FlexGrant

applications have closed for the 2022 period

Winners will be selected and announced on March 17, 2022

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Health Equity FlexGrant

Announcing a limited grant opportunity to support pediatric medical device innovators who are focused on addressing health inequities in pediatrics through their technology. The CDC defines Health Equity as a person’s “opportunity to attain his or her full health potential, and no one is disadvantaged from achieving this potential because of social position or other socially determined circumstances."

The proposed solution can focus on any factor that impacts health equity, including but not limited to:

  1. Social determinants of health, including race/ethnicity, socioeconomic status, built environment, education, employment status, etc.
  2. Disease states that disproportionately impact underserved communities
  3. Business models that ensure equitable access to and distribution of the technology

Companies will be awarded grants up to $15,000 to support activities that apply or adapt their existing medical device to help address health inequities in children. Medical devices with adult indications that are expanding or wish to expand their clinical indication to pediatrics are welcome to apply.

submit your application

You will need to attach a company executive summary (max 2 pages) and/or pitch deck (max 25 slides) and a proposal of how you will utilize your medical device to help address health inequity(ies) in children.

Grant Details

Eligibility criteria

All companies must meet CTIP's minimum criteria to receive support:

  1. Medical device that has a pediatric application as defined by the FDA (0 to 21 years of age)
  2. Medical device regulated by the FDA
  3. Feasible for CTIP to support
  4. US-based company

In addition to the minimum criteria noted above, all companies must also:

  • 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  • Please be aware that there is new draft guidance regarding software as a medical device.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.
  • Academic research teams are not eligible for this grant opportunity.  Academic researchers are welcome to apply for the CTIP CPI grant.

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

Evaluation

Proposals will be evaluated on the following criteria:

  • Clear definition of the health inequity(ies) your solution proposes to address
  • How your solution will address pediatric health inequity(ies)
  • Scientific, technical, engineering merit
  • Clinical merit
  • Feasibility of achieving stated goals with requested funding
  • Sustainability of both the proposed solution and the team

To help you put together your proposal, we have curated some resources listed below.

Award & Post-Award Responsibilities

  • Reporting: The grantee will be expected to provide a quarterly progress report every three months after the start date of the projects. The reports will include both work progress and funds encumbered. At the conclusion of the grant, a Final Report must be submitted. Further details regarding reporting will be included in the award package.

Disclosure Terms and Conditions

This is a grant, not a loan or investment for equity. CTIP acknowledges that the submission of this application does not grant CTIP any rights to the work and any accompanying intellectual property is owned by the submitter. All rights to inventions, whether patentable or not, conceived or first actually reduced to practice by one or more applicants will belong to the submitter. 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. The submitter acknowledges that material submitted for review by CTIP for which the submitter requests support is their own work or is submitted with permission from the entity that has legal rights to the material. CTIP may use the submitter‘s name, the submitter‘s institution, the project name the project description and associated brand assets for, including but not limited to, CTIP‘s internal tracking, record keeping, branding, website, press releases and social media presence, as well as to comply with reporting requirements mandated by the FDA (as part of our contractual obligation).