Developing a Framework for Conducting Health Technology Assessment in a Resource-Constrained Setting

Health Technology Assessment (HTA) is crucial for achieving Universal Health Coverage (UHC) but remains underdeveloped for medical devices (MDs) in low- and middle-income countries (LMICs), particularly within fragmented public health sectors. Local MD manufacturers face significant barriers navigating the medical device value chain (MDVC), often failing to bring context-appropriate innovations to market due to regulatory, evidence generation, and market access challenges known as the "valley of death". While early HTA (EHTA) and lifecycle HTA offer potential solutions, practical, context-sensitive frameworks incorporating guidance for these manufacturers are lacking. This study aimed to develop a conceptual HTA framework that incorporates comprehensive guidelines to help local MD manufacturers use EHTA and HTA to navigate MDVC bottlenecks in resource-constrained environments. The research employed a pragmatic paradigm, utilising Design Science Research Methodology (DSRM). The development process involved iterative cycles that incorporated extensive literature reviews, the application of an adapted international framework in an instrumental case study, and rigorous validation through semi-structured interviews and ranking exercises with subject matter experts (SMEs). The research produced a final, validated conceptual HTA framework presented across four canvases, including specific guidelines tailored for local manufacturers. An operational HTA management tool was subsequently developed to implement this framework. The framework provides a systematic, lifecycle-based process that integrates EHTA principles for MD evaluation and is structured around six core processes. The Microsoft Excel-based management tool operationalises this framework, offering practical templates, checklists, and a progress dashboard designed for users with limited HTA expertise. This research contributes a theoretically grounded and empirically validated conceptual framework applicable to real-world healthcare contexts. The framework and its accompanying guidelines, operationalised through the management tool, provide a structured and transparent approach to enhancing the capacity of local MD manufacturers and supporting evidence-informed decision-making among health system actors. Ultimately, this promotes the adoption of appropriate MDs while offering theoretical transferability to other resource-constrained settings.

Grantor dc:publisher

Stellenbosch : Stellenbosch University

Year dc:date.issued

2026

Author dc:creator

• Chikunichawa, Tinashe Ashley

Advisors dc:contributor.advisor

• Grobbelaar, Sara Saartjie
• Persson, Mikael

Language dc:language.iso

en

Repository record dc:identifier.uri

https://scholar.sun.ac.za/handle/10019.1/135685

OAI identifier oai:identifier

oai:scholar.sun.ac.za:10019.1/135685