Design validation is crucial, especially if verification fails during the executing phase. It is important to confirm that each numbered input meets the user’s needs, before it is tested in a clinical setting. The stakes are higher in clinical testing, so all the risks and user requirements should be clearly stated before we reach that stage. It will also prevent unnecessary financial and time expenditure on those trials. If validation is not met, then adjustments might be needed to the scope and testing protocols. Safety and effectiveness of the final product should be evaluated, especially for medical devices.