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 will be considered by the CPI Grant Committee. Based on the comparative merits of all proposals submitted, the most qualified proposals will be designated as finalists. Finalists will be invited to submit a full application.
Eligibility requirements for the Catalyzing Pediatric Innovation (CPI) Grant include the following:
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.
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.
Maybe. There are specific rules from the FDA about the timing and amount of funding companies, groups, or individuals can receive from multiple PDCs. If you have previously received any form of direct funding or monetary grant from another FDA Pediatric Device Consortium for a specific technology or medical device, please contact us via email@example.com first before submitting your Letter of Intent.
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.
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.
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.
No. The grant is intended to fund novel pediatric medical devices or technologies, not for testing of existing devices.
No. These grants are limited to pediatric innovations. The FDA do not classify fetal technologies under pediatric devices/technologies.
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.
No, the grant must be used for direct costs. Overhead and indirects are not allowed. CPI Grants are funded with allocated Direct Device Funding (DDF) from the CTIP FDA Pediatric Device Consortium grant. Activities supported by this DDF include prototyping, testing, and modeling. DDF funding is not intended to support overhead or indirect costs of awardees. Institutions with a federal indirect cost rate agreement must submit documentation signed by an authorized institutional official acknowledging that an application budget submitted in response to this funding opportunity announcement will not include indirect costs.
No. All intellectual property belonging to the innovator or company will remain its own property irrespective of funding decision.
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.
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.