Let's Talk Risk! Podcast

Filtered episodes(8)

• StandardSummaries only
  Deep Dive: When the Risk Baseline and the QMS Both Break Down

  Published Sep 25, 2026

  Deep Dive

  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 product line.At the same time, key QMS processes were also failing.Key highlights covered in the audio

• StandardSummaries only
  Deep Dive: When FDA Qualifies the Ruler

  Published Sep 18, 2026

  Deep Dive

  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 Tools (MDDT) program creates a different pathway: qualify a tool for a defined context of use, and spons

• StandardSummaries only
  Deep Dive: What FDA’s QMSR Warning Letters Are Revealing

  Published Sep 11, 2026

  Deep Dive

  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 one common lens: the integration of risk management across the quality system.The cases illustrate ho

• StandardSummaries only
  Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices

  Published Sep 4, 2026

  Deep Dive

  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.Key highlights covered in the audio:* Not all PFAS present the same risk. The discussion distinguishes sm

• StandardSummaries only
  Deep Dive: When Patient Preference Becomes Regulatory Evidence

  Published Aug 28, 2026

  Deep Dive

  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 audio:* PPI is not the same as a patient-reported outcome. PROs describe what patients experience. PPI ask

• StandardSummaries only
  Deep Dive: Designing Safety Into Autonomous Robotic Devices

  Published Aug 21, 2026

  Deep Dive

  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® may signal that this last major manual bottleneck is beginning to change.But this Deep Dive is about muc

• StandardSummaries only
  Deep Dive: First FDA Warning Letter Under QMSR

  Published Aug 7, 2026

  Deep Dive

  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 individual expectations are not entirely new. What has changed is the regulatory structure through which

• StandardSummaries only
  Deep Dive: FDA's RWE Guidance

  Published Jul 24, 2026

  Deep Dive

  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 regulatory decision.One important change is FDA’s recognition that a sponsor’s inability to obtain participant-