Advanced Functional Materials · 2021 · 135 citations · 90 references
EngineeringBioengineeringBiomedical EngineeringBiomemsBiosensorsClinical EngineeringMedical InstrumentationPoint-of-care Diagnostic DevicesClinical Sample HandlingDiagnostic Sample HandlingIntegrated Diagnostic PlatformsInvasive SamplingMicrofluidic Diagnostic DevicesNoninvasive DiagnosticsReadiness For Technology Adoption
Integrated diagnostic devices that perform sample‑in‑answer‑out testing are increasingly viewed as the ultimate solution for simplifying healthcare workflows, leveraging advanced fluidic, mechanical, chemical, biological, and electronic components to accelerate intervention and improve patient outcomes. This review surveys pioneering developments in integrated diagnostics and evaluates their potential for non‑invasive sampling. The authors highlight the clinical relevance of various sample types, analyze technology‑readiness factors that influence market transition, and propose alternative strategies to enhance device survival.
Abstract “Sample‐in‐answer‐out” type integrated diagnostic devices have been widely recognized as the ultimate solution to simplify testing across healthcare systems. Such systems are equipped with advanced fluidic, mechanical, chemical, biological, and electronic components to handle patient samples without any manual steps therefore have the potential to accelerate intervention and improve patient outcomes. In this regard, the combination of integrated devices and non‐invasive sampling has gained a substantial interest to further improve the comfort and safety of patients. In this Review, the pioneering developments in integrated diagnostics are covered and their potential in non‐invasive sampling is discussed. The key properties of possible sample types are highlighted by addressing their relevance for the clinical practice. Last, the factors affecting the transition of integrated devices from academia to the market are identified by analyzing the technology readiness levels of selected examples and alternative remedies are explored to increase the rate of survival during this transition.
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