When design controls are not set up properly, it results in a failed medical device as stated by those examples above. In the case of recalled medical devices, it would be interesting to study and review their design controls and analyze errors and what could have been done differently. It would also be interesting to study what those companies missed and how to prevent future mistakes. The possibility that a device design can fail or be recalled is in itself a failure in design controls, as it shows it is a flawed system. Using AI or machine learning to learn from past mistakes and hundreds of device examples could help foolproof and improve the process.