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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
Vetting technologies Clinical and research champions Technical feasibility Intellectual Property Marketability Regulatory barriers
Category Title Description Criteria/ Parameter Notes Clear Problem Statement
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
Personnel Support Availability
Availability of university, clinical and industry specialists to assist in defining solutions and possibly directly supporting the development of the proposal.
Names, departments, companies.
Ethical Considerations
Are there ethical issues (positive or negative) that need to be considered in solving this problem?
Summary of good and bad issues.
Positive or negative score allowed.
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?
Cases over time, payer interest, clinical/patient interest
Intellectual Property
Is there confidence that we can develop unique Intellectual property and associated financial motivation with a solution?
Patent search, WARF, BME undergrad design projects?
Marketability 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?
Dollars, competition, past failed attempts at entering.
Clinical Implementation
Is it feasible that a solution can pass the hurdles associated with clinical implementation in a reasonable timeframe?
Physician, clinical interest.
Clinical Trials Do we feel that we can get a commitment to do trials in the Madison area?
Contacts, UHS.
Regulatory Barriers
Do we feel that we can get support to take the solution through the regulatory approval process? Projected time may be considered.
FDA approval of similar items
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
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