MedXT (YC W13) Announces FDA-Cleared Medical Image Platform

Re:MedXT (YC W13) Announces FDA-Cleared Medical Image Platform by akiselev on Tuesday July 15, 2014 @07:10PM (#8039681)

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.

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Re:MedXT (YC W13) Announces FDA-Cleared Medical Image Platform by VikingCoder on Wednesday July 16, 2014 @10:41AM (#8042247)

You're confusing the burden of running a practice, with the regulatory burden of developing a medical device.

The two are completely different.

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Re:MedXT (YC W13) Announces FDA-Cleared Medical Image Platform by akiselev on Wednesday July 16, 2014 @11:26AM (#8042503)

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).

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Re:MedXT (YC W13) Announces FDA-Cleared Medical Image Platform by VikingCoder on Wednesday July 16, 2014 @12:52PM (#8043043)

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.

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Re:MedXT (YC W13) Announces FDA-Cleared Medical Image Platform by akiselev on Thursday July 17, 2014 @10:59PM (#8051466)

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.

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