Developing a wearable medical device to detect opioid overdose

Project Summary This proposal is submitted in direct response to PA-25-212 Innovation Corps (I-Corps™) at NIH Program for NIH and CDC Translational Research (Admin Supp Clinical Trial NOT Allowed). Persons of all ages with Opioid Use Disorder (OUD) are at risk for opioid overdose, which can cause Opioid Induced Respiratory Depression (OIRD), leading to hypoxia and death. Most overdose deaths in the U.S. occur without anybody else present, preventing bystander administration of the lifesaving drug naloxone. Technology to detect OIRD and issue an emergency signal could help ensure responders arrive at the scene of an overdose to administer naloxone in a timely fashion. Currently, there are no FDA-approved products to detect opioid overdose or OIRD that are designed for continuous wear in a discreet location on the body. Resilient Lifescience’s goal is to develop a wearable medical device that can detect OIRD and issue an emergency alert, calling a friend, loved one, or emergency medical service to the scene. The hypothesis for this I-Corps project is that this lifesaving overdose detection technology can be marketed directly to family members of individuals with OUD, and that doctors prescribing opioids to patients with elevated risk for OIRD will be interested in co-prescribing monitoring technology. The objective of this I-Corps research is to conduct customer discovery activities in order to validate, refine, and/or redefine Resilient Lifescience’s business model, which is based on the above hypothesis. This will be completed by conducting interviews with (1) users of prescribed and illicit opioids and their loved ones (2) physicians that prescribe opioids, specifically in states with naloxone co-prescription laws, and (3) industry stakeholders relevant to the distribution and financing of opioid patient safety products, such as health insurance leaders, state opioid response teams, and more.