A Product Life Cycle Approach to Medical Device Development for Low-Resource Settings—A Systematic Literature Review Validated in Bolivia

Abstract

Abstract Rural areas in most of the world lack functional medical devices for essential care. Even though devices exist on the global market, they are often designed for high-income countries with efficient healthcare systems and abundant resources. When these devices are operated in low- and middle-income countries with fewer resources, an estimated 70–90% of donated devices are not operational due to numerous challenges throughout the entire product life cycle. This article aims to synthesize the existing knowledge from the literature about these challenges, to validate them through a field study in Bolivia, and to identify the product life cycle stages that have the greatest need for further research. Through a systematic keyword search using the PRISMA method, 26 relevant articles are identified and analyzed according to the product life cycle stages they cover. The results of the literature review are validated through a 1-month field study in Bolivia with hospital visits, interviews, and focus groups with 30 participants. The results of the literature study reveal a lack of knowledge, especially about the final life cycle stages, i.e., recycling and disposal, and a wide range of challenges for the use, consumption, and maintenance stages, as well as the marketing and sales of devices. The significant overlap of the identified gaps in generalized knowledge and the practical experience in Bolivia provide a call to action for researchers and medical device developers to investigate and determine critical areas to make high-quality medical devices more accessible and sustainable in low-resource settings.