BME 6081 - Biomedical Device Innovation I

First semester of a two semester graduate level project based learning class focused on medical device design and documentation within the regulatory framework of FDA QSR, business plan development, and business startup concepts. This course will bring together students in medicine and medical residency, traditional engineering students, business, and law students for a multidisciplinary experience in medical product innovation. The medical device ideas will be produced and refined through a summer clinical immersion course where students are exposed to clinical environments and identify unmet needs through interaction with the environment, clinicians, and patients. During the first semester (design input phase), students will design, prototype, and document a medical device using FDA requirements for design control. To accomplish this goal, all projects will utilize customer driven inputs to motivate the development of product specifications. Prototypes will then be developed based upon these specifications. To provide students with the training in device development, two weekly lab sessions will be held to focus on machine shop tools and prototyping. There will also be two lectures per week to introduce concepts including FDA QSR, design documentation, project management, software and hardware tools, and risk management. Outputs of this phase include design input documentation (project plan, design requirements, design specifications).