3 ms·
> “We hope to achieve FDA market authorizations of these exciting technologies in the coming years,” she said. I've never thought about what it takes to run a
by chollida1 10y ago
> “We hope to achieve FDA market authorizations of these exciting technologies in the coming years,” she said.
I've never thought about what it takes to run a medical devices company but think about that statement. It looks like Theranos just did a huge pivot and they won't be able to generate any revenue from the resulting pivot for atleast a few years?
At this point, shouldn't goal number one be to get a product, any product approved by the FDA, are they the only governing body they need to get approval from?, and then get it to market ASAP?
Someone get Holmes a copy of Ben Horowitz book "The hard thing about hard things". If she wasn't already, she is now a war time CEO.
- ceejayoz 10y ago> If she wasn't already, she is now a war time CEO. It looks more like she's a post-Hiroshima CEO.
- EpicEng 10y agoPerhaps, if the test offers a strategic or tactical advantage. I work in biotech on FDA regulated devices and assays. Just throwing something out there doesn't mean it has sufficient clinical utility to reach volume, and the process is very expensive.