Background: Gradual dose reduction is essential for safely discontinuing many chronic medications, including proton pump inhibitors (PPIs) and corticosteroids. However, patients often face barriers such as rebound symptoms, unclear tapering instructions, and lack of tools to track progress or symptoms. These gaps in tapering support can lead to poor adherence, premature discontinuation, or unnecessary long-term use. While tapering kits and compounding exist, they are often inaccessible or impractical given medication fragility. Digital and device-based solutions may offer a more structured, scalable, and FDA-compliant alternative.

Objective: To evaluate a dual-solution approach involving a mobile app (DoseMate) and a microdosing hardware device (DoseAutomate) developed to support provider-guided tapering. This required a comprehensive review of FDA regulatory frameworks, including 510(k) pathways, product codes (e.g., NJG, KYX), Class I exemptions, and labeling restrictions (e.g., “do not crush”/“do not split” language). The objective is to assess feasibility, user engagement, and regulatory positioning for broader deployment in outpatient tapering use cases.

Methods: The goal of the DoseMate mobile app is to enable patients to follow physician-directed tapering schedules, record symptoms, log daily weights for microgranule-based medications, and export structured data for provider review. The companion device (DoseAutomate) is being designed as a Class I dispensing tool designed to automate measurement of partial doses by patients. The project is being advanced through the NSF I-Corps program for customer acquisition and a 50k grant. 

Results: Data collection is ongoing.

Conclusion: If effective, the DoseMate app and DoseAutomate device may offer a scalable, patient-centered solution to support precision tapering of medications under physician guidance. Together, they have the potential to improve tapering outcomes, reduce symptom burden, and bridge regulatory and operational gaps in deprescribing workflows.