Hello,
Does anyone have any experience with artificial intelligent software medical devices?
I am wondering if the training/learning of the algorithm continues when the software is on the marketing. Or is the training/learning of the algorithm part of the design and development process which is then 'frozen' and validated prior to release of the device?
Thanks
In our organization we have taken part in various AI projects including MD ones. I would say AI training / configuration differs from one project to another but surely I would call it software development. You configure the network and provide/train its configuration data (models). Thus you can easily meet identification and configuration management requirements for AI software component. The verification is a bit more tricky as you do not have classical algorithm specifications (detailed design). Instead, I would recommend using input data / vs. expected outcomes to create test level specification - at the end that's what AI is about
. Once you have the test level specification can run verification and reuse the same test level for validation on Staging / Production environments.
After GoLive training of AI may continue, and IMHO should continue. Still, I would train it in parallel to the already validated AI deployment / configuration. This way you use your production data to train new version of AI without impacting your currently validated software system. When you are satisfied with the new AI version you can think about new release with updated AI component/software unit.