Abstract

To be effective, healthcare technologies should be attuned to particular contexts of use. This article examines how such attuning is articulated in global innovation practices for tuberculosis and HIV diagnostics, and to what effect. It examines the development of point-of-care (POC) diagnostics - promised to be designed for users outside laboratories or in resource constrained settings - to study what developers and implementers do to align diagnostic technologies to the POC. Fieldwork among global health actors involved in diagnostic development, including manufacturers, donors, industry consultants, international organizations, policymakers, regulators and researchers, is combined with fieldwork among users of diagnostics in India, including decision-makers, NGOs, program officers, laboratory technicians and nurses. The article adds to STS's theory of alignment and user interaction, where the setting and user to which developers and implementers of global health diagnostics align are multiple, varied, emerging and keep shifting. The characteristics of a local user setting include multiple engaged and imagined user settings, but also the settings of developers, of global intermediaries, competitors and diseases. As such, alignment is happening across multiple dimensions and scales and has an important temporal dimension. The results reveal how alignment happens to some extent in the dark, characterized by uncertainty about the elements that should align. Standardizing elements, politics and scarce resources cause frictions in the temporalities of aligning and over what constitutes a well-aligned diagnostic.

Highlights

  • To be effective, healthcare technologies should be attuned to particular contexts of use

  • POC diagnostics include, for instance, rapid antibody tests based on lateral flow technology as well as miniaturized molecular diagnostics that incorporate polymerase chain reactions (PCR) into devices the size of a small printer

  • How do innovators of POC diagnostic and delivery programs for TB and HIV incorporate local settings into the innovation process? How do they know the POC and users? How and what forms of expertise and knowledge are made accessible? And what are implications of these innovation practices for meeting promises of what is considered a good POC test? The majority of ethnographic studies on POC diagnostics have focused on how such technologies are used and to what effect (Beisel et al, 2016; Engel et al, 2017; Hutchinson et al, 2015; McDowell et al, 2018; Umlauf and Park, 2018) but not on how these diagnostics have been attuned to local contexts, how they were imagined, designed and developed, and how these processes interact with their use

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Summary

Introduction

Healthcare technologies should be attuned to particular contexts of use. This article examines how such attuning is articulated in global innovation practices for tuberculosis and HIV diagnostics, and to what effect It examines the development of point-of-care (POC) diagnostics – promised to be designed for users outside laboratories or in resource constrained settings – to study what developers and implementers do to align diagnostic technologies to the POC. While the particular challenges of developers in innovating diagnostics for global health have been explored (Engel et al, 2016; Palamountain et al, 2012) and others have examined end-user needs (Rompalo et al, 2013), I examine the innovation process of POC diagnostics, and in particular the efforts to attune to local contexts and align multiple actors, settings and development steps. Using and implementing such technical artifacts involves constructing and manipulating them in daily practices (Crabu, 2014) Combined, these two perspectives highlight that aligning diagnostics to the POC involves continuously attuning to multiple social and technoscientific elements and the components that make up diagnosis

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