> I work in Biotech and every time I read one of these articles/posts about how somebody hacked their insulin pump people start asking why there aren't already

> I work in Biotech and every time I read one of these articles/posts about how somebody hacked their insulin pump people start asking why there aren't already affordable closed-loop pumps on the market if people are hacking their own with raspberry pis and the like, and they clearly don't understand the regulatory process or the level of clinical testing that's needed to validate something that, if it malfunctions at night, can kill you. 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..