Let's Talk Risk! Podcast

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 candidates are competing for fewer well-matched opportunities, applying has become easier at scale, and artificial intelligence is beginning to reshape both how people work and how companies hire. So how do professionals stand out? In this epi...

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 Change Control Plans (PCCP) are often discussed as a regulatory mechanism for managing future device modifications—particularly for AI-enabled medical devices. But their strategic significance goes considerably further. A well-designed PCCP...

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 of the Let’s Talk Risk! conversation , host Naveen Agarwal explores a requirement in ISO 14971 that is often documented but not fully integrated into medical device risk management: characteristics related to safety . Too often, organizatio...

Robust 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 September 2026 biocompatibility town hall provided a detailed look at how the Agency is evaluating chemical characterization and toxicological evidence under ISO 10993-18. The emphasis was not simply on whether testing was p...

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! conversation , host Naveen Agarwal speaks with Susan Neadle , Principal Consultant and President of Combination Products Consulting Services, to explore what changes when medical device and pharmaceutical risk-management approaches come together in a...

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 goes well beyond incomplete documentation. The underlying risk-management foundation was weak. Risk-control verification remained incomplete for critical areas, and FDA reportedly found no design, process, or use-related FMEAs for the WoundPro...

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 of friction in medical device development is not the device itself—but the tool being used to measure its performance? Historically, FDA evaluated many of these tools as part of individual device submissions. The Medical Device Development To...

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 without triggering design controls? When operators quietly rework nonconforming product? Or when serious post-market signals never make it back into the risk file? This Deep Dive examines recent FDA inspection and warning-letter examples through...

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 risk for the patient? This Deep Dive examines the growing regulatory tension around PFAS and medical-device fluoropolymers , and why evaluating substitution requires more than asking whether a material belongs to a broad chemical category. K...

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 meaningful clinical benefit? This Deep Dive examines how FDA’s evolving approach to Patient Preference Information (PPI) can turn those tradeoffs into quantitative evidence for regulatory benefit-risk decisions. Key highlights covered in the aud...

The 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 reaches the tube. Yet one of the most common invasive procedures in healthcare still depends on a person finding a vein by sight and touch and manually inserting a needle. FDA’s De Novo authorization of Vitestro’s Aletta® ma...

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 Naveen Agarwal speaks with Allyson Mullen , Director at Hyman, Phelps & McNamara, P.C., about what FDA’s early enforcement activity under the Quality Management System Regulation (QMSR) may tell medical device manufacturers about the agency’s e...

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 letter to Linemaster Switch Corporation provides an early look at QMSR enforcement in practice. The cited deficiencies extend across risk management, rework, corrective action, environmental controls, calibration, and software validation. The ind...

Summary “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 Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Kerry Flecknoe, Senior Manager, Global Quality – HHE at Getinge, about the role of Health Hazard Evaluations in postmarket risk management. Kerry explains that...

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 Real-World Evidence to Support Regulatory Decision-Making for Medical Devices , supersedes the 2017 guidance and provides a more detailed framework for determining when real-world data can generate evidence suitable for a medical device regulator...

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 oversight—more procedures, approvals, documentation, and checklists. Ankita Mishra offers a different way to think about it: governance should be designed into the digital health product lifecycle from the beginning. In this episode of the L...

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 system issue, a patient safety issue, and a lifecycle management issue. For connected and software-enabled devices, it is not enough to show that the software works as intended. Manufacturers also need to show how cybersecurity risks were iden...

Summary “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 this special episode of the Let’s Talk Risk! conversation , host Naveen Agarwal brings together a panel of medtech safety and risk management leaders to discuss key takeaways from IMSC26 in Boston. The conversation highlight...

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 future concept in MedTech. It is already inside medical devices, quality systems, regulatory workflows, post-market processes, and product development decisions. In this episode of the Let’s Talk Risk Podcast , host Naveen Agarwal sits down w...

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 marketing submission. It changes the way teams need to think about use-related risk, critical tasks, labeling, training, post-market evidence, and design change control across the product lifecycle. In this audio case study, we walk through why Ca...

Summary “Tools do not remove uncertainty” In this Let’s Talk Risk! conversation , host Naveen Agarwal speaks with Vilma Nasteckiene, PhD , founder of Holistic Business Risk , about a broader and more human view of risk management. Vilma brings experience from banking, fintech, operational excellence, consulting, research, and business transformation. Her work focuses on reconnecting risk managemen...

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 Sugalski about how MedTech professionals can communicate safety, risk, and innovation more effectively to senior leaders. Eric brings a broad product-development perspective across engineering, manufacturing, regulatory strategy, commercializa...

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 Grilli about how MedTech teams can use AI responsibly in product development without losing control of risk, quality, or accountability. David brings experience across medical device risk management, system safety, reliability engineering, an...

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 Improvement Program (VIP), and how it can help MedTech leaders go beyond inspection readiness toward true quality maturity. Mike explains how VIP grew out of FDA’s Case for Quality initiative, why the program uses a maturity-appraisal model rat...

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 Podcast , host Naveen Agarwal speaks with Michelle Lott about what early FDA 483 observations under QMSR are already revealing: a clear shift from procedural compliance to evaluating how well companies actually make risk-based decisions acro...