Hi, everyone! I'm a PhD student in bioengineering, and I love designing and building hardware+software tools. For my thesis, I'm studying challenges and strategies for open-source medical devices for global health equity: how might platforms and communities be built to support cooperative production of medical devices appropriate for local contexts, all the way from invention to implementation?
@ethanjli Start here... https://openaps.org/ for a positive story...
I think you will find your biggest issue is that people die if medical equipment fails... Medical professionals have a code of ethics that they are held to. Software engineers do not. Pretty much every license I have seen states in capitals, 'no warranty for any purpose'.
So, fantastic idea and the openaps project shows it can be done... but no guarantees and certainly not from corporates. I'm keen to see how you get on!!
@carl_klitscher Thanks! 😀 From what little I know about OpenAPS, it seems really really cool. I've read that the DIY aspect makes clinicians nervous, (in my opinion) with good reason. I see a big need for frameworks to help makers collaborate with clinicians on safety, since COVID maker projects from past 8 months have shown that the two sides don't always understand each other.
@ethanjli aye... and I think part of that goes back to the ethics comment I made. Medical professionals are trained to see the risks and mitigate them... in IT we tend to ignore them because nobody dies. Another aspect is the US legal system which is litigation as a weapon. The impression I got from Dana at her LinuxConf session https://www.youtube.com/watch?v=p76hGxv3-HE was that the device manufacturers needed the end user to keep verifying the dose by pushing a button... their get out of jail free card...
@ethanjli So what Dana and OpenAPS have done is taken that 'personal responsibility' step a stage further and said 'I agree to do that automatically' and build their own systems. No-one forces anyone to do things the OpenAPS way... everything is laid out and there is ample evidence that it works so you as an individual can make your own decision... and people do.
But you are correct, how do you enable that safely and ethically... and that's what you are going to tell us, right?
No pressure... :)
@carl_klitscher Oh, that's a really neat way to put it! One of the projects I'm helping with is trying a strategy of releasing only a reference design and documentation for safety standards, and making manufacturing partners take responsibility for final safety - so actually that echoes OpenAPS's approach with users. I don't think I'll get much certainty by the end of my thesis, but hopefully I'll at least have an informed guess for when/why a strategy might be better or worse :P
@ethanjli That's a very tough question, but you may be interested in the many articles on "pancreatic looping". You may also be interested in Karen Sander's situation with her fibrillator.
@Lofenyy Thanks for the recommendations! I hadn't seen Karen Sandler's talk before, and I enjoyed it. There's something interesting to reflect on in combining the points she made about proprietary software security in medical devices together with the fact that OpenAPS works by relying on a security flaw in the proprietary firmware of certain old insulin pumps!
@ethanjli Yeah, definitely. Note that if insulin pumps were programmable, and free firmware was available (and well made), you could theoretically have a best-of-both-worlds type situation, where you can take full advantage of your device while also avoiding potentially lethal security flaws in your software.
This is especially true because free software in general, over the long term, does tend to have less critical flaws over time than competing software.
@ethanjli A counter-point to this is that supposedly according to one article I've read, that at least one patient has died in their sleep while looping, after taking a lethal dose of insulin.
Thus, medical device manufacturers would argue that users shouldn't be allowed to modify the software on their own devices.
@Lofenyy Yeah, arbitrary DIY changes to life-critical software sound risky to me. Beyond community review & testing, like how OpenAPS has done, ideally projects could build & validate under quality controlled processes and distribute to users. It'll be interesting to see how things go with Tidepool's Loop project, since they've been working with the FDA on safety and will go through the Apple App Store (so it's open-source but probably will restrict the DIY changes to FDA-approved ones).
@ethanjli I didn't know that someone was trying to get this FDA-approved! I remember there being a podcast episode that also talks a lot about this stuff, along with stuff about the FDA. I could be misremembering, it's been a few months now and I wasn't paying full attention. I can't remember if it was on @librelounge (LibreLounge) or Free as in Freedom.
@ethanjli Also, I don't think the victim made a radom abritrary change to his software. The article made it sound like it was the softwares fault, and that the user was following instructions properly.
I could be wrong, it's been a long time since I've read about this stuff.
@ethanjli I mean, he set up an artificisl pancreas, which is not FDA or manufacturer approved, but I recall that he did it all properly like many others have in the past. He passed away from a strange issue where he received an overdose of insulin. That's all I remember.
@Lofenyy Ah, I'll have to look into this further - thanks for the pointers with the podcast names! I know the FDA had received a report of a patient who had a serious insulin overdose but didn't die (ref: https://www.fda.gov/news-events/press-announcements/fda-warns-against-use-unauthorized-devices-diabetes-management), but I also just found a journal article reporting a case where someone intentionally (and fatally) overdosed on insulin using an off-the-shelf device, so I'm probably only seeing the tip of the iceberg.
@ethanjli Welcome to Mastodon, Ethan! Sounds like a fantastic line of inquiry for your thesis. Also I'm interested in whatever other hardware+software tools you've built.
@jgoerzen Thanks! My projects are still in-progress and sparsely documented, but I've been involved in developing the electronics for a low-cost scanning/tracking microscope for diagnostic & research use (https://www.biorxiv.org/content/10.1101/684423v1 + more to come soon), prototyping an electricity-free centrifuge for use in remote settings (https://www.medrxiv.org/content/10.1101/2020.06.30.20143255v1), and developing a reusable architecture + software for life-critical embedded systems as part of a COVID ventilator project (https://www.pez-globo.org/).
Scholar Social is a microblogging platform for researchers, grad students, librarians, archivists, undergrads, academically inclined high schoolers, educators of all levels, journal editors, research assistants, professors, administrators—anyone involved in academia who is willing to engage with others respectfully.