Evidence map›Paper›PMID 33558071›Full record

ArticleJournal of pediatric surgery2021

Advancing pediatric medical device development via non-dilutive NIH SBIR/STTR grant funding.

Raphael C Sun, Ishan Kamat, Achu G Byju, Matthew Wettergreen, Michael J Heffernan, Richard Willson, Balakrishna Haridas, Chester J Koh

Abstract read
In one paragraph

Article in Journal of pediatric surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. A novel maturity index for assessing medical device startups.Journal of clinical and translational science · 2022
    Article
  4. Article
  5. Turning Neural Prosthetics Into Viable Products.Frontiers in robotics and AI · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Raphael C SunTexas Children's Hospital and Baylor College of Medicine, Houston, TX, USA.
Ishan KamatTexas Children's Hospital and Baylor College of Medicine, Houston, TX, USA.
Achu G ByjuTexas A&M University, College Station, TX, USA.
Matthew WettergreenRice University, Houston, TX, United States.
Michael J HeffernanFannin Innovation Studio, Houston, TX, USA.
Richard WillsonUniversity of Houston, Houston, TX, USA.
Balakrishna HaridasTexas A&M University, College Station, TX, USA.
Chester J KohTexas Children's Hospital and Baylor College of Medicine, Houston, TX, USA. Electronic address: ckoh@bcm.edu.

Funding

Research Training Program in Cardiovascular SurgeryT32HL139430 · NHLBI · BAYLOR COLLEGE OF MEDICINE · PI Todd K Rosengart · 2018 to 2026
$2.9M
FDA HHS P50 FD006428NHLBI NIH HHS T32 HL139430
6 · The paper itself

Abstract

introductionA 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.

methodsThe 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.

resultsPediatric 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.

conclusionNIH 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.

Indexed as

EcosystemFinancing, OrganizedChildHumansUnited StatesBiomedical engineeringCommercializationDevice developmentEntrepreneurshipFederal grant fundingInnovationPediatric device development

Identifiers

PMID33558071
PMCPMC9125501

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.