Academic institutions, teaching hospitals, and other non-profit research centers continue to provide a rich source of innovative and valuable new biomaterials, medical devices, and medical technologies. Traditional technology transfer of these intellectual assets have been managed through standard option and license agreements between institutions and companies with the expectation that the companies will conduct and pay for all required regulatory activities associated with the commercialization process. CIMIT and other academic technology integrators are exploring many new models for active partnering that are designed to accelerate the development cycle, explore enabling embodiments, and integrate investigator participation throughout the development cycle. These collaborative approaches are effectively overcoming many long-established barriers to innovation, but also require new regulatory strategies and conflict management techniques to insure that the interests of the patient, the manufacturer, the institution, and the investigator are all included in a successful partnership design.

This presentation will highlight several of these new partnering models, identify key regulatory design elements, describe critical transitions, and suggest techniques for companies interested in more active investigator participation in successful product development.