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I'm sceptical generally of Theranos, but none of this feels in the least bit like a smoking gun. Wouldn't you expect feedback like that for a truly revolutionar

I'm sceptical generally of Theranos, but none of this feels in the least bit like a smoking gun. Wouldn't you expect feedback like that for a truly revolutionary product? There's no claim of fraud, there's no claim their technology doesn't work, just complaints about technicalities. Am I wrong?

rayiner 11y ago
The government doesn't give you "feedback." Also, out of the five observations, only the last one is a "technicality." The process documentation and design specification and validation issues are not optional. Not just in medicine, but in any engineering field where lives are on the line. E.g. > Observation 1: "Design validation did not ensure the device conforms to defined user needs and intended uses." You don't build a bridge without defining the maximum carrying load you intend to use it for, or validating that it will carry that load. Getting lucky and having the bridge not fall down (at first) doesn't ameliorate that process defect. P.S. I haven't been following the Theranos story closely. I am taking the fine article at face value.
- peteretep 11y ago
  > The government doesn't give you "feedback." http://www.fda.gov/ICECI/Inspections/ucm256377.htm http://www.fda.gov/ICECI/Inspections/ucm256377.htm > when an investigator(s) has observed any conditions > that in their judgement may constitute violations Sure sounds like feedback to me. > The process documentation and design specification > and validation issues are not optional No, but they can be iterated on. > I am taking the fine article at face value The "fine article" presents small snippets of a heavily redacted article. There's not that much value to take...