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.
Keywords
Abbreviations:
FDA (U.S. Food and Drug Administration), NIH (National Institutes of Health), SBC (Small business concern), SBIR (Small Business Innovation Research grants (R43 / R44 grants)), STTR (Small Business Technology Transfer grants (R41 / R42 grants))To read this article in full you will need to make a payment
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References
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Article info
Publication history
Published online: January 24, 2021
Accepted:
January 13,
2021
Received in revised form:
January 6,
2021
Received:
October 16,
2020
Identification
Copyright
© 2021 Elsevier Inc. All rights reserved.
