This two-semester 8-credit course is a required sequence for students enrolled in the BME Master of Engineering program. Students will work with leading clinicians to observe and identify unmet clinical challenges, design and develop innovative engineering solutions to those challenges, and explore the regulatory, intellectual property, and reimbursement pathways that will ultimately advance the standard of patient care through the deployment of their innovations. During the first semester, students will qualify for Medical Observer Status and the Boston Medical Center and project teams will conduct formal Needs Finding protocols, select projects, and design alternative solutions. During the second semester, project teams will develop their designs, and make multiple prototypes. Formal Design Control, Life Cycle, Risk Analysis, Project Management, and Intellectual Property Strategies will be introduced. Using formal Product Develop Protocols, students will prepare a detailed regulatory and implementation pathway analysis for completing the commercialization process needed to eventually bring their innovations into clinical practice. 8 credits over 2 semesters - must enroll for both semesters