Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding

Introduction: A shortage of medical devices designed for children persists due to the smaller pediatric population and market factors. Furthermore, pediatric device development is challenging due to the lim-ited available funding sources. We describe our experience with pediatric device projects that successfully received federal grant support towards commercializing the devices that can serve as a guide for future innovators. Methods: The developmental pathways of pediatric device projects at a tertiary-care children's hospital that received NIH SBIR/STTR funding between 2016-2019 were reviewed. The clinical problems, designs, specific aims, and development phase were delineated. Results: Pediatric faculty successfully secured NIH SBIR/STTR funding for five pediatric devices via qual-ified small business concerns (SBC's). Three projects were initiated in the capstone engineering design programs and developed further at two affiliated engineering schools, while the other two projects were developed in the faculty members' labs. Four projects received funding via established SBC's, while one was awarded funding via a newly established SBC. Conclusion: NIH SBIR/STTR grants are an essential source of external non-dilutive funding for pediatric device innovation and especially for academic-initiated projects. This funding can provide needed early-stage support to facilitate commercialization. In addition, these grants can serve as achievable accom-plishments for pediatric faculty portfolios toward academic promotion. Our experience shows that it is possible to build a robust innovation ecosystem comprised of academic faculty (clinical/engineering) col-laborating with local device development companies while jointly implementing a product development strategy leveraging NIH SBIR/STTR funding for critical translational research phases of pediatric device development. (c) 2021 Elsevier Inc. All rights reserved.