FDA funds grants for pediatric medical devices addressing substance use disorder and addiction

NEWS RELEASE: Grants offered for technologies addressing youth substance use disorder and addiction

Pediatric consortium distributing $150K for solutions advancing diagnostics, treatment

WASHINGTON – The Alliance for Pediatric Device Innovation (APDI), a nonprofit consortium led by Children’s National Hospital and funded through the Food and Drug Administration (FDA), today announced 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.

“Tragically, drug overdose is now the third leading cause of death among adolescents and, to improve outcomes, we need medical technologies that are specifically designed for the youth,” says Kolaleh Eskandanian, Ph.D., M.B.A., vice president and chief innovation officer at Children’s National and APDI principal investigator and program director. “Teens and tweens are such enthusiastic users of technology. We believe that the time is right for new health technology solutions that can save lives and improve the health of our young people.”

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.

Dr. Eskandanian described the kinds of pediatric-focused innovations the grant seeks to attract, which align 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.

As most medical devices are designed for adults, Dr. Eskandanian notes that this limits useability and acceptance by adolescents. She adds that existing algorithms supporting medical devices are often based on adult data and are not optimized for adolescents, limiting their usefulness.

“Our goal is to bring more effective pediatric medical devices to market to address the alarming rate of harm substance misuse and addiction is creating for young people and their families,” says Dr. Eskandanian. “Since this is an area of focus for NIDA, we see an opportunity to help create a pipeline of qualified companies that can apply for NIDA follow-on funding.”

Interested innovators can learn more and apply for the APDI funding opportunity online at innovate4kids.org. The application deadline is July 30, 2024.

APDI is one of five nonprofit consortia in the FDA’s Pediatric Device Consortia grant program that receives funding to provide a platform of services, expertise and grants to support pediatric innovators in bringing medical devices to the market that specifically address the needs of children. Along with Children’s National, APDI members include Johns Hopkins University, CIMIT at Mass General Brigham, Tufts Medical Center, MedStar Health Research Institute, MedTech Color and OrthoPediatrics Corp.

The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.