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Medical Devices to Address Youth Substance Use Disorders and Addiction

Summary

The Alliance for Pediatric Device Innovation (APDI) has opened a grant opportunity for pediatric medical devices that improve the monitoring, diagnosis or treatment of youth suffering from substance use disorder and addiction. Grants up to $50,000 each are available for pediatric-specific solutions selected by a panel of experts from submitted proposals. Up to $150,000 in grant funds are available for distribution through this program.

The National Institutes of Health (NIH) reports that over 3.6 million U.S. youth, ages 12 to 17, used illicit drugs in 2022. In that same period, an average of 22 youth, ages 12 to 18, died weekly from an overdose. Often, these adolescents did not show the expected warning signs before an overdose, such as problems with alcohol, drugs or prior substance use treatment. Of the teens and tweens who fatally overdosed, only 1 in 10 had a history of treatment for a substance use problem, and only 1 in 7 had ever experienced a prior nonfatal overdose.

APDI’s call for proposals coincides with the National Advisory Council on Drug Abuse (NACDA) approval last month of the concept “Promoting Medical Device Development for Youth Affected by Drug Addiction and Substance Misuse,” which describes potential funding opportunities. In anticipation of future federal funding from the National Institute on Drug Abuse (NIDA), APDI is providing early support by identifying potential innovations. Along with APDI grant funding, the consortium is providing awardees with support services across all phases of the medical device product lifecycle, including facilitating access to NIDA technical assistance.

The kinds of pediatric-focused innovations the grant seeks to fund and which are aligned with NACDA’s listed priorities. They include, but are not limited to, the following: 

• Artificial intelligence-based algorithms that collect, integrate, analyze and visualize various types of data related to the diagnosis or treatment of drug misuse and addiction in youth.

• Stand-alone or add-on digital therapeutics focused on behavioral health interventions to diagnose, treat, prevent and mitigate drug misuse and addiction.

• Wearables and connected digital therapeutics at a point-of-need intended to detect, diagnose and treat opioid-induced respiratory depression. 

• Therapeutic devices, such as neuromodulation, intended to improve SUD treatment outcomes and prevent recurrence. 

Key Dates

Submission deadline – July 30, 2024

Winners announced – August 15, 2024

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

Font size: 11 Arial, Margin: 0.5 inches

Application should include:

1. Cover page (1 page) with the following information:

a.  Title of Project

b.  Applicant Name(s), Titles, Email Addresses

c.  Company, Institution, or School and Department and Geographic Location

d.  Point of Contact and Notification email address

e.  Requested Award Amount (please note that indirect costs are not allowed)

f.  Abstract – A short executive summary (250 words maximum)

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

a. Product:  Describe the pediatric medical device (including software as a medical device) that will be developed. As applicable, provide detail on the prototype fabrication, materials, specifications, any software requirements, and method of manufacturing

b. SignificanceDescribe the benefits the project will have on the technologies, treatments, services, or preventative interventions that relate to improvement in pediatric healthcare

c. Approach/MilestonesIdentify 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 grant funding for which you are applying. Specify the status of your intellectual property, anticipated regulatory pathway, and reimbursement strategy. Provide an outlook describing potential sources of funding beyond the seed grant funding.

d. Product marketing plansDescribe your market analysis to date. Please include a description of potential competitors and/or competing technologies or practices.

e. Project team, resources and environmentDescribe your project team and the resources you will require to complete the work proposed. Briefly describe any relevant prior experience.

3. 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 cannot exceed $50,000 for one year.

4. 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.

General Guidelines

Eligibility

The Alliance for Pediatric Device Innovation (APDI) is seeking proposals from inventors in the established businesses, startup entities, 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 proposal should be directed towards development of a commercializable product, not research of a scientific concept. Issues such as prototyping, manufacturing, marketing, and FDA regulatory clearance or approval will be paramount and should be addressed explicitly. The FDA Pediatric Device Consortia grant program places special emphasis on helping bridge the gap that often follows the prototyping phase, as the promising medical devices must also be manufactured, cleared or approved by the FDA, marketed, and sold.  Therefore, we enthusiastically welcome projects that are past the initial prototyping phase.

Review Process and Scoring Criteria

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 children. The application should include a description of the long term funding strategy.

Publications arising from a grant funded by this program are required to acknowledge APDI 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 APDI’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 ign-off at this phase of the competition.

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