FOA for Next Gen Wearables

NIH recently posted Funding Opportunity Announcement (FOA) “Wearables to Track Recovery and Relapse Factors for People with Addiction” (R43/R44) The estimated funding is expected to be $2,000,000 in FY 2018 with applications due August 15, 2017.

Currently, there are no cost effective tools that enable researchers to study drug addiction relapse in real-time. The standard test still remains doing a urine analysis, but depending on the drug, the urine analysis can only detect recent drug use in the previous 24 to 72 hours.

The FOA will attempt to address this gap by working towards mobile health approaches such as developing recovery wearables and supporting mobile applications. Today, miniaturization and cost reduction of sensors have made it technologically feasible to capture digital biomarkers collectable through digital tools associated with drug use and relapse.

So far, wearables have had limitations for use which must be overcome prior to FDA approval or product launch. Issues noted include being able to accurately and continuously capture data in natural environments, reduce the number of false negatives, increase technology acceptability, address privacy issues, and define standards to use for analysis, data validation, and implementation.

A number of wearable and mobile applications have been approved by FDA, but there are no FDA-approved wearables or supporting mobile applications which can indicate reinitiating drug use and relapse in a patient with a substance use disorder.

The purpose for releasing the FOA is to incentivize small businesses to develop next generation wearables and supporting mobile applications to identify digital biomarkers and then create a model for just-in-time intervention.

The FOA explains that Phase I supports the development of research-enabling tools, technologies or products to measure the efficacy of biosensors. Phase II envisions that the awardee will have a device that will be ready for testing for a suitable population to demonstrate that the data is suitable for FDA consideration.

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