I disagree those two are decoupled. The DIY project has a much lower risk of getting sued, true. But lower of risk of death is highly dependent on edge cases an

I disagree those two are decoupled. The DIY project has a much lower risk of getting sued, true. But lower of risk of death is highly dependent on edge cases and corner cases, and I'd challenge you to produce evidence that there is an overall lower risk of death. None of this is to say I'm against any effort to develop an artificial pancreas. I used to work at Medtronic Diabetes. The slothful pace with which this endeavor is proceeding, despite the mountains of money behind it and the obvious and profound unmet clinical need, pains all of us. But "why was it taken so long?" is a question to which there is no simple answer. And though FDA is very much in the corner of "let's get it done" now, that was not always so. For instance, the quote from the director at FDA re: "you can do everything but manage diabetes on your phone, you should be able to do that as well" masks the history of the med device industry for years trying to get applications on the iPhone approved by FDA and not being able to do so because you couldn't lock the iPhone down (i.e. prevent programmatically anyone from running any other program).