When the process is not used properly, it results in a failed medical device as stated by those examples above. In the case of those recalled medical devices, it would be interesting to know what their design controls were and if they passed. It would also be interesting to know what made those companies feel that their products was able to be put on the market. Maybe those devices did go through all of the design controls, but there were some that were not thought of. If there were design controls that were not addressed for those devices, that would certainly be a case where the process was insufficient.