A market for diagnostic devices for extreme point-of-care testing: Are we ASSURED of an ethical outcome?

The World Health Organisation (WHO) is leading a global effort to deliver improved diagnostic testing to people living in low-resource settings. A reliance on the healthcare technologies marketplace and industry, shapes many aspects of the WHO project, and in this situation normative guidance comes by way of the ASSURED criteria - Affordable, Sensitive, Specific, User-friendly, Rapid and robust, Equipment-free, and Delivered. While generally improving access to diagnostics, I argue that the ASSURED approach to distributive justice - efficiency - and assessment of worth - productivity - may constrain efforts to deliver timely and accurate diagnosis in the developing world equitably by holding back new and innovative diagnostics and indirectly encouraging program and device design that may unfairly discriminate against certain groups. Even as we try to overcome the problem of global healthcare injustice, we may be entrenching disadvantage. I present my critique of ASSURED by 1) referencing Boltanski and Thévenot's theory of orders of worth to highlight the industrial and market foundations of the ASSURED guidelines; 2) comparing ASSURED with other normative guides that elevate the importance of civic responsibility in evaluations of distributive justice; 3) presenting a case study of the failed promise of microfluidic diagnostic devices. I conclude that a new approach to normative guidance is required to assess the value of developing world diagnostics, preferably, one that does not force global public goods into the marketplace.