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US Regulators Find Serious Deficiencies At Theranos Lab (wsj.com)
An anonymous reader writes: 2016 has not started well for blood-testing startup Theranos. Already facing allegations of data manipulation, the Centers for Medicare and Medicaid Services have found problems with Theranos' laboratory in Newark, California, putting the company's relationship with the Medicare program in danger. WSJ reports: "It isn't clear exactly what regulators have faulted Theranos for in their latest inspection, which took several months. Adverse findings would be another regulatory setback for one of Silicon Valley's highest-profile startups, valued at about $9 billion in 2014. Theranos already has stopped collecting tiny samples of blood from patients' fingers for all but one of its tests while it waits for the Food and Drug Administration to review the company's applications for wider use of the proprietary vials called 'nanotainers.' In October, the FDA said it had determined that the nanotainers were an 'uncleared medical device.'"
Nothing easy about it
I led a team that developed a shipping/receiving system for the collection of tissue.
At the time that we did the work the direction from the FDA led us to believe that it would not be a medical device
18 months later, when they saw out spiffy new system in the field, they questioned why we did not apply to have it released as a medical device...
This became a 'Big Deal' as the FDA threatened to recall about three months of product ($50 - $70 million in value) if we could not demonstrate complete traceability through the system with clear reporting of every sample
Fortunately we designed every piece of the system as if it were a med device and came through the audit with flying colors
Unfortunately the company that I worked for would not submit the system for formal review as a medical device and we pulled it out of service.
Understanding the FDA requirements for a medical device, and staying in touch with them throughout your development process to make certain that they have not changed their direction is essential to staying alive in that market space
The real story here is not about some medical device or a failed test.
The story, and reason we take pleasure in this downfall is because a charismatic, supposed prodigy, Stanford-privileged, everyone-wants-to-believe-in-successful-woman CEO, who was able to convince funders based on flashy visions and compelling talk, has been found out to have nothing behind the emperor's clothes. And that so many people who are purportedly expert at evaluating technology got collectively duped/brainwashed into believing a whole bunch of fluff based on no more than a TED talk-level technology pitch.
While others who are working on real demonstrable technology, and do not get the benefit of celebrity status, Silicon Valley connections, get passed over for grants / VC money / recognition because they're not connected or privileged in the same way.
Stop believing so much in the vision and hype. Ask for and act on real results more.