Shows / Let's Talk Risk! Podcast
Let's Talk Risk! Podcast
Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions.
naveenagarwalphd.substack.com
Episodes
Let's Talk Risk! PodcastExecutive Brief: Scaling Software as a Medical Device
Software velocity is not simply a development challenge. It is becoming an enterprise capability. Software is increasingly driving differentiation, recurring…
Let's Talk Risk! PodcastLTR 166: Building a MedTech Career in the Age of AI
Summary “At the end of the day, this business of getting a job, keeping a job, getting promoted is human to human.” The MedTech job market has changed. More…
Let's Talk Risk! PodcastExecutive Brief: PCCPs as a Competitive Strategy
PCCPs can turn regulatory cycle time into a competitive advantage, but only if the evidence needed to support future change is funded in advance. Predetermined…
Let's Talk Risk! PodcastLTR 165: Managing Characteristics Related to Safety
Summary “If we don’t have connections and linkages in our risk management file from top to bottom, it’s hard to manage lifecycle risk.” In this open discussion…
Let's Talk Risk! PodcastExecutive Brief: What FDA is Looking For in Your Tox Data to Ensure Safety
Robust chemical characterization is essentially the gateway to biological safety. A toxicological risk assessment is only as strong as the analytical data…
Let's Talk Risk! PodcastLTR 164: Susan Neadle on Combination Device Risk Management
Summary “ISO 14971 and ICH Q9 are not competing frameworks. They are asking different questions about risk.” In this episode of the Let’s Talk Risk!…
Let's Talk Risk! PodcastDeep Dive: When the Risk Baseline and the QMS Both Break Down
The baseline is completely broken and the iteration process is blind. FDA’s August 21, 2026 warning letter to Pensar Medical LLC illustrates a failure that…
Let's Talk Risk! PodcastDeep Dive: When FDA Qualifies the Ruler
A qualified tool does not eliminate regulatory scrutiny. It eliminates the need to keep proving that the same ruler works. What if one of the biggest sources…
Let's Talk Risk! PodcastDeep Dive: What FDA’s QMSR Warning Letters Are Revealing
If you’re trying to manage risk in isolated silos, your quality management system is already obsolete. What happens when a supplier changes a device label…
Let's Talk Risk! PodcastDeep Dive: The PFAS Substitution Risk Paradox in Medical Devices
FDA: There is no reason to restrict the continued use of fluoropolymers in medical devices. What happens when pressure to eliminate a material creates greater…
Let's Talk Risk! PodcastDeep Dive: When Patient Preference Becomes Regulatory Evidence
Patient preference is no longer a soft qualitative afterthought. What if a device carries significant risks, but patients are willing to accept them for a…
Let's Talk Risk! PodcastDeep Dive: Designing Safety Into Autonomous Robotic Devices
The vulnerability of the modern clinical lab is quite literally concentrated at the point of the needle. Clinical laboratories have automated almost everything…
Let's Talk Risk! PodcastLTR 163: FDA’s New Risk Lens Under QMSR
Summary “I don't think it's as easy to outsource risk as it used to be. Risk is pervasive now.” In this episode of the Let’s Talk Risk! conversation, host…
Let's Talk Risk! PodcastDeep Dive: First FDA Warning Letter Under QMSR
Under QMSR, FDA is not only looking for individual quality failures. It is examining how failures connect across the entire quality system. FDA’s warning…
Let's Talk Risk! PodcastLTR 162: Using HHE for Risk-Based Decisions
Summary “When done well, HHE evolves from a procedural requirement into a strategic tool that reflects how your organization makes risk-based decisions.” In…
Let's Talk Risk! PodcastDeep Dive: FDA's RWE Guidance
Real-world data does not become regulatory evidence simply because it is large, current, or readily available. FDA’s December 2025 final guidance, Use of…
Let's Talk Risk! PodcastLTR 161: AI Governance by Design
Summary “Let’s treat AI governance by design as the connective tissue of a product lifecycle ecosystem.” AI governance is often introduced as another layer of…
Let's Talk Risk! PodcastCase Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations
You cannot bolt cybersecurity onto a medical device at the end of development. FDA’s cybersecurity guidance makes a clear shift: cyber risk is now a quality…
Let's Talk Risk! PodcastLTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety
Summary “The biggest takeaway was realizing that our perspectives on risk and safety are not isolated. They are shared, validated, and strengthened by others…
Let's Talk Risk! PodcastLTR 159: The Evolving Regulatory Landscape for AI in MedTech
Summary “Stop thinking of AI as replacing humans. Think about humans staying in charge while AI is placed in the loop” Artificial intelligence is no longer a…
Let's Talk Risk! PodcastCase Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions
You cannot reverse engineer your human factors regulatory strategy at the 11th hour. FDA’s new human factors guidance is not just about what goes into a…
Let's Talk Risk! PodcastLTR 158: Three Questions To Keep Risk Connected to Decisions
Summary “Tools do not remove uncertainty” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Vilma Nasteckiene, PhD, founder of Holistic…
Let's Talk Risk! PodcastLTR 157: Why Risk Doesn't Get Heard and How to Change That
Summary “Quality and risk people need to translate safety into business terms.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Eric…
Let's Talk Risk! PodcastLTR 156: Using AI as a Thinking Partner in Product Development Without Losing Control
Summary “AI can be a powerful helper, but it should not be the decision-maker.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with David…
Let's Talk Risk! PodcastLTR 155: Leverage VIP to Move from Compliance to Capability
Summary “Compliance alone does not drive quality” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Mike Cook about the the Voluntary…
Let's Talk Risk! PodcastLTR 154: From Procedures to Judgment - Leading Through QMSR Inspections
Summary “FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.” In this episode of the Let’s Talk Risk…
Let's Talk Risk! PodcastLTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability
Summary “Just having a policy in place is one thing. Having a QMS that aligns to it is the next.” In this Let’s Talk Risk! conversation, host Naveen Agarwal…
Let's Talk Risk! PodcastLTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems
Summary “FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?” In this…
Let's Talk Risk! PodcastLTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences
Summary “Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.” What happens when a highly regulated medical…
Let's Talk Risk! PodcastCase Study: How Patient Preference Data Rescued a High-Risk Device
Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious…
Let's Talk Risk! PodcastLTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices
Summary “AI brings novel risks and addressing them will require a more creative approach to human factors engineering.” In this Let’s Talk Risk! conversation…
Let's Talk Risk! PodcastLTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design
Summary “The clinical study is actually where your risk analysis is going to meet reality.” In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks…
Let's Talk Risk! PodcastLTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
Summary “Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.” Companion diagnostics (CDx)…
Let's Talk Risk! PodcastLTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development
Summary “Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes…
Let's Talk Risk! PodcastLTR 146: Ganesh Sabat on Scaling MedTech Through Quality
Summary “A company can become world class the day the quality team decides.” In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ganesh…
Let's Talk Risk! PodcastLTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
Summary “You don’t want to be implementing QMSR while the FDA is waiting in the lobby.” As the FDA transitions from the Quality System Regulation (QSR) to the…
Let's Talk Risk! PodcastLTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management
Summary “Risks occur. They happen but they don’t exist… hazards do.” In this Let’s Talk Risk! conversation, host Naveen Agarwal sits with Jean Blom, a QMS &…
Let's Talk Risk! PodcastLTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era
Summary “Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.” In this episode of the…
Let's Talk Risk! PodcastLTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
Summary “For years, clinical evaluations were mostly a story. What was missing were clearly defined outcome parameters, something measurable that connects the…
Let's Talk Risk! PodcastLTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR
Summary “Delaying a product that is adequately safe and effective is itself a risk, one we rarely acknowledge in our quality systems.” In this episode of the…
Let's Talk Risk! PodcastLTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls
Summary “Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.” In…
Let's Talk Risk! PodcastLTR 139: Steve Silverman on FDA Readiness for QMSR
Summary “QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.” In this episode of the…
Let's Talk Risk! PodcastLTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
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! PodcastLTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
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…
Let's Talk Risk! PodcastLTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
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!…
Let's Talk Risk! PodcastLTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech
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…
Let's Talk Risk! PodcastLTR 134: James Pink on Responsible AI and Future of MedTech Safety
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…
Let's Talk Risk! PodcastLTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
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…
Let's Talk Risk! PodcastLTR 132: Bijan Elahi on Future of MedTech Safety and the 2026 Conference in Boston
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…
Let's Talk Risk! PodcastLTR 131: Rick Wedge on the Human Side of Safety Risk Management
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! PodcastLTR 130: Hannah Walter on Human Factors and Inclusive Design in Medical Devices
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…
Let's Talk Risk! PodcastLTR 129: Viral Thakkar on breakthrough innovation and the Lungpacer story
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…
Let's Talk Risk! PodcastCase Study: The WATCHMAN TruSeal Recall and the Hidden Risk of Procedural Variation
In this audio brief, we unpack a recent Class I recalls of the Boston Scientific Watchman TruSeal Access System. What began as a rare but catastrophic risk of…
Let's Talk Risk! PodcastLTR 128: Edward Ball on AI, Vigilance and Future of MedTech Regulation
Summary “Risk management is nothing without asking questions. And just as important, we need to create a culture where people aren’t afraid to ask them…
Let's Talk Risk! PodcastLTR 127: Ajay Dankar on Proactive AI Governance in MedTech
Summary “Ethical and compliant AI adoption isn’t a barrier to innovation. It makes your business stronger and more resilient.” In this Let’s Talk Risk!…
Let's Talk Risk! PodcastFDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
In this audio brief, we unpack the practical implications of the FDA’s Final Guidance on Computer Software Assurance (CSA), issued September 2025. The debate…
Let's Talk Risk! PodcastLTR 126: Adam Foresman on Proactive Compliance and Future of MedTech
Summary “Compliance can’t just be a once-per-year audit anymore. It has to be continuous, proactive, and built into the way we work every day.” In this Let’s…
Let's Talk Risk! PodcastLTR 125: Kevin Schawinski on Building Trustworthy AI and MedTech Readiness
Summary “EU MDR is the spiritual ancestor of the EU AI Act”. In this Let’s Talk Risk! conversation, host Naveen Agarwal welcomes Kevin Schawinski…
Let's Talk Risk! PodcastCase Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against…
Let's Talk Risk! PodcastLTR 124: Omar Al Kalaa on Wireless Coexistence and Risk in Connected Medical Devices
Summary “Wireless coexistence is not a checkbox. It’s a risk management approach”. In this Let’s Talk Risk! conversation, Dr. Naveen Agarwal sits down with…