TY - JOUR
T1 - Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding
AU - Sun, Raphael C.
AU - Kamat, Ishan
AU - Byju, Achu G.
AU - Wettergreen, Matthew
AU - Heffernan, Michael J.
AU - Willson, Richard
AU - Haridas, Balakrishna
AU - Koh, Chester J.
N1 - Funding Information:
After prototype creation, pediatric device innovators can proceed with further development including commercialization steps toward future clinical introduction of novel pediatric devices. To support these commercialization steps, the Small Business Innovation Research (SBIR) (R43/R44) and Small Business Technology Transfer (STTR) (R41/R42) programs serve as viable non-dilutive funding options for the early stages of pediatric device development, although it can take at least 9 months after submission for a successful application to receive a SBIR / STTR award (https://www.ninds.nih.gov/Funding/Small-Business-Grants/Grant-Timeline). The SBIR and STTR grant programs are designed to stimulate innovation and research and development within small businesses, which often collaborate with academic research centers to obtain access to advanced subject matter expertise. While the SBIR / STTR programs of the National Science Foundation (NSF) are well-known in the engineering and device development fields, the similar grant programs at the NIH may not be well known by many clinicians and clinical scientists due to the emphasis on independent (R01) research grant funding. Furthermore, while NIH research funding overall continues to be extremely competitive with paylines in the single digits, the SBIR / STTR grants represent an often more achievable option for grant funding for pediatric clinicians and surgeons to support continued pediatric device development.
Funding Information:
Conventional grant funding via NIH K and R01 basic science grants continue to be extremely competitive for the pediatric physician-scientist, with paylines often in the single digits. With respect to the extensive required resources to build and maintain basic science labs and employ lab personnel, the current funding environment can be challenging for pediatric physician-scientists. However, the STTR /SBIR grant programs offer pediatric physician-scientists funding pathways that are often more achievable, with many Impact Score paylines at 25 or greater. The National Cancer Institute (NCI), National Institute of Allergy and Infectious Disease (NIAID), National Heart, Lung and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) routinely report on their paylines for SBIR and STTR grants, which have consistently ranged from 28 to 33 in 2019 and 2020. Furthermore, the zone of consideration for NHLBI SBIR and STTR grants based on the impact score was 10 to 40 for both 2019 and 2020. Of note, these grants emphasize the clinical translation of device solutions toward becoming clinically available and commercially viable, although there are several other challenges beyond grant funding to achieve commercialization (regulatory, reimbursement, fundraising, manufacturing, marketing, etc.). Therefore, STTR/SBIR grants represent opportunities for pediatric physician-scientists to successfully obtain grant funding and achieve accomplishments that can be used for academic promotion, as well as provide pathways for solutions for unmet pediatric device needs that they may encounter in the clinical realm.
Funding Information:
All phases of this study were supported by FDA P50 Pediatric Device Consortia Grant # 5P50FD006428 (SWPDC) (Dr. Koh – Contact PI)
Publisher Copyright:
© 2021
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Biomedical engineering
KW - Commercialization
KW - Device development
KW - Entrepreneurship
KW - Federal grant funding
KW - Innovation
KW - Pediatric device development
UR - http://www.scopus.com/inward/record.url?scp=85100620784&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85100620784&partnerID=8YFLogxK
U2 - 10.1016/j.jpedsurg.2021.01.025
DO - 10.1016/j.jpedsurg.2021.01.025
M3 - Article
AN - SCOPUS:85100620784
JO - Journal of Pediatric Surgery
JF - Journal of Pediatric Surgery
SN - 0022-3468
ER -