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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 Unique Features of BIOME Challenges 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 Vetting technologies Category Title Clear Problem Statement Personnel Support Availability Ethical Considerations Clinical and research champions Technical feasibility Intellectual Property Marketability Regulatory barriers Description Criteria/ Parameter Is there a clear statement of the problem that is understandable by the team members or the assigned champion? Clarity of problem and vision of solution. Sponsor Availability of university, clinical and industry specialists to assist in defining solutions and possibly directly supporting the development of the proposal. Names, departments, companies. Are there ethical issues (positive or negative) that need to be considered in solving this problem? Summary of good and bad issues. Technical Feasibility Within the guidelines of “Translational Research), is there confidence that we can find technologies and resources to clearly define a deployable plan by the end of the semester, not necessarily developing a prototype? Departments, consultants, labs, grants Clinical Impact Is there confidence that there will be a significant clinical or patient impact in a relatively broad sense? Intellectual Property Marketability Is there confidence that we can develop unique Intellectual property and associated financial motivation with a solution? Cases over time, payer interest, clinical/patient interest Patent search, WARF, BME undergrad design projects? Clinical Implementation Clinical Trials Regulatory Barriers Are we confident that there is a big enough market for the solution and that we can take a sufficient share of that market, easily, with a solution? Is it feasible that a solution can pass the hurdles associated with clinical implementation in a reasonable timeframe? Dollars, competition, past failed attempts at entering. Physician, clinical interest. Do we feel that we can get a commitment to do trials in the Madison area? Do we feel that we can get support to take the solution through the regulatory approval process? Projected time may be considered. Contacts, UHS. FDA approval of similar items Notes Positive or negative score allowed. 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