NCC PDI 2014

RFP Title : NCC PDI RFP 2014
Due Date : February 3, 2014
Status : Closed
Key Date :

General Guidelines
The application submission is now closed. The deadline was February 3, 2014. Please check back for other funding opportunities

NCC-PDI is seeking proposals from inventors in medical institutions, private practices, the business community, and academic researchers who have medical device concepts or ideas for use with pediatric patients. Proposals should address a significant, yet unmet need within the pediatric population with a device idea that lends itself to commercialization.

The FDA defines a medical device as:

A medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Furthermore, a pediatric medical device is:

Pediatric medical devices treat or diagnose diseases and conditions from birth through age 21. Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use.

The proposal should be directed towards development of a commercializable product, 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 prototype phase.

Key Dates

  • Submission of Round 1 deadline – 2/3/2014–CLOSED
  • The committee decides on the selection for Round 2 – Week of 2/17/2014
  • Notification to Round 2 applicants – Week of 2/17/2014 — CLOSED
  • Presentations scheduled – Week of 03/03/14 –CLOSED
  • Awardees notified – By 03/14/14 –CLOSED

Review Process and Scoring Criteria
presentation.  The written proposal format is listed below and must be submitted by February 3, 2014.  A subset of submissions will be asked to prepare a 10 minute presentation the week of February 17th, 2014.  The presentations may be presented in person or through a web conference format.

Scoring by the NCC-PDI Review Committee and Pediatric Device Development Panel 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 seed 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 the seed grant program will be measured by advancement through the product development progress, generation of intellectual property, clinical trials progress, steps toward FDA approval, follow-on funding, and clinical impact.

Publications arising from a grant funded by this program are required to acknowledge NCC-PDI as the source of funding.

Awardees will be required to submit three quarterly progress reports and a final report. This information will be used in NCC-PDI’s 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 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.

Submission and Questions

Innovation Competition Applications must be submitted directly to the program via the web and do not need institutional sign-off at this phase of the competition.

Applications should be submitted as a single PDF document through the online system.

Late submissions will not be accepted. Please submit by February 3, 2014.

NCC-PDI will hold an online webinar in early January to assist any innovators who have questions or need assistance.  Check back for a specific date and time.  However, feel free to contact one of the coach coordinators at anytime.

The objective of the NCC-PDI is to help move products from concepts to working products that have commercial viability. In addition to seed grant funding, NCC-PDI provides assistance to inventors in the areas of technical, clinical, trial design, biostatistics, business planning, marketing, regulatory, legal and intellectual property.

Proposals may only be sponsored by one FDA sponsored consortium at a time.

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

Font size: 11 Arial, Margin: 0.5 inches

Application should include:

Cover page (1 page) with the following information:

  • Title of Project
  • Applicant Name(s), Titles, Email Addresses
  • Company, Institution, or School and Department
  • Notification address
  • Requested Award Amount (please note that indirect costs are not allowed)
  • Abstract – A short executive summary

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

  • Unmet need in pediatric care: Describe the clinical application/situation/condition that the project is to address. Estimates of the number of potential patients that would benefit and describes the intended patient population such as age range, weight, etc.
  • Product: Describe the pediatric medical device that will be developed with seed grant funding. As appropriate, provide detail on the prototype fabrication, materials, specifications, any software requirements, and method of manufacturing.
  • Significance: Describe the benefits the project will have on the technologies, treatments, services, or preventative interventions that relate to improvement in pediatric healthcare.
  • 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.
  • Product marketing plans: Describe your market analysis to date. Please include a description of potential competitors and/or competing technologies.
  • 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.

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.

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 two-step selection process, applicants are encouraged to work on their 10-minute presentation should they be selected for Round 2.