4 ms·

>This sounds like it will be an absolute disaster: It does; but isn't the status quo also an absolute disaster?

AnimalMuppet 11y ago
No, IMHO. The status quo is an attempt to walk a knife-edge ridge with cliffs on both sides. There are failures on both sides, and different people getting burned by the failures on each side. Both groups decide that the status quo is an absolute disaster, but disagree on which direction the disaster is.
- fnordfnordfnord 11y ago
  Your statement seems to be a bit self-contradictory, or else I've read it wrong. So you agree that the status-quo is bad, but you think that almost anything else would be worse? I notice in another reply ITT you stated that you were once employed in engineering medical devices and left that line of work because of the "horrible environment". That's another anecdote I'd use to support my opinion.
  - AnimalMuppet 11y ago
    > So you agree that the status-quo is bad, but you think that almost anything else would be worse? I think the status quo is a trade-off between too easy and too restrictive. Too easy kills people; too restrictive kills different people. Saving more of one set of people almost automatically means killing more of the other. Re the horrible environment: It was horrible in that we didn't (at the time I was there) have much automation to handle the FDA documentation requirements. (Don't think the standard "document your code" here; FDA requirements are much more than that.) The result was a mass of manual paperwork for the software engineers, which (at least for this one) is a horrible environment to work in. It got better after I left, as they got more tools to help them. > That's another anecdote I'd use to support my opinion. But I don't see it as supporting your opinion, and I'm the guy it happened to.
    - fnordfnordfnord 11y ago
      >Too easy kills people; too restrictive kills different people. Saving more of one set of people almost automatically means killing more of the other. Your statement I just quoted above is FUD. I'm not arguing that the OP link describes the best way to reform the FDA, but I refuse to believe without substantial proof that there is no room for improvement the FDA medical device approval process. >But I don't see it as supporting your opinion, and I'm the guy it happened to. But it's my opinion. You get to make and have your own opinion, but not mine. Here's what I took from it: A likely competent software engineer quits field due to onerous work requirements. A lot of assumptions are being made here, but your anecdote isn't dissimilar from other ones that I have heard, and negative anecdotes are in the majority WRT this field. Overriding conclusion is that better engineers are avoiding or leaving the field; leaving those jobs for less-capable candidates and driving costs up.
      - AnimalMuppet 11y ago
        > I refuse to believe without substantial proof that there is no room for improvement the FDA medical device approval process. I never said that there is no room for improvement. I said that changing things so that devices are released faster almost certainly means that some number of devices get released that are unsafe. Changing things so that devices that are released slower almost certainly means that some other number of devices get held back that would have been safe. I take no strong position on where we are in relation to the optimum spot. My personal opinion is that the FDA was in about the right spot about 6 years ago, but I am not dogmatic about that opinion. > Here's what I took from it: A likely competent software engineer quits field due to onerous work requirements. Thanks. I'd like to think that, too. But it's also possible that an engineer whose temperament was to move too fast and not careful enough found that he was in the wrong environment.

No, IMHO. The status quo is an attempt to walk a knife-edge ridge with cliffs on both sides. There are failures on both sides, and different people getting burned by the failures on each side. Both groups decide that the status quo is an absolute disaster, but disagree on which direction the disaster is.

fnordfnordfnord 11y ago
Your statement seems to be a bit self-contradictory, or else I've read it wrong. So you agree that the status-quo is bad, but you think that almost anything else would be worse? I notice in another reply ITT you stated that you were once employed in engineering medical devices and left that line of work because of the "horrible environment". That's another anecdote I'd use to support my opinion.
- AnimalMuppet 11y ago
  > So you agree that the status-quo is bad, but you think that almost anything else would be worse? I think the status quo is a trade-off between too easy and too restrictive. Too easy kills people; too restrictive kills different people. Saving more of one set of people almost automatically means killing more of the other. Re the horrible environment: It was horrible in that we didn't (at the time I was there) have much automation to handle the FDA documentation requirements. (Don't think the standard "document your code" here; FDA requirements are much more than that.) The result was a mass of manual paperwork for the software engineers, which (at least for this one) is a horrible environment to work in. It got better after I left, as they got more tools to help them. > That's another anecdote I'd use to support my opinion. But I don't see it as supporting your opinion, and I'm the guy it happened to.
  - fnordfnordfnord 11y ago
    >Too easy kills people; too restrictive kills different people. Saving more of one set of people almost automatically means killing more of the other. Your statement I just quoted above is FUD. I'm not arguing that the OP link describes the best way to reform the FDA, but I refuse to believe without substantial proof that there is no room for improvement the FDA medical device approval process. >But I don't see it as supporting your opinion, and I'm the guy it happened to. But it's my opinion. You get to make and have your own opinion, but not mine. Here's what I took from it: A likely competent software engineer quits field due to onerous work requirements. A lot of assumptions are being made here, but your anecdote isn't dissimilar from other ones that I have heard, and negative anecdotes are in the majority WRT this field. Overriding conclusion is that better engineers are avoiding or leaving the field; leaving those jobs for less-capable candidates and driving costs up.
    - AnimalMuppet 11y ago
      > I refuse to believe without substantial proof that there is no room for improvement the FDA medical device approval process. I never said that there is no room for improvement. I said that changing things so that devices are released faster almost certainly means that some number of devices get released that are unsafe. Changing things so that devices that are released slower almost certainly means that some other number of devices get held back that would have been safe. I take no strong position on where we are in relation to the optimum spot. My personal opinion is that the FDA was in about the right spot about 6 years ago, but I am not dogmatic about that opinion. > Here's what I took from it: A likely competent software engineer quits field due to onerous work requirements. Thanks. I'd like to think that, too. But it's also possible that an engineer whose temperament was to move too fast and not careful enough found that he was in the wrong environment.