As many have mentioned above, the more insufficient the design controls are, the more likely it is for the product to fail. There are a few examples of this scenario, such as when vehicle manufacturers have to recall a certain model due to some structural issues. Ethically, this can be related to the Ford Pinto fiasco. The bending iPhone 6 and 6 plus is also another example. Medically, insufficient use of design controls could have catastrophic results on the health of the patient as well as cost companies millions of dollars as a result of recalls, lawsuits, future trust, etc.