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BIOME ™ : B io I nnovations and O pportunities in M edicine and E ngineering. Robert G. Radwin, Professor & Chair, Biomedical Engineering Lawrence A. Casper, Asst. Dean, Research & Tech. Transfer. biome.wisc.edu. Basic Format of the Course.
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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
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
Challenges • 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
Example • 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