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It's a trade-off. You can choose to wait for something to come to the market and suffer the potential consequences, or you can go the DIY route and reap the be

It's a trade-off. You can choose to wait for something to come to the market and suffer the potential consequences, or you can go the DIY route and reap the benefits today. There are risks either way. My wife and I aren't willing to experiment with our son's life. If it were for myself, I'd absolutely give OpenAPS a shot. My son has a Dexcom & a Tandem x2 pump, and in Q4 they'll deliver a software update that will provide a basic closed-loop system. 'Basic' in the sense that it will only be able to reduce the likelihood of a high blood sugar. We're still waiting for the dual-hormone pumps that will be able to control blood sugar in both directions. 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/ https://www.betabionics.com/

ryandrake 7y ago
The situation reminds me of the regulatory environment in aviation. Aviation in general is super regulated for the usual “people could die” set of reasons. If you buy a normal certificated airplane like one from Cessna or Piper, you are subject to heavy regulations around what you can do to it in terms of maintenance. You can’t do much as run a USB charger to the cockpit panel without the FAA coming down on you like a ton of bricks. You have to go to people with the right government $tamp to get anything fixed. It’s a huge burden but it’s all in the name of safety. 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.

ryandrake 7y ago

The situation reminds me of the regulatory environment in aviation. Aviation in general is super regulated for the usual “people could die” set of reasons. If you buy a normal certificated airplane like one from Cessna or Piper, you are subject to heavy regulations around what you can do to it in terms of maintenance. You can’t do much as run a USB charger to the cockpit panel without the FAA coming down on you like a ton of bricks. You have to go to people with the right government $tamp to get anything fixed. It’s a huge burden but it’s all in the name of safety. 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.