Episode 68 - From Stethoscopes to Smart Devices: FMEA in a Complex Device Landscape with Dr John Salvato – SOLABS Knowledge Base

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Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments.

This is the first installment of a two-part series on design controls and risk management in medical device development with guest Dr. John Salvato, founder of Design Quality Services and an ISO 13485 lead auditor with over 30 years of experience in medical device and automotive engineering. Together with our host Philippe Gaudreau, they argue that as devices grow more connected and AI-enabled, foundational tools like design controls and FMEA matter more, not less.

John traces FMEA's origins from the U.S. military in the 1940s to NASA's Apollo program and Ford's automotive use in the 1970s. He contrasts legacy devices like stethoscopes, with their handful of known failure modes, against today's wearable and connected devices, where added functions and data flows multiply the failure modes engineers must account for.

The conversation turns to new risks from connectivity and embedded AI/ML models, and to "thin data,". The episode's throughline is that design controls and FMEA, far from outdated paperwork, remain the engineering backbone that novel, complex devices depend on.

Key Takeaways
01:19 Introducing today's topic: design controls and FMEA
02:33 Introducing today's guest, Dr. John Salvato
06:27 The origins of FMEA, from military use to NASA and automotive
10:44 Why design fundamentals matter more as devices grow complex
16:49 New risk categories from wearable and connected devices
20:53 The concept of "thin data" in novel device risk estimation
24:14 The QMSR change and the end of legacy device exemptions

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