4 ms·

Observation 5: "Documents were not reviewed and not approved by designated individual(s) prior to issuance." this one is the most damning. FDA gave them the op

Observation 5: "Documents were not reviewed and not approved by designated individual(s) prior to issuance." this one is the most damning. FDA gave them the opportunity to correct this, and they sat on it for a year. The culture of move fast and break things is fine for consumer products, but the cavalier attitude with people's lives is overstepping.

eitally 11y ago
I'm tempted to argue that the SV model of tech startups essentially prohibits the creation of any functional biotech or medical device company. The compliance and process parts require real industry experience senior expertise, and time. like you said, a cavalier attitude is completely inappropriate and will never pass scrutiny. I worked for a medical device manufacturer for about 15 years. 21 CFR 11, and the test & quality tracking requirements, make it extremely hard to pivot quickly.
- calgoo 11y ago
  You can still develop the tech without those experts. However, if you ever want to apply it to humans, you got to follow the rules.
- seehafer 11y ago
  Certainly the pivot-constantly, push-code-daily mentality is not translatable to medical technology. That said, biotech & device companies could stand to be a hell of a lot more agile. Compliance is necessary but it isn't a complete impediment to moving quickly.
- ska 11y ago
  Pivoting doesn't make a lot of sense in this space. However it is entirely possible to be agile and (relatively) fast in this space - not by breaking rules but by designing the process to be light where it can, detailed where it must. And then paying attention to how it is working and improving it constantly. You can probably cut time to market in half relative to industry averages this way, which is nothing to sneeze at.
  - hga 11y ago
    Pivoting after losing your reputation for quality and playing straight with the FDA makes no sense whatsoever to me. In fact, the FDA is known for getting very vindictive after that sort of thing happens. I count this as different than the 23AndMe situation where they're arguing with the FDA over how the results can interpreted and passed on to the consumer, that's a difference in opinion that doesn't rest on the quality of the testing science.
    - ska 11y ago
      that's a difference in opinion Indications for use aren't a matter of opinion. 23AndMe clearly screwed up there, but I agree it was a different nature of screw up.
- ageyfman 11y ago
  Pivoting with same indications can be done, but I agree, if you have a Class II or god forbid Class III device, and you change your indications, you've got to redo much of your 21CFR11 documentation. I built a Class I device that eventually became a Class II device, and it was a tough slog to get the QSR and CFR docs in order, however, we were a team of 15, with not nearly $400m in funding. There is an air on incompetence about this whole thing, and Holmes isn't doing herself any favors battling with poor evidence against WSJ in public.

eitally 11y ago

I'm tempted to argue that the SV model of tech startups essentially prohibits the creation of any functional biotech or medical device company. The compliance and process parts require real industry experience senior expertise, and time. like you said, a cavalier attitude is completely inappropriate and will never pass scrutiny. I worked for a medical device manufacturer for about 15 years. 21 CFR 11, and the test & quality tracking requirements, make it extremely hard to pivot quickly.

calgoo 11y ago
You can still develop the tech without those experts. However, if you ever want to apply it to humans, you got to follow the rules.
seehafer 11y ago
Certainly the pivot-constantly, push-code-daily mentality is not translatable to medical technology. That said, biotech & device companies could stand to be a hell of a lot more agile. Compliance is necessary but it isn't a complete impediment to moving quickly.
ska 11y ago
Pivoting doesn't make a lot of sense in this space. However it is entirely possible to be agile and (relatively) fast in this space - not by breaking rules but by designing the process to be light where it can, detailed where it must. And then paying attention to how it is working and improving it constantly. You can probably cut time to market in half relative to industry averages this way, which is nothing to sneeze at.
- hga 11y ago
  Pivoting after losing your reputation for quality and playing straight with the FDA makes no sense whatsoever to me. In fact, the FDA is known for getting very vindictive after that sort of thing happens. I count this as different than the 23AndMe situation where they're arguing with the FDA over how the results can interpreted and passed on to the consumer, that's a difference in opinion that doesn't rest on the quality of the testing science.
  - ska 11y ago
    that's a difference in opinion Indications for use aren't a matter of opinion. 23AndMe clearly screwed up there, but I agree it was a different nature of screw up.
ageyfman 11y ago
Pivoting with same indications can be done, but I agree, if you have a Class II or god forbid Class III device, and you change your indications, you've got to redo much of your 21CFR11 documentation. I built a Class I device that eventually became a Class II device, and it was a tough slog to get the QSR and CFR docs in order, however, we were a team of 15, with not nearly $400m in funding. There is an air on incompetence about this whole thing, and Holmes isn't doing herself any favors battling with poor evidence against WSJ in public.