Risk management is a crucial part of any design and development process. There is a series of checks and balances that must be met, and companies must have an established risk management process in place that complies with industry regulations.
In the case of the two recent 737 MAX 8 plane crashes, a great deal of time has been spent trying to determine the root cause of the crashes. One notion is that critical components and software failed due to improperly conducted risk analyses early in the design stage.
This paper discusses what went wrong with the hardware and software systems of these aircrafts and how we can apply the findings to the medical device industry to ensure that risk controls are properly implemented and verified as effective.