I would have to agree with you. I’m an undergraduate BME student and this is my first time taking the course with Dr. Simon. The only time learned about FDA regulation was in BME 304 Introduction to Biomaterial course with Dr. Collins. Afterward, I think I only touched upon project management topics that we are learning in this course a little in my capstone class, where I learned a little about FDA regulation, how to write a requirements document, manage a Gantt Chart, and write a test plan. Also, my capstone class had to take part in “design review” meetings, where we critiqued other group design requirements and the possible aspects that should be improved. This is the first course that I’m learning about what is involved medical device development in a greater detail such as the different phases of project development, risk management and about different documentations that I never heard about before. Moreover, I have not worked in the industry, so I do not have any inkling what it is like, except what I learn from college. I think the simulations in this course really helps reinforce the what I learned and how to I would approach the challenge given to us. I think it is not only important to know the technical knowledge in BME, but it is also important to have knowledge of what is involved in developing a project, which makes it a viable project for a company.