1. BIOME ™ : Bio Innovations and Opportunities in Medicine and Engineering Robert G. Radwin, Professor & Chair, Biomedical Engineering Lawrence A. Casper, Asst. Dean, Research & Tech. Transfer biome.wisc.edu

2. Basic Format of the Course Interdisciplinary grad course (engineering, medicine, business, law, others) Identifies new medical technologies needed in clinical practice through collaborative technology assessment Students vet innovations based on technical feasibility, market, IP, FDA, reimbursement, and faculty Outcomes include technologies at various stages that can be carried forward through translational research and commercialization projects

3. Unique Features of BIOME

4. Vetting technologies  Clinical and research champions  Technical feasibility  Intellectual Property  Marketability  Regulatory barriers Fostering an Innovation Community  Needs assessment panels and focus groups  Solicitations for physician initiated projects  Grand rounds  Physician shadowing  Identifying interested faculty in medicine and engineering Expertise in technology and commercialization  Interdisciplinary teams  Guest speakers in patenting, IP barriers, FDA, venture investing Challenges

5. Need: External fixation devices utilized for lengthening a bone requires surgical angular corrections and almost always results in infection Innovation: A solution that combines the technologies of an intramedullary lengthening device and the external fixator device is an extramedullary implantable device using a linear drive motor for angular correction and infusion of bone growth promoting materials and medications Market: 5,000 to 10,000 units per year at a patient cost of $5,000 each ($25 to $50 million in annual sales) IP: Disclosed to WARF and a patent was applied for Regulatory: Premarket Approval (not anticipated. A 510k can be filed using existing technologies Faculty: New collaboration with orthopedic surgeon, biomedical engineer and mechanical engineer Follow-on: Coulter TRP/ CTSA pilot project Example