I was just reading an article from The Economist on open source software as a solution to security and safety in medical devices. I then looked through the comments and was led to a video on the topic. After digesting both, I’m not sold on this being the best idea. However, I do think the subject makes for an interesting discussion topic. And whether you do support an open source movement or not, I’d venture to guess that most in the industry would agree that software development for medical devices is not handled in the best possible way with the current system.
Should device manufacturers be the sole party responsible (essentially) for ensuring that their device software is bug-free, safe, and secure? Should FDA step-up the oversight on the software that lies within more and more of today’s medical devices? If the FDA was tasked with inspecting the actual source code for the medical device software, would it stall device approvals even more? These are only a few of the questions that this topic creates. And to be completely honest, I, for one, do not have the answers to these. Further, I’d venture to guess that the answers I would get would differ significantly and be dependent upon who I asked.
Getting back to open source software, I’m certainly a proponent of it. I use a number of open source programs myself and have considered going completely open source for my home computer. Let me repeat that last part…for my home computer. I’m not so sure it’s the answer for medical devices. Then again, having more eyeballs (and brains, as the article points out) reviewing software for bugs and security can only be a good thing, right? Perhaps it’s just my prejudiced viewpoint on the difference between a pacemaker and my personal computer; does that mean open source is any less safe than what we have now for medical device software?
If nothing else, I will concede one item in the article as being an extremely cool vision for a future in which open source medical solutions are in regular use. ‘“My dream”, says Dave Arney, a researcher on the project, “is that a hospital will eventually be able to print out an infusion pump using a rapid prototyping machine, download open-source software to it and have a device running within hours.”’ That, indeed, would be a pretty incredible healthcare environment.