One interesting link:
https://www.drugtopics.com/view/hacking-diabetes-the-diy-bio...
I would trust the people that hack on these systems to be even more motivated than the manufacturers to make sure they don't fuck up, it's the equivalent of flying a plane you built yourself.
A great analogy because people die that way. I personally would never push code to another person’s insulin pump (or advertise code as being used for an insulin pump) because I couldn’t live with the guilt if my bug got someone else killed.
And to the best of my knowledge none of the closed-loop people have died as a result of their work and they are very good at peer reviewing each others work to make sure it stays that way. And I'd trust my life to open source in such a setting long before I'd do it to closed source. At least I'd have a chance to see what the quality of the code is, which in the embedded space ranges from 'wow' all the way to 'no way they did that'.
which is why lots of systems and processes (sometimes called red tape) exist to try and prevent the undesired outcome, and dont rely on the competency of a single person as the weak link!
Advertising that code, IMHO would be as showing of you doing extreme sports, for example. I do not think is any bad. A good disclaimer should be enough to take away any guilt.
By personal choice I use a commercial CGM (if I could “touch it,” I’d be firmly on the side of certainty about killing myself through sheer stupidity), but reading something like “associated with” really makes me angry. Before making such subtle insinuations about the open-source world (the source of the revolution of the last 10 years in this field), regulatory bodies should open their eyes to what is actually happening with the quality of current sensors and the real problems they are causing.
So the question really becomes - Are these people working on their own pumps with open source more or less invested than the random programmers hired by a company that pretty clearly can't get details right around licensing, and is operating with a profit motive?
More reckless as well? Perhaps. But at least motivated by the correct incentives.
Your "prototype" is a plane from the original manufacturer with no physical modifications but a software patch to use data from sensors the plane already had to prevent the computer from getting confused under high wind conditions in a way that has already caused two fatal crashes.
Now you have to fly somewhere and your options for a plane are the one with the history of fatal crashes or the same one with your modifications, and it's windy today. Which plane are you getting on?
Instead they got McDonnell Douglas'd
As it turns out the motivations matter way more than you might think.
I would think it's the opposite. People that hack on this only risk their own life. Companies risk many people's lives and will get sued. Of course the person doing the hacking doesn't want to die but they're also willing to take the risk.
The baseline worst-case scenario of messing this up on yourself is that you die.
Yeah, only their own life, yknow, something not particularly valuable or motivating to conserve for them, as opposed to the companies financials!
Provided they do not risk anyone elses, that is entirely their right.
- people try to wingsuit through narrow obstacles and miss
- people try to build their own planes and helicopters and die
- people try to build submersible vehicles to go see the titanic and, uh, don't have a 100% success rate
- people try to build steam-powered rockets and die
"It's their life, they won't fuck it up" doesn't exactly cover a lot of behaviors.
I'd argue home-rolling your own medical device firmware is closer to daredevil/"hold my beer" behavior than normal.
I would say that can have a lot to do with your average diabetic loop hacker.