In general, validation is an important part of getting a product to market because it verifies that the user needs are met. Even though it may take up to a few years to complete, it can improve the launch success and reduce the chances of product recalls. Also, other benefits can include the reduction of scrap, increase in outputs, eliminate rework that help with the product’s success. In addition to this, the human factors are one of the additional process that can improve the launch success. I agree with the statements above that this testing assist in identifying errors during user interaction that could lead to harming the patient. Similarly, it is used to assess the effectiveness of risk management and confirm that the mitigation for residual risks is acceptable.

http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm484345.pdf
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm259760.pdf