Smart Medication Dispenser Case Study

This case study outlines the collaboration between MedicaSafe and Fathom in the development of an innovative device aimed at addressing Opioid Use Disorder (OUD). MedicaSafe specializes in creating medical products that integrate drugs, devices, and healthcare information technology for remote therapeutic monitoring and chronic care management. The project began with a grant from the National Institutes of Health in 2018, leading to the design of a device that dispenses sublingual medications through a SmartKey while logging each authorized dose. Fathom contributed by refining the product's design for manufacturability, providing fast-turn 3D-printed parts, and facilitating rapid tooling for field trials. The collaboration ensured compliance with stringent material and production documentation requirements, including FDA regulations. The product has successfully passed verification and validation testing, including ISO 60601 and EMC/FCC testing, and is now deployed to meet the needs of patients with OUD.