Most medical devices are inaccessible to healthcare facilities in low-resource settings (LRSs), severely limiting medical care for a vast proportion of the world's population. This article characterises the process used for designing medical devices for LRSs and investigate how the context-of-use is integrated into the process. A systematic review of 64 papers was conducted to identify peer-reviewed studies of devices intended for LRSs. Using the biodesign process as an analytic framework, a qualitative meta-analysis was conducted. Findings show the studies predominantly describe the later stages of medical device design, whilst largely neglecting how knowledge of the context is considered. To support engineers and improve outcomes, it is imperative that an understanding of the context is integrated throughout the design and product development process. This article highlights this gap and hopes to stimulate research into how context can be better incorporated into the design process for medical devices targeting those populations most in need.