Medical device standards…



  • @Magus said in In other news today...:

    @anotherusername If you need something for medical reasons, absolutely! But those have very careful standards.

    Yes, there is a lot of standards. Like most bureaucracy, they are not particularly efficient at enforcing quality.

    Though, maybe not all hope is lost. The company I currently work for (subcontractor of) is really deep in a pile of WTF. It is mostly your standard run-of-the-mill undefined, but undefined nonetheless:

    • The company needs to replace old application.
    • The project suffers second system syndrome and inner platform effect: there is supposedly generic core (which can't be really made future-proof anyway, because nothing can) and “business rules” in XML-based in-house format with no useful debugging capabilities.
    • The project is big, so Indian subcontractors were hired. Two or three hundred people. The kind that gives Indian subcontractors their worst reputation.
    • As a result, the project is a twisty maze of copy-pasta and fragile code. Every time they are told to fix a bug, they do, but break something else in the process.
    • Besides being fragile, the thing is also pretty slow and laggy. The old WinXP-based thing thing running on ancient laptop board was waaaay better than the new thing running on the beefiest Pixel tablet.
    • Representative property: the full build generates something like 65 libraries (C# (Xamarin mobile app) and C++) and copies them around over hundred times!
    • The testing (which is important—FDA will want to see test protocols) was also given to an Indian subcontractor—who bid way too low to include meaningful automation of functional tests (our company, which did most testing on earlier projects, estimated something like 10 times higher effort!).
    • The project is pretty badly managed. There is a lot of work, but people often don't know what to do.

    Now in a sense, there is a hope. For “salvation”. See, if my information is correct, this is already a second attempt to replace the old system. The first one was shot down by FDA. So there is a chance they actually do review the project and will shot down this one too, making it just a failure it deserves to be and not a “success” of the “worse than failure” kind. Of course not good for the company, but I am not that emotionally attached to it.



  • @bulb said in Medical device standards…:

    See, if my information is correct, this is already a second attempt to replace the old system. The first one was shot down by FDA. So there is a chance they actually do review the project and will shot down this one too, making it just a failure it deserves to be and not a “success” of the “worse than failure” kind. Of course not good for the company, but I am not that emotionally attached to it.

    I want to know what the hell they came up with that the FDA shot down and THIS was the SECOND attempt.



  • @e4tmyl33t said in Medical device standards…:

    @bulb said in Medical device standards…:

    See, if my information is correct, this is already a second attempt to replace the old system. The first one was shot down by FDA. So there is a chance they actually do review the project and will shot down this one too, making it just a failure it deserves to be and not a “success” of the “worse than failure” kind. Of course not good for the company, but I am not that emotionally attached to it.

    I want to know what the hell they came up with that the FDA shot down and THIS was the SECOND attempt.

    No, you don't. Medical software (including and especially medical record software) is notorious for the levels of undefined present. If the FDA measured such things, those would be way past the safe limits.



  • @benjamin-hall said in Medical device standards…:

    @e4tmyl33t said in Medical device standards…:

    @bulb said in Medical device standards…:

    See, if my information is correct, this is already a second attempt to replace the old system. The first one was shot down by FDA. So there is a chance they actually do review the project and will shot down this one too, making it just a failure it deserves to be and not a “success” of the “worse than failure” kind. Of course not good for the company, but I am not that emotionally attached to it.

    I want to know what the hell they came up with that the FDA shot down and THIS was the SECOND attempt.

    No, you don't. Medical software (including and especially medical record software) is notorious for the levels of undefined present. If the FDA measured such things, those would be way past the safe limits.

    Oh believe me, I've got an inkling. I'm the technical supervisor for a helpdesk that services pharma sales reps. The amount of undefined is already at hazard levels, I can only imagine how much worse it gets inside the other side of things.



  • @e4tmyl33t I was recruited by one of the major medical records firms (hint: they still use MUMPS), so I spent some time researching them and their business practices. What I found made me refuse further interviews even at the cost of staying unemployed. Glad I did, my current job is way better and none of the moral objections.



  • @e4tmyl33t said in Medical device standards…:

    I want to know what the hell they came up with that the FDA shot down and THIS was the SECOND attempt.

    I am not sure. It was just somebody telling me by the way since I am not here that long. However, I think it concerns a bit of hardware. The old application runs on a very old custom “notebook”. And there is a newer version of that “notebook”, which is still WinXP-based and runs the same application, but lacks certain specialized hardware, so it can be used for most things except one important action that needs that hardware.


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