Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding.
Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding.
复制标题
DOI：
10.1016/j.jpedsurg.2021.01.025
复制
发表时间：
2021-11
影响因子：
2.4
通讯作者：
Koh CJ
中科院分区：
文献类型：
--
作者：
Sun RC;Kamat I;Byju AG;Wettergreen M;Heffernan MJ;Willson R;Haridas B;Koh CJ
由于儿科人口较少和市场因素，专为儿童设计的医疗器械持续短缺。此外，由于可用资金来源有限，儿科设备开发面临挑战。我们描述了我们在儿科设备项目方面的经验，这些项目成功获得了联邦拨款支持，以将设备商业化，可以为未来的创新者提供指导。对 2016 年至 2019 年间接受 NIH SBIR/STTR 资助的一家三级儿童医院儿科设备项目的发展路径进行了回顾。描述了临床问题、设计、具体目标和开发阶段。儿科教师通过合格的小型企业 (SBC) 成功获得了 NIH SBIR/STTR 资助，用于五种儿科设备。三个项目是在顶点工程设计项目中启动的，并在两所附属工程学院进一步开发，而另外两个项目是在教职员工的实验室中开发的。四个项目通过已成立的 SBC 获得资金，而一个项目则通过新成立的 SBC 获得资金。 NIH SBIR/STTR 赠款是儿科设备创新，特别是学术发起项目的外部非稀释性资金的重要来源。这笔资金可以提供促进商业化所需的早期支持。此外，这些赠款可以作为儿科教师在学术晋升方面可实现的成就。我们的经验表明，可以建立一个由学术人员（临床/工程）与当地设备开发公司合作组成的强大的创新生态系统，同时利用 NIH SBIR/STTR 资金共同实施产品开发战略，用于儿科设备开发的关键转化研究阶段。
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. 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. 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. 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.
登录
查看更多内容
影响因子：
8
作者：
Ulrich, Linda C.;Joseph, Francesca D.;Koenig, Robert L.
通讯作者：
Koenig, Robert L.
影响因子：
2.4
作者：
Sack BS;Elizondo RA;Huang GO;Janzen N;Espinoza J;Sanz-Cortes M;Dietrich JE;Hakim J;Richardson ES;Oden M;Hanks J;Haridas B;Hury JF;Koh CJ
通讯作者：
Koh CJ
影响因子：
0.9
作者：
Peiris, Vasum;Xu, Kui;Lewis, Debra Y.
通讯作者：
Lewis, Debra Y.
影响因子：
8
作者：
Hwang, Thomas J.;Kesselheim, Aaron S.;Bourgeois, Florence T.
通讯作者：
Bourgeois, Florence T.
影响因子：
0.8
作者：
Grant, Matthew;Stanasel, Irina;Koh, Chester J
通讯作者：
Koh, Chester J