The concerns that have been brought up in this thread make a good argument for the importance of test method validation. It is important to make sure that the testing that is done is in fact adequate for verifying the test criteria. While Lenzer brings up concerns with having sufficient clinical evidence, there is a lot of bench-top testing that is done in a lab before the device will be used in animals and eventually humans. By using validated test methods, there is more evidence that the device has been sufficiently tested before it starts being used on patients.