South Carolina Research Authority has been awarded approximately $750,000 in federal grant funding by the U.S. Economic Development Administration as part of the 2018 Regional Innovation Strategies Competition. The grant will fund the creation of the South Carolina Medical Device Alliance to invent and develop products and bring them to market. The alliance is a multi-stakeholder partnership including Clemson University (CU), Medical University of South Carolina (MUSC), and industry leaders; it will form a regional innovation cluster to increase the economic impact of this sector through job creation and startup formation and to attract international businesses to South Carolina. The MDA will move technologies to market by designing solutions, determining initial commercial feasibility, de-risking innovations with multidisciplinary teams, and launching startups that have been rigorously evaluated by seasoned industry experts. Chris Gesswein, Executive Director of the Clemson University Research Foundation, said this about the alliance, “The S. C. Medical Device Alliance brings together life science expertise throughout the state to support commercialization of innovative, early-stage medical technologies from our research institutions. By embedding industry knowledge and expertise early in the development phase, the Alliance will ensure that the technologies it supports address the validated market needs critical to successful commercialization.”
SCRA’s capabilities in managing collaborations and its state-wide focus on fueling the innovation economy, provide the MDA’s foundation. Through CU’s Bioengineering and MBAe programs, MUSC’s clinical capabilities, and SCRA’s industry advisors, the state has substantial expertise and intellectual assets in the field that, once coordinated by the MDA, will lead to tremendous opportunity for economic impact. Leveraging South Carolina’s existing expertise, infrastructure, and funding, the MDA will facilitate and accelerate commercialization of medical technologies; build entrepreneurial capabilities among students, faculty and clinicians; and foster startup formation in the sector.
Key personnel are Dr. John DesJardins, Hambright Leadership associate professor in bioengineering at CU; Christine Dixon Thiesing, MBA, Director of Academic Programs at SCRA and co-founder of CuRE Innovations; Michael J. Yost, Ph.D., Professor of Surgery and Vice Chairman of Surgery for Research at MUSC.
In Phase I, engineering students and clinical innovators will design preliminary solutions and identify commercially viable projects. CU and MUSC have a unique existing partnership in a senior design program that engages clinical innovators with engineering students to identify, develop, and solve critical clinical problems and move those solutions to become commercial products. Prior to public disclosure, the first phase of the MDA will bring industry insight to the initial stages of medical device development. Beginning with the 2018-2019 program, CU’s existing Industry Advisory Board will identify the top commercially-viable senior design program projects. The top projects will then be disclosed to their respective technology transfer offices, where preliminary technology evaluations will be performed to determine patentability and commercial opportunity. The early industrial advisory board (IAB) input and preliminary technology transfer office (TTO) evaluation will better enable the TTOs at CU and MUSC to justify investing in patent filings prior to public disclosure, protecting the ability to file for patent protection world-wide. The TTOs and SCRA will identify the top faculty innovations from across the state to feed into Phase II. According to Dr. John DesJardins, Hambright Leadership Associate Professor, Department of Bioengineering, Clemson University, “Our clinical and industry partnerships in design are essential to this educational process, and we are excited to have the medical devices invented in our senior design program serve as a pipeline in the development and commercialization of innovative biomedical devices.”
Phase II will see development of product profiles and determination of initial feasibility. SCRA will lead the effort to develop product profiles for the top technologies from Phase I. The profiles will include a regulatory assessment, comprehensive market and competitive analysis, production assessment/cost of goods analysis, patent landscape, and reimbursement assessment. The product profiles will be provided to the medical device commercialization advisory panel (MDCAP) as the background information necessary to determine the next steps of development for each project. The MDCAP also will evaluate each project based on an established, multifaceted rubric for the potential commercial value and make recommendations regarding which projects should advance to Phase III.
In Phase III, multidisciplinary teams will attempt to decrease device risks. CU will hire a Professor of Practice with extensive industry experience in medical device development who will curate and lead multidisciplinary teams consisting of masters-level bioengineering students, business students, and law students, along with clinical subject matter experts. The teams will de-risk the medical devices to address the needs identified by the IAB and MDCAP. This phase will include funding fellowships in entrepreneurship for bioengineering graduate students. The student teams will conduct market research by convening focus groups in coordination with clinicians at MUSC and other clinical partner institutions. After one year, the students will present their findings to the MDCAP for re-evaluation and determination of the next steps.
Phase IV’s focus will be to implement translation/maturation. The MDCAP, in conjunction with the PoP, will determine which of four paths a project will take in this phase:
1) Optimally, projects will be adequately de-risked to serve as the basis of a startup company and attract follow-on funding. Funding from the i6 will be deployed to hire an EIR to provide a strong foundation for the startup and increase the potential for successful translation into the marketplace;
2) Some projects may require additional de-risking. In such cases, the project will revert to Phase III for an additional year of development;
3) Some projects will be best suited to an out-licensing model by the relevant TTO upon completion of Phase III;
4) A portion of projects will have encountered an insurmountable issue, resulting in termination.
At the end of the Performance Period, South Carolina will have a sustainable mechanism to produce entrepreneurial jobs in the medical device field and expand the entrepreneurial capacity of the state. This will serve as an outlet for previously unmined clinical needs to have a significant and enduring economic impact for the state.>
