Functionalized Design of Electrochemical Biosensing Technologies for Intelligent Healthcare
TL;DR
Functionalized design is presented as an application‐backward, cross‐scale framework that links clinical needs and biomarker–matrix constraints with recognition chemistry, biointerfaces, functional materials, transduction architectures, calibration, data interpretation, manufacturability, and validation.
Abstract
Electrochemical biosensing technologies offer an important route toward continuous and body‐interfaced health monitoring, but their translational value cannot be judged by analytical sensitivity, miniaturization, or device integration alone. This Review presents functionalized design as an application‐backward, cross‐scale framework that links clinical needs and biomarker–matrix constraints with recognition chemistry, biointerfaces, functional materials, transduction architectures, calibration, data interpretation, manufacturability, and validation. We first define this framework and examine platform‐level opportunities and failure modes across wearable, minimally invasive transdermal, implantable, and complementary transistor‐based systems. We then discuss how biomarker class, matrix accessibility, temporal dynamics, and clinical role determine sensing requirements, before evaluating representative technologies across four task‐defined scenarios: longitudinal monitoring, early molecular detection and risk stratification, continuous sensing in difficult physiological environments, and diagnosis‐linked wound management. Finally, we assess data intelligence and translation with emphasis on data quality, model robustness, interpretability, technology readiness, manufacturing reproducibility, clinical utility, regulation, and deployment. By distinguishing proof‐of‐concept performance from evidence relevant to practical use, this review provides a design and assessment framework for advancing electrochemical biosensing toward reliable, clinically actionable healthcare systems.