User-Centric Development of a Detection Module for a Closed-Loop Solution to Opioid Overdose

Project Summary/Abstract This Phase I SBIR proposal aims to advance the commercialization of Rescue Biomedical LLC’s Automatic Antidote Delivery Device (A2D2) by first developing and commercializing its overdose detection component, the Automatic Detection Device (AD2). Despite growing awareness of opioid dangers, 81,083 opioid overdose deaths occurred in 2023, exacerbated by COVID-19. Fentanyl overdose deaths nearly doubled from 11.4 per 100,000 people in 2019 to 21.8 per 100,000 in 2021. These potent drugs can cause respiratory failure within minutes, leaving little time to administer antidotes like naloxone. This crisis has imposed immense financial burdens on the healthcare system and devastated thousands of families each year. The A2D2 is a comprehensive, closed-loop solution that combines a user-centric wearable with an implantable drug delivery system, automatically administering naloxone upon detecting opioid-induced respiratory depression. This device has the potential to (1) reduce the need for intensive treatment, (2) decrease hospitalization days, and (3) alleviate the financial burden on patients. These benefits extend to the healthcare industry by freeing up resources to address other health issues. Early customer discovery and regulatory interactions have led to the strategic decision to commercialize the detection component (AD2) separately and first. This approach provides customers with options and allows us to establish a market presence earlier, paving the way for the full A2D2 solution. Our initial focus will be on refining the detection software, strategizing go-to-market plan, and ensuring manufacturability. To achieve this, we propose the following Specific Aims for Phase I: Aim 1: Demonstrate User Acceptability: Understand patients’ willingness to wear the AD2 and validate the interface during the detection of an overdose. Aim 2. Assess Market Integration: Conduct targeted research to evaluate the market readiness and logistical considerations, including potential partnerships with clinics and marketing strategies. Aim 3. Determine Manufacturing Feasibility: Evaluate manufacturability while concurrently designing an early alpha prototype in a wearable form factor. In this Phase I SBIR proposal, Rescue Biomedical aims to validate the acceptability of an overdose detection device among OUD patients, ensuring it contacts emergency services for prompt medical intervention and has a sufficient alert notification interface. We will collaborate with RMS to quantify user willingness to adopt such devices. Additionally, we will identify stakeholders at private treatment centers, such as LCDCs and psychiatrists, to assess their openness to incorporating new solutions like the AD2. Finally, with the help of Kablooe Design, we will ensure the AD2 can be manufactured on a large scale, allowing us to refine the design early during development. The long-term objective of this project is to reduce opioid overdose-related deaths by providing a reliable, user-friendly device that can be integrated into the daily lives of high-risk patients. By addressing the urgent need for effective overdose detection and immediate prompt for medical intervention, this project aligns with the mission of the funding agency to improve public health and save lives. The research design includes a comprehensive approach to user adoption, market integration assessment, and manufacturability evaluation, ensuring the project's relevance and feasibility for broad-scale implementation.