How many episodes of hypoglycemia do you think one needs to have, in an utterly broken healthcare system in which being ordered paramedics and given sugar pills costs you $XXXX per occurance.
And if you're gonna talk to me about responsbility and healthy living please join the real world some time.
That's why people choose to take actions into their own hands. Because being a victim of a system that just doesn't care enough leads you to either take the handles or down under.
All power to these knowledgeable, individuals, for doing something dangerous but potentially great. This is HN, full of smart people who understand the risk of failure and will monitor the crap out of their system and adjust and tinker until it's ok. The problem is people making tutorials and publicizing their work, which leads to people not as smart following their tutorial and thinking it will be alright.
There are tons of papers on closed-loop systems, and probably clinical trials are happening as I write this comment. Medicine isn't one of the industries to "disrupt" though, as much as people on here want to believe.
There's so many pitfalls here where teams of engineers with the whole part spec and from different disciplines have failed before. It sounds very dangerous.
Either way, I agree I'm not really subscribed to the idea that DIY life critical systems are a good idea beyond POC.
Not enough is also bad but hopefully they'll notice and can act accordingly - still a threat too though.
It's not that we're all saying this is an unsafe machine, we're saying that a random person DIY'ing and using such a solution is very risky, there's a reason why commercial medical equipment requires rigorous testing/certifications, etc.
This does become a serious problem when it gets into the hands of people who don't know what they're doing, if they're convinced to trust the tech because "obviously the smart people working on it made sure it's safe".
>This doesn't mean that we shouldn't do it.
Why should she put her son at risk for a science experiment?
If it seems horrible, that's because the reality that diabetics have to live with is horrible.
https://www.webmd.com/diabetes/news/20190628/fda-recalls-ins...
Prior to this pump + Dexcom, he had a Medtronic 530g + glucose monitor. It was not internet connected out of the box, it required a $100 gadget that would transmit his blood sugar to his cell phone and then to medtronic's awful website. Fortunately folks developed Nightscout to scrape Medtronic's website and provide a much better experience. With Dexcom being a much more modern option (the CGM transmitter has built-in bluetooth) - we don't really need Nightscout, but it's convenient for me to watch his sugar on my 2nd monitor when he's at school (he's only 7.)
The problem is not in my opinion regulatory processes or clinical testing. It's been simply a lack of urgency/competition. Beta Bionics has started to make Medtronic and other competitors step up their game in recent years. https://www.betabionics.com/
The FAA does however have a parallel track, called Experimental-Amateur Built (E-AB) where if you build the airplane yourself for educational or recreational purposes, it’s subject to a mostly separate set of rules. They are generally more relaxed in terms of what maintenance and modifications you can do but stricter in terms of what you can do while flying (can’t take passengers for hire, for example). Most pilots prefer the certified/safety-first/highly regulated track, but the government recognizes it’s a trade-off and offers the other option for those who prefer a more DIY-friendly world.
Not saying this would necessarily work for medical devices, but there is precedent for acknowledging the trade-offs when it comes to DIYing safety-critical stuff.
So, given that whatever decision they make will kill masses of people, regulators have very strong incentives to kill them by being too restrictive, rather than kill a different mass of people by not being restrictive enough.
The solution to this problem is clear: the person with the strongest incentive to keep you alive is you. Any regulator or drug-company executive will reliably put other considerations above your survival under some circumstances. So, except in cases of people who really cannot be trusted with life-and-death decisions — children and some severely mentally impaired people — you should have the final say on what medical treatments you try or don't try.
In short, the whole regulatory structure should be scrapped. We still need clinical trials, but not before new treatments become available; after.
This sounds like a radical proposal, but in fact it's how the process worked in the US during the time that we owe most of our revolutionary medical treatments to, the 1920s through the 1960s. That's when most (all?) of our currently marketed antibiotic families were discovered, when one dude spent a couple of years prototyping the pacemaker in his barn and then convinced his friend at a hospital to start trying it in patients, when artificial joints were developed. We're still coasting on the legacy from that era.
plenty of closed loop feedback systems we are all hooked up to which can malfunction and kill you.. casually thinking of automotive industry I can come up with:
- abs brakes - engine control units - transmission control units - power steering - traffic lights
and that's just one sector, let alone aviation, mass transit, power plants, etc etc etc.
granted the malfunction:fatality ratio is probably different, but not so altogether crazy to think that 'closed loop is impossible' .. though perhaps you are strictly speaking w/r/t regulatory climate..
that said, we have had pacemakers for many years..
The FDA is setup to optimize survival not quality of life. The standards will be much higher for these pumps.
I spent a year hooked up for 8 hours a night to a CPD dialysis machine - I read the massive manual and there is a long section on what can go wrong including "Death" - no way would I start hacking on that.
Though I did think about using a camera and ML to monitor the waste output for signs of contamination.
You're not going to squeeze a lifetime worth of lost salary out of a random Redditor who told you how to tweak your insulin pump.
Because the risk is worthwhile at times.
The exceptions typically apply to rare diseases that impact a population too small to be profitable enough to justify the $1B or more it may cost to shepherd a device or medication through the normal process.
These are populations who would be potentially unserved otherwise. (I'm of the personal opinion that this is where the government should step in instead of private industry, but I'm pretty left of center.)
https://www.fda.gov/industry/developing-products-rare-diseas...
IIRC, an exception of this sort was used to expedite an Ebola vaccine due to the recent outbreak... because, well, Ebola.