I mean, I get the business incentives involved, but I also think it's high time to realize they're getting insane and should be altered.
Exactly what patient need do you believe open source would meet that is not being met by the current closed-source development process?
The need to know, and be able to control if necessary, what a device that affects your life and health is doing.
I'll give an example from my own experience. I have sleep apnea and have to use a CPAP machine. There is a nice little SD card in the machine that records detailed data from every use--which means it records how long I sleep, how soundly I sleep, how many (if any) apnea episodes I have, etc. This would be very useful information to me, but I have no way of getting it, because the software and data inside the device is proprietary. The only way for me to have anyone look at this data is to pull the SD card out and take it to a sleep therapy doctor, and even then I won't see the actual raw data; the best I'll get is some proprietary analysis report designed by the device manufacturer.
Furthermore, the ostensible use for the data is to be able to adjust the pressure the CPAP machine is set at in order to improve the therapy. If I had access to the data and the settings inside the machine, I could easily do this myself. Instead, if I want any adjustment made, again, I have to go see a sleep therapy doctor--which means I need to make an appointment, which usually means waiting weeks or months, and I need to take off from work to go to the appointment, etc., etc.
It should be obvious how open source would greatly improve this situation.
How do you know this?
For starters, without access to the hardware and understanding what it's supposed to be doing, how do you know if the code is right or not?
Let me clarify that I'm not opposed to open sourcing the code, once issues around Trade Secrets are handle. But I don't think it would have even remotely the impact this group believes. The vast majority of device problems I've seen were system issues, not just a coding error.
I also don't need to know much about the intended function of the device to find coding styles that cause problems in an embedded environments.
Why should the patient who has the pacemaker implanted care? This seems like a clear situation in which the patient's interests trump everybody else's. Pacemaker manufacturers should be competing in how well their devices meet patient needs. Closed source doesn't meet a key patient need.