Using open source software in safety-critical medical devices

Earlier this year the nice folks at O’Reilly Associates were kind enough to invite me to speak about how to use open source in safety-critical medical devices. The open source conference (“OSCon 2011”) was terrific and I met some old friends as well as made tons of new friends. Many of you have asked me to upload my presentation from the talk and I’m happy to oblige.

As we know, FDA regulated medical devices are considered safety-critical systems due to their ability to affect patient lives. Given the nature of scrutiny and the requirement to play it safe, most medical device vendors end up choosing proprietary or custom solutions for operating systems, databases, messaging platforms, alarm notification systems, and event logging. This talk uncovered some of the common misconceptions around government regulations and how there are not inherent limitations around using FOSS in safety-critical systems so long as the requisite risk analysis and quality assurance work is conducted.

I presented my recent work on modern medical device architectures, the challenges and opportunities associated with using open source software in medical devices, and real-world findings from use of open source answering questions such as:

• Will the FDA accept open source in safety-critical systems?
• Are open source systems safe enough for medical devices?
• What kind of assessments are needed for open source software in medical devices?

By the way, I will be also be covering this topic of open source later this week in Boston at the Medical Device Connectivity Conference (along with many more topics in greater detail). This year I am Chairing the “Manufacturers” track, participating in one panel, and giving two talks – my short talk is a presentation entitled “Best Practices for Embedded Medical Device and Gateway Software Applications” and the other is a longer workshop called “How to use Open Source Software and other Low-Cost Design Techniques To Build Safety-Critical Medical Device Platforms and  Meaningful Use EHR Gateways”.