Matthew Romey I find this entire story very interesting... and baffling at the same time. For a company reportedly worth $10 billion, they sure are making some seemingly amateurish mistakes. I know there's two sides to every story, but that's why you hire good regulatory talent: to make sure your side of the story is as error-free as possible. Small start-ups tripping up on design validations, I get it. But I've got to think Theranos has moved out of the garage. Haven't they?

Michael Salit Like so many others, I keep scratching the back of my head each time these stories about Theranos surface. You have wonder how they process information. There is something to the notion ... perception is reality. Personally, I perceive arrogance.

It's gotten worse: CMS draws blood, says Theranos poses 'immediate jeopardy to patient health' - FierceMedicalDevices http://ow.ly/XEpv0

Mike McDaniel Watch Infinity Medical Engineering close for the answer to this. We will be releasing our new technology the correct way following proper channels!

Michael Salit Mike, as the Theranos story has captured so many. Learning more from you when the timing is right would be an interesting comparative.

These private equity valuations ( in this case $9 billion) are kind of an inside joke. For Theranos, the emperor really might have no clothes. Another example of endless Quantitative Easing from the Fed ( too much money looking for a home) creating asset valuation distortions.There will be more like this in the very near term.

Matthew Romey More bad news: "Walgreens severs some times to Theranos amid CMS lab inspection fallout". http://www.fiercemedicaldevices.com/story/walgreens-severs-some-ties-theranos-amid-cms-lab-inspection-fallout/2016-01-28

Interesting story. Thanks for sharing.

Michael Kohlman From Bloomberg:
http://www.msn.com/en-us/money/companies/time-is-running-out-for-theranos/ar-BBoRKV5?

Dr. William Landgraf Its difficult to understand why some folks think its easy to get Reg. approval. It takes a lot of skill and knowledge of devices or drugs to achieve an approval. I have been thru the process several times with much experience,a PhD and MBA. and with dedication and some good luck.

Michael Kohlman Dr. William Landgraf Having been in both worlds (Med Devices and Tech Startups) I see why these stories are happening. Much of it has to do with the culture that has come out of Silicon Valley, which is an attitude of: develop a prototype, market it as a finished, sellable product to quickly raise enough VC to be considered a "Unicorn", THEN actually begin beta-testing the product while continuing to promise that "it will get there" until either the cash runs out or you succeed.

The challenge, of course is this lines up poorly with a world (Med Tech) where mistakes in this area result in dead/hurt people and big investigations.

Matthew Romey Michael Kohlman : I think you nailed it. In this case the result was a full-speed slam into the reality that is the FDA.

Dr. William Landgraf: While some devices are difficult to get approval for, not all are. I would imagine a blood collection container would be fairly straightforward. Theranos didn't even try to register their "nanotainer", probably out of ignorance or oversight. This is why entrepreneurs need to hire seasoned professionals to give them up to date regulatory and quality advice. (I imagine some companies do, and then fire them when they don't get the answers they want.)

Michael Kohlman Regulators propose banning Theranos founder for at least two years

http://www.msn.com/en-us/money/companies/regulators-propose-banning-theranos-founder-for-at-least-two-years/ar-BBrIvkR?ocid=spartanntp

Michael Salit Michael, Thank you for sharing the link re: banning the Theranos founder. Standing by for "the other shoe to drop".

So does this technique work?? Is it just too difficult to do practically? Or is this completely bogus?