Let's Talk Risk! with Dr. Naveen Agarwal
By Casual and informal conversations about practical aspects of medical device risk management.
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Episodes: 146
Description
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!
naveenagarwalphd.substack.com
naveenagarwalphd.substack.com
| Episode | Date |
|---|---|
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LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
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Dec 12, 2025 |
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LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech
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Dec 05, 2025 |
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LTR 134: James Pink on Responsible AI and Future of MedTech Safety
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Nov 28, 2025 |
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LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
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Nov 21, 2025 |
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LTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
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Nov 14, 2025 |
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LTR 131: Rick Wedge on the Human Side of Safety Risk Management
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Nov 07, 2025 |
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LTR 130: Hannah Walter on Human Factors and Inclusive Design in Medical Devices
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Oct 31, 2025 |
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LTR 129: Viral Thakkar on breakthrough innovation and the Lungpacer story
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Oct 24, 2025 |
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Case Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
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Oct 20, 2025 |
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LTR 128: Edward Ball on AI, Vigilance and Future of MedTech Regulation
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Oct 17, 2025 |
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LTR 127: Ajay Dankar on Proactive AI Governance in MedTech
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Oct 10, 2025 |
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FDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
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Oct 06, 2025 |
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LTR 126: Adam Foresman on Proactive Compliance and Future of MedTech
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Oct 03, 2025 |
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LTR 125: Kevin Schawinski on Building Trustworthy AI and MedTech Readiness
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Sep 26, 2025 |
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Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
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Sep 22, 2025 |
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LTR 124: Omar Al Kalaa on Wireless Coexistence and Risk in Connected Medical Devices
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Sep 19, 2025 |
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LTR 123: Richard Matt on Effective Risk Communication
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Sep 12, 2025 |
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Case Study: What AI/ML Device Recalls Reveal About Emerging Risks
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Sep 08, 2025 |
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LTR 122: Tibor Zechmeister on PSUR Best Practices
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Sep 05, 2025 |
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LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
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Aug 29, 2025 |
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Case Study: Contrasting U.S. and EU Approaches to AI Regulation
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Aug 25, 2025 |
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LTR 120: Atty Chakraborty on India's Rising MedTech Sector
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Aug 22, 2025 |
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LTR 119: AI, Risk and Regulatory Strategy with Dr. Jay Vaishnav
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Aug 15, 2025 |
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Case Study: When Clues to a Future Recall Hide in Plain Sight
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Aug 11, 2025 |
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LTR 118: Off-Label Use with Kristen Petersen
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Aug 08, 2025 |
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LTR 117: Queenita Fernandes on Smart Use of AI for Clinical Evaluation
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Aug 01, 2025 |
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A Quick Primer on FDA's Final Guidance for Cybersecurity in Medical Devices
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Jul 28, 2025 |
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LTR 116: Priyanka Murawala on ISO 10993 Update, Biocompatibility, Learning from Recalls
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Jul 25, 2025 |
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LTR 115: Startup Lessons from EU MedTech Shark Tank
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Jul 18, 2025 |
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LTR 114: What QA/RA Professionals Need to Know About Rapidly Growing MedTech in India
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Jul 11, 2025 |
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Case Study: When Underestimating Risk Leads to a Warning Letter
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Jul 07, 2025 |
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LTR 113: Highlights from the International Medical Device Safety Risk Management Conference
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Jul 04, 2025 |
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LTR 112: Overcoming organizational barriers to risk management through collaboration
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Jun 27, 2025 |
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LTR 111: How to sustain and grow a community of practice in risk management
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Jun 20, 2025 |
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Case Study: A Warning Letter Exposes Issues in Risk Analysis
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Jun 16, 2025 |
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LTR 110: Focusing on reliability to build safe medical devices
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Jun 13, 2025 |
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Case Study: A Promising Device Fails in the Market Due to Usability Issues
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Jun 09, 2025 |
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LTR 109: Focus on risk, not just testing, for biocompatibility of medical devices
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Jun 06, 2025 |
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LTR 108: Databases and automation tools for clinical evaluation
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May 30, 2025 |
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LTR 107: A 3-step approach to developing secure medical devices
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May 23, 2025 |
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LTR 106: Critical role of Medical Safety in device risk management
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May 16, 2025 |
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LTR 105: AI-based virtual auditors are coming to MedTech
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May 09, 2025 |
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LTR 102: Collaboration that drives innovation, not delays
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May 08, 2025 |
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LTR 104: Navigating the regulatory landscape for SaMD in India
|
May 02, 2025 |
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LTR 103: Start treating human factors as a science, not an art
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Apr 25, 2025 |
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Subatack Live: Navigating the chaos at FDA
|
Apr 17, 2025 |
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LTR 101: Power up your career with mentoring
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Apr 11, 2025 |
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Substack Live: Let’s talk about cyber risk in MedTech!
|
Apr 09, 2025 |
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LTR 100: What we will need to lead in the age of AI
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Apr 04, 2025 |
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LTR 99: An exciting growth opportunity for MedTech in India
|
Mar 28, 2025 |
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Substack Live: How will tariffs affect pharma and med device supply chains
|
Mar 25, 2025 |
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LTR 98: Critical role of medical safety officer in medical devices
|
Mar 21, 2025 |
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LTR 97: Surviving chaos and uncertainty at the FDA
|
Mar 19, 2025 |
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LTR 96: A patient-centric approach to medical device R&D
|
Mar 14, 2025 |
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LTR 95: The case for software risk management in AI-driven home health devices
|
Mar 07, 2025 |
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LTR 82: Tips for Regulatory Success with AI Devices in Radiology
|
Mar 06, 2025 |
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LTR 94: The road ahead for PCCPs and AI/ML amidst chaos at the FDA
|
Mar 05, 2025 |
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LTR 93: AI use cases in MedTech regulatory applications
|
Feb 28, 2025 |
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LTR 92: Understanding the notified body perspective on clinical evaluation
|
Feb 26, 2025 |
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LTR 91: International conference on medical device safety risk management
|
Feb 21, 2025 |
|
LTR 90: Lead with empathy to grow your Quality career
|
Feb 14, 2025 |
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LTR 89: Navigating uncertain times at the FDA
|
Feb 12, 2025 |
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LTR 88: Decoding Privacy Laws in Clinical Research
|
Feb 07, 2025 |
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LTR 87: A Strategic Approach to Regulatory Success with GenAI Devices
|
Feb 05, 2025 |
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LTR 86: Managing Post-Market Design Changes
|
Jan 31, 2025 |
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LTR 85: The problem with CAPA problem statements
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Jan 24, 2025 |
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LTR 84: Think of human factors for AI as levels of automation
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Jan 17, 2025 |
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LTR 83: Road to market for AI devices in the EU just got more complex
|
Jan 15, 2025 |
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LTR 81: 4 key themes in risk management and an upcoming conference
|
Jan 03, 2025 |
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LTR 80: Building safety by design into medical devices
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Dec 27, 2024 |
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LTR 79: Tips for SaMD development and success with FDA
|
Dec 20, 2024 |
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LTR 73: It's time to up our game on medical device cybersecurity
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Dec 19, 2024 |
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LTR 78: New challenges in managing risks of software in IVDs
|
Dec 13, 2024 |
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PCCP: Opportunity for risk practitioners to shine
|
Dec 11, 2024 |
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LTR 77: How GenAI is transforming Quality in MedTech
|
Dec 06, 2024 |
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EU vs. FDA: Aligned but different in their approach to safety of AI/ML devices
|
Dec 04, 2024 |
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LTR 76: Challenges and opportunities of AI/ML in MedTech
|
Nov 29, 2024 |
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LTR 70: Best practices for applying usability engineering to medical devices
|
Nov 28, 2024 |
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LTR 74: AR/VR devices in MedTech
|
Nov 15, 2024 |
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LTR 72: A clinician's insights on risk and collaboration in MedTech
|
Nov 01, 2024 |
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LTR 64: Opportunities and challenges to leverage PCCP for speed to market
|
Oct 31, 2024 |
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LTR 71: Medical device cybersecurity now more critical than ever
|
Oct 18, 2024 |
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LTR 69: A quick update on the 4th edition of IEC 60601
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Oct 04, 2024 |
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LTR 68: Tips for making customer-focused decisions
|
Sep 27, 2024 |
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LTR 67: 3 pillars for defining your IVD risk management strategy
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Sep 20, 2024 |
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LTR 66: Understanding human factors aspect of augmented reality applications in medical devices
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Sep 13, 2024 |
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LTR 65: Demystifying risk-based approach vs. risk management
|
Sep 06, 2024 |
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LTR 63: A lawyer's perspective on the QMSR transition
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Aug 23, 2024 |
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LTR 62: Overcoming barriers to cross-functional communication and collaboration
|
Aug 16, 2024 |
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LTR 61: Treat human factors as a driver of customer satisfaction, not a check-the-box activity
|
Aug 09, 2024 |
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LTR 60: Defining state of the art can be challenging; here are a few tips.
|
Aug 02, 2024 |
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LTR 59: FDA's pre-sub program and how it can accelerate medical device innovation
|
Jul 26, 2024 |
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LTR 58: Tips for clinicians transitioning into a medical safety role in MedTech
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Jul 19, 2024 |
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LTR 57: It's time to focus on supply chain resiliency not just supplier management
|
Jul 12, 2024 |
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LTR 56: How to communicate effectively with senior management
|
Jul 05, 2024 |
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LTR 54: Start your risk analysis by first defining the intended use
|
Jun 21, 2024 |
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LTR 53: Three big trends to watch in MedTech
|
Jun 07, 2024 |
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LTR 52: The key to success as a risk practitioner in the medical device industry.
|
May 31, 2024 |
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LTR 50: Humility is the key to startup success
|
May 17, 2024 |
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RM roundup #3: 10 noteworthy risk-related LinkedIn posts
|
May 10, 2024 |
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LTR 49: A clinician's view on AI/ML enabled medical devices
|
May 03, 2024 |
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LTR 48: Integrating purchasing controls across product lifecycle
|
Apr 26, 2024 |
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LTR 46: Tips to boost effectiveness of medical device post-market surveillance
|
Apr 12, 2024 |
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LTR Weekly Digest #31 - 6th April, 2024
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Apr 06, 2024 |
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LTR 45: A patient's perspective on CGMs
|
Apr 05, 2024 |
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LTR 44: Why we need a new approach to learning medical software and medical AI
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Mar 22, 2024 |
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RM roundup #2: 10 noteworthy risk-related LinkedIn posts
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Mar 14, 2024 |
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LTR 43: Tips for integrating risk analysis with design controls
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Mar 08, 2024 |
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RM roundup #1: 10 of my favorite risk-related LinkedIn posts
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Mar 01, 2024 |
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LTR 42: State or event? Thinking clearly about hazards will help you manage risk.
|
Feb 23, 2024 |
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LTR 40: A guest podcast with NAMSA - Part 1
|
Feb 16, 2024 |
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LTR 39: Overcoming challenges in linking risk management with design controls
|
Feb 09, 2024 |
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LTR 38: How medical safety professionals can serve as culture brokers in MedTech
|
Feb 02, 2024 |
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LTR 36: Why we should not overlook the quality-of-life benefit in risk evaluation
|
Jan 19, 2024 |
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LTR Weekly Digest #19 - 13th January, 2024
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Jan 13, 2024 |
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LTR 35: Tips for improving collaboration in risk management
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Jan 12, 2024 |
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LTR Weekly Digest #18 - 6th January, 2024
|
Jan 06, 2024 |
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LTR 34: Build a culture of Quality to achieve inspection-readiness at all times
|
Jan 05, 2024 |
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LTR 33: AI and the future of work for QA/RA professionals
|
Dec 22, 2023 |
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LTR 32: A new paradigm for building connected medical devices
|
Dec 15, 2023 |
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LTR 31: Focus on the purpose to measure process effectiveness
|
Dec 08, 2023 |
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LTR 30: It is time to unfake risk management!
|
Dec 01, 2023 |
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LTR 29: Challenges and opportunities for digital technologies in medical applications
|
Nov 17, 2023 |
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LTR 28: It is time to build equity in medical device design control
|
Nov 10, 2023 |
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LTR 27: Practicable or not, that's the question for risk control
|
Oct 27, 2023 |
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LTR 26: Seek clinical input early in development to achieve market success later
|
Oct 20, 2023 |
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LTR 25: Career tip - learn to effectively communicate regulatory risk in business terms
|
Oct 13, 2023 |
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LTR 24: Clinical evaluation is a lifecycle process, not a one-time activity
|
Oct 06, 2023 |
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LTR 23: Focus on intended use in the clinical environment for risk management of IVDs
|
Sep 29, 2023 |
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Ep 22: Think of post-market surveillance as a value adding business process
|
Sep 22, 2023 |
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Ep 21: Why risk practitioners must build the empathy muscle
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Sep 15, 2023 |
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Ep 20: Team diversity helps boost competence in risk management
|
Sep 01, 2023 |
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Ep 19: How QA/RA professionals can help drive innovation in AI/ML
|
Aug 25, 2023 |
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Ep 18: Risk based approach to building a QMS in a startup
|
Aug 18, 2023 |
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Ep 17: Risk management lessons learned from running the Boston marathon
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Aug 11, 2023 |
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Ep 16: Clinical evaluation is now more important than ever under EU-MDR
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Aug 04, 2023 |
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Ep 15: Collaboration is the secret sauce for success in risk management
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Jul 08, 2023 |
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LTR14: The most important question for risk management: who is taking the risk?
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Jul 01, 2023 |
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Ep 13: Compliance: an obstacle or an opportunity?
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Jun 24, 2023 |
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LTR12: Risk lessons learned from working on a hydrogen-powered car
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Jun 17, 2023 |
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Ep 11: Understanding a physician's view on risk
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Jun 10, 2023 |
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LTR 10: Safety is important, but not the only objective for risk management
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May 27, 2023 |
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Ep 09: Tips for a risk-based approach to auditing Quality Systems
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May 20, 2023 |
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Ep 08: Understanding the interface between clinical evaluation and risk management
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May 13, 2023 |
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Ep 07: Risk management of IVDs requires a different approach
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May 06, 2023 |
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Best practices for using FMEAs for medical devices
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Apr 22, 2023 |