Periodic Reporting for period 4 - DiaDev (Investigating the Design and Use of Diagnostic Devices in Global Health) Reporting period: 2021-11-01 to 2023-04-30 Summary of the context and overall objectives of the project Point-of-care diagnostic devices are increasingly recognised as critical to meeting global health priorities. A new generation of rapid and portable devices that detect the presence of pathogens and biomarkers in a drop of blood, sweat or urine, opens up the possibility of laboratory quality testing reaching under-resourced settings.The DiaDev project, Investigating the Design and Use of Diagnostic Devices in Global Health, explores the emergent role that diagnostic devices are playing in the transformation of health systems in low and middle-income countries. Drawing on novel conceptual and methodological tools from social anthropology, it investigates the social, cultural and technical processes involved in developing, deploying and using diagnostic devices in resource-limited settings.Through the telling of diagnostic stories, the mapping of diagnostic infrastructures, and collaborations with stakeholders, DiaDev identifies the lessons that can be drawn from the successes and failures of point-of-care diagnostic devices in the places where they are developed and deployed. The project aims to improve our understanding of relationships between technological innovation and health systems strengthening, with a view to guiding global health policy. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Research activity in the first reporting period of the grant focused on recruitment, background research, partnership building and fieldwork.Design: We built up detailed case studies of six diagnostic devices, undertook an overarching review of the global health diagnostics sector, and began a detailed ethnographic case study of the Boston diagnostics hub. Elimination: A senior research fellow undertook a scoping review of tests and organisations working in this area.Emergency: Furing an initial period of partnership building in Sierra Leone we conducted a scoping review of laboratory strengthening activities in the country post-Ebola, undertook a stakeholder mapping exercise and consulted key stakeholders to build investment in the research and enhance future uptake of finding, and we submitted and received ethical approval for project fieldwork. During the period of extended fieldwork, we worked with in-country collaborators to map the diagnostic system, gain a detailed understanding of everyday life in laboratories at different levels of the health system, and follow the ways in which diagnostic testing shapes patient pathways through the health system. In addition, we undertook background research on three diagnostic devices developed and deployed during the Ebola outbreak and published one ‘device biography’ on the website.Integration: During an initial period of partnership building we undertook a background review of the district health system, conducted a stakeholder mapping exercise and consulted local stakeholders. Fieldwork consisted of research in primary health facilities and their catchment communities, conducting observations and interviews to understand people’s experiences of diagnostic testing and the role played by point-of-care tests and laboratory tests in the diagnostic system.Collaboration: We collaborated with colleagues at McGill University in Canada to develop their existing diagnostic checklist tool into a mixed-methods mapping tool that enables the rapid collection of qualitative data on diagnostic availability and quality. We were invited to participate in the development of materials for an exhibition on ‘Parasites: the fight to survive’ at the National Museum of Scotland, which opened in December 2019. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) This project is the first large-scale, comparative and anthropological investigation of point-of-care diagnostic devices and health system strengthening in resource-constrained settings. A significant body of public health and medical literature has documented the operational limitations of point-of-care diagnostic devices in these settings, namely their infrastructure requirements and the lack of successful market models for diagnostic development. This project goes beyond the state of the art by bringing together methodologies and theoretical frameworks from anthropology, science and technology studies and geography, to explore the social relationships and value negotiations that determine the life-cycle of specific diagnostic devices. The project takes a novel whole-life-cycle approach, examining the dynamic relationships between diagnostic design and deployment and bringing together ethnography of product developers, academic laboratories and health care settings within a single theoretical framework. Not only will the findings help to guide global health policy, they will also contribute to new theorisations of global health partnerships, health systems and socio-technical relationships in the social sciences. Preliminary analysis of data collected in the first reporting period is suggestive of some key areas in which findings are likely to go beyond the state of art in theory and practice. First, case studies of diagnostic start-up companies in Boston, USA, show the challenges involved in developing a viable business model for diagnostic devices for global health. Where current literature focuses on the development of market incentives, our research questions the value and efficacy of a product-based approach to improving diagnostic capacity in resource-constrained settings. Second, bringing together our research on product development and global health policy with initial findings from our ethnographic research on the deployment of point-of-care devices in Sierra Leone and India, our preliminary analysis questions the focus on diagnostics over diagnosis. We have developed a theory of the ‘diagnostic system’ to counter the emphasis on technology as a magic bullet solution for global health contexts. The diagnostic system is also the working title of the co-authored book that we plan to publish by the end of the project. Over the lifetime of the project, expected results include a substantial body of ethnographic field notes, interview transcriptions, focus group transcriptions, process maps, survey data, and photographic documentation from the USA, Europe, Sierra Leone and India. In addition, we will develop a cutting edge mixed-methods diagnostic mapping toolkit, a web-portal for guiding diagnostic developers in a systems approach to product development, and a mobile exhibition that will take project findings to a wide audience of global health stakeholders in Europe, the USA, Asia and Africa. Our results will be disseminated via academic and policy conferences, a body of scholarly articles published in anthropology, STS, public health and medical journals, and a substantial collection of blog and opinion pieces published online in open-access forums.