The rapid growth of point-of-care (POC) diagnostic tests necessitates a clear vision of when, where, and why a new POC diagnostic test needs to be developed and how it can be used in a way that matches a local health care context. Here, we present an innovative approach toward developing a concept target product profile (CTPP), which is a new mapping tool that helps researchers match a new diagnostic test to a specific local health care context early in the research and development process. As a case study, we focus on the diagnosis of visceral leishmaniasis (VL) in rural resource-limited regions of Kenya and Uganda. Our stepwise approach integrates elements of design thinking and uses a combination of literature reviews and field research for a context analysis of local health care systems and practices. We then use visual thinking in the form of Gigamaps and patient journeys to identify use case scenarios and to present our findings from the field research to key stakeholders. The use case scenarios describe the diagnostic scope of a new POC test based on the feasibility of the new test, the local need, and the contextual fit. For our case study of VL, we identify 2 valuable use case scenarios, namely test-of-cure and screening and confirmation, and we formulate a CTPP. We anticipate that a CTPP will enable researchers to match a new POC diagnostic test during the research and development process to the local health care context in which it will be used.
To comply with the large global need for surgery, surgical equipment that fits the challenging environment in low- and middle-income countries (LMICs) should be designed. The aim of this study is to present a context-specific design of an electrosurgical unit (ESU) and a monopolar handheld to improve global access to surgery. This paper presents both a detailed description of electrosurgery in clinical practice in LMICs and the design of an ESU generator and monopolar handheld for this specific setting. Extensive fieldwork (by means of surveys, interviews, observations, and collection of maintenance records) was done by authors RO, KO, and LH. Feedback from users working in Kenya on the first demonstrator designs was obtained, after which the designs were adapted into conceptual prototypes. These were further evaluated by surveying respondents who attended the annual meeting of the College of Surgeons of East, Central, and Southern Africa (COSECSA) in Kigali, Rwanda in December 2018. Conceptual prototypes were developed for (a) an affordable ESU that is compact and battery powered and (b) a robust reusable monopolar handheld that can be cleaned in the autoclave and by chemicals (e.g., glutaraldehyde solution). The conceptual prototypes were positively received by the 51 respondents of the survey. The findings from the field work and the feedback from users during the design phase have led to a clear understanding of the specific needs and potential solutions. The presented conceptual prototypes need to be further developed into functional prototypes, which could be implemented in Kenya and other settings for further evaluation.
Compared to other parts of the world, the incidence of hydrocephalus in children is very high in sub-Saharan Africa. Magnetic resonance imaging (MRI) would be the preferred diagnostic method for infant hydrocephaleus. However, in practice, MRI is seldom used in sub-Saharan Africa due to its high prize, low mobility, and high power consumption. A low-cost MRI technology is under development by reducing the strength of the magnetic field and the use of alternative technologies to create the magnetic field. This paper describes the embodiment design process to match this new MRI technology under development with the specific characteristics of the healthcare system in Uganda .A context exploration was performed to identify factors that may affect the design and implementation of the low-field MRI in Ugandan hospitals and Ugandan healthcare environment. The key-insights from the technology- and context-exploration were translated into requirements which were the starting point for the design process. The concept development did have a focus on Cost-effective design, Design for durability & reliability, and Design for repairability. The final design was validated by stakeholders from the Ugandan Healthcare context.
Schistosomiasis is a neglected tropical disease of Public Health importance affecting over 252 million people worldwide with Nigeria having a very high number of cases. It is caused by blood flukes of the genus Schistosoma and transmitted by freshwater snails. To achieve the current global elimination objectives, low-cost and easy-to-use diagnostic tools are critically needed. Recent innovations in optical and computer technologies have made handheld digital and smartphone-based microscopes a viable diagnostic approach. Development, validation and deployment of these diagnostic devices for field use, however, require the optimisation of its optical train for the registration of high-resolution images and the realisation of a robust system design that can be locally produced in low-income countries. Field research conducted in Nigeria with active involvement of key stakeholders in research and development (R&D) led to the design of an initial prototype device for the diagnosis of urinary schistosomiasis, called Schistoscope 1.0. In this paper, we present further development of the Schistoscope 1.0 along two parallel design trajectories: a Raspberry Pi and a Smartphone-based Schistoscope. Specifically, we focused on the optimization of the optics, embodiment design and the electronics systems of the devices so as to produce a robust design with potential for local production.