The use of open-source software in medical devices has been a topic of discussion for many years. The Economist article Open-source medical devices: When code can kill or cure highlights continuing activity in the academic community and interest by the FDA in developing processes around its use.
One of the big unknowns in this area is how a community might be formed (Dreaming of Flexible, Simple, Sloppy, Tolerant in Healthcare IT has some thoughts on this).
From the article:
Eventually, medical devices might evolve into collections of specialised (and possibly proprietary) accessories, with the primary computing and safety features managed by an open-source hub.
This is in reference to both hardware and software, but in either case one major challenge will be how to incentivize contributions. Open-source means free to use and modify. If there is no financial gain to be had, other benefits for contributing need to be developed. Also, proprietary and open-source in the same sentence seems like an oxymoron, so I’m not sure how that’s going to work.
Another barrier would be liability risk. Let’s say you contributed software to this hub and that component ended up in a device that harmed or killed someone. All of the legal waivers, disclaimers, and releases in world wouldn’t necessarily keep you out of a court room.
I don’t think the basic arguments discussed in Open Source Medical Device Connectivity have changed a great deal. At the end of the day the medical device manufacturer will ultimately be responsible for ensuring the safety and efficacy of their device.