162 research outputs found

    Medical devices with embedded electronics: design and development methodology for start-ups

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    358 p.El sector de la biotecnología demanda innovación constante para hacer frente a los retos del sector sanitario. Hechos como la reciente pandemia COVID-19, el envejecimiento de la población, el aumento de las tasas de dependencia o la necesidad de promover la asistencia sanitaria personalizada tanto en entorno hospitalario como domiciliario, ponen de manifiesto la necesidad de desarrollar dispositivos médicos de monitorización y diagnostico cada vez más sofisticados, fiables y conectados de forma rápida y eficaz. En este escenario, los sistemas embebidos se han convertido en tecnología clave para el diseño de soluciones innovadoras de bajo coste y de forma rápida. Conscientes de la oportunidad que existe en el sector, cada vez son más las denominadas "biotech start-ups" las que se embarcan en el negocio de los dispositivos médicos. Pese a tener grandes ideas y soluciones técnicas, muchas terminan fracasando por desconocimiento del sector sanitario y de los requisitos regulatorios que se deben cumplir. La gran cantidad de requisitos técnicos y regulatorios hace que sea necesario disponer de una metodología procedimental para ejecutar dichos desarrollos. Por ello, esta tesis define y valida una metodología para el diseño y desarrollo de dispositivos médicos embebidos

    Retail Distribution Within the New York City Organic Cacao Market

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    The purpose of this multiple case study was to explore strategies small physical commodities firm owners need to establish a distribution channel within the commodities market to enhance profits. The general business problem was that importing physical commodities from emerging markets was not profitable. The specific business problem was some small physical wholesale commodities firm managers lacked strategies to establish distribution channels for imported commodities. The information presented in this study is important to suppliers, manufacturers, distributors, and retailers of organic cacao products to identify strategies to enhance their distribution channels. Disruptive innovation and the theory of constraints grounded the conceptual framework to relate ideas presented in this study. The central research question guiding the study concerned strategies small physical wholesale commodities firm owners used to establish distribution channels within the commodities market. Participants included 6 small business owners who gave recorded responses during in-depth, face-to-face interviews. The 6 interview recordings were transcribed, then coded and interpreted. Data analysis revealed 6 themes, which included price point strategy, B2B relationships, differentiation, strategic locations, sufficient operating capital, and customer relationships. Enhancing profits in the distribution channels of small organic cacao companies requires a holistic approach in the New York City area. The social implications of this study may draw attention to organic cacao, which is a healthy alternative to confectionery chocolate. Strategies introduced to enhance profits may increase economic growth in the local communities in the New York Tri-State area

    Enabling late-stage translation of regenerative medicine based products

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    The primary aim of the thesis is to contribute to demonstrating how established and emerging science in the regenerative medicine (RM) domain can be translated into profitable commercial practice, and generate clinically- and cost-effective therapies. It achieves this by exploring and assessing underlying economics, including investment readiness and economic assessment, exploring regulatory and reimbursement frameworks, developing stem cell culture systems and assessing fit with clinical practice. The thesis is the first public domain wide-ranging analysis of business trends in the production, manufacturing and supply segments of the RM industry. It analyses the clinical potential of the domain as well as the translational and commercial challenges facing the industry. The industry is at a turning point as big pharmaceutical companies engage with RM in order to explore technologies as potential therapeutics and discovery tools. This unlocks the industry by confirming an exit path for RM based small- and medium-sized enterprises. Translation has come to be recognised as a core issue in the overall space and translation of regenerative therapies into the clinic is presently challenging, high-risk and expensive. This research addresses the question what are the mechanisms required to enable translation of emerging scientific knowledge into commercially viable clinical RM products? These mechanisms are particularly important as their creation involves and requires major investment decisions, which can determine the success or failure of RM developments and indeed of the companies concerned. The lack of well-established business models and the complexity of the domain suggested a conceptual approach drawing upon relevant literature from product and process development, applied business and revenue models, technological evolution and capital market ingenuity. The research was carried out in two phases. The first phase was concerned with identification of key challenges and mapping the overall industry emergence including emergence of related regulations to provide a context and framework for understanding the domain. Based on the emergence mapping a timeline of key parallel factors was identified, and their inherent connections explored to identify transforming events affecting and influencing multiple factors on the journey to clinical success within a business environment. This creates the reference model. The second phase was concerned with manufacturing a stem cell based therapeutic and applying health economic principles to determine available headroom for investment, cost of goods and return on investment, taking hearing disorders as a case exemplar, and exploring the behaviour of the net present value curve to identify key parameters affecting the economic positioning of this novel regime. A key output of the research is the investment readiness reference model. It integrates key RM business issues against reducing uncertainty and increasing value. The model argues that the complex nature of RM products means that the issues affecting industry emergence and development go well beyond the primarily scientific and technological concerns on which much current research focuses. The performance of RM firms ultimately hinges upon the successful clinical application of their developed products, the key step for creating and realising value, and their ability to deal with the fundamental business issues specific to the area. The framework deals with these business issues, which are investment & technology readiness, business models, organisational challenges, public policy and industry emergence. This thesis explores ideas that may bridge the chasm between the promise and reality of RM i.e. mechanisms to enable late stage translation of RM products. It links technological capability and business models for firms in the domain. Furthermore, it offers a unique perspective on the nature and characteristics of investment readiness and financial assessment, specifically identifying key parameters affecting economic positioning. The key contributions are therefore: New insights into the key challenges involved in realising the commercial potential of cell based therapeutics. Technology road mapping to link fundamental enabling technological capability for developing RM products with robust business plans integrating strategy, technology development and the regulatory and reimbursement framework. A generic investment readiness reference model generated from the enabling technology, value and supply chain structures to identify key indicators and characteristics of industry readiness. A novel experimental programme demonstrating expansion, maintenance and differentiation of human embryonic stem cells by manual and automated methods. New insights into economic positioning by mapping net present value, and economic analysis by estimating available headroom, cost of goods and return on investment for a putative hearing therapeutic

    Strategic Roadmaps and Implementation Actions for ICT in Construction

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    How to create value by entrepreneurially using the innovation vertical indoor farming in smart sustainable cities

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    This master thesis report investigates the potential of five different innovations for value creation in the context of Smart Sustainable Cities by 2050, applying the research question “How to create value by entrepreneurially using innovations in Smart Sustainable Cities?” The individual part focuses on the innovation of Vertical indoor farming. Interviews, calculations, research, and sustainability assessments have been done. In conclusion, environmental sustainability without sacrificing price, quality or other advantages leads to an increase of value

    Supporting Development Decisions with Software Analytics

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    Software practitioners make technical and business decisions based on the understanding they have of their software systems. This understanding is grounded in their own experiences, but can be augmented by studying various kinds of development artifacts, including source code, bug reports, version control meta-data, test cases, usage logs, etc. Unfortunately, the information contained in these artifacts is typically not organized in the way that is immediately useful to developers’ everyday decision making needs. To handle the large volumes of data, many practitioners and researchers have turned to analytics — that is, the use of analysis, data, and systematic reasoning for making decisions. The thesis of this dissertation is that by employing software analytics to various development tasks and activities, we can provide software practitioners better insights into their processes, systems, products, and users, to help them make more informed data-driven decisions. While quantitative analytics can help project managers understand the big picture of their systems, plan for its future, and monitor trends, qualitative analytics can enable developers to perform their daily tasks and activities more quickly by helping them better manage high volumes of information. To support this thesis, we provide three different examples of employing software analytics. First, we show how analysis of real-world usage data can be used to assess user dynamic behaviour and adoption trends of a software system by revealing valuable information on how software systems are used in practice. Second, we have created a lifecycle model that synthesizes knowledge from software development artifacts, such as reported issues, source code, discussions, community contributions, etc. Lifecycle models capture the dynamic nature of how various development artifacts change over time in an annotated graphical form that can be easily understood and communicated. We demonstrate how lifecycle models can be generated and present industrial case studies where we apply these models to assess the code review process of three different projects. Third, we present a developer-centric approach to issue tracking that aims to reduce information overload and improve developers’ situational awareness. Our approach is motivated by a grounded theory study of developer interviews, which suggests that customized views of a project’s repositories that are tailored to developer-specific tasks can help developers better track their progress and understand the surrounding technical context of their working environments. We have created a model of the kinds of information elements that developers feel are essential in completing their daily tasks, and from this model we have developed a prototype tool organized around developer-specific customized dashboards. The results of these three studies show that software analytics can inform evidence-based decisions related to user adoption of a software project, code review processes, and improved developers’ awareness on their daily tasks and activities
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