It's a damn shame that years after this became a thing we are still waiting for a proper commercial product to hit the market at a reasonable price, I had a male relative with T1 diabetes and it was a complete burden on his life, We have the technology to improve peoples lives markedly (because we already did) but because of what the author mentioned in the article and the lack of "skin in the game" manufacturers are still dicking about and a lot of this only works because those manufacturers couldn't secure a blowjob in a brothel.
$8000 is just insane (yes I know FDA approval, testing all that jazz) but there ~1.3m Americans with Type 1 diabetes alone, there is a massive demand for a cost effective product at scale.
Someone who can and will build their own is very committed to understanding a great many things. This guy has gone and read what doctors with diabetes have to say because doctors without diabetes are not an adequate source of information for his purposes.
To build one you can sell to anyone who has diabetes (and the money or insurance to cover it) you have to do a lot of "idiot proofing." You can't assume they will keep up with all the information, best practices, etc.
They want it to just work and that's not what you are seeing with the build-your-own crowd.
Making a hardware product that is validated in a regulated market is non trivial. At least part of the cost goes to reducing overall risk to a large market, which open source projects aren't really resourced to address.
Isn't it possible to design the product such that its risks are greatly reduced? E.g. by limiting the amount of insulin it can deliver in a given timeframe?
This comment falls under the "why don't you just..." cluster. Even implementing a feature like that (assuming it made sense) carries risk (imagine if your limiter's sensor broke and it failed open).
Designing reliable systems is incredibly hard. It requires a ton of resources (money, lawyers, engineers) And experience and long time frames with relentless effort to document everything so that when somebody does die, you can root cause it and fix the problem without regressions.
I've been continuously impressed with what open source hackers have done with open biology projects, but that doesn't mean any of these products are reasonable replacements for the products that are used by tens to hundreds of millions of people.
yes, it's spot on, but only a tiny part of a much larger system. And even implementing that feature is devishly complicated. Hence my statement "why don't you just".
Agreed - open body-hacking projects are amazing feats of community and perseverance, but the systemic cost and access issues that plague high-end medicine will persist until they’re addressed systemically.
A bit of elaboration on the risks you could encounter here:
- CGM sensors can be faulty, depending on the rate of change of glucose (they’re actually not measuring blood directly, but interstitial fluids, which are generally lagging by about 15mins and can be inaccurate with large swings)
- battery dying out isn’t so bad, since the pump will just default back to its previous basal delivery settings
- there are safety maximums on insulin delivery, which prevent among other things, your typical overflow/precision errors
- maximums over time though is a more complex issue, something I haven’t yet dug into
And then there are... pump actuator failure, syringe seal failure (on syringe based pumps), valve failure (on valve based pumps), user error (on all systems), reservoir running out, occlusion, air bubbles and a thousand other things that can go wrong. This is not exactly easy material in the best of cases and most sensor packages do not have redundancy and will at best address only a small fraction of all possible failure modes.
Delivering something fast, accurate and under wildly changing conditions in the human body is far more complicated than most people assume.
I still remember when I had to be hooked up to an infusion pump for many hours at a time. In theory this was all pretty simple - I had a port (a permanent link to my blood system), the machine was hooked to the port, the machine was configured to deliver x ml per hour. Easy, right? Well ... moving my arm had a non-zero chance to trigger the alarm (alarm means "the machine has a problem to deliver the configured amount", please do something), moving in the bed had a higher chance, walking over the hospital corridor I could almost guarantee that at some point in a single walk (i.e. one length of the corridor) it would freak out and again start the alarm. And that's for a far easier system in very easy conditions. An insulin pump has to change what it delivers all the time and it has to work always. Sport, work, driving, running, ...
Adding to what others said, too little insulin can be dangerous, so if users don't know/notice that it stopped delivering more insulin, they might not manually add the requisite amounts.
Forgetting to take medication is dangerous, overdosing medication is dangerous. It is just not that easy to design a system like this.
Making a class 3 medical device (really it's a system of devices, infusion + cgm) that works off the shelf versus something that a hobbiest can throw together are two different games.
Seems to me this is a principle-agent problem, really. Manufacturers and the FDA are only liable for one part of the system's safety - immediate injury or death attributable directly to a specific error. They're not liable for the gradual systemic damage caused by not using closed loop algorithms (due to worse blood glucose control).
Hence hobbyists home brewing this stuff. Only when you're making things for yourself are incentives properly aligned.
One would think that insurance companies would jump through flaming hoops to get their diabetes clients the best possible treatment. It is such an expensive condition (I would guess the most expensive), which just gets worse with time.
My sister has T1, and it's a sh!tty disease. She's young, lives a very healthy lifestyle, but still these complications keep creeping up.
I (and my sister) are very lucky to live in a country with socialized healthcare, so there's no financial burden on her - but I can only imagine how expensive it would be for those without that option - worst case the uninsured; more so in the long run.
Also once the device is built and certified subsequent devices are at the cost of materials, support and production (and some profit) ... which I suspect is a bit a bit less than 8000.
$8000 is just insane (yes I know FDA approval, testing all that jazz) but there ~1.3m Americans with Type 1 diabetes alone, there is a massive demand for a cost effective product at scale.