Grant Details

Criteria:

• Must be a novel pediatric medical device or technology.

• Medical devices must meet the FDA definition of a medical device.

• Please be aware that there is new draft guidance regarding software as a medical device.

• Development of novel drugs and chemical therapies will not be funded. Process improvement and innovations are also not eligible for funding. In addition, fetal devices / technologies (without other pediatric applications) will not be funded.

• Projects must be a pediatric medical device or technology innovation that leads to improved patient experience, quality, outcomes, or efficiency.

• Eligible projects must have clear achievable milestones for the funding period with specific metrics or deliverables.

• Projects should be short in duration with funding intended to last no more than 12 months.

• No indirect costs will be allowed.

Use of funds:

Funds may be used for the following:

• Acquisition of equipment, materials and supplies

• Animal studies

• Prototype design and development

• Design and usability studies

• Consulting and contractor fees to cover regulatory assistance, business plan development, competitive analysis, reimbursement strategy, biostatistics, and prototype design

• Research assistant and student time dedicated to the project

• Software programming and development

• Computer software and database purchases

• Specialized, dedicated hardware

• Project-specific administrative and project management resources may be funded where appropriate

Funds may not be used for:

• Reimbursement of investigator and co-investigator time, salaries or benefits

• Travel and conference fees

• Patent costs or other legal fees

• Marketing and sales