What is the mission of FDA’s Pediatric Device Consortium Grant Program?

FDA provides grants to consortia whose business model and approach to device development either results in, or substantially contributes to, market approval of medical devices designed specifically for use in children.  Although administered by the Office of Orphan Products Development (OOPD), this grant program is intended to encompass devices used in all pediatric diseases, not just rare diseases.

Source: Pediatric Device Consortia

What is a medical device?

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.”

Source: FDA – Medical Devices

What defines a “pediatric” medical device?

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.

Who is eligible to apply for NCC-PDI seed funding?

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

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.

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

I have an idea for a medical device for adults, can I apply for NCC-PDI seed funding?

While we encourage innovators working in all areas of medical device development, this consortium was created to assist in helping pediatric products to market and is currently not funding medical devices for adults.

I am not a US citizen or do not live in the US, can I apply for seed funding?

Though we highly encourage that you have a collaborator in the United States, this is not a requirement and you may still apply. Should your project be funded and require the conduct of clinical trials, we will work with you to ensure that your site meets all requirements with respect to sound and ethical protection of human subjects. These assurances should then be reviewed by our sponsor, the FDA.

Where can I learn about the medical device process?

You may read more about the various stages in medical device development or contact our coach coordinators for more information at innovationinstitute@childrensnational.org

I live outside the national capital regional area, can I still apply?

Yes!  We accept submissions from individuals living anywhere.  We additionally have resources located around the country.

Do you fund pediatric or orphan drug development?

NCC-PDI was formed for assistance with pediatric medical device development and we are not funding drug development.  Please refer to the question above or the FDA website; if you are not sure if your idea is a device.  If you think you have a combination drug/device feel free to discuss with our coach coordinators for further clarification.  The FDA’s office for orphan drug development has many resources for drug development. Please visit their website: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OfficeofScienceandHealthCoordination/ucm2018190.htm and if you still have any questions, please contact the Coach Coordinators.

I have applied for funding by another FDA-sponsored Pediatric Device Consortium. May I apply for additional funding from NCC-PDI for the same proposed project?

In order to fund a range of projects, your project can receive funding from one consortium at a time.

I have an idea for a pediatric medical device, now what?

You may apply for up to $50,000 of seed funding through our first annual grant solicitation.  Alternatively you may contact our coach coordinators to receive an assessment of your idea and the prior work you have completed to receive advice on how to proceed.  Our coach coordinators may also connect you with resources to assist you in the development of your device.

How do I access NCC-PDI resources for a concept?
You may explore our website for useful links and information or you may contact our coach coordinators to learn more about the various resources the NCC-PDI provides to innovators.
Where can I find out about alternative funding resources?

We understand that seed funding may not cover all your costs and we have a wide network of dilutive and non-dilutive funding sources we can connect you with.  Please contact our coach coordinators at innovationinstitute@childrensnational.org for more information

Is my idea protected? What is being disclosed if I speak with the consortia?

You will retain all rights to intellectual property in accordance with U.S. patent law. All rights to inventions, whether patentable or not, conceived or first actually reduced to practice by one or more applicants/grantees will belong to those applicants/grantees. Inventorship is decided between and among the team members involved with a given invention. Team members agree to negotiate in good faith the disposition of joint invention.

NCC-PDI has no right to your intellectual property. Our role is to facilitate access to resources that help your project to successfully move though the phases of device development.

All submissions to NCC-PDI will be shared with the FDA only (as part of our contractual obligation) and otherwise are kept confidential.