Let's Talk Risk! Podcast

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The conversation explores how FDA is signaling its expectations well before inspections begin, particularly through new draft guidance for pre-market submissions.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.

Chapters

00:00 Why QMSR readiness matters now

01:00 Industry complacency and false hope for delays

05:00 FDA signals through pre-market guidance

09:00 Compliance vs. assurance: what FDA really wants

11:00 What “risk-based” means beyond ISO 14971

14:00 Where companies should prioritize immediately

17:00 Management review and executive accountability

26:00 The opportunity for QA/RA leadership under QMSR

Suggested 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* New PMA draft guidance signals FDA’s shift from compliance evidence to assurance of sustained safety and effectiveness.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.

Keywords

QMSR 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 leadership

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.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

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.

Chapters

00:00 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.

Keywords

QMSR, 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 Setty

Geethapriya (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.

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.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

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.

Chapters

00:00 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 remarks

If 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.

Keywords

QMSR, ISO 13485, FDA inspections, design controls, CAPA, corrective action, preventive action, effectiveness criteria, complaint handling, risk-based quality, regulatory strategy, post-market surveillance

About Adam Isaacs Rae

Adam 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.

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.

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.

Chapters

01:20 Introducing Allison Komiyama

03:40 How FDA thinks about benefit and risk

08:10 Why benefits must be evidence-based, not marketing claims

10:45 The missing benefit–risk conversation in 510(k) submissions

13:45 Reverse-engineering FDA’s benefit–risk guidance for real devices

14:30 How AI/ML challenges traditional benefit–risk evaluation

17:00 Why intended use and indications are the foundation

18:40 Bringing marketing, clinical, and reimbursement into early conversations

20:05 QA/RA as strategic leaders, not gatekeepers

24:30 How the patient voice reframes quality and purpose

26:00 The mission behind Bluestocking Health

30:15 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.

Keywords

Benefit–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 Komiyama

Allison 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.

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.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

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.

Chapters

00:00 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 & Closing

If 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.

Keywords

AI safety, medical device risk management, patient safety, regulatory strategy, ISO 42001, human-in-the-loop, responsible innovation, AI assurance, EU AI Act, risk literacy

About James Pink

James 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.

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.

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.

Chapters

00:00 Why QMSR matters now

02:00 Inside the startup mindset: energy, agility, and chaos

04:30 From checklists to connected processes

06:45 How FDA’s expectations are evolving

09:50 Integrating risk management with design controls

13:30 Competence vs. training: what QMSR really demands

15:30 Startups and global thinking: harmonization as opportunity

18:00 Leveraging networks and external expertise

22:00 Building courage and translating skills to new domains

24:00 Overcoming imposter syndrome and redefining expertise

26:30 Final takeaways and Megan’s vision for Relia

Suggested 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.

Keywords

QMSR, ISO 13485, FDA, risk management, competence, startups, leadership, regulatory strategy, AI/ML, medical devices

About Megan Kane

Megan 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.

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.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

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.

Chapters

00:00 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 takeaways

If 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.

Keywords

MedTech 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 Safety

About Bijan Elahi

Bijan 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.

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.

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 practice

This conversation reminds every MedTech professional that behind every risk file is a real human story—and sometimes, that story could be our own.

Chapters

00:00 – Introduction: The human side of risk and living with diabetes

02:00 – Rick’s medical journey and sudden onset of diabetes

06:00 – Emotional and psychological recovery after surgery

10:30 – From biosensors to combination products: a full-circle career

13:30 – The rise of CGM technology and what made it possible

18:00 – Data overload, trust, and the benefit-risk balance

24:00 – Failures, vigilance, and lessons for risk professionals

26:00 – Empathy as a leadership skill in risk management

29:00 – Closing reflections: patient-centricity as personal mission

Suggested 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.

Keywords

Risk management, design control, combination products, empathy, patient experience, diabetes, continuous glucose monitoring, benefit-risk, medical devices, leadership

About Rick Wedge

Rick 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.

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.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

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.

Chapters

00:30 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 Reflections

If 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.”

Keywords

Human 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 guidance

About 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.

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.

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.

Chapters

00:42 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 comments

Suggested 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.

Keywords

MedTech 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 technology

About Viral Thakkar

Viral 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.

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.

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