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Comment by Shivetya | Hacker News Reader

really sounds if they went to certification's stage too early, regulatory bodies do not tend to support rapid iteration of products

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> regulatory bodies do not tend to support rapid iteration of products

I disagree. 21 CFR 820 is deliberately written such that it does not prescribe any one specific development process; AAMI TIR-45 for example aligns agile methodologies with medical device software development and is an FDA recognized consensus standard.

What regulatory bodies do demand is that one document what one will do, and then, actually do what one has documented. Sounds like Theranos had trouble with that.

Thank you for pointing this out. You'd be surprised how many people even within medical device think design control necessarily means some slow-as-hell waterfall development method.

The company is already 12 years old.

I fully understand that part, perhaps the FDA needs to adapt as well. Testing doesn't need to be static, there is room for cooperative certification and corrective actions to insure the test completes. With the rapid advances in some areas of technology you could run into a situation where you obsolete the technology you are working on as certification issues reveal improvements.

While the medical field certainly has additional concerns I do see a time where, with proper processes in place, that the final delivery may not exactly be what entered the certification phase.

But they seem to have pivoted several times already. The founder's original patent was for a wearable device that transmits readings to your doctor.

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