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In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment. Mike challenges MedTech professionals to rethink how we engage with the system, exposing how widespread underreporting and data hygiene problems not only weaken safety efforts but also increase legal risk. This eye-opening discussion reveals where the breakdowns are occurring, who’s responsible, and what industry and regulators can do to fix it.Key Timestamps[02:30] What is the MAUDE database, and why does it matter?[06:10] The critical difference between reportable and non-reportable adverse events[11:20] Limitations of MAUDE: Why FDA warns against using it for rate comparisons[17:45] Underreporting, late submissions, and missing da