4 ms·

I must be missing something. That sounds almost exactly like the Boeing situation to me.

by ken 6y ago

ska 6y ago
It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades. How is that parallel to the Boeing situation? We know there was an engineering failure followed by a process failure wrt 737 max. If we have similar evidence in devices (i.e. the process isn't working, or the developers are cutting corners, or both) that should certainly be addressed. But drawing that line with information such as this article seems a stretch, at best.
- kansface 6y ago
  Forgive me, but I also had the same thought as OP and honestly can't tell the difference between what you are describing and Boeing. > It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades. Just like the FAA and Boeing until it didn't? > We know there was an engineering failure followed by a process failure wrt 737 max. My reading of the situation was a process failure, a couple of engineering screw ups, and possibly user error.
  - ska 6y ago
    How are the both of you not included all regulatory oversight in the same bucket? Could the FDA process become weaker to the point of a problem, sure. Is there any evidence that it currently is? I haven't seen any. Is this something they (the FDA and similar) should keep an eye on, absolutely Honestly, I don't see how you are drawing the parallel. In what wad do you think the FDA is making the "same" mistake as the FAA did?
    - at_a_remove 6y ago
      Ah, well, the FAA did not make Boeing go through recertification for the new "version" of the plane. Close enough. Same thing. Did it back then, should be alright. And so the safety process was not seen through on this new model. Similarly, the FDA grandfathered in a bunch of devices and because they are "substantially equivalent," the FDA did not ask for recertification and the safety process was not gone through for these devices.
      - ska 6y ago
        What I am saying is I think that your last paragraph is a misunderstanding of what the 510(k) and de-novo pathways are, and that they are a safety process, which was and is followed. If you argued that the V&V necessary for a 510(k) filing is insufficient, I would understand where you are coming from, and it could be interesting. If you argued that a PMA is needed for all medical devices, I would understand the argument but probably disagree. Your 'similarly' just isn't that similar, unless I've vastly misunderstood the FAA/Boeing case. Again it's clear that the FDA could fall into a state where it's review and audit processes had the same sort of problems that the FAA exhibited with the 737max. But I don't see evidence at all that this has actually happened. What do you think the substantively equivalent bar for a 510(k) allows a company to do? Regulatory capture is a real risk for any regulatory oversight, but it is not synonymous with that regulatory oversight.
        kansface 6y ago
        > What I am saying is I think that your last paragraph is a misunderstanding of what the 510(k) and de-novo pathways are, and that they are a safety process, which was and is followed. I don't think anyone in this chain has tried to claim that the 510(k) is not a safety process nor that it is not followed - merely that avoiding more rigorous testing and review of a new device by tying it to the safety rating of a previous device sounds exactly like what happened with boeing's 737 max, and secondly, that existing regulations incentivize bad outcomes whereby companies make more expensive/dangerous/worse products that get less testing. > What do you think the substantively equivalent bar for a 510(k) allows a company to do? Honestly, I have literally no idea, and have been trying to tease that information out of you. Specifically, how does that bar differ from the one that Boeing had to clear with the 737 Max took which took 5 years and a few billion dollars (I don't know how much of that was for compliance, but we can guess its at least 10s of millions). This is literally the first article I found when I searched google: https://www.medicaldesignandoutsourcing.com/boeings-737-max-crisis-why-the-medical-device-industry-should-care https://www.medicaldesignandoutsourcing.com/boeings-737-max-...

I must be missing something. That sounds almost exactly like the Boeing situation to me.

by ken 6y ago

I must be missing something. That sounds almost exactly like the Boeing situation to me.

ska 6y ago

It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades. How is that parallel to the Boeing situation? We know there was an engineering failure followed by a process failure wrt 737 max. If we have similar evidence in devices (i.e. the process isn't working, or the developers are cutting corners, or both) that should certainly be addressed. But drawing that line with information such as this article seems a stretch, at best.

kansface 6y ago
Forgive me, but I also had the same thought as OP and honestly can't tell the difference between what you are describing and Boeing. > It's a rigorous process, that is designed to remove or reduce the need for a different rigorous process. It's been working pretty well for decades. Just like the FAA and Boeing until it didn't? > We know there was an engineering failure followed by a process failure wrt 737 max. My reading of the situation was a process failure, a couple of engineering screw ups, and possibly user error.
- ska 6y ago
  How are the both of you not included all regulatory oversight in the same bucket? Could the FDA process become weaker to the point of a problem, sure. Is there any evidence that it currently is? I haven't seen any. Is this something they (the FDA and similar) should keep an eye on, absolutely Honestly, I don't see how you are drawing the parallel. In what wad do you think the FDA is making the "same" mistake as the FAA did?
  - at_a_remove 6y ago
    Ah, well, the FAA did not make Boeing go through recertification for the new "version" of the plane. Close enough. Same thing. Did it back then, should be alright. And so the safety process was not seen through on this new model. Similarly, the FDA grandfathered in a bunch of devices and because they are "substantially equivalent," the FDA did not ask for recertification and the safety process was not gone through for these devices.
    - ska 6y ago
      What I am saying is I think that your last paragraph is a misunderstanding of what the 510(k) and de-novo pathways are, and that they are a safety process, which was and is followed. If you argued that the V&V necessary for a 510(k) filing is insufficient, I would understand where you are coming from, and it could be interesting. If you argued that a PMA is needed for all medical devices, I would understand the argument but probably disagree. Your 'similarly' just isn't that similar, unless I've vastly misunderstood the FAA/Boeing case. Again it's clear that the FDA could fall into a state where it's review and audit processes had the same sort of problems that the FAA exhibited with the 737max. But I don't see evidence at all that this has actually happened. What do you think the substantively equivalent bar for a 510(k) allows a company to do? Regulatory capture is a real risk for any regulatory oversight, but it is not synonymous with that regulatory oversight.
      - kansface 6y ago
        > What I am saying is I think that your last paragraph is a misunderstanding of what the 510(k) and de-novo pathways are, and that they are a safety process, which was and is followed. I don't think anyone in this chain has tried to claim that the 510(k) is not a safety process nor that it is not followed - merely that avoiding more rigorous testing and review of a new device by tying it to the safety rating of a previous device sounds exactly like what happened with boeing's 737 max, and secondly, that existing regulations incentivize bad outcomes whereby companies make more expensive/dangerous/worse products that get less testing. > What do you think the substantively equivalent bar for a 510(k) allows a company to do? Honestly, I have literally no idea, and have been trying to tease that information out of you. Specifically, how does that bar differ from the one that Boeing had to clear with the 737 Max took which took 5 years and a few billion dollars (I don't know how much of that was for compliance, but we can guess its at least 10s of millions). This is literally the first article I found when I searched google: https://www.medicaldesignandoutsourcing.com/boeings-737-max-crisis-why-the-medical-device-industry-should-care https://www.medicaldesignandoutsourcing.com/boeings-737-max-...