2. Opportunity Description
Funded by the Food and Drug Administration (FDA), the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) solicits proposals from medical device companies with FDA-cleared or approved medical devices that may address an unmet need in the pediatric population, and therefore seeking pediatric market clearance in the US. If chosen, the partnering team will provide technical expertise where needed and include (1) access to mentors, (2) design study protocol implementing RWE methodologies, (3) facilitate IRB submission, (4) facilitate study implementation, (5) furnish cloud services and data science support, and (6) provide regulatory, reimbursement, and supply chain consultation. The partnering team will facilitate meetings with the device sponsors and FDA.
The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.
Section of Application
Brief Abstract suitable for a lay-person audience
List contact information for 2-3 experts in the field who we can approach to include in the review of your submission. Please contact these individuals to advise them that they may be contacted for assistance with our review process. Reviewers must not have a conflict with the applicant’s company and must be willing and qualified to perform the review.
Please Indicate the Class of your approved device in the market
Class II, Class II de novo, Class III PMA, Class III HDE Class I devices will not be reviewed
– Describe your cleared or approved device in the market and for what age groups it has been cleared or approved.
– What is the pediatric market for the product or process? By what means have you determined this? What will be your market share and why? Who will be your customers? What key strategies will make your product introduction to pediatrics successful?
– What are the competing products? What is being used now? Who will be your competition? What is the uniqueness of your product or process?
– Describe your strategy and timeframe (following the completion of this project) for seeking pediatric labeling. What other problems must be solved before commercialization can be achieved? What additional research and development will be required before the pediatric version of the device can be commercialized? Who will do that?
– List the measurable results.
Bibliography and References Cited (Optional)
Provide a bibliography of any references cited in the Research Plan. Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Follow scholarly practices in providing citations for source materials relied upon in preparing any section of the application. While there is no page limit, but it’s important to be concise and select literature pertinent to proposed research.
No page limit
For each key person in your team, provide a CV or bio
No more than 2 pages per person