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Investigating the Design and Use of Diagnostic Devices in Global Health

Periodic Reporting for period 1 - DiaDev (Investigating the Design and Use of Diagnostic Devices in Global Health)

Reporting period: 2017-05-01 to 2018-10-31

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 resource-limited 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.

The project is split into four work packages: design, emergency, integration and collaboration.

The design work package develops case studies for three diagnostic devices that are currently at different points of development, that diagnose different kinds of disease (Communicable, non-communicable, neglected), and that involve different models of funding and partnership.

The emergency work package follows how diagnostic devices for Ebola Virus Disease were used and integrated with established health infrastructures over the course of the 2014-2016 outbreak in Sierra Leone and explores the role of point-of-care devices in post-outbreak laboratory strengthening.

The integration work package investigates the relationships through which diagnostic devices are reshaping and are shaped by health infrastructures in routine primary healthcare in rural India.

The collaboration work package addresses the overall aim of the project - whether, and how diagnostic devices can strengthen health infrastructures - by engaging with the partnerships, modes of knowledge production and infrastructure involved in the development and deployment of diagnostic devices.
Research activity in the first reporting period of the grant focused on recruitment, background research, partnership building and fieldwork.

Design WP1: 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. I recruited a research fellow to work exclusively on the development of diagnostic tests for elimination and they undertook a scoping review of tests and organisations working in this area.
Emergency WP2: Work focused on partnership building in Sierra Leone, where the research environment and governance systems have changed significantly since the DOA was written. I recruited a research assistant and a research fellow. We undertook background research on three diagnostic devices developed and deployed during the Ebola outbreak and published one ‘device biography’ on the website. 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 findings. We submitted and received ethical approval and commenced extended fieldwork in health facilities.
Integration WP3: We undertook a background review of the district health system, conducted a stakeholder mapping exercise, consulted local stakeholders, and commenced fieldwork in communities and health facilities.
Collaboration WP4: 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 made contacts in the emerging open hardware and open access diagnostics movement, enabling us to plan a collaborative Data-Hack event focused on these novel approaches to diagnostics for the second reporting period. 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 will open in December 2019.
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.