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Make Your Medical Device Pitch for Kids! ™ – Joint NCC-PDI + CTIP Edition

RFP Background

Under this solicitation, two FDA-funded Pediatric Device Consortia grant programs, CTIP and NCC-PDI, have come together to maximize their resources to select and support a new cohort of device innovators to receive grant funding and wraparound services by the two consortia. We are seeking proposals from inventors from all sectors – including the business community and academic medical centers – who are proposing a medical device solution to address a significant unmet need in the pediatric population.

 

Proposals should be directed towards the development of a commercializable product, and not research of a scientific concept. Issues such as prototyping, manufacturing, marketing, and regulatory clearance will be paramount and should be addressed explicitly. The FDA Pediatric Device Consortia program places special emphasis on helping bridge the gap that often follows the prototyping phase, as the promising medical device must also be manufactured, cleared by the FDA, marketed, and sold. Therefore, we enthusiastically welcome projects that are past the prototyping phase.

Key Dates

Submission deadline – Monday, September 18, 2023

Finalists notified – Friday, September 22, 2023
Presentation date – Sunday, October 8, 2023
Awardees notified – Sunday, October 8, 2023

 

Pitch competition will take place in Anaheim, California during the 11th Annual Symposium on Pediatric Device Innovation, co-located with the MedTech Conference, powered by AdvaMed. Finalists must commit to present in person.

Application Details

Applicants are asked to submit their application online and attach a proposal as outlined below.

 

 

     – Proposal Page limit: 8 pages total (includes 2 pages for refs and budget)

     – Font size: 11 Arial, Margin: 0.5 inches

 

 

Application should include:

 

1. Cover page (1 page) with the following information:

 

  1.      a. Title of Project
  2.  

     b. Applicant Name(s), Titles, Email Addresses

 

 

     c. Company, Institution, or School and Department

 

 

     d. Notification email address

 

 

     e. Requested Award Amount (please note that indirect costs are not allowed)

 

 

     f. Abstract – A short executive summary

 

 

2. Description of proposed project following the outline provided below (5 page maximum). The Applications are generally for one year of funding.

 

     a. Product – Describe the pediatric medical device that will be developed with the grant funding. As appropriate, provide detail on the prototype fabrication, materials, specifications, any software requirements, and method of manufacturing.

 

     b. Significance – Describe the benefits the project will have on the technologies, treatments, services, or preventative interventions that relate to improvement in pediatric healthcare.

 

 

     c. Approach/Milestones – Identify the current state of development of your device (concept, prototype, preclinical, clinical, manufacturing, marketing or commercial use) and describe your approach for moving it through the next few phases with seed grant funding for which you are applying. Provide an outlook describing potential sources of funding beyond the seed grant funding. Specify the current status of your intellectual property.

 

 

     d. Product marketing plans – Describe your market analysis to date. Please include a description of potential

competitors and/or competing technologies.

 

 

     e. Project team, resources and environment – Describe your project team and the resources you will require to complete the

work proposed. Briefly describe any relevant prior experience.

 

 

3. Budget & Budget Justification (1 page):

 

 

Provide an itemized budget for funds requested. Prototype production, data collection and analysis, clinical and pre-clinical studies, testing, manufacturing costs, cost of consultants, quality systems development, materials, and personnel support are eligible budget categories. Grants are expected to range from $5,000 to a maximum of $50,000

for one year.

 

 

4. References (no page limit, but 1 page is recommended):

 

 

References and citations may be used in support of the description of the proposed project, but should be kept within the page limit.

Because this is a rapid selection process, applicants are encouraged to work on their 10-minute presentation should they be selected to present live in Anaheim on October 8, 2023.

Review Process and Scoring Criteria

Scoring will be done by a panel of judges and will be based on an assessment of the following

factors:

 

     1. clinical significance of the pediatric device

 

     2. approach to product development

 

     3. likelihood of being marketed successfully

 

     4. project team, environment, and resources

 

     5. potential for additional funding

This grant funding is intended to promote the commercialization of a medical device for pediatrics. The application should include a description of the long term funding strategy.

 

The success of this grant program will be measured by advancement through the product development progress, generation of intellectual property, clinical trials progress, FDA clearance or approval, follow-on funding, and clinical impact.

 

Publications arising from this solicitation are required to acknowledge the funders citing the grant numbers.

 

Awardees will be required to submit semi-annual progress reports and a final report. This information will be used in our updates to the FDA and must be submitted in a timely fashion. Investigators that do not submit this report will be at risk of losing continued funding support.

 

Applicants must be up to date with, or be able to obtain Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) approval for work proposed, if applicable. Any additional relevant certifications (FWA numbers, CITI certifications, etc.) must be made available upon request.

Competitive Renewals

In cases of exceptional products, competitive renewals may be considered based on progress

of the previously funded project. Investigators may request an informal review before

submission of a renewal application.

Submissions and Questions

Applications must be submitted directly to this program via the web and do not need institutional

sign-off at this phase of the competition.
 
Submit a PDF file of the proposal via this link:
 
Late submissions will not be accepted.
 
The deadline for receipt of proposals is Monday, September 18, 2023.