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