Institute For Biomedical Engineering (IBE)

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Browsing Institute For Biomedical Engineering (IBE) by Author "Turner, Anne Mary Margaret"

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    Strengthening the value chain of medical devices : a conceptual framework
    (Stellenbosch : Stellenbosch University, 2023-03) Turner, Anne Mary Margaret; Grobbelaar, Sara; Nieuwoudt, Martin; Salie, Faatiema; Stellenbosch University. Faculty of Engineering. Institute of Biomedical Engineering.
    ENGLISH SUMMARY: The medical device value chain (MDVC) describes every value-adding activity (VA) in Idea generation, Research & Development, Production/ Manufacturing, Market, Distribution & Use, Waste Management, and those that occur Systemically. The medical device industry is highly complex and comprises multidisciplinary stakeholders, typically from Academia, Industry, Healthcare or Government. Much literature examines parts of the MDVC or variations thereof. However, a full MDVC map that facilitates a holistic approach to bottleneck alleviation has yet to exist. Additionally, incorporating multiple perspectives is valuable, given the various roles that add value along the chain. This research project addresses the need for a holistic MDVC map by implementing a Design Science Research (DSR) approach to develop a conceptual framework. The MDVC framework, created in this study, structures how insights can be generated from value chain analysis, fishbone analysis, functional analysis and qualitative analysis to support identifying and alleviatingMDVC bottlenecks. By mapping every VA, bottlenecks can be located, targeted and alleviated. The research design implemented is divided into two phases and five components. Phase one is theoretical and incorporates two rigour cycles to inform the first design cycle. A preliminary review, two systematic literature reviews and one conceptual literature review identify the necessary MDVC categories, VAs, bottlenecks, and alleviations used to inform the conceptual framework. The existing frameworks for strengthening MDVCs (or variations thereof) are identified and support the development of domain concepts to which fishbone analysis could contribute. Thereby, an initial framework is developed based on the existing knowledge base. Phase two is evaluative and incorporates three components to refine the MDVC framework and ensure the practical value of the artefact. The MDVC framework is evaluated using two relevance cycles according to the DSR approach. The first relevance cycle validates the MDVC developed through obtaining feedback from an MDVC stakeholder. The second relevance cycle evaluates the efficacy, quality, and generalisability of the initial MDVC framework through expert reviews. The expert reviews consist of semi-structured interviews and surveys with 17 South African stakeholders representative of the multidisciplinary expertise found in the medical devices industry. The expert reviews confirm the quality and efficacy of the MDVC framework and highlight findings such as the need for a structured process for identifying and alleviating bottlenecks. The results are translated into conceptual and structural improvements during the second design cycle to develop suggestions for a refined MDVC framework. Bottlenecks in the Western Cape’s MDVC are identified systematically as a result. This involved value chain-, fishbone-, functional- and qualitative analysis. Alleviations are also suggested as a result of the value chain- and the qualitative analysis. The findings thus contribute to strengthening the Western Cape’s MDVC as bottlenecks are identified across the chain, and alleviations are suggested. This study adds to the foundation of MDVC research. However, future iterations of the MDVC framework and a more vast interviewee pool are necessary to translate these findings into a more meaningful impact. Study limitations and recommendations are discussed last.