ABSTRACT
This chapter presents a case study on the development and translation of the LeVe CPAP system – a frugal, low-cost respiratory support device – originally designed in the UK during the COVID-19 pandemic and adapted for clinical use and local manufacture in Uganda. The LeVe system was developed to address critical gaps in respiratory care, particularly in low-resource settings, by focusing on core functionality, cost reduction, and optimised performance. Through a collaborative, multidisciplinary approach involving partners at Mengo Hospital and Makerere University, the system underwent rigorous laboratory testing, clinical evaluation, and iterative design improvements. Clinical studies demonstrated its safety and effectiveness in both adult and paediatric populations, including during Uganda's COVID-19 response. The project also established a local manufacturing pipeline, regulatory pathway, and supply chain strategy, culminating in Uganda's first ISO 13485-certified medical device manufacturer. The chapter highlights the importance of embedding frugal innovation within local contexts, not only in design but also in training, maintenance, and policy alignment. It concludes by advocating for investment in regional manufacturing infrastructure and regulatory harmonisation to support scalable, sustainable frugal medical technologies across sub-Saharan Africa.
