Abstract
Effective use of university translational research funding programs can accelerate commercialization of academic medical and surgical innovations. The goal of this commercialization will often lead to an exit or “hand-off” to a commercial entity to complete development and bring these new innovations into healthcare as regulatory approved medical devices and diagnostics. These commercial entities are either existing medical device or diagnostic companies (strategics) or startups that embark on a simultaneous effort of product development and fund raising from angel or venture capital investors. Hand-offs typically occur in the form of intellectual property licensing agreements between universities and commercial entities. Academic medical innovators have opportunities to understand the incentives for these commercial entities to invest in university-based technologies, and leverage resources within universities and translational research funding programs to tailor academic research and development plans to align with commercial entity incentives, and increase the probability of reaching successful exits. The current funding environment and returns faced by strategics and angel/Venture capital investors creates a challenging environment for creating hand-offs directly out of a university research lab. Focusing research efforts on de-risking technology is not enough in most cases. The Coulter model established through funding from the Wallace H Coulter Foundation, and the evolution of the University of Michigan Coulter Translational Research Partnership program (UM-CP) described in this chapter as an example, provides a successful blueprint for accelerating exits. This blueprint involves transitioning from a Risk Reduction approach to a New Product Planning and Development approach. This latter approach involves active engagement with the Coulter team and industry network, with early and frequent interactions with target strategics and investors. Through these efforts, academic teams can pre-identify exit plans, validate criteria for licensing, and develop funding milestones to meet these criteria and greatly improve odds of generating exits.
The UM-CP has developed a systematic process to reach these goals, and has achieved an exit rate increase from 14% with a risk-reduction focus to 31% with a new product planning and development focus. Additional currently funded projects through the UM-CP are well-positioned for exits with ongoing-discussions with strategics who in some cases, have become active partners in development activities. Thus this approach has had a significant impact on improving outcomes of the UM-CP. This transition to a new product planning and development focus is adoptable to other academic medical centers and universities, provided there is a strong commitment to both funding and execution on commercially relevant funded milestones.
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For an overview of the FDA medical device approval process and pathways, visit https://www.fda.gov/ForPatients/Approvals/Devices/default.htm.
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Marten, T. (2019). Funding Engineering/Surgical Partnerships to Accelerate Commercialization of Academic Medical and Surgical Innovations: The Coulter Model for Translational Partnership between Medicine, Engineering, and Industry. In: Cohen, M., Kao, L. (eds) Success in Academic Surgery: Innovation and Entrepreneurship. Success in Academic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-030-18613-5_12
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