The South African medical device industry is growing industry and holds huge potential of contributing towards health care. According to SAMED (2014), the industry was estimated at USD1.2bn in 2013 and ranked among the top 30 largest in the world and it is expected to grow by a compound annual growth rate of 7.7% between 2013 and 2018. Despite the positive outlook on the growth of the medical device industry in South Africa, it is conspicuous by the dominance of imports which cater for about 90% -95% of the market by value (Abbott et al., 2013). As a result, the market is inundated with imported medical devices which may not be appropriate and affordable to the users. The imports undermine the development of medical devices by local manufacturers most of whom cannot complete with multinational companies. The medical device market in South Africa targets clients mainly from the private sector where it derives most of its revenues as it constitutes about 70%, while only 30% of the clients are in the public sector (KPMG, 2014). This reflects a dichotomous health system which is characterised by well-developed private sector and an overburdened burdened public sector.
According to WHO (2010) medical devices are often a low priority or even absent from the agenda in low- and middle-income countries. For example, a study that was conducted by de Jager et al., (2017) revealed that, although some of the universities in South Africa are actively involved in the development of medical devices, they are far outnumbered by the foreign institutions. This is mainly due to the fact that developing countries lack policies, budgets, infrastructure (basic services, human resources, trained staff, logistics), and rules and regulations regarding medical devices (WHO, 2010a). These constraints result in many developing countries relying on donations for medical devices. In some countries, nearly 80% of health-care equipment is donated or funded by international donors or foreign governments (Borrás, 2017, Finch et al., 2014; Heimann, et al, 2000).
Various measures have been taken to promote access to medical devices in developing countries, but with limited success. Chakma et al., (2010) conducted a study in South Africa in which he advocated for the use of incubators to facilitate the establishment and growth of new health technology enterprises by bringing together a critical mass of human and financial talent. Although incubators are effective, the main disadvantage is the long-time frames before a technology is ready for use. Given the disease burden of Africa and the high demand for medical devices, it is difficult to rely on incubation. It is against this background that this chapter presents an approach used in the teaching of a Biomedical Engineering course on medical device.