Raphael C Sun1, Ishan Kamat1, Achu G Byju2, Matthew Wettergreen3, Michael J Heffernan4, Richard Willson5, Balakrishna Haridas2, Chester J Koh6. 1. Texas Children's Hospital and Baylor College of Medicine, Houston, TX, USA. 2. Texas A&M University, College Station, TX, USA. 3. Rice University, Houston, TX, United States. 4. Fannin Innovation Studio, Houston, TX, USA. 5. University of Houston, Houston, TX, USA. 6. Texas Children's Hospital and Baylor College of Medicine, Houston, TX, USA. Electronic address: ckoh@bcm.edu.
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.
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:
Biomedical engineering; Commercialization; Device development; Entrepreneurship; Federal grant funding; Innovation; Pediatric device development
Authors: Vasum Peiris; Kui Xu; Heather L Agler; Eric A Chen; Rashmi Gopal-Srivastava; Brian M Lappin; Debra Y Lewis; Gayatri R Rao Journal: J Med Device Date: 2018-07-13 Impact factor: 0.582
Authors: Bryan S Sack; Rodolfo A Elizondo; Gene O Huang; Nicolette Janzen; Jimmy Espinoza; Magdalena Sanz-Cortes; Jennifer E Dietrich; Julie Hakim; Eric S Richardson; Maria Oden; John Hanks; Balakrishna Haridas; James F Hury; Chester J Koh Journal: J Pediatr Surg Date: 2017-02-06 Impact factor: 2.545