We are proud to announce our third pediatric medical device grant!
Pediatric patients have long been an underserved population in the technology space with many having to deal with ill-fitted medical devices and a lack of access to effective diagnostic or therapeutic devices. CTIP aims to address these unmet needs.
Introducing the Catalyzing Pediatric Innovation (CPI) Grant, CTIP's pediatric medical device competition to assist the development of medical device projects for children. We invite proposals addressing the development of novel devices and technologies for pediatric patients.
Letters of Intent are due April 15, 2019
Up to $25,000-$50,000 per grant will be awarded.
1 year grants.
Letter of Intent due April 15, 2019 (see details in linked document).
Eligibility requirements for the Catalyzing Pediatric Innovation (CPI) Grant include the following:
Must be a novel pediatric medical device or technology.
Medical devices must meet the FDA definition of a medical device.
Development of novel drugs and chemical therapies will not be funded. Process improvement and innovations are also not eligible for funding. In addition, fetal devices / technologies (without other pediatric applications) will not be funded.
Projects must be a pediatric medical device or technology innovation that leads to improved patient experience, quality, outcomes, or efficiency.
Eligible projects must have clear achievable milestones for the funding period with specific metrics or deliverables.
Projects should be short in duration with funding intended to last no more than 12 months.
Who can Apply:
Who can apply?
Any company, group or individual working on the development of an innovative pediatric (but not fetal) medical device or technology within the US is eligible to apply.
Can international entities apply to the grant competition?
Unfortunately, only projects taking place in the US are eligible to apply for this grant. Funding from the FDA cannot be given to non-US entities.
Can I apply for this grant if I have received money from another FDA sponsored Pediatric Device Consortium (PDC) for this same project?
No. Companies, groups, or individuals that have previously received any form of direct funding or monetary grant from another FDA Pediatric Device Consortium for a specific technology or medical device are not eligible to apply to fund that particular technology or medical device.
If I have received funding from another PDC for one technology does that disqualify me from receiving funding from this grant for a different new technology?
No. If a company has previously received funding and support for a medical device from another PDC, but for a different device, there is no conflict. A company can submit a proposal and receive funding for a different medical device.
Can only technologies/innovations associated with academic institutions apply?
No. Applications are encouraged from both companies and academic institutions. Funding decisions are based on the merit of the project and feasibility of the milestones with respect to funding.
Use of Funds:
Can funds be used to repurpose an adult device for kids?
No. For our grant competition, we are looking for novel solutions addressing pediatric needs. Validation or repurposing of adult technologies/medical devices for pediatric applications does not meet this criteria.
Is the grant intended only for the development of new technologies and medical device, or can funds be requested to test existing technologies?
No. The grant is intended to fund novel pediatric medical devices or technologies, not for testing of existing devices.
Can funds be used toward the development of fetal devices?
No. These grants are limited to pediatric innovations. The FDA do not classify fetal technologies under pediatric devices/technologies.
Will you cover research?
Yes. All research projects that involve human subjects research must be submitted and approved by an Institutional Review Board (IRB) prior to initiation of the research. All research projects that involve animal research must be submitted and approved by the Institutional Animal Care and Use Committee (IACUC) prior to initiation of the animal experiments.
Can funds be applied toward overhead and indirect costs?
No, the grant must be used for direct costs. Overhead and indirects are not eligible for funding.
Will CTIP own any of the intellectual property in my idea or require an equity stake?
No. All intellectual property belonging to the innovator or company will remain its own property irrespective of funding decision.
Is the grant aimed at consumer grade products or clinical grade devices?
Both are welcome. Funding decisions are based on the merit of the project and feasibility of the milestones with respect to funding. The key criterion is that projects be a pediatric medical device or technology innovation that leads to improved patient experience, quality, outcomes, or efficiency.
In addition to the grant, are there other ways that CTIP helps pediatric device projects?
Yes. Project applicants, regardless of ultimate funding decision, may be eligible for additional types of support through CTIP. Available support includes consulting services for regulatory assistance, business plan development, grant writing, competitive analysis, reimbursement strategy, biostatistics, and prototype design.