All Episodes
Let's Talk Risk! with Dr. Naveen Agarwal — 161 episodes
Case Study: How Patient Preference Data Rescued a High-Risk Device
LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices
LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
LTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development
LTR 146: Ganesh Sabat on Scaling MedTech Through Quality
LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
LTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management
LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era
LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR
LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls
LTR 139: Steve Silverman on FDA Readiness for QMSR
LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech
LTR 134: James Pink on Responsible AI and Future of MedTech Safety
LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
LTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
LTR 131: Rick Wedge on the Human Side of Safety Risk Management
LTR 130: Hannah Walter on Human Factors and Inclusive Design in Medical Devices
LTR 129: Viral Thakkar on breakthrough innovation and the Lungpacer story
Case Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
LTR 128: Edward Ball on AI, Vigilance and Future of MedTech Regulation
LTR 127: Ajay Dankar on Proactive AI Governance in MedTech
FDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
LTR 126: Adam Foresman on Proactive Compliance and Future of MedTech
LTR 125: Kevin Schawinski on Building Trustworthy AI and MedTech Readiness
Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
LTR 124: Omar Al Kalaa on Wireless Coexistence and Risk in Connected Medical Devices
LTR 123: Richard Matt on Effective Risk Communication
Case Study: What AI/ML Device Recalls Reveal About Emerging Risks
LTR 122: Tibor Zechmeister on PSUR Best Practices
LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
Case Study: Contrasting U.S. and EU Approaches to AI Regulation
LTR 120: Atty Chakraborty on India's Rising MedTech Sector
LTR 119: AI, Risk and Regulatory Strategy with Dr. Jay Vaishnav
Case Study: When Clues to a Future Recall Hide in Plain Sight
LTR 118: Off-Label Use with Kristen Petersen
LTR 117: Queenita Fernandes on Smart Use of AI for Clinical Evaluation
A Quick Primer on FDA's Final Guidance for Cybersecurity in Medical Devices
LTR 116: Priyanka Murawala on ISO 10993 Update, Biocompatibility, Learning from Recalls
LTR 115: Startup Lessons from EU MedTech Shark Tank
LTR 114: What QA/RA Professionals Need to Know About Rapidly Growing MedTech in India
Case Study: When Underestimating Risk Leads to a Warning Letter
LTR 113: Highlights from the International Medical Device Safety Risk Management Conference
LTR 112: Overcoming organizational barriers to risk management through collaboration
LTR 111: How to sustain and grow a community of practice in risk management
Case Study: A Warning Letter Exposes Issues in Risk Analysis
LTR 110: Focusing on reliability to build safe medical devices
Case Study: A Promising Device Fails in the Market Due to Usability Issues
LTR 109: Focus on risk, not just testing, for biocompatibility of medical devices
LTR 108: Databases and automation tools for clinical evaluation
LTR 107: A 3-step approach to developing secure medical devices
LTR 106: Critical role of Medical Safety in device risk management
LTR 105: AI-based virtual auditors are coming to MedTech
LTR 102: Collaboration that drives innovation, not delays
LTR 104: Navigating the regulatory landscape for SaMD in India
LTR 103: Start treating human factors as a science, not an art
Subatack Live: Navigating the chaos at FDA
LTR 101: Power up your career with mentoring
Substack Live: Let’s talk about cyber risk in MedTech!
LTR 100: What we will need to lead in the age of AI
LTR 99: An exciting growth opportunity for MedTech in India
Substack Live: How will tariffs affect pharma and med device supply chains
LTR 98: Critical role of medical safety officer in medical devices
LTR 97: Surviving chaos and uncertainty at the FDA
LTR 96: A patient-centric approach to medical device R&D
LTR 95: The case for software risk management in AI-driven home health devices
LTR 82: Tips for Regulatory Success with AI Devices in Radiology
LTR 94: The road ahead for PCCPs and AI/ML amidst chaos at the FDA
LTR 93: AI use cases in MedTech regulatory applications
LTR 92: Understanding the notified body perspective on clinical evaluation
LTR 91: International conference on medical device safety risk management
LTR 90: Lead with empathy to grow your Quality career
LTR 89: Navigating uncertain times at the FDA
LTR 88: Decoding Privacy Laws in Clinical Research
LTR 87: A Strategic Approach to Regulatory Success with GenAI Devices
LTR 86: Managing Post-Market Design Changes
LTR 85: The problem with CAPA problem statements
LTR 84: Think of human factors for AI as levels of automation
LTR 83: Road to market for AI devices in the EU just got more complex
LTR 81: 4 key themes in risk management and an upcoming conference
LTR 80: Building safety by design into medical devices
LTR 79: Tips for SaMD development and success with FDA
LTR 73: It's time to up our game on medical device cybersecurity
LTR 78: New challenges in managing risks of software in IVDs
PCCP: Opportunity for risk practitioners to shine
LTR 77: How GenAI is transforming Quality in MedTech
EU vs. FDA: Aligned but different in their approach to safety of AI/ML devices
LTR 76: Challenges and opportunities of AI/ML in MedTech
LTR 70: Best practices for applying usability engineering to medical devices
LTR 74: AR/VR devices in MedTech
LTR 72: A clinician's insights on risk and collaboration in MedTech
LTR 64: Opportunities and challenges to leverage PCCP for speed to market
LTR 71: Medical device cybersecurity now more critical than ever
LTR 69: A quick update on the 4th edition of IEC 60601
LTR 68: Tips for making customer-focused decisions
LTR 67: 3 pillars for defining your IVD risk management strategy
LTR 66: Understanding human factors aspect of augmented reality applications in medical devices
LTR 65: Demystifying risk-based approach vs. risk management
LTR 63: A lawyer's perspective on the QMSR transition
LTR 62: Overcoming barriers to cross-functional communication and collaboration
LTR 61: Treat human factors as a driver of customer satisfaction, not a check-the-box activity
LTR 60: Defining state of the art can be challenging; here are a few tips.
LTR 59: FDA's pre-sub program and how it can accelerate medical device innovation
LTR 58: Tips for clinicians transitioning into a medical safety role in MedTech
LTR 57: It's time to focus on supply chain resiliency not just supplier management
LTR 56: How to communicate effectively with senior management
LTR 54: Start your risk analysis by first defining the intended use
LTR 53: Three big trends to watch in MedTech
LTR 52: The key to success as a risk practitioner in the medical device industry.
LTR 50: Humility is the key to startup success
RM roundup #3: 10 noteworthy risk-related LinkedIn posts
LTR 49: A clinician's view on AI/ML enabled medical devices
LTR 48: Integrating purchasing controls across product lifecycle
LTR 46: Tips to boost effectiveness of medical device post-market surveillance
LTR Weekly Digest #31 - 6th April, 2024
LTR 45: A patient's perspective on CGMs
LTR 44: Why we need a new approach to learning medical software and medical AI
RM roundup #2: 10 noteworthy risk-related LinkedIn posts
LTR 43: Tips for integrating risk analysis with design controls
RM roundup #1: 10 of my favorite risk-related LinkedIn posts
LTR 42: State or event? Thinking clearly about hazards will help you manage risk.
LTR 40: A guest podcast with NAMSA - Part 1
LTR 39: Overcoming challenges in linking risk management with design controls
LTR 38: How medical safety professionals can serve as culture brokers in MedTech
LTR 36: Why we should not overlook the quality-of-life benefit in risk evaluation
LTR Weekly Digest #19 - 13th January, 2024
LTR 35: Tips for improving collaboration in risk management
LTR Weekly Digest #18 - 6th January, 2024
LTR 34: Build a culture of Quality to achieve inspection-readiness at all times
LTR 33: AI and the future of work for QA/RA professionals
LTR 32: A new paradigm for building connected medical devices
LTR 31: Focus on the purpose to measure process effectiveness
LTR 30: It is time to unfake risk management!
LTR 29: Challenges and opportunities for digital technologies in medical applications
LTR 28: It is time to build equity in medical device design control
LTR 27: Practicable or not, that's the question for risk control
LTR 26: Seek clinical input early in development to achieve market success later
LTR 25: Career tip - learn to effectively communicate regulatory risk in business terms
LTR 24: Clinical evaluation is a lifecycle process, not a one-time activity
LTR 23: Focus on intended use in the clinical environment for risk management of IVDs
Ep 22: Think of post-market surveillance as a value adding business process
Ep 21: Why risk practitioners must build the empathy muscle
Ep 20: Team diversity helps boost competence in risk management
Ep 19: How QA/RA professionals can help drive innovation in AI/ML
Ep 18: Risk based approach to building a QMS in a startup
Ep 17: Risk management lessons learned from running the Boston marathon
Ep 16: Clinical evaluation is now more important than ever under EU-MDR
Ep 15: Collaboration is the secret sauce for success in risk management
LTR14: The most important question for risk management: who is taking the risk?
Ep 13: Compliance: an obstacle or an opportunity?
LTR12: Risk lessons learned from working on a hydrogen-powered car
Ep 11: Understanding a physician's view on risk
LTR 10: Safety is important, but not the only objective for risk management
Ep 09: Tips for a risk-based approach to auditing Quality Systems
Ep 08: Understanding the interface between clinical evaluation and risk management
Ep 07: Risk management of IVDs requires a different approach
Best practices for using FMEAs for medical devices