medical devices, risk management, regulatory compliance, healthcare professionals, patient safety, documentation, post-market surveillance, medical writingAbout Kristen PetersenKristen Petersen is Manager – CER Specialist (Medical Devices) at Global Regulatory Writing & Consulting (GLOBAL), where she leads the development of Clinical Evaluation Reports (CERs) under EU MDR and MDD, having authored and overseen more than 50 such reports. With over eight years in the medical device industry, she helps organizations translate clinical data into regulatory-ready narratives and mentors teams on best MDR practices. She holds a Bachelor’s degree in Political Science and Government from Brigham Young University.Since this recoding, Kristen has transitioned to a new role as a Principal Medical Writer/ Clinical Evaluation Specialist at Johnson & Johnson MedTech (Shockwave Medical).Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 need for effective communication through storyboarding and the proactive approach required in the medical device industry. Dr. Fernandes concludes with key takeaways that inspire risk practitioners to embrace change and work towards better patient outcomes.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:13 Introducing Dr. Queenita Fernandes02:02 Personal Journey and Influences03:44 Literature Review from a Clinician's Perspective07:56 Integrate Clinical Perspective with Engineering to Design for Safety10:04 Working Smart with AI Tools for Reviewing Clinical Literature16:58 Using Storyboards for Effective Communication20:50 Embracing AI Tools to Facilitate Collaboration23:19 Imagining a Validated Real-Time AI System for Clinical Review25:43 Announcements, Key Takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Databases and automation tools for clinical evaluation. LTR: Understanding the notified body perspective on clinical evaluation. ACHIEVE: FMEA Workshop.Key Takeaways* Think proactive and partner cross-functionally.* Embrace technology and work smart.* AI should be viewed as a tool, not a replacement.* People generally intend to do good things.* Literature review can be intimidating but manageable.* Engage healthcare professionals in decision-making.* Use storyboarding for effective communication.* Signal detection is crucial in adverse event reporting.* Collaboration is key in the medical device industry.* Always put the patient at the center of evaluations.KeywordsRisk management, healthcare, clinical evaluation, AI in healthcare, adverse events, medical devices, literature review, signal detection, technology in healthcare, collaborationAbout Queenita FernandesQueenita Fernandes is a physician executive and certified patient safety expert with over 20 years of experience in medical safety, post-market surveillance, and regulatory writing. Her background spans clinical medicine, nutrition, and leadership roles across the MedTech ecosystem.Queenita is known for her work in proactive PMS, systematic literature reviews, and benefit-risk analysis under EU MDR and FDA frameworks. She brings a unique ability to translate clinical insight into regulatory strategy, improving safety signal detection and patient outcomes.A frequent speaker at international conferences and webinars, she is a trusted voice on how to strengthen post-market processes through rigor, ethics, and cross-functional collaboration.Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 effectiveness has become more important.Further;In addition, cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cyber incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally. Such cyber incidents and exploits may lead to patient harm as a result of clinical hazards, such as delay in diagnoses and/or treatment.It is important to view FDA’s expectations outlined in this final guidance from the perspective outlined above. Cybersecurity is not an add-on; rather it is now considered to be an essential factor in assessing medical device safety and effectiveness throughout its total product lifecycle. A risk-based approach is recommended to compile documentation for pre-market review, and continued surveillance and actions in the post-market phase. 🎧Listen to a brief audio summary of this guidance and recommendations QA/RA and Risk professionals can apply in practice. Thanks for reading! If you liked this post, please share with others. Note:The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:* FDA: Final Guidance for Cybersecurity in Medical Devices, Issued June 27, 2025.* FDA: Draft Guidance for Cybersecurity in Medical Devices, Issued September 27, 2023.* FDA: Cybersecurity in Medical Devices Frequently Asked Questions, Website accessed July 01, 2025 This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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 biocompatibility, and best practices for ensuring safety in medical devices. The conversation emphasizes the importance of risk assessment and the need for effective communication in the medical device industry.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:15 Introducing Priyanka Murawala02:16 Key Focus in Revised ISO 10993: Foreseeable Misuse and Cumulative Use04:320 Comparing EU and US Regulatory Approaches to Biological Evaluation07:27 Challenges in Meeting Regulatory Expectations for Biological Evaluation11:49 Learning from Device Recalls 19:37 Considering Risk of Residual Processing Agents in Manufacturing22:45 Announcements, Key Takeaways and Closing CommentsIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: Focus on risk, not just testing for biocompatibility of medical devices. Nelson Labs: ISO 10993-1 Key update on the new revision of this critical standardACHIEVE: FMEA Workshop.Key Takeaways* ISO 10993-1 is being updated to focus on foreseeable misuse.* The EU and FDA have different approaches to biocompatibility evaluation.* Regulatory bodies often require extensive testing even for minor design changes.* Biocompatibility recalls highlight the importance of thorough risk assessment.* Involving biocompatibility experts early can improve safety outcomes.* Quality management systems should comply with ISO 13485 standards.* Post-market surveillance is crucial for learning from device performance.* Effective communication of risks is essential in medical device labeling.* Anticipating risks early in the design phase can prevent future issues.KeywordsBiocompatibility, risk assessment, foreseeable misuse, ISO 10993, medical devices, regulatory differences, FDA, EU, biological evaluation, recalls, best practicesAbout Priyanka MurawalaPriyanka Murawala a seasoned regulatory affairs expert and founder of Eunoia Compliance, where she helps medical device companies navigate FDA and EU MDR requirements with a focus on biocompatibility and quality systems. Priyanka holds a PhD in Physical and Materials Chemistry and has conducted postdoctoral research in regenerative medicine at TU Dresden. With deep expertise in ISO 10993 and ISO 13485, and a strong background in biomaterials and nanotechnology, she brings a unique blend of scientific insight and regulatory strategy to every project. Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

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…

Summary“MedTech in India is poised to generate $50 billion in revenues by 2030.”In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Sanjay Arudi, VP of Regulatory and Quality at GE Healthcare in India, to discuss the rapidly evolving MedTech environment in India. They explore the current state of the MedTech industry, government initiatives supporting healthcare, the regulatory landscape, and the importance of post-market surveillance. Sanjay shares insights on the challenges faced in regulatory compliance and offers career advice based on his extensive experience in the field. The conversation highlights India's potential to become a significant player in the global MedTech market by 2030.Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters00:20 Introducing Sanjay Arudi01:25 Current State of MedTech in India03:24 Government Initiatives and Domestic Manufacturing07:44 How Tariffs Might Impact MedTech Companies09:12 Regulatory Environment for Medical Devices14:06 Post-Market Surveillance and Reporting Requirements19:50 Regulatory Compliance Challenges in India22:33 Career Insights and Advice from Sanjay25:31 Announcements, Key Takeaways and Future OutlookIf you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.Suggested links:LTR: An exciting growth opportunity for MedTech in India. LTR: Navigating the regulatory landscape for SaMD in India. ACHIEVE: FMEA Workshop.Key Takeaways* India's MedTech industry is projected to generate 50 billion by 2030.* Government initiatives are crucial for expanding healthcare access.* 80% of medical devices in India are currently imported.* The CDSCO license facilitates entry into multiple markets.* Post-market surveillance is becoming increasingly important.* Regulatory compliance requires collaboration with regulators.* Transparency in reporting adverse events is essential for patient safety.* India's healthcare market is rapidly evolving post-COVID.* Investments in domestic manufacturing are on the rise.* Career success in regulatory roles requires active contribution and solution-oriented thinking.KeywordsMedTech, India, healthcare, regulatory environment, government initiatives, post-market surveillance, medical devices, industry growth, career advice, healthcare innovationAbout Sanjay ArudiSanjay Arudi is the Vice President of Regulatory and Quality at GE Healthcare. He has over 30 years of professional experience in engineering, management and senior leadership roles. His expertise includes product transfers, program management, implementation of Quality & Regulatory requirements across Design, Sourcing, Manufacturing, Install Base & Commercial activities. He has many years of experience in working with global regulators in creating a compliant & friendly manufacturing environment. He holds a Bachelor’s degree in Polymer Science & Technology. Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.DisclaimerInformation and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe

The DxI 9000 Access Immunoassay analyzer instrument and assays are used to diagnose serious conditions such as Hepatitis B and heart attacks, and to monitor levels of therapeutic drugs such as Digoxin used in treatment of heart failure and atrial fibrillation. In a recent warning letter, FDA cited several examples of incorrect severity assignments, Severity Rating has been incorrectly selected for many assays’ false result failure modes. Additionally, FDA found issues with procedures for CAPA, Nonconformances and Design Controls:* Criteria for escalating nonconformances to CAPA are not defined clearly* No process for assessing risk assessment of individual nonconformances * Severity classification of nonconformances released to the field is not adequately defined* No criteria for escalating complaints to CAPA based on trend analysis* CAPA actions are not verified and validated for effectiveness and additional adverse effect(s) on the finished devices* Inadequate procedures for verification and validation of design changes🎧Listen to a brief audio summary of this case above and lessons QA/RA and Risk professionals can apply in practice. Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.Note:The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. Here is the list of resources used for this analysis:* FDA: Warning letter, Beckman Coulter Inc., CMS 678042, March 15, 2024. * K011920, EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229, cleared July 2, 2001.* K121214, ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM, cleared June 14, 2013.* K221225, Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer, cleared November 10, 2022. * Beckman Coulter: Therapeutic Drug Monitoring Flyer FL-47564. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe