This two-semester 8-credit course is a required sequence for students enrolled in the BME Master of Engineering program. Successfully completing the sequence fulfills one technical and one leadership requirement towards completing their Master of Engineering degree. 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 by observing current clinical challenges first-hand under the guidance of senior members of the clinical community. Based on these observations, students will compare alternative design strategies, and select an optimum approach based on weighed clinical requirements for an innovative design solution. During the second semester, project teams will develop their designs, make multiple prototypes using the resources of the Engineering Product Innovation Center. 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.