In terms of determining whether to perform validation or not, validation should still be conducted in order to keep better understanding the product, and that human factors evaluation should be completed as well. Even if there were no changes to the product after verification, you still need to make sure that the majority of the population will be able to use and understand the device. A device may be extremely useful, but very difficult to operate, understand the results, or manage on a daily basis for an individual. By conducting a human factors evaluation even with no clinical trial or changes to the device, you are marketing your device better by learning exactly how the user is interacting with the device, and how it can made simplified so that more users will purchase and continue using the device. Validation may cost the company more money, but it will give them the ability to perfect their device and make even more money after sales.