The design of medical devices has failed to satisfy the needs of resource-limited settings (RLSs). Whether purposefully designed for RSLs or transferred from a high-income country, the resulting devices often misalign with the characteristics of the context and the real needs of users. The challenges of contextualising medical devices in RLSs are widely acknowledged, but research to overcome these issues in practice is lacking. This study focuses on examining and defining the context for medical devices in RLSs.

Two perspectives were employed for the study of context of medical devices in RLSs. The first approach, using design expert interviews and a systematic literature review, resulted in a contextual framework with factors relevant for the design, use and deployment of medical devices in RLSs. These factors were categorised in eight groups: public health, industrial, technological, institutional, financial, socio-cultural, geographical or environmental and economic. This approach, however, falls short in understanding the complexities behind these contextual factors. In order to tackle these limitations, the second approach used generative techniques for network mapping and mixed-methods for network analysis. This network approach resulted in the identification of networks surrounding MDs in RLSs, and the roles played by medical devices in these networks. These roles were categorised by type of interaction in six types: wellbeing, affiliation, organisational, clinical practice, cognitive and technical. Three assemblies of entities were also identified that were responsible for ensuring that MDs stay in the network and are available, used, maintained, and ultimately replaced when they fail. From this perspective, the investigation focused on how devices move in the network, change roles and are supported by other actors. In other words, the elements that assemble and allow medical devices to exist and subsist in the networks of care. Complexity and non-reducibility are at the core of this approach. The results from the exercise show that the approach sheds light on interesting and unexpected aspects of the use, adoption or deployment of medical devices in RLSs. However, the approach is abstract and overwhelmingly difficult to grasp in practical research.

The approaches are compared and contrasted using an example of a MDs designed for RLSs. The approaches are not seen as competing but as complementary views of context. Their advantages and disadvantages are described, and recommendations are made for their application and improvement. The conclusions from this study contribute to new approaches to exploring the context of use for products in Design research by using, on the one hand, the concept of the collectives---as proposed by the actor-network theory---and, on the other hand, the idea of a holistic contextual framework for product design and development. For the field of global health, this research contributes to improving the design of much-needed technologies as solutions to global challenges.