Future Trends in Drug and Medical Device Integration

Abstract

Drug and medical device integration has advanced from mechanically combined products (tablet + plastic blister packaging, vial + syringe) to genuinely integrated biomedical systems where the pharmacological and device components are inseparable contributors to therapeutic effect. The trajectory across the past two decades includes drug-eluting stents that transformed cardiovascular intervention, closed-loop insulin delivery systems that are redefining diabetes care, device-delivered advanced therapy medicinal products that enable cell and gene therapy at clinical scale, digital therapeutics that deliver therapeutic intervention through software, and emerging categories including electroceutical combinations, theranostic drug-device pairs, and AI-personalised combination therapies where the therapeutic regimen adapts to individual patient physiology. Looking forward, several trend vectors are converging to reshape combination product development: AI-enhanced personalisation of both drug and device components, manufacturing technology convergence including 3D printing and continuous manufacturing, regulatory framework maturation for novel combination product categories, and increased emphasis on real-world evidence generation throughout the combination product lifecycle. This review synthesises current and emerging drug-device integration trends across five dimensions: technological convergence trends reshaping combination product architecture, regulatory framework evolution accommodating novel combination product categories, clinical evidence generation advances supporting combination product development, manufacturing technology trends enabling new combination product categories, and commercial and access trends affecting combination product availability and affordability. For each dimension, the review synthesises current status, near-term trajectory (2025-2028), medium-term horizon (2028-2032), and key uncertainty factors that will determine actual outcome paths. The review synthesises findings across the 33 comparative framework studies published in this journal during 2024-2025 that form the empirical evidence base for the trend analysis