Direct Device Funding (DDF)

Direct Device Funding (DDF) is sponsored by Midwest Pediatric Device Consortium (supported by the FDA). This opportunity supports mission-aligned projects and measurable outcomes.

Our Inventors | Midwest Pediatric Device Consortium Whether you’re an individual or corporation, bright student or passionate clinician, we are supporting any inventors with the hope to advance pediatric medical devices. Direct Device Funding (DDF) is an extension of our FDA grant to support milestone achievement in a pediatric project at any point along the development pathway, from ideation through commercialization.

Activities supported could include prototyping, testing, clinical trials, consulting and other product development needs.

Typical awards are $10,000 to $50,000 but could be up to $250,000 with contributions from PDC partnerships and sponsors As part of the evaluation process, applications are reviewed by our Advisory Council to provide feedback and an MPDC Needs Assessment to advise applicants and identify next steps for potential MPDC support and guidance. This includes consulting with members of the MPDC team and Advisory Council.

Among possible next steps, the MPDC specifically sponsors work facilitated with Ohio based vendors as part of state related funding. Typically, between $5,000 to $10,000 in sponsored efforts, any project or group, regardless of location, is eligible for this funding after completing a Needs Assessment with the MPDC.

Introduction to Project, Product, and Team Semi Annual (Spring/Fall) Review by Advisory Council Advisory Council Feedback Next Step Meeting with MPDC Team MPDC Directors and Advisement As part of the evaluation process, applications are reviewed by our Advisory Council to provide feedback and an MPDC Needs Assessment to advise applicants and identify next steps for potential MPDC support and guidance.

This includes consulting with members of the MPDC team and Advisory Council. Among possible next steps, the MPDC specifically sponsors work facilitated with Ohio based vendors as part of state related funding. Typically, between $5K – $10K in sponsored efforts, any project or group, regardless of location, is eligible for this funding after completing a Needs Assessment with the MPDC.

To learn more about the funding process and requirements, view the full application. Frequently Asked Questions DO YOU ONLY FUND MEDICAL DEVICES? WHAT KIND OF PROJECTS DO YOU FUND?

The award will only support the development of a novel pediatric medical device that leads to improved patient experience, quality, outcomes or efficiency. Medical devices must meet the FDA definition of a medical device , including Software as a Medical Device ( SaMD ). Grant Funding (DDF) takes place twice a year.

There is a cycle in the spring and fall of each calendar year. WHEN IS THE GRANT FUNDING YEAR PERIOD? Projects should be achievable within the funding period, which is limited to 12 months.

HOW MUCH MONEY IS AVAILABLE? Grants will be awarded in the range of $10,000 to $250,000 per grant. However typical awards range from $10,000 to $50,000.

CAN I APPLY IF I’VE BEEN WITH ANOTHER PDC? Yes! We encourage all companies to reach out to all of the PDCs for respective grants, resources and connections.

See our “About the PDC” page for more information. HOW MUCH FUNDING CAN MY COMPANY RECEIVE FROM THE FDA PEDIATRIC DEVICE CONSORTIA PROGRAM PER YEAR? Maximum awards are $50,000 in a single year, with a $100,000 limit over multiple years (if projects are repeatedly awarded).

This limit is per PDC with corresponding amounts for each individual PDC. DO I HAVE TO LIVE IN THE UNITED STATES TO SUBMIT AN APPLICATION AND JOIN THE PDC? Any company or group working on the development of pediatric medical devices based in the U.S. is eligible to apply for grant funding specifically.

Other resources are available to everyone. The company does not need to be based in the Midwest or Ohio. WHAT STAGE OF DEVELOPMENT DOES MY DEVICE HAVE TO BE IN TO APPLY?

Funds will be granted to support milestone achievement in pediatric project at any step along the development pathway, from ideation through commercialization. However, projects with strongly identified milestones and next steps often score higher in our reviews. DO DEVICES ONLY FOR THE PEDIATRIC POPULATION QUALIFY FOR PDC SUPPORT?

Correct. This would include devices created specifically for neonates up to 22 years of age as defined by the FDA. DO I NEED TO SIGN AN NDA WITH THE MPDC?

No, the MPDC does not require an NDA to engage in our resources or services. Companies with concerns related to NDA should reach out to discuss more. WILL THE MPDC HELP WITH PI SALARIES, OR BENEFITS?

HELP WITH TRAVEL OR CONFERENCE FEES? No. Funds may be used for the following purposes: Acquisition of equipment, materials and supplies. Prototype design, development and manufacture.

Design and usability studies. Consulting and contractor fees to cover regulatory assistance, business plan development, marketplace competitive analysis, reimbursement strategy and biostatistics support. Research assistant and student time dedicated to the project (stipend and benefits).

Software programming and development. Computer software and database purchases. Specialized, dedicated hardware.

Project-specific administrative and project management resources may be funded where appropriate. IF I WORK AT AN ORGANIZATION THAT TAKES INDIRECT OUT OF GRANT AWARDS, ARE INDIRECTS TAKEN OUT OF MPDC AWARDS? No, per the FDA Administration through OOPD, DDF funding cannot be used to support overhead or facilities and administrative (indirect) costs of awardees.

Development of novel drugs and chemical therapies are not eligible for funding. Process improvement and process innovation are also not eligible for funding. Fetal devices/technologies (without other pediatric applications) will not be considered.

Ready to apply? View the application and learn more about the funding process.