I believe that design controls should be part of the process used to determine the commercial viability of a product in development. Design input requirements can help customers and stakeholders identify and satisfy product requirements. Another vital part of the product development process is design output. A medical device cannot exist without it. Design output enables companies/entrepreneurs to sell their creations. Design output gives the inventor/seller the objective evidence needed to communicate precisely what the medical device is and the clinical needs it serves.
Design verification determines whether the design output meets design input requirements. More simply stated, it helps companies figure out if the medical device meets specifications. This is a basic component of any design effort, and therefore it is valuable.

So is design validation, which can help manufacturers determine whether the medical device being developed actually works. Design validation is performed in the environment or simulated environment in which the product is intended to operate.