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I have my suspicion that medical devices aren't as rigidly programmed as the general public would like. Ie programmed by a biomedical/electrical engineer who is
by JimTheMan 5y ago
I have my suspicion that medical devices aren't as rigidly programmed as the general public would like. Ie programmed by a biomedical/electrical engineer who isn't really a software specialist. But I'd be keen to hear from someone in the trenches.
- ska 5y agoThe industry changes slowly, and definitely regulators like the FDA were too hardware focused for a long time. Less so in the last 10-20 years. They've always been pretty good about critical systems but less so about "secondary" ones, and there are old devices out there where it shows. These days most of the industry has reasonable guidance and standards to follow. Characterizing "the industry" is hard; it includes cloud based data handling products and embedded devices with minimal software, etc. - a huge range. In both these areas (and others,to be sure), there is a formal engineering process that looks quite similar - and you need to embrace it in your software development or there will be a lot of friction. The goals of it are pretty sensible, but the approaches may seem odd to some with more mainstream software backgrounds.
- zmmmmm 5y agoIt's a different version of rigorous to what a normal software industry interpretation would be. It's about controlled processes, highly auditable, very sharply optimised focused managing the medical (and medico-legal) risk at the expense of every other type of problem. Generic software specialists I think actually aren't very good at it and take a while to acclimatise to it.