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Shantesh Digambar Hede an Approach to Develop Sustainable Medical Devices

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Shantesh Digambar Hede an Approach to Develop Sustainable Medical Devices Universidade do Minho Escola de Engenharia Shantesh Digambar Hede An Approach to Develop Sustainable Medical Devices An Approach to Develop An Approach Sustainable Medical Devices Shantesh Digambar Hede UMinho | 2013 Junho de 2013 Universidade do Minho Escola de Engenharia Shantesh Digambar Hede An Approach to Develop Sustainable Medical Devices Tese de Doutoramento Bioengenharia Trabalho efectuado sob a orientação de Doutor Luís Alexandre Rocha Doutor Manuel José Lopes Nunes Doutora Paula Varandas Ferreira Junho de 2013 Acknowledgements The contribution of MIT Portugal Program, University of Minho and Fundação para a Ciência e Tecnologia (FCT), Portugal (Foundation Of Science and Technology, Portugal) for the scholarship grant SFRH / BD / 33794 / 2009. Throughout the doctoral research, the feedback from the following experts has been included within the thesis: Dr. Koti Sreekrishna, Senior Scientist at P&G; Narayan Srinivasan, Director of Business Intelligence at Academic Partnerships Inc.; Jaineel Aga and Deepak Bawari, Duke Universiy Alumni; Prof. David Primo, University of Rochester and Prof. Robert Clemen, Duke University; Dd. Dipl.-Vw. Malte Kaufmann, The Bucharest Academy of Economic Studies and Prof. Marieta Olaru, Ph. D., The Bucharest Academy of Economic Studies; Richard D. Wolff is Professor of Economics Emeritus, University of Massachusetts, Amherst and Jen Hill, Co-founder and Communications Strategist of Democracy at Work; Dr. Simona Alba Grano, University of Zürich; Prof. Axel Michaelowa, Institute of Political Science, University of Zürich; Bethel U. Ihugba, University of Wales Cardiff, Greenwich School of Management London; Brian Hasbrouk, iPolitical Risk; Dr. Nagraj Huilgol, Dr. Mekala Chandrasekaran and Mr. Naresh Trivedi (from Balabhai Nanavati Hospital); Manit Patel, Strategy Architect-Sterkem Pharma; P. Sainath, a renowned Indian Journalist; Michael Gillenwater co-founder of the Greenhouse Gas Management Institute. It is essential to acknowledge the sources of inspiration and insight from the intellectuals from the public sphere whose articles; discussions and interviews have espoused thoughts that have directly and indirectly contributed to certain novel ideas in this paper. However, this does not imply that there was complete agreement with the thoughts disseminated by each intellectual while building a perspective for the thesis. They are namely, Dr. Ian Bremmer, Eurasia Group; Rajiv Malhotra, Infinity Foundation; Dr. Subramanium Swamy, President, Janata Party in India; Prof. Noam Chomsky, Professor Emeritus from MIT; Dr. Christian Parenti and Mr. Michael Parenti, renowned award winning authors; Clive Hamilton; Chris Hedges, an Pulitzer prize winning journalist; Prof. Anil Gupta iii Professor at Indian Institute of Management, Ahmedabad; Alex Lightman; James Clark of the World Technology Network (The WTN); Mr. John Hagel III, Co- chairman, Deloitte LLP Center for the Edge; Emanuel Pastreich; Chip Pitts, a Lecturer in Law at Stanford Law School; Gordon Sumner (popularly known as Sting) Musician and Activist; Pierce Brosnan, a renowned Hollywood actor and environmental activist; Def Leppard, a legendary music group. It is also crucial to acknowledge the role of social media on Linkedin, Facebook and Twitter to provide connections between likeminded people as well people with conflicting viewpoints which eventually brought about shaping certain perspectives that were reflected within the Thesis. Likewise, the role of my supervisors Prof. Luís Rocha, Prof. Paula Varandas Ferreira and Prof. Manuel Lopes Nunes and specifically the moral support of Profa. Madalena Araújo, Head of Centro de Gestão Industrial e da Tecnologia (CGIT). Ultimately, the role of Family, Friends and Critics has been crucial for the ‘successful journey’ of the doctoral research as the doctorate degree is a career milestone and not a destination. The author gratefully acknowledges the support of the people and institutions previously mentioned. However, the sole responsibility for the content of this thesis lies with the author iv AN APPROACH TO DEVELOP SUSTAINABLE MEDICAL DEVICES Abstract 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 v 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. Keywords: Sustainability; Multicriteria Hierarchical Model; Medical Devices; New Product Development. vi UMA ABORDAGEM AO DESENVOLVIMENTO DE DISPOSITIVOS MÉDICOS SUSTENTÁVEIS Resumo O desenvolvimento e comercialização de dispositivos médicos contemporâneos é por inerência de natureza multidisciplinar. Consequentemente, estes dispositivos têm que passar por um procedimento de regulamentação rigoroso, num ambiente de negócios cada vez cada vez mais acirrado e competitivo. Durante o ciclo de vida do produto, os dispositivos médicos consomem recursos renováveis, bem como recursos não-renováveis, o que origina impactos sociais, económicos e ambientais significativos. Assim, é imperativo considerar as diferentes dimensões da sustentabilidade nas fases iniciais de desenvolvimento do produto. O modelo conceptual proposto explora exaustivamente um propósito mais amplo de desenvolvimento de produtos sustentáveis, principalmente do ponto de vista pragmático da engenharia de sistemas, em comparação com a avaliação e abordagem contemporânea de desenvolvimento de novos produtos. A abordagem proposta suporta-se no modelo de apoio à decisão intitulado Multi Criteria Hierarchy Model (MCHM), que é uma extensão do modelo Analytical Hierarchy Process (AHP). O MCHM contém três níveis de critérios relevantes para alcançar a sustentabilidade global. A estrutura do MCHM reflete o que é obrigatório e não negociável no nível 1, e ainda a importância crescente dos
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