An approach to develop sustainable medical devices

Tese de doutoramento BioengenhariaThe 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.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 critérios de sustentabilidade do nível 2 para o nível 3. Além disso, o modelo proposto demonstra a relevância da inclusão do MCHM no design e desenvolvimento do produto em conjunção com um amplo espectro de ferramentas técnicas e conceptuais. As metodologias de investigação incluem entrevistas, questionários e estudo de casos que envolveram, principalmente, a observação ativa. A realização de estudos de caso teve como objetivo avaliar a adequação do MCHM em ambiente industrial. Os dispositivos médicos considerados durante o estudo de casos incluíram uma diversidade de materiais e tecnologias que vão desde próteses metálicas e não-metálicas (externas e internas), instrumentos, implantes e suportes poliméricos biodegradáveis usados em medicina regenerativa. A revisão bibliográfica identificou a necessidade de desenvolver um estudo exploratório, suportado em entrevistas a peritos académicos e industriais. Estes peritos apresentaram a sua opinião relativa aos critérios considerados no MCHM, de acordo com a sua experiência e conhecimento sobre o desenvolvimento de produtos em circunstâncias económicas diversas. A comparação par a par dos critérios permitiu avaliar a sua importância relativa. Os resultados das entrevistas foram documentados para serem incorporados nos estudos de caso. Nos estudos de caso, o MCHM foi incorporado na fase inicial do desenvolvimento de novos produtos para garantir sustentabilidade ambiental e rentabilidade, em concordância com da regulamentação em vigor. Durante o processo de tomada de decisão, o design do produto foi analisado de modo a cumprir simultaneamente os aspetos acima mencionados e incorporar as recomendações dos peritos. Além disso, estas recomendações foram consideradas em conjunto com as estratégias de negócio e técnicas de resolução de problemas técnicos, tais como o Case Based Reasoning (CBR), Design by Analogy (DA) e Theory of Inventive Problem Solving (TRIZ) para a resolução de conflitos entre os critérios do nível 1 e dos outros níveis. A tese proporciona aos decisores e às equipas de desenvolvimento de novos produtos um modelo para obter uma perspectiva mais holística sobre o desenvolvimento de produtos sustentáveis, relativamente às políticas, ferramentas técnicas/não-técnicas e estratégias de negócio. O objetivo é capacitar essas equipas de desenvolvimento de novos produtos para implementar soluções pragmáticas que assegurem a competitividade a longo prazo e o bem-estar dos stakeholders

Industrial Design

A new breed of modern designers is on the way. These non-traditional industrial designers work across disciplines, understand human beings, as well as business and technology thus bridging the gap between customer needs and technological advancement of tomorrow. This book uncovers prospective designer techniques and methods of a new age of industrial design, whose practitioners strive to construct simple and yet complex products of the future. The novel frontiers of a new era of industrial design are exposed, in what concerns the design process, in illustrating the use of new technologies in design and in terms of the advancement of culturally inspired design. The diverse perspectives taken by the authors of this book ensure stimulating reading and will assist readers in leaping forward in their own practice of industrial design, and in preparing new research that is relevant and aligned with the current challenges of this fascinating field

Innovative Design for Active Disassembly and Sustainable Product Recovery

Closed loop product lifecycle requires product ease of disassembly. Active disassembly, which uses external triggers that remotely disassemble active joints purposefully impeded in a product, shows great potential. The objectives of this dissertation are: first, to fulfill the need for comprehensive sustainability assessment that justifies incorporating active disassembly in product design; and second, to provide a methodology that enables systematic design and innovation of active joints that provide active disassembly. These two objectives are accomplished by developing a framework equipped with methods and tools that guide the process of incorporating active disassembly in product design. At the first level of the framework, two assessment models are developed: The first model assesses the opportunity to reuse an end-of-life (EOL) product as a whole, while the second model assesses the opportunity to recover only portions of the EOF product as modules and parts. The proposed models are novel in terms of the logic they apply, comprehensiveness of factor they use, and their balanced consideration of the three bottom lines of sustainability. There is no known literature that encompasses an assessment model combining all of the above features. The second level of the proposed framework addresses the need for Active Disassembly, where active joint design methodology is developed. The methodology, equipped with several tools, helps product designers create and innovate active joints for products. The method is novel in its structure and its targeted design domain (the first dedicated method for active joints). The applicability of the developed assessment models is validated through two case studies. Results show that EOL decision is significantly improved over what is known in literature (46% - 86%); the first model shows a complete match with industrial practice, while the second model shows a near complete match (i.e.: out of 10 assessed items, 9 are correctly assessed). Two other case studies validate the design methodology. The implementation demonstrates the effectiveness of the method: A new active joint is invented while the other two improved variants of an existing joint are obtained using the method. The results of this research also demonstrated that active disassembly helps close the loop in product life cycle and ultimately contribute to sustainable development

Advances on Mechanics, Design Engineering and Manufacturing III

This open access book gathers contributions presented at the International Joint Conference on Mechanics, Design Engineering and Advanced Manufacturing (JCM 2020), held as a web conference on June 2–4, 2020. It reports on cutting-edge topics in product design and manufacturing, such as industrial methods for integrated product and process design; innovative design; and computer-aided design. Further topics covered include virtual simulation and reverse engineering; additive manufacturing; product manufacturing; engineering methods in medicine and education; representation techniques; and nautical, aeronautics and aerospace design and modeling. The book is organized into four main parts, reflecting the focus and primary themes of the conference. The contributions presented here not only provide researchers, engineers and experts in a range of industrial engineering subfields with extensive information to support their daily work; they are also intended to stimulate new research directions, advanced applications of the methods discussed and future interdisciplinary collaborations

The conceptual design of 3D miniaturised / integrated products as examined through the development of a novel red blood cell / plasma separation device

This thesis was submitted for the award of Doctor of Philosophy and was awarded by Brunel University LondonThe aim of this research is to examine the conceptual design issues concerned with integrating product capabilities that can only be generated at the micro- scale (through feature sizes generally of the order of 100nm to 100μm) directly into 3-dimensional products at the macro-scale. Such macro-scale products could accordingly contain internal devices that are too small to be seen or touched by unaided human designers, which begs the question as to how to enable designers to work with objects which are beyond direct human experience, and how can the necessary collective discussion take place within teams of designers, and between these teams and those responsible for product manufacture? This thesis examines and tests a concept that theoretical 2-dimensional diagrams of function may be transformed into 3-dimensional working structures using procedures allied to those used by graphic designers to create solid objects from 2-dimensional prototype geometries through, for example, extrusion or rotation. Applying such procedures to theoretical diagrams in order to transform them into scalable 3-dimensional devices is not yet in general use at the macro-scale, but with increasing recognition of the unique capabilities of the micro- scale the idea may grow in appeal to alleviate the difficulties of conceiving of functional structures that, when built, will be too small to experience directly. Furthermore this design method, through its basis upon a common currency of functional diagrams, may overcome many of the problems of describing and discussing the design and manufacture of normally intangible objects in 3 dimensions. Finally, it is shown through the example of a novel Red Blood Cell / Plasma Separation Device that the geometric transformation process can lead to the design of functional structures which would not readily be arrived at intuitively, and that may be effectively and efficiently integrated into host products

Advances on Mechanics, Design Engineering and Manufacturing III

This open access book gathers contributions presented at the International Joint Conference on Mechanics, Design Engineering and Advanced Manufacturing (JCM 2020), held as a web conference on June 2–4, 2020. It reports on cutting-edge topics in product design and manufacturing, such as industrial methods for integrated product and process design; innovative design; and computer-aided design. Further topics covered include virtual simulation and reverse engineering; additive manufacturing; product manufacturing; engineering methods in medicine and education; representation techniques; and nautical, aeronautics and aerospace design and modeling. The book is organized into four main parts, reflecting the focus and primary themes of the conference. The contributions presented here not only provide researchers, engineers and experts in a range of industrial engineering subfields with extensive information to support their daily work; they are also intended to stimulate new research directions, advanced applications of the methods discussed and future interdisciplinary collaborations

Proceeding Of Mechanical Engineering Research Day 2016 (MERD’16)

This Open Access e-Proceeding contains a compilation of 105 selected papers from the Mechanical Engineering Research Day 2016 (MERD’16) event, which is held in Kampus Teknologi, Universiti Teknikal Malaysia Melaka (UTeM) - Melaka, Malaysia, on 31 March 2016. The theme chosen for this event is ‘IDEA. INSPIRE. INNOVATE’. It was gratifying to all of us when the response for MERD’16 is overwhelming as the technical committees received more than 200 submissions from various areas of mechanical engineering. After a peer-review process, the editors have accepted 105 papers for the e-proceeding that cover 7 main themes. This open access e-Proceeding can be viewed or downloaded at www3.utem.edu.my/care/proceedings. We hope that these proceeding will serve as a valuable reference for researchers. With the large number of submissions from the researchers in other faculties, the event has achieved its main objective which is to bring together educators, researchers and practitioners to share their findings and perhaps sustaining the research culture in the university. The topics of MERD’16 are based on a combination of fundamental researches, advanced research methodologies and application technologies. As the editor-in-chief, we would like to express our gratitude to the editorial board and fellow review members for their tireless effort in compiling and reviewing the selected papers for this proceeding. We would also like to extend our great appreciation to the members of the Publication Committee and Secretariat for their excellent cooperation in preparing the proceeding of MERD’16

Systematic design of biologically-inspired engineering solutions

Biological organisms, phenomena and strategies, herein referred to as biological systems, provide a rich set of analogies that can be used to inspire engineering innovation. Biologically-inspired, or biomimetic, designs are publicly viewed as creative and novel solutions to human problems. Moreover, some biomimetic designs have become so commonplace that it is hard to image life without them (e.g. velcro, airplanes). Although the biologically- inspired solutions are innovative and useful, the majority of inspiration taken from nature has happened by chance observation, dedicated study of a specific biological entity (e.g., gecko), or asking a biologist to explain the biology in simple terms. This reveals a fundamental problem of working across the engineering and biological domains. The effort and time required to become a competent engineering designer creates significant obstacles to becoming sufficiently knowledgeable about biological systems (the converse can also be said). This research aims to remove the element of chance, reduce the amount of time and effort required to developing biologically-inspired solutions, and bridge the seemingly immense disconnect between the engineering and biological domains. To facilitate systematic biologically-inspired design, a design methodology that relies on a framework of tools and techniques that bridge the two domains is established. The design tools and techniques that comprise the framework achieve: Identification of relevant biological solutions based on function; translation of identified biological systems of interest; functional representation of biological information such that it can be used for engineering design activities; and conceptualization of biomimetic engineering designs. Using functional representation and abstraction to describe biological systems presents the natural designs in an engineering context and allows designers to make connections between biological and engineered systems. Thus, the biological information is accessible to engineering designers with varying biological knowledge, but a common understanding of engineering design methodologies. This work has demonstrated the feasibility of using systematic design for the discovery of innovative engineering designs without requiring expert-level knowledge, but rather broad knowledge of many fields