Let's Talk Risk! with Dr. Naveen Agarwal

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“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“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“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“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“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“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