Sustainable Design of Medical Devices and Health Technology Management in Sub-Saharan Africa: A Case Study on Oxygen Concentrators

The aim of this thesis is to examine how engineering analysis, health-systems assessment, and context-aware governance can be integrated to improve reliable access to safe and effective medical devices, with a particular focus on medical oxygen in sub-Saharan Africa. I address this challenge across the full technology life cycle, from design and degradation mechanisms to deployment, facility readiness, and regulation. By combining systematic reviews, laboratory experiments, field surveys, and legal and ethical analysis, the work seeks to identify actionable, locally adapted strategies that strengthen device perfor mance and enable practical implementation. I begin by reviewing the evidence base for medical oxygen concentrators in sub-Saharan Africa. A systematic review spanning more than 1,000 publications identifies only 20 studies that directly address design, maintenance, and cost-effectiveness. These studies consistently describe a gap between oxygen demand and availability, frequent malfunction under challenging environmental and operational conditions, and limited emphasis on resilient designs and maintenance systems that reflect local constraints. I then translate these insights into a facility-level perspective by applying a validated f ield assessment framework to twenty hospitals in Ethiopia. The assessment reveals recurring deficiencies in infrastructure, technical staffing, maintenance planning, oxygen supply continuity, and safety devices, and shows how structured readiness data can inform investment priorities and capacity building. I next focus on the technical causes of premature concentrator failure by characterizing exhausted zeolite beds collected from devices in Uganda, Ethiopia, and South Africa. Using diffraction, fluorescence, surface area analysis, and thermogravimetric analysis with mass spectrometry, I identify water uptake as the primary driver of zeolite degra dation, with no evidence of significant mineral dust accumulation. This finding provides clear guidance for humidity management and for redesigning concentrators to operate xii Abstract reliably in tropical environments. Building on this result, I develop and test a repro ducible protocol for thermal regeneration and cyclic stability assessment of exhausted zeolites, offering a practical approach to extending device life in settings where replace ment cartridges and supply chains are constrained. Finally, I extend the analysis from device and facility performance to system-level deter minants by examining medical device regulation and frugal engineering as mechanisms for structural change. Through a detailed case study of Benin, I show how regulatory models developed in high income regions are often transplanted into low-resource set tings without sufficient adaptation, limiting feasibility and compliance in practice. To address this, I propose a hermeneutic framework for context-aware regulation that ex plicitly accounts for local institutions, cultures, and constraints. In parallel, I describe frugal engineering as a design approach that reduces costs while preserving essential func tion and optimizing performance, and I argue that its principles can strengthen medical device provision across all health systems, not only those with limited resources. Taken together, the work provides a coherent multi-level account of why medical oxygen technologies fail to deliver consistent benefit in low-resource environments and how that gap can be reduced. The thesis contributes engineering evidence on degradation mech anisms and regeneration strategies for oxygen concentrators, a validated framework for assessing facility readiness, and conceptually grounded proposals for context-sensitive regulation and frugal design. In doing so, it supports the transition from reactive, short lived deployments toward medical devices that are reliable, sustainable, and aligned with the realities of the environments where they are most needed.