Anyone has made other experiences?
Spent some years working on an a class 2b diagnostic device. Potential for harm not that high, but the lack of rigour in testing leaves me wondering to this day whether it worked at all as advertised.
If medical devices are ever open sourced, millions of critical bugs are going to fall out.
Already happening with Diabetics. I know a girl that has cracked her pump for closed loop performance and she says the results are mostly better, but take close monitoring and an active hand.
It's a tricky thing still. Yes, the devices are buggy (all things are), but half of medical devices are used by people with below average intelligence (by definition). It's still a balancing act and is likely to be for a long time.
I tried to contact them regarding the fact that their url for jquery tools no longer resolves and that their SSL certificate has expired. I filled out the contact form and hit submit and then was presented with an empty results screen (probably because the js is broken). Hopefully they fix it up, but might not.
[0] https://diabetes.diabetesjournals.org/content/42/2/341.short
Regulatory bodies are aware but are sitting on it, as disclosure would be almost as damaging reputationally to them as to the manufacturer.
You know the catchphrase, "think of the children", often used to justify some kind of overreach?
In this case, please, _think of the children_ and for the sake of us all, even anonymously, get that info to the media.
It’s still in the “shouldn’t have happened” category, and the manufacturer in question reported themselves, and steps have already been taken to prevent a recurrence, and similar potential bugs have been identified and addressed.
It’s tough. There is a lot of political opposition from bad or amoral players to any regulation. They’re faced with the choice of voluntarily opening themselves up to fierce criticism over a, in the grand scheme of things, minor issue, or sweeping it well under the carpet, learning from it, and moving on, and spreading their reach for regulation and enforcement.
It’s a trolley car problem if I’ve ever encountered one, and I am not confident that I could make a good call.
And after all, this is the most important thing for a regulatory agency.
In large orgs "conservative" managers who escalate and block issues usually don't get fired, they just get pushed to some other part of the org. And when/if the issue blows up, they get pulled back in to clean up the mess. Cause few others will have credibility. Same dynamic applies in reverse. The bunch that were in charge, during a blow up will be sent into the background. But will be pulled back when more "aggressive" management tactics are required.
We just had a potential safety issue in the last few months because of a manufacturing process defect. While no one was injured, this was a potentially hazardous situation. The company stopped the production, and reworked every affected system on customer site. While our profit have taken a hit this year, at least I am glad the right decision was taken, and no one (that I know of) challenged it.
To be fair, I don't know at which level above me the (costly) decision was taken, but at least someone had the courage to take it. But I am working at a fairly big company so likely it is easier to absorb an unexpected cost to defend the company brand, compared to a smaller company that have only one product line and that maybe can't afford it.