Beyond the Device: A Digital Infrastructure Framework for Sustainable Point-of-Care Diagnostic Services in Low-Resource and Infrastructure-Constrained Settings.

Point-of-care and near-patient diagnostics can shorten the time between testing and clinical or public-health action, but a technically effective test does not by itself create a sustainable diagnostic service. Evidence from diagnostic-access research, digitally connected point-of-care testing, human-centered design, and implementation science indicates that diagnostic technologies must be developed as components of wider service systems encompassing workflows, quality assurance, data governance, maintenance, supply chains, user trust, and linkage to care. Drawing on these bodies of literature, this Perspective introduces the I2Med digital infrastructure framework for point-of-care diagnostics in low-resource and infrastructure-constrained settings. These settings are defined functionally as clinical or public-health environments in which resource or infrastructure constraints can disrupt one or more stages between testing and appropriate action. The I2Med framework integrates six domains: (1) access and context of use; (2) the result-to-action diagnostic workflow; (3) digital interfaces and data governance; (4) quality, risk, usability, and design-control alignment; (5) sustainability, maintenance, and supply continuity; and (6) equity, trust, and community accountability. Operational tools-including a setting typology, a domain-to-artifact matrix, an evidence-to-scale maturity ladder, and a hypothetical application vignette-illustrate how the framework can guide development and implementation planning. The I2Med framework's central contribution is to reposition the diagnostic device as one component of an interconnected service system and to provide academic, translational, and early-stage development teams with a common structure for identifying implementation dependencies, evidence gaps, and responsibilities. As a conceptual framework, it requires prospective application and evaluation across diverse settings before its utility and transferability can be established.