"As far as I am aware, for every significant UI change we do at the medical device company I am working for, we bring a panel of final users (doctors and techs)

"As far as I am aware, for every significant UI change we do at the medical device company I am working for, we bring a panel of final users (doctors and techs) to our facility and we have to do some validation tests, and finally show these validation results to the FDA before releasing the product." I also work for a device company and a lot of these panel members aren't really competent at giving good feedback because they lack the technical knowledge. And the FDA mostly just checks for completeness of paperwork. They look at the actual product only once there is a problem in the field.