The majority of the global population is diagnosed and treated in low-resource medical settings, which are abundant in low-income countries and in some cases are also present in remote areas or suburbs of high-income nations. However, 90% of the global medical device market is in high-income countries (e.g., USA, EU and Japan accounting for 80% of the market). Consequently, medical devices end up being designed to comply with the needs, markets and regulations of high-resource settings, which designers take for granted.

This dichotomy jeopardises the safety and effectiveness of medical devices in low-resources settings. What happens when a medical device designed for the European market is used in a low-resource setting? Is a CE-marked oxygen concentrator still safe and effective when operated in settings where there is a deficit of anaesthesiologists, lack of spare parts, no maintenance programs, and much higher humidity, temperatures and dust levels?

In order to help answer these questions, in the past 24 months I ran five field studies in SSA countries (Benin, Ethiopia and South Africa) and several focus groups with world-leading scholars experienced in the design, maintenance and assessment of medical devices or medical settings.

This talk will present some relevant case studies.