There are three things to an "artificial pancreas": glucose sensor,insulin pump, and the control logic. The difference between an artificial pancreas and the "manual" operation is just that the control logic is automated.
You even can't "fuck up" very easily, unless you add other diabetic stupidities on top of a malfunctioning control logic. Two failure conditions: a) Too little (or no) insulin delivered. b) Too much insulin.
The second one is the more dramatic/short term. The insulin pump has a limited supply of insulin. The speed of injection is limited. There are probably additional safeguards in the pump's software around knowing you are not an elephant breaking into a candy shop. And you feel the pump acting. You can pull it out if it behaves strangely.
Too little insulin delivered may be trickier, but you still have to check the glucose levels occasionally, probably multiple times a day.
Patients already use "algorithms" for insulin delivery. But they are comparatively shitty and designed for example to deliver insulin as a bolus after a meal. Continuous administration of insulin over a pump already has a lot of benefits. A continuous monitoring already has benefits.
So, Theranos can exist, and if the money that had gone to Holmes and then this indeed would be a solved problem. But it didn't. Note that there are pumps with a closed loop option on the market today, but they are neither convenient nor simple to use. It is work in progress. I fully expect a simple to use closed loop system to be available in quantity somewhere in the next year or two based on recent market research. The time is indeed ripe. The basic tech is there and the pumps have achieved a level of miniaturization and reliability that it is feasible, there are still problems to overcome but those are all within the realm of the possible, do not require unobtanium and enough parties are working on it (competition is fierce) that at least one of them will solve it within that time frame.
It's surprisingly tricky to measure chemical concentrations continuously without replacing the "sensor". Blood and other liquids attack and clog everything.
Without continuous glucose monitoring, you can't do artificial pancreasing.
It has just taken time.
$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.
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.
Hence hobbyists home brewing this stuff. Only when you're making things for yourself are incentives properly aligned.
As an FYI, you can’t “move fast and break things” when it comes to medical devices.
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.
How many people is the device allowed to kill when it fails? Who pays the bill when that happens?
The answer to those questions defines the price and availability of a medical device.
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.
https://www.tidepool.org/blog/tidepool-loop-medtronic-collab...
Personally I’ve been using their Tidepool software for two years before this and it’s very good. The Tidepool Loop is actually based off of another FLOSS APS called Loop - so it’s likely the efforts will not go to waste. That being said, there’s still possibility that the pump manufacturers have interest to stifle their development - but we’ll see.
I hope they don't mess up the encryption on the pump commands. Especially with pumps that can deliver high doses that can be really problematic.
One thing that's unclear, and perhaps I didn't read carefully enough, is how you're connected to this system.
Do you wear it? Or are you only connected while sitting, sleeping, etc?
https://openaps.readthedocs.io/en/latest/docs/Gear%20Up/pump...