Context-sensitive design methodology for open-source medical devices in low resource settings

Medical devices (MDs) are crucial equipment to deliver quality healthcare services, however significant proportion of the global population lacks access to safe and appropriate MDs. In low-resource settings (LRS) donations address this gap, but most donated MDs fail due to incompatibility with local conditions. This PhD project aimed to develop a context-specific design methodology for resilient MDs tailored for LRS. As a case study, an in-vitro diagnostic tool was developed, covering the entire malaria diagnostic process, from sample preparation to sample reading and quality assessment. An on-field needs assessment in Nairobi consented to analyse the key barriers in MD access: these data were used to develop a list of 21 context-sensitive requirements to guide engineers in MDs design for LRS. This methodology was validated designing the malaria diagnostic toolkit composed by the thin blood smearer, a staining box, a filter and an image acquisition, stage. Moreover, a phyton script was developed to assess the quality of the sample, by automatic image analysis. The toolkit overall demonstrated comparable quality to commercial system while betters fitting the constrains of LRS. Beyond malaria, this research promotes collaborative, sustainable MDs design for LRS, fostering innovation and enhancing global healthcare equity.