With my background of mechanical engineering, the process of Design controls for medical device development is very similar to our product design process. The process steps are as follows: define the problem, brainstorm, research and generate ideas, identify criteria, select an approach, model/prototype, test and evaluate, refine, and communicate results. Following this type of process greatly eliminates inefficiencies in the design process. By consistently documenting all steps made, it’s very easy to refer back to work and indicate where errors or changes need to be made.