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Why Design Validation is More Than Testing: How do we validate our validation?

The “textbook” approach to design validation is intended to make sure we design the “right” device, i.e., the device meets user needs and intended uses.  But what exactly does that mean and how do we do it?  More importantly, how do we know we did it right?  If we tick the validation checkbox, can we assume our validation is correct? 

Validation usually involves a lot of testing.  But what tests do we do?  What tests do we not do?  When can we use standard tests and when do we have to develop new ones? More importantly, how do we know we’re doing the right tests? If a test is “required” must we do it? In other words, how do we validate our validation?  And how do we defend our validation when FDA criticizes it?

Finally, the “textbook” approach to design validation is very myopic.  What else needs to be validated? human factors plan? reprocessing methods? post-market surveillance system? what else?