Barriers and Facilitators of Implementing Point-of-Care Diagnostics in Resource Constrained Healthcare Systems

Abstract

Stroke represents a growing health burden in low- and middle-income countries (LMICs), where limited diagnostic capacity and delayed care result in high rates of preventable mortality and disability. In Rwanda, access to imaging technology is re stricted to higher-level facilities, and time-sensitive treatments such as thrombolysis depend on rapid and accurate diagnosis that lower levels of care cannot currently provide. A critical gap therefore exists between clinical need and available diagnostic infrastructure. This thesis examines how organizational, institutional, and system-level factors influ ence the market entry and implementation of point-of-care diagnostic technologies in resource-constrained healthcare systems, using the Strokefinder MD100 in Rwanda as a case. The study combines market entry theory with implementation science, to follow the technology from entry into the market through to its integration into clinical practice. It uses a qualitative case study design, drawing on semi-structured interviews with clinicians, hospital staff, system-level actors, and startup representa tives conducted during field work in Rwanda in from February to end of April 2026. Thematic analysis identified key themes, which were mapped onto the Consolidated Framework for Implementation Research (CFIR) and interpreted alongside market entry theory to identify factors relevant across both stages. The findings reveal six facilitating themes and seven barriers spanning the regu latory, organisational, financial, and contextual conditions that shape whether the technology reaches the market and becomes part of routine practice. The study also sets out practical considerations for firms entering the Rwandan market.