Implementing medical devices in low- and middle-income countries

Abstract

Stroke is a leading cause of death and disability globally, with a particularly heavy burden falling on low- and middle-income countries (LMICs). Despite the existence of diagnostic innovations that could improve stroke care, a persistent implementa- tion gap prevents many evidence-based technologies from reaching routine clinical use. This study examines the enabling and hampering conditions for implement- ing medical devices in stroke diagnostic processes in LMICs, using the Strokefinder MD100 in the Western Cape, South Africa as the empirical case. The study is conducted prior to implementation and applies the Consolidated Frame- work for Implementation Research (CFIR) as its primary analytical lens, comple- mented by change management theory. Data is collected through a case study de- sign, combining three qualitative methods: interviews, observation, and document study. The findings show that the Western Cape healthcare system operates under sig- nificant structural strain, shaped by resource constraints, and a fragmented stroke pathway in which most patients fall outside the treatment window. Within this con- text, Strokefinder MD100 is identified as most applicable in the early stages of the pathway, where it could support faster triage and more targeted referral decisions. Twelve conditions are identified across CFIR’s five domains as influencing imple- mentation, each capable of functioning as either enabling or hampering depending on how it is managed. Based on the findings, the study proposes a framework that differentiates imple- mentation implications along two dimensions, enabling versus hampering, and static versus dynamic, where static conditions are fixed and must be designed around, while dynamic conditions can be actively influenced. This yields four categories, each car- rying different implications for action. Furthermore, sustainability is identified as a cross-cutting condition not adequately captured within CFIR’s existing domains, and is proposed as an additional construct of particular relevance in LMIC contexts.