Clinical Validation of Wearable Drug Delivery Systems

Abstract

Wearable drug delivery systems (WDDS) -- body-worn devices that administer medications through transdermal microneedle arrays, on-body injector patches, iontophoretic delivery platforms, and closed-loop wearable infusion systems -- represent a paradigm shift from episodic clinic-based administration to continuous patient-controlled therapy. With the commercial success of on-body injectors for biologics (Omnipod insulin pump, Neulasta Onpro pegfilgrastim injector) and the clinical development of microneedle patches for vaccines and hormones, WDDS are transitioning from concept to clinical practice. This study presents the Wearable Drug Delivery Validation Framework (WDDVF), evaluating five WDDS platforms -- passive transdermal patches, dissolving microneedle arrays, on-body large-volume injectors, wearable iontophoretic systems, and sensor-integrated closed-loop wearable pumps -- across four clinical validation tasks: bioequivalence to conventional administration, dose accuracy and reproducibility, patient usability and adherence, and skin tolerability over repeated use. Our Wearable Delivery Validation Score (WDVS) integrates pharmacokinetic concordance, dose precision, human factors performance, dermal safety, and wear compliance. Sensor-integrated closed-loop wearable pumps achieved the highest WDVS (0.924) through continuous subcutaneous infusion with real-time dose adjustment that achieved 96% PK concordance with IV reference profiles, while dissolving microneedle arrays achieved the highest patient acceptance (0.955) through painless, patch-based delivery requiring no needles, sharps disposal, or healthcare provider involvement