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EmilyGorcenski's profile
Emily G
Emily G
Emily G
Verified account
@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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    1. 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
    2. 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
    3. 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
    4. 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
    5. 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
    6. 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
    7. 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
    8. 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
    9. 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
    10. 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
      Emily G‏Verified account @EmilyGorcenski 24 Oct 2016

      This pathway is most applicable to IoT devices.

      4:39 AM - 24 Oct 2016
      • 6 Likes
      • iKyle kylie ⚡️tradley Erka Koivunen
      1 reply 0 retweets 6 likes
        1. New conversation
        2. 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
        3. 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
        4. 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
        5. 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
        6. 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
        7. 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
        8. 1 more reply

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