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9 Responses

  1. Kim
    Kim August 24, 2010 at 3:56 pm | | Reply

    A good point, that it takes a lot longer to successfully develop something that is life-saving, vs. something that is convenient/neat/a way to pass the time. Thanks for taking the time to write this post. :)

  2. MG
    MG August 24, 2010 at 7:19 pm | | Reply

    As a sw eng, I have always viewed this whole line of controlling pumps with a consumer device ridiculous. These devices are not built with any of the same safety, reliability, battery life, etc requirements.

    An open platform is fundamentally unsafe. What happens when your latest greatest app has a memory leak and corrupts your pump sw? What unrelated sw should be loaded during testing? Which ones should be running? What about firmware updates to the phone? What about when the battery runs out? The list is endless.

    And who is responsible for all this testing? Not the FDA. So is it the developers, and federal agencies and consumers should just trust them?

    A reliable, purpose-built, closed system, that can be properly and fully tested, with minimal functionality, and very limited ((no) sw/fw upgrades is the only solution.

    The rest is hype.

  3. T1 in Boston
    T1 in Boston August 24, 2010 at 8:54 pm | | Reply

    “All of the diabetes device manufacturers are working feverishly to automate insulin delivery and ultimately close the loop….”

    Music to my ears – hope it’s true! Thanks, Samantha!

  4. kelly close
    kelly close August 25, 2010 at 12:01 am | | Reply

    I think FDA is right to ask for testing of unproven diabetes technologies, but I am not nearly as sanguine; the agency seems to want zero risk, and that is simply not possible. To wit – the Veo is approved in the EU and we’re said to be still two years away in the US, where so many patients would be helped by a device that could reduce severe hypoglycemia. Better, simpler, more powerful technologies will serve patients and public health well and while safety is paramount, we also don’t want to see innovation stifled, given how much help patients still need. Thank you for the column!

  5. Todd Shirley
    Todd Shirley August 27, 2010 at 9:32 am | | Reply

    To MG: It’s not that ridiculous! Most insulin pumps can be controlled on the pump itself, so if your iphone stops working as a controller you can always just take the pump out of your pocket. I’ve left my one-touch Ping controller at home before and while that left me without a Glucose tester, I was in no danger and was able to control the pump. Plus, what does my ping controller actually do for me? It reads my glucose and suggests a bolus. Then I have to dial up a dosage manually anyway. Are you saying an integrated iPhone case/glucose tester can’t do that safely? Even if it was totally one-way communication from the pump to the iphone (so the phone doesn’t actually control the pump, just receives info from it), this system would be light-years better than my crappy Ping controller.

    All your hypotheticals about testing seem to assume that the entire insulin delivery system would fail if the controller failed. That’s ridiculous!

    Your “solution” of “a closed system, with minimal functionality, and very limited ((no) sw/fw upgrades” is insulting and depressing. How about an OPEN system, with TONS of functionality, and REGULAR software updates? Just make it the secondary controller in the system. Why can’t the FDA and people like you wrap your head around this idea and allow it to happen?

  6. pking
    pking August 29, 2010 at 12:28 am | | Reply

    Todd said: “Why can?t the FDA and people like you wrap your head around this idea and allow it to happen?”

    Well, because if a “secondary controller” has the ability to dose insulin, if has to be rigorously tested. Failure doesn’t just mean leaving it at home or running over it with your car, it also means being effected by EM radiation near a microwave or some other intentional or unintentional interaction between applications on the device. That’s just to get started on the reasons why the 2009 prize winner was a pipe dream, albeit a creative one.

    I’m just as frustrated as anyone else by the slow pace of innovation with insulin pumps, if you can even call it innovation compared to what I’m used to in silicon valley. But I don’t think we should be so willing to abandon the safety net provided by the FDA. They don’t have a perfect system, but I wouldn’t trust Apple (let alone a 3rd party app developer) or anyone else with my life without some serious regulatory body as a gate keeper.

  7. Todd Shirley
    Todd Shirley August 29, 2010 at 4:17 am | | Reply

    Pking:

    Good point. But we could still move forward with my other suggestion of having an iPhone accessory that just RECEIVED data from the pump and didn’t actually control it. In fact, if I had a case that served as a glucose meter and came with some innovative software for tracking (and didn’t talk to the pump at all) I’d still be way better off than I am now. I know the FDA has to regulate meters as well, but it seems like an established meter manufacturer could pull this off relatively quickly.

  8. Ian
    Ian September 29, 2010 at 6:02 pm | | Reply

    It is certainly good to finally see the promising use of technology for more worthwhile purposes than just the leisure market. It may not be as profitable for the makers, but surely more use of these advancements could be produced and developed more timely.

  9. Jim Brown
    Jim Brown October 1, 2010 at 8:05 pm | | Reply

    Many insulin pump makers are talking about eventually offering iPhone or Android solutions to control the pump (including http://www.pancreum.com), but the FDA is going to make it very tough for them.

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