The reason design controls fails is because either procedures are not followed or the procedures themselves are poorly written, and the planning of every aspect of the device and documentation is poor. However, in a medical device industry that rarely occurs when design controls are inefficient. The FDA is very strict with its guidelines and acceptance criteria in 510k submissions or PMAs, that if design controls do fail for the company it usually does not reach the FDA submissions phase for that device. Usually a thorough design development plan is thought of along with the project proposal, with design review meetings to make sure the device is progressing. Verifications and validations are performed to find bugs before the product is launched on market, however as others have noted sometimes these protocols do not find these issues before the product is out on the market.