Regulatory Compliance Officers Need Not Fear Open Source Software in Medical Devices or Mission-Critical Healthcare IT Systems

I spent the past few days in Boston at the Harvard Medical School Conference Center speaking audiences at the Medical Device Connectivity Conference (I presented lectures on how to design next-generation medical devices and gateways). Many people that attended my lectures showed a great deal of trepidation when I brought up the fact that they should use open source software (OSS) to reduce cost and potentially increase the quality of their devices; the most common excuse I heard was that the regulatory compliance folks wouldn’t allow OSS or that the FDA would disapprove.

Having taken part in numerous regulated medical device development efforts that included open source software, including the world’s largest medical devices with a 510(k), I know for a fact that the FDA doesn’t have anything against open source software in particular (as long as you can prove safety). So, the problem in most cases likely stems from a lack of experience with open source in the regulatory compliance groups within companies. I thought I’d take this opportunity to write up a quick summary of how R&D groups should properly experiment with and include open source software in safety-critical systems...