The FDA has regulations in place in order to protect the general public. Therefore, the design process of a product is crucial to its success. I believe that in order to ensure a flawless design process the most important step is to create a team with the necessary expertise to create this design process. This is where technical ability surpasses interpersonal ability. There is an extreme level of detail that needs to be attended to when creating an adequate design process, and it should not be limited to the capabilities of those team members. Additionally, the FDA should also have a representative that is assigned to overlook over the design process and give the needed knowledge on FDA regulations.