Advancing Pediatric Medical Device Development via Non-Dilutive NIH SBIR/STTR Grant Funding
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In brief
In brief
This article examines five successful pediatric medical device projects at a children's hospital that secured NIH SBIR/STTR grants between 2016-2019. The authors demonstrate how non-dilutive federal funding can bridge the gap in pediatric device development by supporting academic-industry collaborations and early-stage commercialization efforts.
Written by the GCMD Library team from the article.
Abstract
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 limited 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 qualified 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 accomplishments 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) collaborating 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.