Publicação

An approach to develop sustainable medical devices

Detalhes bibliográficos
Resumo:	The development and commercialization of contemporary Medical Devices is inherently of a multidisciplinary nature. Consequently, they have to undergo a stringent regulatory compliance procedure in conformity with an ever increasingly fierce and competitive business environment. Throughout the product life cycle, medical devices would significantly consume renewable as well as non-renewable resources and as a result exert a substantial social, economic and environmental impact(s). Accordingly, it is imperative to consider the criteria of the aforementioned domains of sustainability in the initial phases of product development. The proposed conceptual multifaceted framework comprehensively explores a broader scope of sustainable product development, mainly from the pragmatic standpoint of systems engineering in comparison to the contemporary evaluation and development approaches. The underpinnings of the proposed framework encompasses the critical role of a decision model titled ‘Multi Criteria Hierarchical Model (MCHM)’ which is in fact an extensive revision of the Analytical Hierarchy Process decision modelling approach. The MCHM contains three tiers of pertinent criteria to attain overall sustainability. The structure of MCHM illustrates the tolerable level of sustainability in Tier 1, which is non-negotiable and compulsory, and the additional degrees of sustainability that increases from Tier 2 to Tier 3. Furthermore, the proposed framework elucidates the active participation of the MCHM in product design and development by conjoining with a wide spectrum of technical and conceptual tools. The research methodologies in the thesis are comprised of interviews, questionnaires and case studies that mainly involved active participatory observation. The objective of incorporating case studies in the thesis is to evaluate the effectiveness of the MCHM in an Industrial environment. In this doctoral research the contemporary medical devices explored during the case studies included a wide spectrum of materials and technologies that range from metal and non-metal prosthesis (external and sometimes internal), instruments, advanced implantable devices and biodegradable scaffolds used in regenerative medicine. The research activities commenced with a thorough literature review that directed the researcher to the need for an exploratory study, accomplished by interviews with experts from academia and industry. These experts provided their feedback on the Sustainability related criteria outlined in the MCHM based on their expertise and knowledge of product development in diverse economic circumstances. The feedback was obtained in the form of assigning numerical scores during pair-wise comparison between two criteria at a time. The scores and recommendations were documented for being incorporated within the case studies. In the case studies, the MCHM was incorporated in the early stage of product development to prioritize bare minimum environmental sustainability and profitability in accordance with regulatory compliance. During the decision making process, the product design was investigated in order to simultaneously accomplish the aforementioned facets by way of incorporating the expert recommendations. Furthermore, these expert recommendations obtained in conjunction with business strategies and technical problem solving techniques, such as Case based Reasoning (CBR), Design by Analogy (DA) and Theory of Inventive Problem Solving (TRIZ) were considered for resolving conflicts between the criteria of Tier 1 and other Tiers. The thesis provides decision makers and the product development teams with a framework to gain a more holistic perspective on sustainable product development with respect to policies, technical/non-technical tools and business strategies. The goal is to enable these product development teams to implement pragmatic solutions for ensuring long-term competitiveness and the welfare of the Stakeholders.
Autores principais:	Hede, Shantesh Digambar
Assunto:	Sustainability Multicriteria hierarchical model Medical devices New product development Sustentabilidade Multicriteria hierarchical model Dispositivos médicos Desenvolvimento de novos produtos
Ano:	2013
País:	Portugal
Tipo de documento:	tese de doutoramento
Tipo de acesso:	acesso aberto
Instituição associada:	Universidade do Minho
Idioma:	inglês
Origem:	RepositóriUM - Universidade do Minho