Abstract
The medical device industry is one of the fastest-growing sectors of the global economy, however, it is dominated by high-income countries (HICs) such as The United States, Germany, Japan and China. Approximately 80% of medical devices in low-to-middle income countries (LMICs) are donated or imported (World Health Organisation 2011). Due to a mismatch between the design of these devices and the context in which they are used, approximately 40% are out of service, 70–90% never function as intended, and up to 98% are broken within five years (Prestero 2010; Malkin and von Oldenburg Beer 2013; Chan 2010). To overcome this mismatch, the World Health Organisation identifies local production as a possible way to increase the sustainability of medical devices in LMICs. South Africa’s (SA) medical device development (MDD) industry is underdeveloped and approximately 90-95% of medical devices in SA hospitals are imported or donated (SAMED n.d., Mitchell 2017). Although MDD process models have been defined, none describe the SA MDD regulatory landscape and most describe the MDD process from an engineering or business perspective rather than a design point of view. The lack of appropriate, sustainable medical devices, particularly in LMICs suggests the need for a shift towards a more human-centred, design-orientated medical device industry, which promotes local manufacture. This paper explores a study that aimed to define a design process model for paediatric Medical Device Design (MDDes) in the South African context to better enable local industrial designers to participate in the field. This paper presents key case study findings in comparison to existing MDD process literature and introduces an MDDes process model more suited to arriving at sustainable medical device outcomes in the South African context.