Multifunctional Hydrogel Microneedles (HMNs) in Drug Delivery and Diagnostics.

Hydrogel microneedles (HMNs) have emerged as a transformative platform for minimally invasive drug delivery and biosensing, offering enhanced bioavailability, controlled drug release, and real-time biomarker detection. By leveraging swelling hydrogels, nanomaterial integration, and stimuli-responsive properties, HMNs provide precision medicine capabilities across diverse therapeutic and diagnostic applications. However, challenges remain in mechanical stability, as hydrogel-based MNs must balance flexibility with sufficient strength for skin penetration. Drug retention and controlled release require optimization to prevent premature diffusion and ensure sustained therapeutic effects. Additionally, biosensing accuracy is influenced by variability in interstitial fluid extraction and signal transduction. Clinical translation is hindered by regulatory hurdles, scalability concerns, and the need for extensive safety validation in human trials. This review critically examines the key materials, fabrication techniques, functional properties, and testing frameworks of HMNs while addressing these limitations. Furthermore, we explore future research directions in smart wearable MNs, AI-assisted biosensing, and hybrid drug-device platforms to optimize transdermal medicine. Overcoming these barriers will drive the clinical adoption of HMNs, paving the way for next-generation patient-centered therapeutics and diagnostics.