Strengthening the value chain of medical devices : a conceptual framework

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dc.contributor.advisorGrobbelaar, Saraen_ZA
dc.contributor.advisorNieuwoudt, Martinen_ZA
dc.contributor.advisorSalie, Faatiemaen_ZA
dc.contributor.authorTurner, Anne Mary Margareten_ZA
dc.contributor.otherStellenbosch University. Faculty of Engineering. Institute of Biomedical Engineering.en_ZA
dc.date.accessioned2023-03-02T12:30:09Z
dc.date.accessioned2023-05-18T07:03:06Z
dc.date.available2023-03-02T12:30:09Z
dc.date.available2023-05-18T07:03:06Z
dc.date.issued2023-03
dc.descriptionThesis (MEngSc)--Stellenbosch University, 2023.en_ZA
dc.description.abstractENGLISH 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.en_ZA
dc.description.abstractAFRIKAANSE OPSOMMING: Die mediese toestelwaardeketting (MDVC) beskryf elke aktiwiteit war waarde gee aan Ideegenerering, Navorsing en Ontwikkeling, Produksie/ Vervaardiging, Mark, Verspreiding en Gebruik, Afvalbestuur, en die wat Sistemies plaasvind. Die mediese toestelbedryf is baie kompleks en bestaan uit multidissiplinere belanghebbendes, tipies van die akademie, nywerheid, gesondheidsorg of die regering. Baie literatuur ondersoek dele van die MDVC of variasies daarvan. 'n Volledige MDVC-kaart wat 'n holistiese benadering tot bottelnekverligting fasiliteer, bestaan egter nog nie. Daarbenewens is die inkorporering van veelvuldige perspektiewe waardevol, gegewe die verskillende rolle wat waarde toevoeg langs die ketting. Hierdie navorsingsprojek spreek die behoefte aan 'n holistiese MDVC-kaart aan deur 'n Design Science Research (DSR)-benadering te implementeer om 'n konseptuele raamwerk te ontwikkel. Die MDVC-raamwerk, wat in hierdie studie geskep is, struktureer hoe insigte gegenereer kan word vanaf waardekettinganalise, visgraatanalise, funksionele analise en kwalitatiewe analise om die identifisering en verligting van MDVC-bottelnekke te ondersteun. Deur elke waardetoevoegende aktiwiteit te karteer, kan probleme geidentifiseer, geteiken en verlig word. Die navorsingsontwerp wat geimplementeer is, word in twee fases en vyf komponente verdeel. Fase een is teoreties en sluit twee streng siklusse in om die eerste ontwerpsiklus in te lig. 'n Voorlopige oorsig, twee sistematiese literatuuroorsigte en een konseptuele literatuuroorsig identifiseer die nodige MDVC-kategoriee, waardetoevoegingsaktiwiteite, knelpunte en verligtings wat gebruik word om die konseptuele raamwerk in te lig. Die bestaande raamwerke vir die versterking van MDVC's (of variasies daarvan) word geidentifiseer en ondersteun die ontwikkeling van domeinkonsepte waartoe visgraat analise kan bydra. Daardeur word 'n aanvanklike raamwerk ontwikkel wat gebaseer is op die bestaande kennisbasis Fase twee is evaluerend en inkorporeer drie komponente om die MDVC-raamwerk te verfyn en die praktiese waarde van die artefak te verseker. Die MDVC-raamwerk word geevalueer deur gebruik te maak van twee relevansie siklusse volgens die DSR-benadering. Die eerste relevansie siklus bekragtig die MDVC wat ontwikkel is deur terugvoer van 'n MDVC-belanghebbende te verkry. Die tweede relevansie siklus evalueer die doeltreffendheid, kwaliteit en veralgemeenbaarheid van die aanvanklike MDVC-raamwerk deur kundige resensies. Die deskundige resensies bestaan uit semi-gestruktureerde onderhoude en opnames met sewentien Suid-Afrikaanse belanghebbendes wat verteenwoordigend is van die multidissiplinere kundigheid wat in die mediese toestelbedryf gevind word. Die deskundige resensies bevestig die kwaliteit en doeltreffendheid van die MDVC-raamwerk en beklemtoon bevindinge soos die behoefte aan 'n gestruktureerde proses om knelpunte te identifiseer en te verlig. Die resultate word in konseptuele en strukturele verbeterings gedurende die tweede ontwerpsiklus vertaal om voorstelle vir 'n verfynde MDVC-raamwerk te ontwikkel. Probleme in die Wes-Kaap se MDVC word as gevolg daarvan sistematies geidentifiseer. Dit het waardeketting-, visgraat-, funksionele en kwalitatiewe analise. Verligtings word ook voorgestel as gevolg van die waardeketting- en die kwalitatiewe analise. Die bevindinge dra dus by tot die versterking van die Wes-Kaap se MDVC aangesien probleme met die ketting geidentifiseer word, en oplosings word voorgestel. Hierdie studie dra by tot die grondslag van MDVC-navorsing. Toekomstige herhalings van die MDVC-raamwerk en 'n groter ondervrapoel is egter nodig om hierdie bevindinge in 'n meer betekenisvolle impak te vertaal. Studiebeperkings en aanbevelings word laaste bespreek.af_ZA
dc.description.versionMasters
dc.format.extentxiii, 135 pages ; includes annexures
dc.identifier.urihttp://hdl.handle.net/10019.1/127076
dc.language.isoen_ZAen_ZA
dc.publisherStellenbosch : Stellenbosch University
dc.rights.holderStellenbosch University
dc.subject.lcshMedical devices industryen_ZA
dc.subject.lcshValue chainen_ZA
dc.subject.lcshMedical devicesen_ZA
dc.subject.nameUCTD
dc.titleStrengthening the value chain of medical devices : a conceptual frameworken_ZA
dc.typeThesisen_ZA
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Masters Degrees (Institute For Biomedical Engineering (IBE))