Healthcare is a topic that matters since it aims to ensure better well-being for people. An important and essential part of health care is medical devices since it has the potential to increase the quality of life for people with a health problem. Among the suppliers of innovation, the medical device industry is a dynamic field providing thousands of products to the market every year with the aim to enhance people's lives. However, there are many actors that influences the medical device development such as regulations that ensures that medical devices follow a specific procedure during development, at the same time buyers and end-users need to be integrated throughout the medical device design, this results in challenges during medical device development. This thesis focuses on new product development (NPD) and investigates how projects are managed in a medical device context. Furthermore, the thesis elaborates projects of different novelty and the influence from the characteristic of complexity. This is done with a single-case study of a case company that develop and market medical devices. The empirical findings shows that the main challenges are in the area of clinical studies and product development, furthermore, managing NPD projects in a medical device context deals with specialized knowledge that is dispersed among a group of actors which can influence the development of the medical device no matter the novelty. It was found that the difference between the studied projects was minor in terms of complexity. Though, it was noticed that the project of radical novelty had more interaction with the end-user, which can relate to uncertainty in the function of the product, as a consequence from being completely new product. As a result from the findings, the implication is that the projects can not be treated and managed similarly as a result from uncertainty, thus, it depends on the integration of actors, consequently, influencing time of development and resources. This thesis contributes to the community of companies operating in a medical device context where there is minor focus on complexity in projects, it was found that it might be beneficial to make distinctions in complexity characteristics when identifying challenges and addressing NPD projects in a medical device context.

<p>Successful concept decisions are crucial for product development organisations. Failure in theconcept decision-making process means costly rework, requiring resources that could havebeen spent on innovative work with new products instead. This licentiate thesis tackles theconcept decision-making process and how to improve it. The research presented here is thefirst part of a research project, with an action research approach, that will develop newsupporting working procedures for concept decision making and thereby contribute to moresuccessful products.Empirical studies were conducted in Swedish industrial practice, particularly focusing oneorganisation, and it was found that concept decisions are not made at a certain point in time.Instead, many decisions and activities, on several organisational levels, were adding up to theconcept decisions in the investigated organisations. The concept decision-making process wasfound to be a web of interconnected activities, with many decisions integrated and embedded in the process. Itwas also found that both formal and informal factors influence the concept decision-makingprocess and main factors were identified as: Project and product request, Supporting structures androutines, Individual competence and driving forces, Teamwork and company culture and Contextualcircumstances. These factors represent different perspectives, meaning on what level theyinfluence concept decision making: individual, team, project, organisation, and context, and in orderto create improvements in the concept decision-making process all levels have to beconsidered. The knowledge of the different perspectives has implications for howimprovements should be designed.Larger product developing companies do often have internally defined formal workingprocedures that prescribe how to develop products within the company. The thesis discusseshow the internal working procedures relate to academic theory and to practice. It wasconcluded that internal formal working procedures has not been discussed in a sufficient wayin earlier engineering design research. Furthermore, means for improving the concept decisionmakingprocess are discussed, and it was concluded, based on interviews with practitioners,that the strongest pragmatic means for improvement were developing mindset and applyingmethods. Mindset addresses the awareness, attitude and approach needed for management (andco-workers) working in early product development phases. Methods mainly addresses the needfor having relevant supporting working procedures in general and templates for evaluationalternative solutions in particular. Finally, recommendations for future design of a template forevaluation alternative solutions are presented.</p>

Knowledge management (KM) is an essential, if sometimes overlooked part of new product development (NPD). It describes the way information and new knowledge is being shared in a commercial organization, hence, how it is stored and made accessible within an organization. KM is applied to many organizational settings, but the application is sparse. KM has the potential to assist NPD, as previously acquired knowledge can be used more efficiently and redundant work can be avoided. However, there is no successful model or guideline for KM in an NPD environment. This project specifically examined the NPD situation, and the research questions included: What do engineering companies in New Zealand do, if anything, to store acquired knowledge? What would encourage engineers to share their knowledge in NPD projects? These research questions were answered by two methods: a survey and then follow-up face-to-face interviews were conducted. Statistical analysis identified various factors as important. Further, differences between New Zealand and German companies were examined. The survey and interview results showed that knowledge was found definitely important for innovation and NPD. However, Germans tended to rate the overall importance of knowledge higher than New Zealanders. It was found that all NPD companies used codification and personalization KM strategies to store knowledge and to make it accessible. However, a tendency towards a stronger emphasis on personalization was found. Particular knowledge sharing encouragements were identified that could result in a higher willingness of engineers to share their knowledge; supporting a communicative work-climate, setting up regular meetings for knowledge exchange and active encouragement to share knowledge. Apart from encouragements, survey and interview results also pointed out the importance of a clearly set direction for KM from management. Companies that were associated with successful KM did not only apply one particular KM process, but a combination of many. Particular KM practices and knowledge sharing encouragements were associated with KM success; the creation of a tidy, well structured database, regular meetings for knowledge sharing, supporting a communicative work-climate and active encouragement of staff to share their knowledge. Furthermore, the influence of personal relationships, trust and power differences on personal knowledge sharing processes were identified. Poor personal relationships and a low perceived level of trust can decrease the willingness of engineers to share knowledge. Engineers found that the most difficult situation in which to seek knowledge was from superiors, while the easiest was from peers. Thus organizational design and hierarchy structures can have an influence on KM. These results were used to construct an integrative model that describes the factors, and their interaction, for successful KM in NPD. Based on the interview and survey results, the main implications for practitioners are that an overall awareness of KM and the benefits thereof for the company itself and the employees are important for successful KM. Executives should consider setting direction, providing the required tools for KM, educating staff regarding KM, and actively encouraging knowledge sharing processes. Further, executives should be aware of the influence of organizational design on personal knowledge sharing mechanisms. NPD project managers should consider educating their project team regarding KM. Especially for the successful application of personal knowledge sharing processes it is important that project managers are aware of personal relationships and potential issues among their team members. In order to achieve a high willingness to share knowledge within the project team, project managers should consider supporting a communicative work-climate, setting up regular meetings for knowledge exchange and actively encouraging their project team members to share their knowledge. These methods were associated not only with a high willingness of employees to share knowledge, but also with KM success in general. Engineers should consider contributing to the KM process by applying the company’s KM strategy and by having a high willingness to share own knowledge and ask questions to acquire knowledge. Furthermore engineers need to be aware of personal relationships with their colleagues and try to maintain a good work-climate, as this affects personal knowledge sharing processes within the NPD project team. New product development requires knowledge, and in an organizational context that knowledge needs to be managed if there is to be an enduring future for the firm. This work has surveyed industry perspectives and identified factors that contribute to successful knowledge management, creating an integrated model that is applicable to new product development.

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The aim of this review is to provide insights to the usage of Kano-model and innovation product development, and at the same time, answer to the research question “How customer needs can be identified by using Kano-model for innovation product development?” The research is conducted by reviewing existing literature on Kano- model and innovation product development (IPD). The relevant literature used for this research is conducted by utilizing the databases of Halmstad University and Google Scholar. A model for customer needs identification by using Kano model for Innovation Product Development (IPD) was constructed based on the reviewed theories. In addition, a general recognition for the term of IPD was acknowledged.

<p>In order to increase the independence in everyday life of the elderly population, we have developed a lifting aid for loading in the private car trunk. Independence from outside assistance affects self-esteem in a positive direction and can help increase the quality of life for a large group of individuals. As people age and experience changes in performance, it is important that aids and support is available, particularly to reduce the experience of aging and it’s increasing physical limitations. The aim was to develop a function prototype characterized by simplicity, which facilitates loading of the private car</p><p>trunk.</p><p>The project was conducted at the request of Autoadapt AB, which is one of the leading</p><p>actors in car adaptations for individuals with disablilities. A function prototype of the product Easy Load has been produced through dynamic product development and its</p><p>various tools. In an attempt to meet the requirements of simplicity and ease of use,</p><p>concepts such as universal design and usability affected the project.</p><p>In order to find a user need that could form the basis of the project, proceedings began</p><p>with a pre-study that included observations and group interviews of members in a</p><p>pensioner club in Halmstad. The Product development work continued with several</p><p>brainstorming sessions with participants from a number of the university's engineering</p><p>programs. Ideas from the sessions, together with the results from the benchmarking,</p><p>formed the basis for final product design and function. A key requirement was that the</p><p>product could be fitted in sedan car models with easy grips and without any permanent</p><p>fixings.</p><p>Construction of the prototype was made mostly in the University’s mechanical</p><p>workshop, using both self-constructed and sourced components. Stress and installation</p><p>testing and risk analysis pursuant to FMEA highlighted deficiencies that the project</p><p>group sought to adjust. In cases where this did not happen, the project group made</p><p>concrete improvement proposals to simplify further development.</p><p>This project shows that lifting aids products without permanent fixings are possible to develop for use in sedan car models. Specific product criteria have been met through a designed function prototype for loading in the private car trunk.</p>

The development process for complex system is typically iterative in nature. Among the critical decisions in managing such process involves deciding how to partition the system development into iterations. This paper proposes a mathematical model that captures the dynamics of such iterative process. The analysis of two special cases of the model provides an insight into how such decision should be made. / Singapore-MIT Alliance (SMA)

BOF slag is a co-product generated from Basic Oxygen steelmaking process with annual production of 1.3 million tons approx. Because of its unique physical and chemical properties, it was considered as waste in the past and dumped to the ocean. After research and development, the BOF slag was used as sea-shore embankment and landfill material. Then it was registered as a product and was further used as land filler of temporary roads and parking lots. For now, BOF slag can be used as engineering materials such as asphalt concrete aggregates and Controlled Low Strength Material. Advancing waste recycling to promote resources optimization is an essential factor to industrial sustainable development. It also meets the global trends of sustainable use of resources and sustainable development of economy and society. Investigating the process of BOF slag resourcilization, it is concluded that the center of the development frame of recycled products is waste resourcilization. The steps to completely solve pollution problems including: input of human and natural resources, basic research and development, and finally converting waste into products. Meanwhile, governmental regulations must not be violated. Relevant regulations, domestic and international experiences and practices, and market investigation must be considered to confirm market need and opportunities for development. After the above are finished, the work team can be formed to start research and development. The recycled product development process can be divided into 7 major stages, including basic properties analysis, selection of application direction, technological research and evaluation, economical feasibility analysis, trial production and market testing, certification and specification modification, commercialization and promotion.

The research aims at analyzing the internal communication in a new product development project of Sandvik with expectation to explore possibilities of improvement. Throughout the research, internal communication seems to have a great impact on innovation and project performance. Several critical factors in building effective communication were identified as team size, superordinate goals, centralization of communication, early involvement, physical proximity, and leadership. Meetings were considered as a major and efficient method of communication within the project. Based on these issues, recommendations for improving internal communication within the project were suggested.

In order to increase the independence in everyday life of the elderly population, we have developed a lifting aid for loading in the private car trunk. Independence from outside assistance affects self-esteem in a positive direction and can help increase the quality of life for a large group of individuals. As people age and experience changes in performance, it is important that aids and support is available, particularly to reduce the experience of aging and it’s increasing physical limitations. The aim was to develop a function prototype characterized by simplicity, which facilitates loading of the private car trunk. The project was conducted at the request of Autoadapt AB, which is one of the leading actors in car adaptations for individuals with disablilities. A function prototype of the product Easy Load has been produced through dynamic product development and its various tools. In an attempt to meet the requirements of simplicity and ease of use, concepts such as universal design and usability affected the project. In order to find a user need that could form the basis of the project, proceedings began with a pre-study that included observations and group interviews of members in a pensioner club in Halmstad. The Product development work continued with several brainstorming sessions with participants from a number of the university's engineering programs. Ideas from the sessions, together with the results from the benchmarking, formed the basis for final product design and function. A key requirement was that the product could be fitted in sedan car models with easy grips and without any permanent fixings. Construction of the prototype was made mostly in the University’s mechanical workshop, using both self-constructed and sourced components. Stress and installation testing and risk analysis pursuant to FMEA highlighted deficiencies that the project group sought to adjust. In cases where this did not happen, the project group made concrete improvement proposals to simplify further development. This project shows that lifting aids products without permanent fixings are possible to develop for use in sedan car models. Specific product criteria have been met through a designed function prototype for loading in the private car trunk.