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So why aren't we creating some high level framework, for development of a large class of devices, validate it a single time - and enable such devices be designe

by petra 11y ago

So why aren't we creating some high level framework, for development of a large class of devices, validate it a single time - and enable such devices be designed with much less effort ?

HeyLaughingBoy 11y ago
Because it doesn't work that way. You can't validate the framework, you have to validate the product Actually you have to validate the iteration of the product. So if your software changed significantly enough from version 1.0 to 2.0, enough that the results of processing data may have changed, now you have the pleasure of going back to validate the entire product to ensure it still works as expected instead of just doing a software verification. Sucks, but it's the price of safety. One of the stories I love to tell from my medical device days was spending about 6 weeks getting the validation procedure document for a software build machine approved and then spending all of 5 minutes actually building the product (which had to be separately validated), never to use the build machine again. Now, that's crossing the line into stupidity!
- fulafel 11y ago
  Considering the tragedies that could be avoided by having access to cheaper ultrasound equipment, the price of safety is not easily quantified here.
  - HeyLaughingBoy 11y ago
    We're talking about two different things. Safety is the lack of Hazard that a Device presents to the Patient (or Operator). If the device doesn't exist, then there's no Safety issue. What you are talking about is access to medical care, which is an entirely different topic
- petra 11y ago
  But why can't you validate the framework ?
  - HeyLaughingBoy 11y ago
    It's not that you can't it's that it makes no difference since it's the final program that has to be validated, not just its components. There are cases where individual elements of a system must be validated separately, but even then, the system as a whole still has to be validated.

by petra 11y ago

So why aren't we creating some high level framework, for development of a large class of devices, validate it a single time - and enable such devices be designed with much less effort ?

HeyLaughingBoy 11y ago

Because it doesn't work that way. You can't validate the framework, you have to validate the product Actually you have to validate the iteration of the product. So if your software changed significantly enough from version 1.0 to 2.0, enough that the results of processing data may have changed, now you have the pleasure of going back to validate the entire product to ensure it still works as expected instead of just doing a software verification. Sucks, but it's the price of safety. One of the stories I love to tell from my medical device days was spending about 6 weeks getting the validation procedure document for a software build machine approved and then spending all of 5 minutes actually building the product (which had to be separately validated), never to use the build machine again. Now, that's crossing the line into stupidity!

fulafel 11y ago
Considering the tragedies that could be avoided by having access to cheaper ultrasound equipment, the price of safety is not easily quantified here.
- HeyLaughingBoy 11y ago
  We're talking about two different things. Safety is the lack of Hazard that a Device presents to the Patient (or Operator). If the device doesn't exist, then there's no Safety issue. What you are talking about is access to medical care, which is an entirely different topic
petra 11y ago
But why can't you validate the framework ?
- HeyLaughingBoy 11y ago
  It's not that you can't it's that it makes no difference since it's the final program that has to be validated, not just its components. There are cases where individual elements of a system must be validated separately, but even then, the system as a whole still has to be validated.