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Any suggestion about medical technology startups on HN inevitably brings a rain of comments (often including one from me) about how the regulatory burden is too

by Agathos 12y ago

Any suggestion about medical technology startups on HN inevitably brings a rain of comments (often including one from me) about how the regulatory burden is too high, getting approval is a job for lawyers not coders, etc. Kudos to MedXT for doing it anyway.

brown 12y ago
The silver lining of regulatory burden is that there is less competition and higher willingness to pay. It is still annoying though. Jonathan Bush, CEO of athenahealth, recently ranted at congress about excessive healthcare regulation. His frustration was palpable: https://www.youtube.com/watch?v=CekfvGDiab8 https://www.youtube.com/watch?v=CekfvGDiab8
- x1798DE 12y ago
  >The silver lining of regulatory burden is that there is less competition and higher willingness to pay. From the perspective of consumers I'd say this is not exactly a silver lining. (Though obviously I don't think you were suggesting that the excessive regulation is a good situation overall, just that at least there's some incentive for startups to power through.)
stillsut 12y ago
From my quick glance, This ISN'T: novel drug/algorithm/X --causes-better--> patientoutcome, which would acquire trial/approval. This IS: things we do now, except in the cloud, so you don't have to keep two IT guys on hand even in the graveyard shift - "virtualization".
VikingCoder 12y ago
I applaud their effort, and I sincerely wish them success... But this is the medical equivalent of Notepad. It is lacking a ton of critical features, which makes it inadequate for almost any real use cases. The regulatory burden is substantially lower when you don't have much functionality. Also, $2 per case is way too expensive for what they're offering. Source: I worked in competing products for a decade. EDIT: Looks like they're moving in a decent direction, though: https://news.ycombinator.com/item?id=8038386 https://news.ycombinator.com/item?id=8038386 EDIT EDIT: I'm not as impressed with the "volume rendering" as I wanted to be. So, time will tell. I wish them luck.
akiselev 12y ago
Sadly most people who complain about regulatory burden know very little about actual regulations. I can't speak to hospitals (they do a LOT) or medical records but if you're doing something like running a clinical diagnostics lab, the "regulatory burden" can be as little as hiring a part time (FDA certified) lab manager who signs off on internal self-regulatory protocols and HIPAA can largely be distilled to "KEEP PATIENT DATA SECRET" with sane retention and security policies. In my experience, healthcare and medical science are so difficult that the cost of the regulatory burden is a rounding error when you consider the amount of due diligence you have to do to make sure you don't badly mess up someone's life/health.
- VikingCoder 12y ago
  You're confusing the burden of running a practice, with the regulatory burden of developing a medical device. The two are completely different.
  - akiselev 12y ago
    FDA 510(K) approval for medical devices takes 3-7 years and tens of millions of dollars for all but the extreme cases (i.e. artificial heart or the new bionic eye). If you're making stuff like pacemakers that keep people alive while implanted in their body, the vast majority of that cost will be unavoidable if you don't want to risk killing a bunch of people (which is, you know, a thing worth paying for).
    - VikingCoder 12y ago
      And the approval process for changing one line in the polling interval in version 19.64.101 of a back-end server that converts from one file format to another file format takes WEEKS. I'm just pointing out that all of your anecdotal stories were related to practice, not device development.
      - akiselev 12y ago
        Please link me to the regulations that require you to wait weeks for approval to change a line of code during device development (BEFORE deployment). After deployment, you need to do a lot of paperwork and testing to change anything, whether it is a drug, medical device, or clinical test and for good reason. You can't just do a git push when you're building a complex system where a misplaced bit can easily kill someone. As for my anecdotes, I worked on bringing online robotics and brand new diagnostic tests (with and without golden standards) which are under entirely different regulations than record keeping or the day to day operations of a lab.
nradov 12y ago
The FDA recently announced that they do not plan to regulate medical device data systems. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm401785.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
- VikingCoder 12y ago
  That's a draft. I hope it passes, but right now it's just a draft.

by Agathos 12y ago

brown 12y ago

The silver lining of regulatory burden is that there is less competition and higher willingness to pay. It is still annoying though. Jonathan Bush, CEO of athenahealth, recently ranted at congress about excessive healthcare regulation. His frustration was palpable: https://www.youtube.com/watch?v=CekfvGDiab8 https://www.youtube.com/watch?v=CekfvGDiab8

x1798DE 12y ago
>The silver lining of regulatory burden is that there is less competition and higher willingness to pay. From the perspective of consumers I'd say this is not exactly a silver lining. (Though obviously I don't think you were suggesting that the excessive regulation is a good situation overall, just that at least there's some incentive for startups to power through.)

stillsut 12y ago

From my quick glance, This ISN'T: novel drug/algorithm/X --causes-better--> patientoutcome, which would acquire trial/approval. This IS: things we do now, except in the cloud, so you don't have to keep two IT guys on hand even in the graveyard shift - "virtualization".

VikingCoder 12y ago

I applaud their effort, and I sincerely wish them success... But this is the medical equivalent of Notepad. It is lacking a ton of critical features, which makes it inadequate for almost any real use cases. The regulatory burden is substantially lower when you don't have much functionality. Also, $2 per case is way too expensive for what they're offering. Source: I worked in competing products for a decade. EDIT: Looks like they're moving in a decent direction, though: https://news.ycombinator.com/item?id=8038386 https://news.ycombinator.com/item?id=8038386 EDIT EDIT: I'm not as impressed with the "volume rendering" as I wanted to be. So, time will tell. I wish them luck.

akiselev 12y ago

Sadly most people who complain about regulatory burden know very little about actual regulations. I can't speak to hospitals (they do a LOT) or medical records but if you're doing something like running a clinical diagnostics lab, the "regulatory burden" can be as little as hiring a part time (FDA certified) lab manager who signs off on internal self-regulatory protocols and HIPAA can largely be distilled to "KEEP PATIENT DATA SECRET" with sane retention and security policies. In my experience, healthcare and medical science are so difficult that the cost of the regulatory burden is a rounding error when you consider the amount of due diligence you have to do to make sure you don't badly mess up someone's life/health.

VikingCoder 12y ago
You're confusing the burden of running a practice, with the regulatory burden of developing a medical device. The two are completely different.
- akiselev 12y ago
  FDA 510(K) approval for medical devices takes 3-7 years and tens of millions of dollars for all but the extreme cases (i.e. artificial heart or the new bionic eye). If you're making stuff like pacemakers that keep people alive while implanted in their body, the vast majority of that cost will be unavoidable if you don't want to risk killing a bunch of people (which is, you know, a thing worth paying for).
  - VikingCoder 12y ago
    And the approval process for changing one line in the polling interval in version 19.64.101 of a back-end server that converts from one file format to another file format takes WEEKS. I'm just pointing out that all of your anecdotal stories were related to practice, not device development.
    - akiselev 12y ago
      Please link me to the regulations that require you to wait weeks for approval to change a line of code during device development (BEFORE deployment). After deployment, you need to do a lot of paperwork and testing to change anything, whether it is a drug, medical device, or clinical test and for good reason. You can't just do a git push when you're building a complex system where a misplaced bit can easily kill someone. As for my anecdotes, I worked on bringing online robotics and brand new diagnostic tests (with and without golden standards) which are under entirely different regulations than record keeping or the day to day operations of a lab.

nradov 12y ago

The FDA recently announced that they do not plan to regulate medical device data systems. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm401785.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...

VikingCoder 12y ago
That's a draft. I hope it passes, but right now it's just a draft.