1 - Theranos should have been more transparent, but what startup doesn't stretch the truth or even leave out data on occasion? It is a fine line between lying and hustling. Startups can often talk about something that doesn't exist yet like it does because they can move fast enough to build it. 2 - I worked at a medical startup in Palo Alto and I can attest that it is incredibly hard complying with all the FDA rules.…
There is a fundamental difference between snapchat and medical tests. You cannot approach one as you approach the other. I have worked for a medical software company and the atmosphere is completely different from the usual move-fast-break-things culture at other places. You digitally sign for every line of code you write or review, every test you write, every test you say is working. If a single bug is found in your…
For much of the lifetime of the industry, NASA was the best there was. They embraced a "zero bug" mentality (http://www.jamesshore.com/Agile-Book/no_bugs.html). It resulted in very slow and costly development and we accepted that as the way things where, ie very expensive and little progress.
SpaceX came in with a move fast and break things mentality. They did not approach this in the way that had always been done (move slow and make no mistakes). They have greatly reduced cost and increased capability to a level that arguably would never have been reached by NASA, all without loss of life.
We don't need to test or develop medical in a haphazard way, but do have to accept that the way things work currently will not result many advancements (at least not rapid advancements). FDA regulations are fine until you realize that you have a currently incurable medial condition, and wonder if medical innovation was easier if you would have a cure.
Is the regulation to ease fear of a potential death/injury worth the many real deaths of people who we do not have treatments for?