November 2025 Newsletter – Building a firm foundation in risk management
Beginning Risk Management for a New Medical Device
“Just grab the FMEA template and let’s start brainstorming potential failures.”
This is not an efficient way to get started with risk management for a new medical device. Instead, teams should first analyze hazards and hazardous situations associated with the intended use of the device and compile a Hazards and Harms List to use as a foundation for all risk assessments of the new device (including FMEAs). This ensures that risk management is comprehensive, systematic, and focuses on the areas of biggest concern.
Risk Management Spotlight
In collaboration with another medical device consultant, we’re launching a new service to perform a quick independent review of a client’s Risk Management File and risk management procedures. Within two weeks, we deliver a clear, actionable gap analysis report that highlights what is missing, incorrect, or unclear at both the SOP and Risk Management File levels. This is a convenient way to find and correct problems before the next audit or FDA submission.
Platform Approach for Software-Enabled Medical Devices
As software becomes a bigger and bigger part of many medical devices, it’s important to adopt development approaches and tools that can keep up with the complexity and rapid changes needed for these products. A platform-based approach enables product teams to efficiently manage all the risks, requirements, tests, and other product data for complex, rapidly evolving software-enabled devices.
What To Do When Things Go Wrong…
Often the advice I read about developing medical devices seems to assume an ideal world. But what about the messy real world where things go wrong, sometimes in a big way? In this article in MPO Magazine my co-author Russell Singleton and I describe two methods to help overcome the challenges that arise in development projects in the real world.
Interview with Russ Singleton and Aaron Joseph on “Phase Zero on Steroids”
Earlier this year we were interviewed on Bill Schick’s MESH Interactive Podcast to explain some key concepts for successful development of innovative new medical devices.