1. The Alfred E. Mann Institute for Biomedical Engineering An Experiment in Technology Transfer Gerald E. Loeb, M.D. Director of the Medical Device Development Facility Professor of Biomedical Engineering University of Southern California

2. Medical Products Consumer Products DevelopmentSales Engineers Management Customers R&DMarketing Scientists Management Patients Regulators Clinical Researchers Engineers Prescribers Insurers Addressing a fundamental difference:

3. History of the AMI The Institute began with the vision of Mr. Alfred E. Mann, Chairman and CEO of MiniMed, Chairman and Founder of several other companies, and prominent entrepreneur in the field of biomedical technology The plan was to establish a university-affiliated organization devoted to research, development, and commercialization of new biomedical technologies to improve human health and well being. As a result of discussions between Mr. Mann and President Steven B. Sample of the University of Southern California, the Institute was established as a non-profit corporation and became affiliated with USC in 1998.

4. AMI-USC Process Model Solicit Project Ideas Perform Market/Feasibility Analysis Develop Project Plan, Schedule, & Budget Create Team of Researchers, Engineers, Clinicians and Support Personnel Develop, Test, and Document Prototype Establish Intellectual Property Position Conduct Clinical Trials Transition Product to a Commercial Entity

5. AMI Contribution Researchers Schools & Colleges Industry AMI Joint Appoint. Collab. Appoint. Joint Grant Appl. Training Projects Dialog Collab. Projects Product Transfer Project Funding and Team Organization Technical Support Infrastructure Clinician Support, Clinical Trials, IRB/FDA Market Research Intellectual Property Management Symposia

6. Facilitating Development and Transfer of Medical Technology Patent attorneys Business development consultants Regulatory science department Quality systems staff Professional engineering staff Core technical facilities

7. A Living Laboratory for Interdisciplinary Teaching Masters in Regulatory Science –Frances Richmond, School of Pharmacy, Director of Clinical and Regulatory Science, AMI Masters in Business Administration –Kathleen Allen, Technology Entrepreneurship, Marshall School of Business and Technology Commercialization Alliance Masters in Medical Device and Diagnostic Engineering –Gerald Loeb, Biomedical Engineering Pilot projects for undergraduate and graduate students

8. Student Entrepreneurship Projects Virtual Visit™ design & demo (NCIIA grant) BION™ clinical applications (MBA projects) BION™ European market analysis (contract) Sencil™ market analysis (RA + contract)