It is important that inputs are equal to user needs or intended needs. “Successful design validation can only occur if the user needs and intended use have been well defined at the very beginning of the design and development phase. One of the major reasons for product failures over the years has been the inability of devices to meet the user and market needs.” If everything was planned accordingly at the beginning and throughout the process than the design validation will be successful.

More information can be found at medicaldesignbriefs, design validation and regulatory requirements.