An orthopaedic medical device refers to a part, implant, prosthetic or orthotic which is used to address damage to the body's musculoskeletal system, primarily by providing stability and mobility. Orthopaedic medical devices play a role in injury-related disorders, which have been highlighted as a key element of the quadruple burden of disease in South Africa. In this thesis, orthopaedic devices are conceptualised as a technological field and a technological innovation system (TIS) framework is applied to understand orthopaedic device development in South Africa. Knowledge development and knowledge diffusion are fundamental components of any innovation system. The thesis hypothesises that the functions “knowledge development” and “knowledge diffusion through networks” of the orthopaedic devices TIS are influenced by contextual factors. The objectives of the study are: to identify the actors who generate knowledge for orthopaedic device development and to characterise the relationships between them; to identify focus areas of orthopaedic device development; to provide insight into the drivers and barriers to knowledge development and diffusion in the TIS; and to identify the contextual factors that influence knowledge dynamics in the TIS. These objectives are investigated using social network analysis based on bibliometric data (scientific publications and patents), keyword networks, a review of institutions, and a set of case studies where the primary data source are interviews with actors. Actors producing knowledge were from the university, healthcare, industry and science council sectors, although science councils played a small role. International actors were shown to bring new ideas into the TIS. The networks were fragmented, illustrating that knowledge diffusion through the networks was limited. This was especially the case in the patent networks as many actors patent in isolation. The keyword networks highlighted unrealised collaboration potential between actors based on their common research interests. The case studies revealed features of cross-sector interaction for orthopaedic device development not evident from network analysis based on bibliometric data. Drivers of knowledge development and knowledge diffusion were: inter-sectoral collaboration; the availability of resources; the affordability of available devices; and the positive externalities of allied TISs. The main barrier to knowledge development and diffusion was in the form of barriers to intersectoral collaboration. These include unmatched expectations from partners in collaboration, different views on intellectual property ownership, and burdensome university administrative processes. The orthopaedic devices TIS was structurally coupled to the embedded TIS and sectoral contexts, and externally linked and structurally coupled to its political context. Knowledge development and diffusion was found to be positively enhanced by innovation in the additive manufacturing TIS, with shared structural elements and resources. Knowledge development and diffusion was influenced by sectoral dynamics of the university, healthcare and industry sectors. This thesis makes the following contributions. First, it applies the TIS framework to a new focus area, namely medical device development, in a developing country context. Second, it makes two unique methodological contributions: it presents an index to capture the extent of sectoral collaboration in a network; and it develops a method for determining the collaboration potential of actors in a network based on cognitive distance.

Treatment and monitoring of tuberculosis have been met with various interventions to reduce its prevalence. One such intervention, to detect and prevent latent tuberculosis infection (LTBI), is the tuberculin skin test (TST), for which an induration response on a patient’s arm is an indication of LTBI. The test requires the patient to return to a clinic 48 to 72 hours after TST administration for assessment of the response. This is a challenge because of financial and accessibility obstacles, especially in under-resourced regions. A mobile health (mHealth) application (app) has been developed for remote assessment of the response to the TST. The previous version of the LTBI screening app, however, had usability limitations. The app is intended for use by patients and healthcare workers; thus, ease of use is important. There is a lack of literature on the usability of mHealth apps, especially in under-resourced settings. In this project, the user interface of the app was redesigned and tested. The Information Systems Research (ISR) framework was integrated with design thinking for this purpose. The project included creating mock-ups of the interface which were iteratively prototyped with ten student participants, adjusted, and assessed according to the user feedback. Thereafter, the Android Studio software was used to adjust the user interface based on the insights gained through the progression of prototypes. The usability of the updated app was tested and assessed with ten healthcare workers at a community health clinic in Khayelitsha in Cape Town, South Africa. Data collection and analysis comprised both qualitative and quantitative methods. Observations, the “think aloud” approach, and the post-study system usability questionnaire were used for data collection. Student participants highlighted various usability limitations of the app during each iteration. The major usability limitations included: the complex image capture protocol, misunderstanding of instructions, and time taken to capture images. Engagement with students allowed for improvement of the app interface and enabled adequate preparation for testing in the field with end-users. Furthermore, improving the app interface before engaging with healthcare workers, enabled context specific limitations that would affect the usability of the app, to be explored during the field testing. These included safety concerns when using the app and the privacy of health information. Future work should explore how these concerns, as well as other social factors, affect usability. Furthermore, improving the image capture protocol is required for improving the usability of the app.

Student engagement is a dynamic and multifaceted concept – it encompasses physical, emotional, and cognitive components. Various instruments to assess student engagement exist, however these are not intended to assess how students engage with one another and with community stakeholders in participatory health projects. Although instruments do exist to assess participation/power-sharing in participatory health projects, none of the available instruments are suitable for the assessment of student engagement in such projects. The current study set out to develop an assessment framework for student engagement in design thinking projects for health innovation. Design thinking is a human-centred and participatory approach to problem-solving. The objectives of the project were: (1) the design and implementation of a questionnaire to assess student engagement in design thinking activities, and (2) assessment of the validity of the questionnaire. A preliminary questionnaire was developed with the aid of the literature and implemented for students taking a postgraduate course called Health Innovation & Design, which follows a design thinking approach for health innovation. Analysis of students’ written reflective reports and a focus group discussion were used to revise the questionnaire items. The revised questionnaire was validated by design thinking practitioners (the course lecturer and facilitators), and further modifications were made based on their views. The assessment framework developed in this study incorporates the design thinking phases according to the IDEO design thinking approach, an educational definition of student engagement, and recommendations by students of the Health Innovation & Design course and their course lecturer and facilitators. This questionnaire may be used to assess engagement in academic settings as well as non-academic settings when design thinking is applied for health innovation.

Background LMICs account for approximately 87% of all new TB cases. Effective TB management is vital if the global end TB goals are to be achieved by 2035. The role of digital health (DH) interventions in achieving these goals are pertinent. TB treatment adherence is considered to be critical not only in successful eradication of the disease, but also in the containment of drug-resistant strains of the disease. This review set out to assess the effect of DH interventions on TB patient treatment adherence in LMICs. Methods A systematic review was conducted by searching various databases (Pubmed, Scopus, EBSCOhost Web of Science) as well as grey literature sources for literature incorporating randomized controlled trials (RCTs), cohort, or cross-sectional studies which assessed DH interventions aimed at improving TB patient treatment adherence within LMICs. Studies were included if they were reported primary outcomes related to patient treatment adherence and were published in English before 30 November 2020. The risk of bias was independently assessed using the Cochrane Risk of Bias Assessment Tool. Results Out of the 1030 articles identified through the databases, 41 articles were full text screened and eleven included in the synthesis of this review. Seven studies utilized text-based reminders, two employed electronic medication monitors, and two employed call reminders, and one involved video observed therapy (VOT). Grouped analysis of all included studies yielded a marginal improvement in positive patient treatment outcomes (RR 1.05, 95% CI 1.02 - 1.09). Conclusion DH interventions show promise in improving patient adherence and positive treatment outcomes. Current available literature remains scarce and of questionable quality. Studies incorporating a patient-centred approach which is executed according to standardized implementation procedures and outcome assessment is required.

Patient safety events are likely to be one of the ten leading causes of death and disability in the world (World Health Organization, 2020). To manage safety, healthcare organisations have traditionally focused on identifying failures, performing analysis of events, and developing strategies to reduce the failures. Several thought leaders have argued that the traditional method is not adequate to manage safety in a complex environment. Their argument is that safety management should not solely focus on what went wrong, it should also include efforts which enable things to go right more often. If healthcare organisations want to broaden their approach towards managing safety, suitable methods must be investigated. The Functional Resonance Analysis Method (FRAM) was developed by Hollnagel in 2004 and has been applied in high-risk industries such as railway, aviation, maritime and healthcare. FRAM investigates the interaction of the different functions within a complex, underspecified system, and improves the understanding of normal work and its variability (Hollnagel, 2012). This systematic review will assess the application of FRAM in healthcare settings to develop a rich understanding of the application of FRAM in healthcare as a complementary method to safety management. Firstly, understanding how FRAM was implemented within healthcare organisations and secondly understanding how healthcare organisations have perceived the value-add of FRAM in terms of safety management. The results are expected to provide healthcare organisations with guidance on applying the FRAM and demonstrate the value it potentially adds to safety management. In the studies reviewed, FRAM was applied in a wide variety of settings and in different contexts. Thematic value-added aspects were identified and discussed. Shortcomings and prerequisites for the application of FRAM was also highlighted. This dissertation wishes to motivate healthcare organisations to investigate and apply alternative methods such as FRAM to enhance their ability to manage safety in a complex environment.

Infectious diseases are a major health concern in South Africa and many other developing countries. The local development of medical devices for infectious diseases in such settings, utilizing the local knowledge base, has the potential to improve the accuracy of and access to diagnoses and to lead to the devices being more context-appropriate and affordable. The aim of this project was to examine the landscape of diagnostic medical device development targeting infectious diseases prevalent in South Africa for the period 2000-2016, particularly with regard to collaboration between institutions in different sectors and the contributions of different collaborators. Such knowledge would be beneficial to future technological and policy developments aimed at improving access to diagnostic services and treatment in the South African context. Collaboration across four sectors was considered: university, hospital, industry and science councils and facilities. A bibliometric analysis was performed, and publications documenting medical device development for diagnosis of infectious diseases were extracted. Co-authorship of the journal and conference articles was used as a proxy for collaboration across organisations. Affiliation data extracted from the publications were used to generate a collaboration network. Netdraw, a network visualisation tool, was used to visualize the network, and network metrics such as degree centrality, betweenness centrality and closeness centrality, as well as group density measures, were produced using UCINET software. The collaboration network and the network metrics were used to determine which organisations have collaborated and which collaborators have played the most active and influential roles in diagnostic device development. The university sector was found to make the largest contribution to the development of diagnostic medical devices in South Africa, and also played a key role in transmitting information throughout the network due to its high frequency of connections to other organisations. The most prevalent type of inter-sectoral collaboration was between universities and science councils and facilities, while universities were found to collaborate most amongst themselves with regard to intrasectoral collaboration. Foreign organisations played a prominent role in diagnostic device development between 2012 and 2016. Tuberculosis was the most prevalent infectious disease in diagnostic device development research, and computer-aided detection was a common feature of research on diagnostic device development.

Post mortem imaging (PMI) is increasingly being adopted as an alternative to invasive autopsies in forensic pathology. PMI can be used as a sole technique or adjunct to an autopsy. The Lodox Xmplar-dr is an X-ray imaging system that has been adopted for use in PMI. The purpose of this study was to evaluate the perceived usability of this imaging system by focusing on the satisfaction of forensic pathologists in use of the system. Assessment of satisfaction was guided by the subjective satisfaction characteristics of likability, pleasure, comfort and trust. Incorporation of user needs into updated system designs may lead to greater perceived ease of use, acceptance and adoption, resulting in increased device utilisation. The study location was the Lodox Xmplar-dr installation site at the Salt River Forensic Laboratory, Cape Town. Five forensic pathologists were observed using the Xmplar-dr system and four were interviewed on their experience using the system. A qualitative research design which used thematic analysis with the aid of NVIVO11 qualitative data analysis software was used to extract key usability and satisfaction themes emerging from the data, to show the extent of user satisfaction. Two key themes emerged. These were categorised as forensic pathologist-related, which focused on the hedonistic and subjective aspects of their satisfaction with the system, and systemrelated, which centred on the satisfaction users derived from the system’s ability to meet their pragmatic and objective expectations in their use of the system. In general, the forensic pathologists were satisfied with the Xmplar-dr system and it exceeded their expectations. Pleasure was derived from the ability of the system to increase work throughput by reducing the need to perform a dissectional post-mortem unless it was deemed absolutely necessary, i.e. when cause of death could not be determined from the X-ray images generated by the system. Participants felt that the system was an indispensable device when performing post mortems. Likability came from the ease of learning to use the basic functions of the system; the study participants stated that the system aided them in determining cause of death and saved time, in line with the definition of the likability characteristic that is centred on the extent to which a user is satisfied with perceived achievements of pragmatic goals. Trust was derived from participants’ views that the system worked as intended, although there could be improvements in terms of robustness, reliability and the imaging system`s support services. Image manipulation on the human-computer interface (HCI) and image representation were concerns highlighted. Most functions could be performed through the system’s HCI rather than by manipulation of the body being examined; this increased the physical comfort satisfaction characteristic. The need for manual placement of bodies on the system`s table by assistants and the associated health consequences were however raised as a concern that diminished the comfort-in-use characteristic of satisfaction. Understanding the user experience of the forensic pathologists who use the Lodox Xmplar-dr system to perform post mortems enabled the identification of areas for improvement. The improvements may increase user satisfaction resulting in better utilisation of the imaging system. The insights gained may be useful for the design of other imaging systems used in forensic pathology.

Three studies were conducted to examine the role of psychosocial factors in the prediction of health innovation uptake. A health innovation is a device, treatment or altered food product intended to improve the health of an individual or group and considered new by the population of interest. Health innovations may be used to address current health problems in individuals but also play a key role in preventative health efforts. Encouraging individuals to adopt appropriate health innovations is often an important strategy in improving the general health and minimising the social cost of illness of a population. The current program of research examined the influence of predictors from the Theory of Planned Behaviour (TPB; Ajzen, 1991), the Technology Acceptance Model (TAM; Davis, 1989; Davis, Bagozzi, & Warshaw, 1989), and risk technology literature (Fischhoff, Slovic, Lichtenstein, Read, & Combs, 1978; Slovic, 1987; Slovic, Fischhoff, & Lichtenstein, 1980) on health innovation decision-making. Additionally, the study examined the background factors of previous experience with the innovation, age, and gender. Guided by the overall conceptualisations of change presented in the Stages of Change Model (Prochaska & DiClemente, 1984; Prochaska & Velicer, 1997) and the Innovation Decision Model (Rogers, 1958, 2003), the three studies aimed to examine the role of the proposed predictors for a number of different innovations at various stages of diffusion. Study 1 (N = 358) employed a correlational design to predict people's intentions and willingness to use the four health innovations of functional foods, vitamin supplements, alternative therapies and pedometers. Participants completed questionnaires based on the TPB examining attitude (favourability towards the innovation), subjective norms (pressure from others for innovation uptake) and perceived behavioural control (PBC; sense of control over adopting the innovation). In addition, participants completed items assessing the constructs of usefulness of the innovation and ease of use of the innovation from the TAM and familiarity of risks and dread of risks associated with the innovation, adapted from the risk literature. Background factors, such as previous innovation use and age and gender of the participants, were also examined. The underlying behavioural, normative, and control belief constructs of the TPB were examined to differentiate between those participants who reported that they were intending to or willing to adopt the health innovation and those who were not intending to or willing to adopt the health innovation. Overall, the results of Study 1 supported the TPB constructs, perceived usefulness from the TAM, and risk familiarity. Study 2 (N = 102) utilized an experimental design where usefulness of the four innovations examined in Study 1 and the familiarity of risks associated with them were manipulated in a 2 x 2 scenario based study. As in Study 1, participants completed measures of the TPB factors, an assessment of the dread of risk and reported background factors such as previous innovation use, and their age and gender. Participants read reports of 'recent research' that contained information about the innovations' usefulness in relation to health benefit and familiarity of risk in comparison to traditional health products. As in Study 1, people's intentions and willingness to use the health innovations were examined, as was a third outcome measure; participant predicted future use of each innovation. The results of Study 2 provided support for the TPB constructs of attitude and subjective norms. The study also provided limited support for the TAM factor of usefulness, as well as for the risk dimensions of familiarity of risks and dread of risks. The TPB construct of PBC and the background factors of age and gender were not supported. Study 3 (N = 116) employed a 2 x 2 between-subjects design where usefulness and dread of risks were manipulated for a previously unavailable health innovation, calcium enriched mints. Study 3 also involved a within-subjects measurement of two behaviour measures (estimated consumption, and a diary recorded measure of consumption) over three time periods. Intention was retained as a third uptake measure of innovation uptake. Participants were presented with manipulated information about the usefulness and dread of risks associated with calcium enriched mints. Study 3 examined the role of the manipulated constructs, the TPB factors, familiarity of risk, and demographics in the prediction of the enriched mints uptake. The design of this study addressed limitations identified in the literature and mirrored a number of authentic health innovation uptake situations. The results of Study 3 strongly supported the role of attitude and subjective norms as influential predictors of intention to consume the calcium enriched mints, and intention as a predictor of estimated and diary recorded measures of consumption. The study offered limited support for the risk factors of familiarity of risks and dread of risks and did not support the TAM construct of usefulness as a predictor of calcium enriched mint uptake. Taken together, the results of this research provided strong support for the role of the TPB factors of attitude and subjective norms, but not PBC, as predictors of health innovation intentions and willingness. The results also supported the role of intention as a predictor of health innovation adoption behaviour. Limited support was found for the risk dimensions of familiarity of risks and dread of risks, suggesting that another conceptualisation of risk may be more appropriate for health innovation decision-making. The results found little support for the TAM variables of usefulness and ease of use, or the influence of demographic characteristics of age and gender. These findings indicate that the general decision-making model of the TPB, with the exception of the role of PBC, provides a useful framework to understand people's health innovation decision-making. Given the limited support for PBC in the prediction of intentions and behaviour in this context, the Theory of Reasoned Action (Fishbein & Ajzen, 1975), with some consideration of risk factors, may be an appropriate approach to adopt to facilitate an understanding the factors underlying people's decision to use innovations designed to improve their health.

Innovation in healthcare is a central way of coping with the changes affecting the healthcare system through the megatrends of demographic change, digitalization as well as the opportunities in the life-sciences sector and the “-omics” subjects. Due to the multiple facets of the topic, research on innovation in healthcare is diverse and draws insights from systems theory, management theory, human resources, innovation and change management. While the literature on innovation in healthcare has grown steadily in the last 20 years and publications on pharmaceutical and medical device innovation, health technology assessment strategies, or digital innovations have increased significantly, other areas such as sectoral health innovation systems, the creation and implementation of innovation in hospitals still remain fairly uncharted. Applying established concepts such as systems of innovation theory, mass customization theory or management of employee involvement in innovation activities to the healthcare sector provides new insights into a field that is often considered a “blackbox”. This thesis adds to the topic in three essays, each focusing on a different aspect and depth level ranging from a macro perspective on healthcare innovation on a global scale to a meso level perspective on the implementation of personalized medicine in one country and putting a micro lens on innovation activities of hospital staff. The aim of this thesis is to provide an overview for researchers, policy makers and healthcare stakeholders about current developments, propose tools for measuring innovation and allow for benchmarking the current status quo in healthcare in order to foster new and innovative developments.

A área da saúde é considerada um dos setores econômicos mais dinâmico em termos de inovação e de acumulação de capital. Desta forma, a compreensão de sua estrutura e funcionamento é indispensável para a construção de políticas efetivas de promoção do bem-estar e do desenvolvimento dos países no âmbito dos Sistemas de Inovação em Saúde (SIS). O progresso tecnológico do setor de saúde vincula-se fortemente à ciência, tendo o advento da biotecnologia moderna acentuado a relação entre ciência e tecnologia para a pesquisa e a inovação médica, sendo que a inovação na área da saúde depende de pesquisas interdisciplinares e das interações entre indústrias e universidades, especialmente centros médicos acadêmicos, que atuam como centros de convergência de fluxos de informação científica e tecnológica. As pesquisas médica e biomédica no Brasil, a despeito de seu progresso em publicações científicas, apresentam caráter predominantemente acadêmico devido, em parte, ao fato de não existir suporte adequado à proteção à propriedade intelectual e ao reconhecimento de patentes no país. Neste sentido, a presente pesquisa tem como objetivo verificar como um empreendimento de base biotecnológica do segmento de fármacos é influenciado pelo SIS onde está inserido, tomando-se como objeto de estudo uma empresa desenvolvedora de produtos para oncologia, identificada aqui com o nome fictício de BIOTEC. Para tanto, foi realizado um estudo qualitativo e exploratório de caso único em duas etapas, a primeira envolvendo pesquisas em fontes de dados secundários e a segunda composta por entrevistas em profundidade com uma das empreendedoras da empresa BIOTEC e com a Gerente da Incubadora Empresarial do Centro de Biotecnologia da UFRGS (IECBiot), um dos parceiros da empresa e um importante ator dentro do Sistema Regional de Inovação em Saúde do Rio Grande do Sul (SRIS-RS). A partir das respostas obtidas, foi possível compreender como se dá a interação da empresa com outros atores do SIS brasileiro, em nível nacional e regional. Verificou-se também que,devido à existência de obstáculos associados ao excesso de burocracia e à dificuldade de ao acesso a fomento e incentivos no estado do RS, este não apresenta um ambiente propício ao desenvolvimento de empresas com o perfil da BIOTEC e que, apesar de existirem esforços do governo estadual em melhorar a situação do SRIS-RS, estas ainda se encontram aquém do necessário, fazendo com que, muitas vezes, as empresas optem por buscar ambientes mais favoráveis aos negócios. / The healthcare sector is one of the most dynamic sectors of the economy in terms of innovation and capital accumulation. Thus, understanding its structure and operation is essential for building effective policies to promote the welfare and development of countries under the health innovation systems (SIS). Technological progress in the healthcare sector binds strongly to science, with the advent of modern biotechnology marking the relationship between science and technology for research and medical innovation. Innovation in healthcare depends on interdisciplinary research and interactions between industries and universities, especially academic medical centers, which act as convergence centers of scientific and technological information flows. The medical and biomedical research in Brazil, despite its progress in scientific publications, have predominantly academic character, in part due to the fact that there isn’t adequate support for intellectual property protection and recognition of patents in the country. This way, this research aims to check how a biotechnology-based enterprise, focused on the production of drugs, is influenced by the HIS where it’s localized, taking as object of study a company that develops products for oncology, here identified with the fictitious name of BIOTEC. Therefore, it was conducted a qualitative and exploratory study of a single case in two stages, the first involving research on secondary data sources, and the second consisting of interviews with the entrepreneurs of BIOTEC company and the manager of the Business Incubator of the Biotechnology Center from UFRGS (IECBiot), one of the company partners and a major player within the health regional innovation system in the Rio Grande do Sul (SRIS-RS). From the answers obtained, it was possible to understand how is the company's interaction with the other actors of SIS, at the national and regional level. It was also found that, due to barriers associated with excessive bureaucracy and the difficulty to access finance promotion and incentives, the Rio Grande do Sul state doesn’t provide an appropriate environment to the development of companies with the BIOTEC’s profile. Although there are government efforts to improve the situation of SRIS-RS, they are still insufficient, which often make the companies choose to seek more favorable environments for business.