Within my senior capstone course I utilized many of the design control requirements without even realizing it. My capstone team developed a seven degree of freedom impedance controller for an intelligent assistive rehabilitation manipulator (iARM). We had to create a proposal on the idea we had which was supported by lots of research. We had our Professor act as the manager and decide whether or not our idea was sufficient enough to be a project. We had to type up a project proposal on what are device was and how it would fill a market gap. Then we had to write a DDP which explained how we were going to go about the project. Each group member was given a responsibility, we scheduled weekly meetings with our Professor and Adviser. Within our first semester we had to formulate a DID which explained the basic model of our controller. It included the number of degrees of freedom we desired, who we would market it to based on the customer needs which was determined from our Adviser. I was held accountable for the mechanics of the controller therefore, in our requirements document (similar to DSD & Design transfer) I had to report CAD models of the controller with detailed information on how to build and assemble it. We developed a test plan (similar to a design verification) to test each of our requirements (DID). In capstone, we were not responsible for design validation because our outputs were our customer needs. The second semester of the course was all about manufacturing the product and testing it. At the end of the term we had to submit all of our documents and meeting notes which accumulated into our DHF.

These nine parts in design control are crucial from my experience because it allows your team to break down your project into fine details so that you can figure out what errors you might encounter and how to avoid them without wasting time or money. I do believe that the design controls that medical device companies go through are similar to other companies such as software. The content will be different but the nine parts will be very similar for any project.