CTIP Catalyzing Pediatric Innovation Grant for Organizations in the U.S. 2025 (Up to $50,000)

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About CTIP Catalyzing Pediatric Innovation Grant

Children have long been an underserved population in the technology space, often having to deal with medical devices that were never designed for them and lack of access to diagnostics and therapeutics that meet their specific needs. The Consortium for Technology & Innovation in Pediatrics (CTIP), an FDA-funded pediatric medical device accelerator centered at Lurie Children's and CHLA, aims to change that by supporting pediatric device innovators from concept to commercialization through funding, advising, networking, and advocacy.

Their Annual Catalyzing Pediatric Innovation (CPI) Grant Competition will provide non-dilutive funds ranging from $25,000-$50,000 to pediatric medical device projects at any stage of development. Applications from startups, industry, and academia are welcome. Award recipients will also be eligible to receive TIP's wrap-around services to support their journey towards commercialization.

• Sponsor Organisation: Consortium for Technology & Innovation in Pediatrics

Benefits of CTIP Catalyzing Pediatric Innovation Grant

Grant

• Pediatric medical device innovators can be awarded up to $50,000 per grant for a term of six months.

CTIP Catalyzing Pediatric Innovation Grant Requirements

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.

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. Check here for more information.
• Please be aware that there is new draft guidance regarding software versus medical devices can be found at the following link
• If you still have questions, you can use the Digital Health Policy Navigator to determine if you qualify as 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.
• Project funding must be spent within 6 months of distribution; projects can last a total of 12 months.
• No indirect costs will be 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 activities such as 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.

Use of funds:

Funds may be used for the following:

• Acquisition of equipment, materials and supplies
• Animal studies
• Prototype design and development
• Design and usability studies
• Consulting and contractor fees to cover regulatory assistance, business plan development, competitive analysis, reimbursement strategy, biostatistics, and prototype design
• Research assistant and student time dedicated to the project
• Software programming and development
• Computer software and database purchases
• Specialized, dedicated hardware
• Project-specific administrative and project management resources may be funded where appropriate

Funds may not be used for:

• Reimbursement of investigator and co-investigator time, salaries or benefits
• Travel and conference fees
• Patent costs or other legal fees
• Marketing and sales

Eligibility:

Any company, group or individual working on the development of pediatric medical devices within the US is eligible to apply. There are funding limitations for companies or groups that have previously received any form of direct funding or monetary grant from another FDA

Pediatric Device Consortium (PDC). If this applies to you, please contact [email protected] to clarify before submitting your letter of intent.

Application Date and Process

Letter of Intent: Please include the following elements in the letter of intent (maximum length 1 page, minimum 11-point font):

• Project name (and company name, if applicable) and Innovator(s) (include list of key collaborators)
• Contact Information: primary contact name, email address, phone number and mailing address
• Description of unmet need, proposed solution, and competitive landscape
  Approximate budget and use of funds
• Expected outcomes from the use of funds

Note, letters of intent must include all of the above elements to be considered. Please label your project's file name using the format: "CPI LOI Project Name" Submit a PDF file of the letter of intent via this link.

The deadline for receipt of the letters is Friday, May 2, 2025. Letters longer than 1 page will not be evaluated.

Human Subjects Protection and HIPAA Compliance. 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.

Animal Studies. 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.

Additional Application Materials. Additional materials such as Institutional Review Board (IRB) and IACUC approvals may be submitted after the application deadline. Applicants submitting proposals requiring IRB or IACUC approval are encouraged to submit their protocols concurrently with the application.

Awards and Post Award Responsibilities

Award Notification: All applicants will be notified of the final decision regarding their application by Friday, August 1, 2025. Successful applicants will receive an award notification package with further details.

Reporting: The grantee will be expected to have check-in meetings every two months and provide a quarterly progress report every three months after the start date of the projects. The reports will include both work progress and funds encumbered. At the conclusion of the grant, a Final Report must be submitted. Further details regarding reporting will be included in the award package.

Intellectual property. Any intellectual property belonging to the innovator or company will remain its own property irrespective of funding decision.

Joint funding. If additional funding is obtained from other sources during the course of the grant, grantees are expected to notify CTIP.

Application Deadline

02 May, 2025

Scholarship Application Portal

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