National Capital Consortium for Pediatric Device InnovationRequest for Proposals

National Capital Consortium for Pediatric Device Innovation Request for Proposals

Title: Facilitating Pediatric Labeling of Cleared or Approved Medical Devices

1. Key Dates

Release Date: December 15, 2022

Application Receipt Date: 5p EST on February 9, 2023

Anticipated Announcement of Winners: March 6, 2023

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.

3. Partnering Team The program features expert assistance from all five FDA-funded Pediatric Device Consortia (PDC) grant program. They include the National Capital Consortium for Pediatric Device Innovation, UCSF-Stanford Pediatric Device Consortium, Consortium for Technology and Innovation in Pediatrics (CTIP), the Pennsylvania Pediatric Device Consortium, the Southwest National Pediatric Device Consortium. In addition, CobiCure/Deerfield Catalyst and MedStar Health Research Institute will be providing significant technical expertise. As part of the collaboration, CobiCure is seeking to support pediatric device labeling opportunities in the fields of interventional cardiology, cardiac surgery, and associated critical care needs. Such support may include funding, regulatory, and project management support for specific projects that fit with CobiCure’s mission. CobiCure is a not-for-profit focused on curing rare, life-threatening diseases in children that is part of Advancium Health Network, which was founded by Deerfield Management and the Deerfield Foundation and is dedicated to advancing healthcare services and health equity.

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.

4. Overview InformationClinical trials are the most time consuming and expensive stage of medical device development, and they are especially challenging in pediatric studies. Children require additional safeguard, and the low volume of pediatric patients is the main factor that extends the study duration and adds to the costs. The lack of available pediatric medical devices often causes clinicians to turn to off-label use of medical devices in children.

Pediatric device development presents several unique challenges. Children have medical device needs that are considerably different from adults. Developing devices for children requires considerations such as growth and development, anatomical and physiological differences, hormonal influences, and activity level.

Traditionally, Randomized Clinical Trials (RCT) have been the gold standard source of information for determination of an investigational medical product’s efficacy and safety. However, many important populations, including children, are excluded from RCTs for ethical reasons. This means that pediatric researchers have to make safety and efficacy decisions in the absence of data from RCTs. Real-world evidence (RWE), including data from electronic health records (EHRs), healthcare claims data, disease registries, and data gathered through other health applications, may close this gap in pediatric studies.

With carefully study designs, real-world data (RWD) could be made more efficient for assessing device-associated safety issues in children, particularly for a rare or long-latency outcome. For children with rare diseases, disease-based registries are one of the best ways to assess long-term treatment outcomes, as well as adverse events.

5. Eligible Applicants
Medical device companies interested in seeking pediatric labeling for their already cleared or approved device.

6. Content and Format of Application Submission
– The proposal section of the submission is limited to 3 pages.
-The applicants should create a single pdf document that includes all items listed in this section and submit online by 5p on February 9, 2023 by going to https:innovate4kids.org The application website will accept applications only by said deadline and will be disabled after 5pm on that date.

Section of Application	Instructions	Page Limit
Project Summary	Brief Abstract suitable for a lay-person audience	200 words
Suggested reviewers	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
Proposal	– 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.	3 pages
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
Bio	For each key person in your team, provide a CV or bio	No more than 2 pages per person

7. Contacts
For additional information (e.g. to discuss any aspect of this RFP, eligibility, etc.) please send an email to ncc-pdi@childrensnational.org