Les changements technologiques ont des effets structurants sur l’organisation des soins dans notre système de santé. Les professionnels de la santé et les patients – les principaux utilisateurs des innovations médicales – sont des acteurs clés dans les trajectoires suivies par les nouvelles technologies en santé. Pour développer des technologies médicales plus efficaces, sécuritaires et conviviales, plusieurs proposent d’intensifier la collaboration entre les utilisateurs et les développeurs. Cette recherche s’intéresse à cette prémisse sur la participation des utilisateurs dans les processus d’innovation médicale. L'objectif général de cette recherche est de mieux comprendre la collaboration entre les utilisateurs et les développeurs impliqués dans la transformation des innovations médicales. Adoptant un cadre d’analyse sociotechnique, cette thèse par articles s’articule autour de trois objectifs : 1) décrire comment la littérature scientifique définit les objectifs, les méthodes et les enjeux de l’engagement des utilisateurs dans le développement des innovations médicales; 2) analyser les perspectives d’utilisateurs et de développeurs de technologies médicales quant à leur collaboration dans le processus d’innovation; et 3) analyser comment sont mobilisés, en pratique, des utilisateurs dans le développement d’une innovation médicale. Le premier objectif s’appuie sur une synthèse structurée des écrits scientifiques (n=101) portant sur le phénomène de la participation des utilisateurs dans les processus d’innovation médicale. Cette synthèse a dégagé les méthodes appliquées ou proposées pour faire participer les utilisateurs, les arguments normatifs véhiculés ainsi que les principaux enjeux soulevés. Le deuxième objectif repose sur l’analyse de trois groupes de discussion délibératifs et d'une plénière impliquant des utilisateurs et des développeurs (n=19) de technologies médicales. L’analyse a permis d’examiner leurs perspectives à l'égard de diverses approches de collaboration dans les processus d'innovation. Le troisième objectif implique l’étude d’une innovation en électrophysiologie lors de la phase de recherche clinique. Cette étude de cas unique s'appuie sur une analyse qualitative d'études cliniques (n=57) et des éditoriaux et synthèses de connaissances dans des revues médicales spécialisées (n=15) couvrant une période de dix ans (1999 à 2008) ainsi que des entrevues semi-dirigées avec des acteurs clés impliqués dans le processus d’innovation (n=3). Cette étude a permis de mieux comprendre comment des utilisateurs donne un sens, s’approprient et légitiment une innovation médicale en contexte de recherche clinique. La contribution générale de cette thèse consiste en une meilleure compréhension de l’apport des utilisateurs dans les processus d’innovation médicale et de sa capacité à aligner plus efficacement le développement technologique avec les objectifs du système de santé. / Technological changes have major effects on health care organization. Health professionals and patients – the main users of medical innovations – are key actors in the ongoing development and refinement of new medical technologies. To develop more efficient, safe and user-friendly medical technologies, many propose enhancing collaboration between technology users and developers. This research investigates the premise of involving users in the medical innovation process. The main objective of this research is to better understand the collaboration between users and developers involved in the transformation of medical innovations. Adopting a sociotechnical approach, this thesis by article has three objectives: 1) Describe how the literature defines the objectives, methods and issues of engaging users in the development of medical innovations; 2) Analyze the perspectives of users and developers of medical technologies with regards to their collaboration in the innovation process; and 3) Analyze how users are mobilized in practice in the development of medical innovation. The first objective is addressed by a narrative synthesis of the scientific literature (n=101) on user involvement in the medical innovation process. This synthesis has identified the methods used or proposed, normative arguments conveyed, and the main issues raised by involving users. Analysis of data from three deliberative focus groups and a plenary involving users and developers (n=19) of medical technology were employed to address the second objective. The analysis details their perspectives on various modes of collaboration in the innovation process. The third objective involves a case study of an innovation in electrophysiology at the clinical research phase. This case study is based on a qualitative analysis of clinical studies (n=57), editorials and reviews in medical journals (n=15) covering a ten year period (1999-2008) and semi-structured interviews with key actors involved in the innovation process (n=3). This study provides insight into how users make sense of, appropriate and legitimize medical innovation in the context of clinical research. The overall contribution of this thesis is a better understanding of user involvement in the medical innovation process and how to more effectively align technological development with the objectives of the health system.

Large resources are invested in healthcare research, but despite this there is a wide gap between research knowledge and healthcare practice. Implementation researchers have addressed this gap, focusing mostly on the role of healthcare practitioners. However, a narrow focus on implementation does not take into consideration the preceding stages and the roles of different actors during the whole innovation process, which starts from research and ends with implementation. The aim of this thesis is to examine the behaviors of three key actors during an innovation process and to explore the influence of selected contextual factors on their behavior. Study I (n=10 funders) identifies several facilitative roles for funders and suggests that implementation risks becoming no one’s responsibility as the funders identify six different actors responsible for implementation, the majority of whom embody a collective or an organization. Study II finds that the implementation knowledge of Swedish funding managers (n=18) is mostly based on experience-based knowledge. The majority of the funding managers define implementation as a process and express limited knowledge of implementation. The findings of Study III (n=4 innovation cases) show that the roles and involvement of academic inventors and ISAs (innovation-supporting actors) are more connected to intellectual property (IP) nature than to intellectual property rights (IPR) ownership. Study IV (n=4 innovation cases) identifies three different logics that influence the behavior of academic inventors: market, academic and care logics. A pattern emerges where the behavior of academic inventors is guided by a unique logic and there is no interaction between logics, despite the existence of multiple logics. The individual strategies to handle multiple logics coincide with the influence of logics. In addition, IP nature, distinguishing between high-tech and low-tech innovations, is connected to the influence of institutional logics: low-tech connected to the care logic and high-tech connected to the market logic. This thesis has three main theoretical and practical implications relevant for practitioners, policymakers and researchers. First, implementation responsibility is an important issue to study and discuss, because without clearly defined responsibilities and management of responsibilities, responsibility might become no one’s responsibility. Second, the finding that experience-based implementation knowledge contributes heavily to policymakers’ knowledge encourages further studies and discussions regarding this relatively neglected issue. Third, the importance of IP nature in shaping innovation processes should be considered and further examined, not only as a factor influencing inventors and ISAs’ roles and involvement, but also as influencing the prevalence of different institutional logics. Further, the relevance of a distinction between low-tech and high-tech IP should be reflected on.

Made available in DSpace on 2016-04-29T13:31:33Z (GMT). No. of bitstreams: 1 Maria Cecilia Chimenti.pdf: 694392 bytes, checksum: fe0a0a7dc42878e8369d2cd5cd1e1d88 (MD5) Previous issue date: 2007-06-11 / The objetive of this research is to study the identity of the chronic cardiac pacient taking into account mainly the sense atributed to the medical technology treatment in the cardiac transplant one. It was intended to analyse the coping process when undertaking a treatment using technology. At the same time, to investigate whether this could exclude the coping process through religiosity. Furthermore, if both process co-exist, to understand how this movement acquires or not an emancipation sense in the transformation of the transplant patient s identity. A contextual research on medical technology and health practice in the contemporary society was carried out especially in the cardiac transplant patient. The method adopted for this qualitative research used the study case by means of the analysis of the narratives of three life histories of non congenital cardiac transplant patients with multiple cardiophaties, in the ligth of theoritical approach of Identity-Metamorphosis of Ciampa and the post metaphysics ideas of Habermas, contributing this way towards the research in the area of Social Psychology. The technique is considered to be necessary but not enough, thus there is a need to search for a meaning which will hardly be offered by tecnology. It was observed that the tecnique interferes significantly in the identity methamorphosis process. As well as that, the patients take religion as way of coping in order to give them a possible emancipation sense to their new identity / O objetivo desta pesquisa é estudar a identidade do paciente cardiopata crônico, considerando, em especial, sentido atribuído à medicalização no transplante cardíaco. Pretendeu-se analisar o processo de enfrentamento pela medicalização através da tecnologia, investigando se esse exclui o enfrentamento através da religiosidade e, no caso de coexistirem, de que forma se dá esta relação, buscando-se entender como este movimento adquire, ou não, sentido emancipatório na transformação da identidade do sujeito transplantado. Foi realizado um levantamento contextual sobre a medicalização e a prática de saúde na sociedade contemporânea, especificamente, no transplantado cardíaco. O método adotado para esta pesquisa qualitativa utilizou o estudo de caso com a análise das narrativas de histórias de vida de três sujeitos transplantados cardíacos não congênitos e com múltiplas cardiopatias, à luz da abordagem teórica da Identidade-Metamorfose de Ciampa e do pensamento pós metafísico de Habermas. Propõe-se que a técnica é necessária, mas não suficiente havendo a necessidade da busca de um sentido que dificilmente pode ser oferecido pela tecnologia. Verificou-se, nos casos estudados, que a técnica interfere significativamente no processo de metamorfose da identidade, bem como, que os sujeitos buscam na religião uma forma de enfrentamento que lhes ofereça um sentido emancipatório possível à nova identidade

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution (Barros 2013) is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality (i.e. differences in effectiveness or efficiency). The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function (i.e. testimonial evidence and evidence of mechanisms) is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies. / <p>QC 20150312</p>

The potential for private sector healthcare business in Africa has been forecasted to reach $35 billion by 2016, with South Africa being regarded as the most industrially advanced country on the continent. South Africa’s entry to modern biotechnology is fairly recent, though, with companies in the private sector still in a developmental phase, and most having limited bioproduct ranges. While considerable research has been conducted in the past to attempt to define the biotechnology environment of South Africa, as yet, a concise overview is lacking. In particular, a synopsis of the biomedical or commercial health technology environment has not been forthcoming for entrepreneurs to refer to as a ‘roadmap’. The purpose of this study was to perform a comprehensive study on the attributes that should be met for a successful, sustainable health technology venture (HTV) to be started in South Africa; while identifying the opportunities and threats that have existed in the South African market; thereby, affecting their success and sustainability to date. In this study, two phases of research were conducted. The first was a small-sampled mixed-methods (both qualitative and quantitative) study involving 21 medical devices, biogenerics, diagnostics, and contract services companies. The second was a quantitative study, involving 107 vaccines, biogenerics, therapeutics, nutraceuticals, reagents, diagnostics, medical devices, biotools, contract services and public services companies. Inferential statistical tests were conducted on the data, including Pearson’s Chi-Square, ANOVA, bivariate correlation, linear regression, logistic regression and multinomial logistic regression. From the study, the overall proportion of business sustainability for HTVs was found to be 66.7%, and at least 30% were unsustainable (or not yet at a level of sustainability). Variations were observed in the overall rate of sustainability for companies, based on their core functional classification, location, production type, size and start-up or R&D spending. By converting the observed frequencies of activity level, as an indication of sustainability, into a probability, it was possible to observe the company type that was most, and least likely to succeed in South Africa. Based on the statistical observations in this study, the HTV type most likely to succeed in South Africa, with a 63.7% probability of reaching sustainability, is a ‘vaccines’, ‘biotools’ or ‘public services’ company from Johannesburg with at least 20 employees; that has developed its goods or services internally, but manufactured externally and spent between R20 million–and–R30 million on its R&D or start-up. Conversely, least likely to succeed (3.2% probability) is a nutraceutical company from Cape Town with between six and 20 employees, that has developed and produced internally, and which has spent between R1 million–and–R10million on its start-up. / Life and Consumer Sciences / M. Sc. (Life Sciences)

Detta arbete beskriver en examensuppsats i datateknik på Linnéuniversitetet. Röntgenavdelningen på SUS, Skånes Universitetssjukhus i Lund, använder en lättviktig flyttbar röntgenmaskin som väger endast cirka 90 kg, för röntgenundersökningar ute på äldreboenden. Bilderna överförs till sjukhusets PACS när maskinen är tillbaka på sjukhuset, genom att man kopplar in Dragon via kabel till sjukhusets nätverk. Målsättningen är att förbättra den trådlösa kommunikationen som för närvarande är för långsam och opålitlig, så att bilderna kan överföras till sjukhusets PACS direkt efter undersökningen. I detta arbete beskrivs vilka alternativ som kan användas. Samt om de mobila bredbandstjänster som finns tillgängliga i Region Skåne är bra nog för att kunna användas för uppgiften. Slutsatsen är att ett 3G HSDPA/HSUPA abonnemang kan vara tillförlitligt nog. Framför allt om extra redundans tillförs med dubbla SIM-kort som använder separata nät och att signalen förstärks med antenn placerad utomhus på transportfordonet. Transportfordonet används som brygga mellan Wifi och mobilt nätverk. Röntgenmaskinen kommunicerar med transportfordonet via Wifi. För de fall Wifi inte fungerar på grund av byggnader och omgivande miljö arbetades ett reservalternativ fram. Jag har också undersökt och jämfört DICOM protokollet mot FTP. Detta för att se om DICOM har en overhead som skulle motivera användet av FTP istället för sändning av bilder. Resultatet av jämförelsen visade att DICOM har 5-10 % overhead jämfört med FTP. / This abstract describes a degree project in computer engineering at Linnaeus University. The Department of Radiology at SUS, Skåne University Hospital in Lund, is using a lightweight portable x-ray machine that weights about 90 kg, for radiography services in nursing homes for elders. The images are transferred to hospital PACS when the machine returns to the hospital, this is done with Dragon connecting to hospital network via wire. The goal is to improve the currently too slow and unreliable wireless communication, so the images can be transferred to hospital PACS directly after examination. This report describes what alternatives can be used and investigates whether the mobile broadband services currently available in Skåne County are good enough to be relied on for the task. The conclusion is that a 3G HSDPA/HSUPA subscription can be used reliably enough, if extra redundancy is added via dual SIM cards using separate mobile networks and the signal is strengthen by an antenna placed outdoors on the transport vehicle. The transport vehicle is used as a bridge between Wifi and mobile networks. The mobile x-ray machine communicates with the transport vehicle via Wifi. In those cases Wifi does not work due to difficult building environments, a backup solution was worked out to be used. I also investigated and compared the DICOM protocol against FTP. This was to find out if DICOM has an overhead that would motivate using FTP instead for the transmission of the images, the result of the comparison showed that DICOM has an 5-10 % overhead compared with FTP. / Mobil röntgen Skånes Universitetssjukhus Lund

Ämnet för uppsatsen grundar sig i en ökad efterfrågan av att kunna införa teknik och informationsteknik (IT), som är testad och anpassad för en verksamhet redan innan införandet. Vidare finns det ett behov av att, genom nya innovationer, uppnå långsiktiga strategiska mål inom vård och omsorg. Därför har Sveriges innovationsmyndighet Vinnova startat en satsning på testbäddar inom vård och omsorg. En testbädd kan liknas vid en innovations- och testmiljö där samarbete mellan vårdpersonal, företag och forskning kan ske för att ta fram produkter, processer och tjänster som är anpassade till den miljö där dessa sedan ska tillämpas. Denna studie berör hur utveckling och organisering av en innovations- och testmiljö kan gå till och vilka utmaningar som finns. Vidare tar vi upp intressenters roller och behov i utvecklingen samt hur innovation kan stimuleras i en organisation. Detta har genomförts med hjälp av en fallstudie kring utvecklingen av en testbädd i Landstinget i Östergötland (LIÖ). Teorier inom områdena intressenter, utveckling och innovation används för att stödja analysen och skapa förståelse för vissa begrepp. Den empiriska undersökningen utförs genom semistrukturerade intervjuer med representanter från olika intressentgrupper till testbädd LIÖ. Analysen genomförs även med hjälp av dokumentstudier som en del i den empiriska undersökningen. Det empiriska materialet diskuteras i relation till den teoretiska referensramen för att uppnå ett kunskapsbidrag i form av en slutsats. Denna berör hur en innovations- och testmiljö kan utvecklas och organiseras, intressenternas roll och behov i utvecklingen samt hur innovationer kan genereras och utvecklas i organisationer. Med fallets hjälp kan praktiken ge ny kunskap om dessa områden inför kommande utvecklingsprojekt av liknande karaktär. / The topic of this paper is based on an increased demand for the introduction of technology and information technology (IT), which is better tested and adapted for a business before the implementation. Furthermore, there is a need that through new innovations, achieve long-term strategic objectives in the care sector. Therefore, the Swedish innovation agency Vinnova started a venture in test beds in healthcare. A test bed can be likened to an innovation and testing environment. In these, collaboration between healthcare professionals, businesses and research is done to develop products, processes and services that are adapted to the environment in which they are then applied. This study concerns the development and organization of an innovation- and testing environment and what the challenges are. It also concerns the roles and the needs of the stakeholders in the development and how innovation can be achieved in an organization. This has been studied by a case concerning the development of the testbed LIÖ in Östergötland County Council. Theories in the fields of stakeholders, development and innovation are used to support the analysis around these parts, and to create an understanding of some concepts. The empirical study is carried out through semi-structured interviews with representatives from various stakeholder groups to testbed LIÖ. The analysis is also carried out with the help of document studies as part of the empirical investigation. The empirical data are discussed in relation to the theoretical framework for achieving a knowledge contribution in the form of a conclusion. This affects how an innovation and test environment can be developed and organized, stakeholder roles and needs of the development and how innovations can be generated and developed in organizations. The study of the case can provide new knowledge in these areas for future development projects of similar nature.

Since 1994, the Public Procurement Act has undergone changes aimed to improve the procurement process and promoting innovation. In order to promote innovation there are a number of government agencies that offer financial assistance, especially to small business with innovative ideas. Despite these efforts, newly established small businesses have difficulties entering the market. The study investigates whether changes have been made in the public procurement of medical devices with regard to price and quality prioritization. The priority criteria is presented by the contracting authority as percentage in the allocation criteria. The study is limited to in vitro diagnostic products contracting in Swedish healthcare between the years 2009 and 2015. All tenders, companies that apply for participation in procurement, were analyzed based on sales, number of employees and year of establishment with the purpose of evaluating differences between winning tenders and other tenders. The result shows that prioritization has been increasingly on price rather than the quality. Regarding the winning tenders the study shows that larger, more established companies dominates the market. Noteworthy is that this dominance has increased over theses last years. The increase may be due to a spiral effect that is created when winning tenders get an increased economic power.

Digital innovation is a key to solve problems of future healthcare. Medical Technology (MedTech) firms will have to employ successful digital business strategies (DBSs) to become innovative and increase the efficiency to solve the problems in healthcare. This thesis aims to outline important aspects when employing a DBS in a MedTech firm. The results are based on empirical data from consultants working with digital strategies as well as professionals working in the MedTech industry. I conduct semi-structured interviews with 11 professionals of different backgrounds to gain their perspectives and insights on how to successfully implement a DBS in an organisation. I discuss and conclude their opinions concerning the business model and change management aspects of a DBS. The focal point of this thesis was partially led by my commissioner, Human Care. From the literature review and interviews, I introduce several interesting findings which can be helpful for both management of MedTech firms as well as consultants working with DBSs. Some of the findings contributing to successful DBSs includes improving the organisation’s innovative ability and creating opportunities for new innovations. This can be done by working more agile, introducing new competences and co-innovating with customers of the firm. Furthermore, the DBS can change firms’ business models. Interviewees find that the impact can be minor or extensive depending on the DBS employed and can ultimately lead to entire new business models being created. The DBS can have disruptive impact on incumbent firms’ current business and create completely new products or services. Management must correctly evaluate their current position and future desired state to develop a strategy fit for their specific firm. Finally, I find that there is a clear correlation between the changes in the business model and the change management work when implementing a DBS. I present some areas that management of MedTech firms must attend in order to increase the chances of success in their DBS. / Digital innovation är nyckeln till att lösa problem inom sjukvården. Medicinteknikbolag måste använda sig av digitala affärsstrategier för att öka effektiviteten och lösa problem som sjukvården väntas möta i framtiden. Denna rapport syftar till att delge viktiga aspekter när man använder sig av och utformar digitala affärsstrategier inom medicinteknikbolag. Resultaten är baserade på empiriska data från konsulter som jobbar med digitala strategier samt personer yrkesverksamma inom medicinteknik. Jag har genomfört 11 intervjuer med personer med olika bakgrund för att få deras perspektiv och insikter om hur man framgångsrikt använder sig av digitala affärsstrategier i en organisation. Jag diskuterar och sammanfattar deras åsikter rörande affärsmodeller och förändringsledningsarbete relaterat till digitala affärsstrategier. Denna rapports utformning är delvis ledd av min uppdragsgivare, Human Care. Resultaten från litteraturgenomgången och intervjuerna visar att företags innovationsförmåga och att skapa förutsättningar för innovation är viktiga aspekter för framgång. Detta sker genom att ändra organisationens sätt att arbeta på, genom agila arbetsmetoder, nya kompetenser och kan leda till att helt nya affärsmodeller skapas. Strategin kan vara disruptiv för företags nuvarande affär och skapa helt nya produkter och/eller tjänster. Ledningen måste utvärdera sin nuvarande situation och framtida målbild för att utforma väl anpassade strategier för bolaget. Jag finner att det finns en tydlig koppling mellan ändringar i affärsmodellen och förändringsarbetet när man implementerar en digital affärsstrategi. Jag introducerar några områden som ledningen måste se över för att öka chansen till framgång i strategin.

More and more aspects of today’s healthcare are becoming integrated with medical technology and dependent on medical IT systems, which consequently puts stricter re-quirements on the companies delivering these solutions. As a result, companies delivering medical technology solutions need to spend a lot of resources maintaining high-quality, responsive customer support. In this report, possible ways of increasing customer support efficiency using machine learning and NLP is examined at Sectra, a medical technology company. This is done through a qualitative case study, where empirical data collection methods are used to elicit requirements and find ways of adding decision support. Next, a prototype is built featuring a ticket recommendation system powered by GPT-3 and based on 65 000 available support tickets, which is integrated with the customer supports workflow. Lastly, this is evaluated by having six end users test the prototype for five weeks, followed by a qualitative evaluation consisting of interviews, and a quantitative measurement of the user-perceivedusability of the proposed prototype. The results show some support that machine learning can be used to create decision support in a customer support context, as six out of six test users believed that their long-term efficiency could improve using the prototype in terms of reducing the average ticket resolution time. However, one out of the six test users expressed some skepticism towards the relevance of the recommendations generated by the system, indicating that improvements to the model must be made. The study also indicates that the use of state-of-the-art NLP models for semantic textual similarity can possibly outperform keyword searches.