That part I find quite like many other startups where the CEO will gladly go on stage saying “we built this amazing app, that does X, and will be launching in 2 months!” And talking to the coders will have them saying “yea he didn’t decide we should do that until last week, so we havn’t actually started, we still havn’t finished The first model he pitched.”
The main difference to Theranos is then that mostly the software promises are just a question of time(AI promises excluded), where they actually had a big unknown in basic feasibility.
Let's not forget that the FDA gave Theranos a CLIA waiver to sell this thing outside of laboratories.
The CEO lied but the regulators failed massively here as well.
While the inspector could have pushed the issue, I don't think they 'failed massively'.
How else can you reasonably assess the work of someone titled “inspector” when they fail to “inspect”? Especially when they approve a device they haven’t “inspected” as an “inspector”.
If you see logic in calling them something other than a massive failure then I’d like to understand your thought process.
A CEO lying about some unneeded product or service, while bad, does not come close to lying about a product that can impact one's health and well-being. She and Sonny both deserve substantial fines and jail time.