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EmilyGorcenski's profile
Emily G
Emily G
Emily G
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@EmilyGorcenski

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Emily GVerified account

@EmilyGorcenski

Lead Data Scientist, activist, survivor. Was actually assaulted by an actual right-wing terrorist. Opinions belong only to me, especially the bad ones. she/they

Deep Space Nine
emilygorcenski.com
Joined June 2013

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    Emily G‏Verified account @EmilyGorcenski 24 Oct 2016

    In a former life, I designed medical devices. So by way of Tweetstorm, here's Emily's Guide to Knowing if IoT Wearable is Full of Shit.

    4:28 AM - 24 Oct 2016
    • 135 Retweets
    • 194 Likes
    • Virtual Observer Neal Analytics turningtechy Juha Makkonen chris 🌲🌲🐻🏬🏢 Flameyyy Micha Bailey jess Tony by the Lake 👻🎃
    3 replies 135 retweets 194 likes
      1. New conversation
      2. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        There are at least six pathways to legally using a medical device on a human in the US: HDE, IDE, PMA, 510(K), de novo, 510(k) exempt.

        1 reply 2 retweets 16 likes
      3. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        1. A Humanitarian Device Exemption is granted to devices intended to diagnose/treat conditions with an incidence of < 4k cases/year.

        1 reply 1 retweet 12 likes
      4. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        The low market potential means that tech startups won't touch this ever.

        1 reply 0 retweets 11 likes
      5. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        2. Investigative Device Exemptions are granted to perform clinical trials on a device before it goes to market.

        1 reply 0 retweets 9 likes
      6. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        Low-risk device studies can self-grant an IDE through the Institutional Review Board, otherwise it has to go through the FDA.

        1 reply 0 retweets 8 likes
      7. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        Tech companies who seek an IDE are serious, but the low-risk exemption most often applies.

        1 reply 0 retweets 7 likes
      8. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        3. Pre-Market Approvals are highly-expensive equivalents to drug approvals, and are only requires for Class 3 and some Class 2 devices.

        1 reply 0 retweets 6 likes
      9. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        PMAs cost millions of dollars and require extensive clinical study, so this isn't going to be techbro startup shit. This is serious stuff.

        1 reply 0 retweets 14 likes
      10. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        4. 510(k)s are premarket notifications, mostly for Class 2, but some Class 1 and 3 devices. It's a de facto clearance these days.

        1 reply 0 retweets 4 likes
      11. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        510(k)s require you to compare your device to an existing substantially-equivalent predicate, can be expensive, and you have to provide data

        1 reply 0 retweets 5 likes
      12. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        5. de novo pathways are for truly new medical devices that don't have an existing counrerpart on the market.

        1 reply 0 retweets 6 likes
      13. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        This process usually follows a failed 510(k) application, and you can actually submit it concurrently to automatically trigger.

        1 reply 0 retweets 6 likes
      14. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        This pathway is most applicable to IoT devices.

        1 reply 0 retweets 6 likes
      15. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        6. 510(k) exemptions are granted to some low-risk Class 1 and Class 2 devices, e.g. toothbrushes, cotton swabs, etc. You self-certify.

        1 reply 1 retweet 7 likes
      16. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        However, you still have to register the device and are beholden to FDA regulations. Most extant IoT devices (e.g. Quip) fit this pathway.

        1 reply 1 retweet 4 likes
      17. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        But IoT-ing a 510(k) exempt device isn't going to break any new public health ground, so be wary of such claims.

        1 reply 1 retweet 10 likes
      18. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        Finally, fitness trackers are not considered medical devices, but rather are general wellness devices, and so you cannot make medical claims

        2 replies 2 retweets 12 likes
      19. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        Emily G Retweeted Several people are typing

        So when a company comes out with some new IoT thing, e.g. below, this will help you decide of they're full of shit.https://twitter.com/Pinboard/status/790512148350992384 …

        Emily G added,

        Several people are typing @Pinboard
        You think I’m joking about the smart tampon? My friend, simply clip the tampon to your belt, for peace of mind https://www.youtube.com/watch?v=mKy_xL4xNWE …
        3 replies 7 retweets 13 likes
      20. Emily G‏Verified account @EmilyGorcenski 24 Oct 2016
        Replying to @EmilyGorcenski

        Simply ask, "do they have the money to go down the right pathway?"

        1 reply 3 retweets 23 likes
      21. 1 more reply
      1. JB‏ @NotTimothy 24 Oct 2016
        Replying to @EmilyGorcenski

        thank you for this - very informative

        0 replies 0 retweets 1 like
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