Originally published at: https://boingboing.net/2019/05/06/loopers-vs-organleggers.html
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Sounds like a job for a mid sized factory in the back blocks of china. There is a lot of quite good, hackable, hardware coming out of China at the moment.
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Not a bad idea. I was thinking a kickstarter for open hardware.
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I agree, but we have to remember that these are medical devices, not MP3 players or home automation gadgets. I’d like to see the mark of some reputable government regulatory body – not necessarily the FDA – or non-profit testing agency on the hardware.
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commercial artificial pancreases are fully locked down and force users to buy proprietary insulin at severe markups
Jesus Christ, it’s like Juicero but for mission-critical enzymes.
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Something as “legitimate” as a Kickstarter would never get past the FDA approval process. This has to be a purely grey market affair for the time being.
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My question is this: if you cannot perform a procedure on someone without a medical license, but you can perform it on yourself… if they procure the parts (either from eBay/Etsy, Amazon, Alibaba or 3D-printed from acceptable materials) and assemble their own, does it really need to meet FDA approval?
I mean, yes, the idea is it needs to be safe, it’s to save a life… but a design is a design, no matter how it’s assembled and distributed, and it’s not like someone is selling them a pump without FDA approval as a medical device, they’re buying the parts and attaching it appropriately.
If you sell the hardware as a functional device, you are correct. If you design a device that can be assembled and sell the parts with the plans being publicly available, is it so cut and dry? Does the FDA have authority over what you make for yourself?
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No, but in the U.S. you can’t sell it to other people as a medical device or as a kit for making one.
Even if the device isn’t being used exactly as designed, the hardware is still carrying out the same functionalities for different purposes. If the hardware or a component is flawed in one of those functionalities (despite the stamp of approval from the Chinese government secured by the vendor) it’s still dangerous.
Do you have a citation on that?
Me too. Sadly the FDA is more about protecting IP and corporate interest than people these days and is not a functional regulatory body which operates to the benefit of the people. Until that changes, people are choosing between food and medicine. Single mothers play the role of pancreas to their children and can’t keep a full time job because of it.
People are dying because of the policies of our reputable government regulatory body.
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Test kits of various sorts are covered in general, and there’s no exception made for on-going testing (like one of the functionalities of these hackable devices).
The key question for the FDA is: is the item being sold and marketed by the vendor as a medical device? I could build my own trepanning kit out of a power drill and various accessories, but if I start selling it to the pubic as a Migraine Relief Kit the FDA will come knocking.
It would be nice if there was an authoritative international standards body that didn’t put protection of corporate IP first, but any move in that direction would be portrayed by the U.S. as the next step on the road to one-world socialism.
There are certain areas where I’m willing to extend some trust to the FDA despite its flaws: the safety of vaccinations are one, the safety of medical devices are another.
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So if my imaginary kit was designated “parts for creating an automated pump for various applications that should definitely not be used for medical purposes”, then I’m in the clear?
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Pretty much. As long as the “not for medical use” disclaimer is there and clear, you’re ok. That warning appears on a lot of products peddled by quacks.
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I’m (in a more global “I’m” for argument, I have less than no interest in getting in this business) not. Imagine being able to buy the bits online but not as a kit, just individually on certain markets. There’s this online community that says hey, you can probably use X and Y together with a Z board that runs this software S that all fits in this enclosure E that you can 3D print at home, and it’ll do this job. I guess the FDA could go after the community, but that just drives it further underground.
Also, it’s beyond ridiculous that we need to be having this discussion for people to be able to afford a simple piece of lifesaving medical gear that is effectively a meter, a pump and a computer and the right table of data mappings to handle the sampling feedback loop without being forced into such a situation.
“The street finds its own uses for things.”
- Burning Sugar.
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I was actually thinking about this quote when I was writing my last reply.
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In this particular case it’s not an issue. The hacked device was approved for its basic functionalities by the FDA, and the firmware creators are being very careful. My concern is more about components from dodgy manufacturers in countries where government inspectors aren’t so diligent or scrupulous – especially when the component is one that can be used for general applications as opposed to medical ones.
If I were making a DIY version of this, I’d be very careful about where I sourced the parts from before slapping the firmware on it and hooking it up to my body. I have a healthy distrust of big pharma’s business practises, but a mid-sized factory in the back blocks of China is not my preferred vendor in that situation unless someone like Bunnie Huang has vetted it and run it past his own network of experts.
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This story is fascinating to me. The promise of an artificial pancreas has been there for years. We have insulin pumps, we have continuous reading glucose meters, all we need is the ability for the two to communicate. I have patients who would go to the ends of the earth for something like this. At the same time, cobbling together parts from Ebay to a homemade circuit board and then attaching it to my body would cause me a great deal of anxiety. At the same time, what Pharma is doing with it is totally unconscionable, and obtaining the insulin to run the thing is gonna cost everything anyway. Damn system is so broke it is borderline unfixable.
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The Dutch company in the link is developing the first artificial pancreas. Rather interesting story where doors were mainly closed. Though in the Netherlands insulin is not as expensive as in the US. Glucagon, however is very expensive.
My Medtronic 670G gets info from the CGM insert, and modifies the basal rate dynamically. Its on the market now, and I’m pretty happy if I ignore the cost. The CGM inserts are yet another big ongoing expense, above and beyond pump expenses. We need a faster insulin - many of the highs come from meals that come in too fast; and we need iterative tweaks to the software and user interface. I thank the hacking community for kicking Medtronic around, and spurring them to action.
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