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

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:
Consumer Products
Development
Engineers
R&D
Sales
Management
Medical Products
Scientists
Clinical
Researchers
Customers
Marketing
Patients
Management
Engineers
Prescribers
Insurers
Regulators
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.
AMI-USC Process Model
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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
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.
Dialog
Collab. Appoint.
Collab. Projects
Joint Grant Appl.
Product Transfer
Training Projects
Facilitating Development and
Transfer of Medical Technology
• Patent attorneys
• Business development consultants
• Regulatory science department
• Quality systems staff
• Professional engineering staff
• Core technical facilities
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
Student Entrepreneurship Projects
• Virtual Visit™ design & demo (NCIIA grant)
• BION™ clinical applications (MBA projects)
• BION™ European market analysis (contract)
• Sencil™ market analysis (RA + contract)