Let's Talk Risk! Podcast

Where MedTech professionals gain clarity and confidence to navigate complex decisions.
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Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com

  1. LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections

    1D AGO

    LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections

    Summary “FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.” In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about what early FDA 483 observations under QMSR are already revealing: a clear shift from procedural compliance to evaluating how well companies actually make risk-based decisions across their quality systems. This conversation goes beyond clauses and documentation. It explores how FDA is now looking at system effectiveness, how risk must be integrated across the full product lifecycle, and why leadership teams need to rethink how decisions are made, justified, and communicated under increasing ambiguity. Michelle brings a practical, field-level perspective on what is changing, where companies are most vulnerable, and how QA/RA teams can prepare their organizations for a more dynamic, judgment-driven inspection model. Key Points * FDA is increasingly citing deficiencies in risk management and system-level effectiveness, not just individual subsystems. * QMSR shifts inspections toward how decisions are made, not just whether procedures exist. * ISO 14971 alone is not enough—risk must extend across processes, lifecycle stages, and QMS interactions. * Post-market signals—not just complaints—are becoming critical inputs to risk management. * Leadership involvement, especially through management review, will face greater scrutiny under QMSR. Chapters 00:00 – QMSR and the New FDA Inspection LensWhat early 483s reveal about how inspections are changing 05:30 – Risk Management Beyond the Procedure (Clause 7.1)Why risk must connect across the full product lifecycle 10:40 – What “Risk-Based Approach” Really Means (Clause 4.1.2(b))How FDA may evaluate decision-making, not just documentation 17:00 – Management Review, CAPA, and Leadership AccountabilityWhy effectiveness and escalation matter more than timeliness 21:30 – From Feedback to Signals (Clause 8.2.1)How post-market data and external signals feed a living risk system 31:30 – What QA/RA Leaders Should Do NowHow teams can prepare for a more judgment-driven inspection model If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: * LTR: Risk, CAPA and FDA Inspections under QMSR. * LTR: QMSR Readiness, Risk-Based Assurance and FDA Expectations. * LTR: A 90-Day Plan to Review QMSR Readiness. Keywords QMSR, FDA inspections, ISO 13485, risk-based approach, risk management, CAPA, preventive action, post-market surveillance, safety signals, management review, quality systems, MedTech regulation, 483 observations, system effectiveness About Michelle Lott Michelle 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. Disclaimer Information 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

    39 min
  2. LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability

    MAY 1

    LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability

    Summary “Just having a policy in place is one thing. Having a QMS that aligns to it is the next.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Sherita Black about one of the most challenging and often misunderstood topics in ISO 14971: creating a policy for risk acceptability. The conversation goes beyond the standard’s wording and gets into the practical questions that many teams struggle with: who top management really is, how to involve them, and how to turn policy into something that actually drives decisions. Sherita brings a strong cross-functional perspective shaped by years of experience in pharmaceutical validation, medical device design quality, complaint handling, and enterprise risk management. In her current role as Risk Management Business Process Owner at BD, she focuses on maintaining risk management procedures, aligning stakeholders, and supporting an effective risk management program across the organization. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 – Introduction02:48 – What ISO 14971 expects from top management03:54 – Why a risk management policy matters05:56 – Three approaches to risk control and acceptability08:44 – How to identify the right top management group14:32 – Risk management policy vs. quality policy18:10 – What evidence auditors expect to see24:31 – Why strong risk management can become competitive advantage If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: LTR: ISO 14971 Fundamentals - Risk Acceptability Policy LTR: Top Management Responsibility for Risk Management. LTR: LTR Risk Coach - AI-Powered Decision Support Tool. Key Takeaways * A risk management policy sets the framework for how an organization defines, controls, and monitors risk across the device lifecycle. * Top management in the context of ISO 14971 should be close enough to understand the device and senior enough to allocate resources and make decisions. * Risk acceptability is not one-size-fits-all; the policy should reflect device context, intended use, and the nature of the risks involved. * A risk management policy may sit within the broader quality framework, but it should remain explicit and focused on safety and benefit-risk decisions. * Auditors will look beyond the written policy and expect evidence that it is actually being executed through design controls, standards compliance, monitoring, and management review. * Strong risk management is not just about compliance; it can improve device quality, customer trust, and long-term business performance. Keywords ISO 14971, risk acceptability, risk management policy, top management, medical device safety, QMSR, design controls, benefit-risk, audit readiness, risk governance About Sherita Black Sherita Black is a quality and regulatory leader with experience across the medical device and pharmaceutical industries. She currently serves as Risk Management Business Process Owner at Beckton-Dickinson, where she is responsible for risk management procedures and cross-functional alignment to support an effective enterprise risk management program. Her background includes design quality assurance, complaint handling, post-market surveillance, regulatory compliance, and global standards implementation, with prior roles at Philips, Regulatory and Quality Solutions, and Boehringer Ingelheim. She holds degrees in biomedical engineering and industrial and human factors engineering. 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. Disclaimer Information 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

    29 min
  3. LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems

    APR 24

    LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems

    Summary “FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?” In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits down with Dr. Omar Al Kalaa to talk about one of the most important emerging frontiers in MedTech: remotely controlled medical systems. From telesurgery to connected infusion therapy, these technologies are expanding what is possible in patient care—but they also introduce a very different kind of system risk. Omar brings a rare perspective at the intersection of medical devices and telecommunications. We explore why the real issue is not just connectivity, but control; why access to care is a major driver of these technologies; and why companies entering this space must think beyond the device itself to the broader ecosystem of networks, partners, responsibilities, and safeguards. Chapters 00:00 – Introduction01:56 – What “remote control” really means in MedTech04:36 – Telesurgery vs. interoperable connected care systems08:30 – Why access to healthcare is driving adoption11:31 – Connectivity failure modes and misunderstood telecom concepts13:47 – What fail-safe means in a telesurgery environment18:24 – Risk ownership, contracts, and service level agreements22:01 – How sponsors should think about FDA for novel connected systems30:13 – Practical advice for engaging FDA in a stressed environment32:35 – Why partnership, not silos, will shape the future of this field If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: * LTR: Wireless coexistence and risk in connected medical devices. * LTR: A new paradigm for building connected medical devices. * Advent Health News: Historic telesurgery connects Central Florida and Angola in world-first medical breakthrough. Key Takeaways * Remotely controlled medical systems are defined by control across distance, not just data transfer. * Access to healthcare is one of the strongest drivers behind telesurgery and other remote-care models. * The biggest risks are not limited to “connectivity problems”; they include misunderstood failure modes, unclear terminology, and weak cross-functional alignment between medical and telecom teams. * Fail-safe behavior cannot be defined in the abstract. It depends on intended use, clinical context, and what the system should do when communication degrades or fails. * In distributed systems, risk ownership is shared. That makes contracts, partner roles, and service expectations critical design inputs—not afterthoughts. * FDA is still asking the same core questions it always does: is the system safe, and is it effective? The challenge is showing evidence across components the sponsor does not fully own. * Sponsors should engage FDA early, bring a structured plan, and ask targeted questions grounded in a clear understanding of the broader ecosystem. * The future of this space will belong to organizations that can collaborate across silos instead of trying to build everything alone. Keywords Telesurgery, remotely controlled medical systems, connected medical devices, healthcare connectivity, telecom, system safety, interoperability, risk ownership, service level agreements, FDA, IDE, systems engineering, cybersecurity, access to care About Omar Al Kalaa Omar Al Kalaa is the Founder and Principal of Inovectrum, a technology advisory and innovation practice bridging MedTech and telecom. He advises companies on the design and deployment of high-performance connectivity solutions for medical devices, clinical environments, and digital health systems. The team at Inovectrum supports clients across the full product lifecycle, from early design decisions through regulatory strategy and FDA submissions, with a focus on how connectivity, EMC, and system behavior translate into real-world performance. The practice also extends into interoperability and electrical safety, enabling a more complete evaluation of devices as they operate within complex, interconnected environments. 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. Disclaimer Information 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

    36 min
  4. LTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences

    APR 17

    LTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences

    Summary “Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.” What happens when a highly regulated medical device depends on a tiny, single-sourced component buried deep in a fragile global supply chain? In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Dr. Sarai Pahla about why supply chain disruption is no longer just an operations problem. It is a real risk issue for life sciences companies. Sarai brings a rare perspective to this conversation, combining medical training, ERP and IT experience, regulatory affairs, and multilingual medical writing. Together, we explore how supply shocks can disrupt patient access, why alternate sourcing is harder in regulated industries, and how predictive analytics may become essential for future supply chain resilience. Listen to the full 30-minute podcast or jump to a section of interest listed below. Chapters 00:00 Introduction05:02 Why modern life sciences supply chains are more vulnerable to disruption08:13 A real example of a single-source component risk in heart valve manufacturing10:27 How supply chain disruption connects directly to patient benefit-risk11:35 Planning ahead: second sources, business continuity, and R&D readiness13:36 Why regulatory-ready suppliers create a strategic advantage16:22 The role of AI and predictive analytics in supply chain risk management23:34 Key takeaways: interdependence, relationships, and future-ready resilience If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter. Suggested links: LTR: Rethinking Supply Chain Risk: QMSR’s New Expectations LTR: It is Time to Focus on Supply Chain Resiliency Not Just Supplier Management. LTR: LTR Risk Coach - AI-Powered Decision Support Tool. Key Takeaways * Supply chain disruption in MedTech is not just a commercial problem. It can directly affect patient access and device benefit. * Single-source components can create outsized risk, especially when they are critical and difficult to replace. * In regulated industries, alternate sourcing is harder because supplier changes often require new evidence, documentation, and regulatory review. * Strong supplier relationships still matter. Trust, transparency, and regulatory understanding are strategic assets. * Forward-looking R&D should include supply chain scenarios, not just technical and regulatory development plans. * Predictive analytics and AI may become important tools for stress-testing supply chains and planning for shocks. * Risk professionals may have an opportunity to expand beyond safety risk into broader supply continuity and resilience strategy. Keywords Supply chain risk, business continuity, MedTech, life sciences, supplier resilience, regulatory strategy, predictive analytics, AI in supply chain, alternate sourcing, benefit-risk About Sarai Pahla Sarai Pahla is a medical doctor, regulatory affairs professional, and medical writer based in Düsseldorf, Germany. Her career spans clinical medicine, SAP/ERP security, multilingual medical and regulatory translation, and regulatory writing across medical devices and pharmaceuticals. She currently serves as Principal Medical Writer at Criterion Edge and also leads her own medical and regulatory writing practice. Sarai brings deep experience across EU and global regulatory environments, with particular strength in multilingual source analysis, clinical and regulatory documentation, and emerging applications of AI and data science in regulatory work. 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. Disclaimer Information 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

    26 min
  5. Case Study: How Patient Preference Data Rescued a High-Risk Device

    APR 10

    Case Study: How Patient Preference Data Rescued a High-Risk Device

    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

    21 min
  6. LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices

    APR 3

    LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices

    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. Chapters 00:00 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 teamwork If 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. Keywords Human factors, usability engineering, AI in medical devices, machine learning, transparency, clinician vigilance, use-related risk, AI training, competence, surgical planning, usability testing, cross-functional collaboration About Jonathan Kendler Jonathan 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. Disclaimer Information 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

    29 min
  7. LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design

    MAR 27

    LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design

    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. Chapters 00:00 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 strategy If 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. Keywords IDE, 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, mentorship About Lavanya Ramnath Lavanya 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. Disclaimer Information 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

    29 min
  8. LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach

    MAR 20

    LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach

    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. Chapters 00:00 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. Keywords Companion diagnostics (CDx), AI/ML diagnostics, FDA CDx policy, reclassification, intended use, uncertainty, explainability, bias, lifecycle control, vigilance. About Chris Daly Chris 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. Disclaimer Information 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

    29 min
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Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com

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  • Creator
    Where MedTech professionals gain clarity and confidence to navigate complex decisions.
  • Years Active
    2023 - 2026
  • Episodes
    165
  • Rating
    Clean
  • Copyright
    © Naveen Agarwal, Ph.D.
  • Show Website
    Let's Talk Risk! Podcast

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