Let's Talk Risk! Podcast
oleh Where MedTech professionals gain clarity and confidence to navigate complex decisions.
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LTR 166: Building a MedTech Career in the Age of AI
LTR 166: Building a MedTech Career in the Age of AI
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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
Episode
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- LTR 166: Building a MedTech Career in the Age of AI · 26 mntSummary “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 candidates are…
- Executive Brief: PCCPs as a Competitive Strategy · 21 mntPCCPs can turn regulatory cycle time into a competitive advantage, but only if the evidence needed to support future change is funded in advance. Predetermined Change Control…
- LTR 165: Managing Characteristics Related to Safety · 27 mntSummary “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 of the Let’s Talk…
- Executive Brief: What FDA is Looking For in Your Tox Data to Ensure Safety · 24 mntRobust chemical characterization is essentially the gateway to biological safety. A toxicological risk assessment is only as strong as the analytical data supporting it. FDA’s…
- LTR 164: Susan Neadle on Combination Device Risk Management · 27 mntSummary “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! conversation, host Naveen…
- Deep Dive: When the Risk Baseline and the QMS Both Break Down · 22 mntThe 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 goes well beyond…
- Deep Dive: When FDA Qualifies the Ruler · 20 mntA 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 of friction in…
- Deep Dive: What FDA’s QMSR Warning Letters Are Revealing · 21 mntIf 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 without triggering…
- Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices · 20 mntFDA: There is no reason to restrict the continued use of fluoropolymers in medical devices. What happens when pressure to eliminate a material creates greater risk for the…
- Deep Dive: When Patient Preference Becomes Regulatory Evidence · 32 mntPatient preference is no longer a soft qualitative afterthought. What if a device carries significant risks, but patients are willing to accept them for a meaningful clinical…
- Deep Dive: Designing Safety Into Autonomous Robotic Devices · 21 mntThe vulnerability of the modern clinical lab is quite literally concentrated at the point of the needle. Clinical laboratories have automated almost everything after the blood…
- LTR 163: FDA’s New Risk Lens Under QMSR · 28 mntSummary “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 Naveen Agarwal speaks…
- Deep Dive: First FDA Warning Letter Under QMSR · 21 mntUnder QMSR, FDA is not only looking for individual quality failures. It is examining how failures connect across the entire quality system. FDA’s warning letter to Linemaster…
- LTR 162: Using HHE for Risk-Based Decisions · 28 mntSummary “When done well, HHE evolves from a procedural requirement into a strategic tool that reflects how your organization makes risk-based decisions.” In this episode of the…
- Deep Dive: FDA's RWE Guidance · 21 mntReal-world data does not become regulatory evidence simply because it is large, current, or readily available. FDA’s December 2025 final guidance, Use of Real-World Evidence to…
- LTR 161: AI Governance by Design · 25 mntSummary “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 oversight—more…
- Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations · 17 mntYou 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 system issue, a…
- LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety · 47 mntSummary “The biggest takeaway was realizing that our perspectives on risk and safety are not isolated. They are shared, validated, and strengthened by others in the field.” In…
- LTR 159: The Evolving Regulatory Landscape for AI in MedTech · 42 mntSummary “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 future concept in…
- Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions · 41 mntYou 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 marketing submission. It…
