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The Alfred E. Mann Institute for Biomedical Engineering An Experiment in Technology Transfer

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. Addressing a fundamental difference:.

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The Alfred E. Mann Institute for Biomedical Engineering An Experiment in Technology Transfer

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  1. The Alfred E. Mann Institutefor Biomedical EngineeringAn 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. Addressing a fundamental difference: Consumer Products Medical Products Development Sales Management Engineers Customers R&D Marketing Scientists Patients Clinical Researchers Management Prescribers Engineers Insurers Regulators

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

  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)

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