The role of user requirements research in medical device development

Aims and Objectives: This research aims to suggest a concise framework to help in the better conceptualisation and integration of users in the medical device development (MDD) process. The current economic, political and social climate concerning the matter of healthcare delivery has resulted in the emergence of numerous users and user groups for whom the healthcare system has not previously catered for. These users have created ambiguity for the designers and manufacturers of medical devices as the boundaries between their needs and requirements have blurred, outdating current methods of MDD to meet consumer needs. Research Design and Methodology: The research methodology begins primarily with conducting a literature search on the theories relating to user requirements and medical device development. The paper outlines these findings through initially describing users and user involvement and relating them to medical devices. The cross-disciplinary nature of healthcare influenced the investigation into multiple disciplines including; IT, Ergonomics – particularly participatory research, Psychology and Design. These disciplines expose various methods and processes, which are useful to user requirements research. These methods were analysed for their compatibility, and then used to construct a conceptual framework for user involvement in MDD. Results: The research insinuates the true significance of user involvement and hence resulted in the formation of a conceptual framework to aid user involvement in the MDD process. The framework is produced by the amalgamation of relevant methods examined across the disciplines, in a complimentary fashion. Conclusion: The originality of this research lies in its use of a multidisciplinary approach. Previous research claiming multi-methods has dealt with combining two disciplines or methods at a time i.e. Computer supported cooperative work (CSCW) with participatory research (Scandurra et al, 2008) for the needs analysis of healthcare professionals only. Collaboration across disciplines has also been investigated (Johnson et al, 2005), but this was for the purpose of redesign rather than initial designs. This framework can help medical device designers to fully access all user requirements through more extensive collaboration right at the start. It reduces the risk of high costs involved in device rejection, usually associated with belated recognition of user needs in the design cycle

A multi-disciplinary perspective on the built environment: Space Syntax and cartography – the communication challenge

8-11 June 2009

Revealing the Vicious Circle of Disengaged User Acceptance: A SaaS Provider's Perspective

User acceptance tests (UAT) are an integral part of many different software engineering methodologies. In this paper, we examine the influence of UATs on the relationship between users and Software-as-a-Service (SaaS) applications, which are continuously delivered rather than rolled out during a one-off signoff process. Based on an exploratory qualitative field study at a multinational SaaS provider in Denmark, we show that UATs often address the wrong problem in that positive user acceptance may actually indicate a negative user experience. Hence, SaaS providers should be careful not to rest on what we term disengaged user acceptance. Instead, we outline an approach that purposefully queries users for ambivalent emotions that evoke constructive criticism, in order to facilitate a discourse that favors the continuous innovation of a SaaS system. We discuss theoretical and practical implications of our approach for the study of user engagement in testing SaaS applications

Pan-European backcasting exercise, enriched with regional perspective, and including a list of short-term policy options

This deliverable reports on the results of the third and final pan-European stakeholder meeting and secondly, on the enrichment with a Pilot Area and regional perspective. The main emphasis is on backcasting as a means to arrive at long-term strategies and short-term (policy) actions

Shotguns vs Lasers: Identifying barriers and facilitators to scaling-up plant molecular farming for high-value health products.

Plant molecular farming (PMF) is a convenient and cost-effective way to produce high-value recombinant proteins that can be used in the production of a range of health products, from pharmaceutical therapeutics to cosmetic products. New plant breeding techniques (NPBTs) provide a means to enhance PMF systems more quickly and with greater precision than ever before. However, the feasibility, regulatory standing and social acceptability of both PMF and NPBTs are in question. This paper explores the perceptions of key stakeholders on two European Union (EU) Horizon 2020 programmes-Pharma-Factory and Newcotiana-towards the barriers and facilitators of PMF and NPBTs in Europe. One-on-one qualitative interviews were undertaken with N = 20 individuals involved in one or both of the two projects at 16 institutions in seven countries (Belgium, France, Germany, Italy, Israel, Spain and the UK). The findings indicate that the current EU regulatory environment and the perception of the public towards biotechnology are seen as the main barriers to scaling-up PMF and NPBTs. Competition from existing systems and the lack of plant-specific regulations likewise present challenges for PMF developing beyond its current niche. However, respondents felt that the communication of the benefits and purpose of NPBT PMF could provide a platform for improving the social acceptance of genetic modification. The importance of the media in this process was highlighted. This article also uses the multi-level perspective to explore the ways in which NPBTs are being legitimated by interested parties and the systemic factors that have shaped and are continuing to shape the development of PMF in Europe

Addressing the Long-Term Management of High-level and Long-lived Nuclear Wastes as a Socio-Technical Problem:Insights from InSOTEC

This report summarises the lessons to be drawn from the three-year collaborative social sciences research project ‘International Socio-Technical Challenges for implementing geological disposal’ (InSOTEC). Adopting an approach that is relatively novel in this context, the project focused its investigations on the complex interplay between what are typically seen as distinct technical and social dimensions of radioactive waste management (RWM), in particular in the context of the design and implementation of geological disposal. The aim of the InSOTEC project was not to arrive at a prescription for facilitating the implementation of geological disposal, but to foster and deepen the growing awareness of the interaction between social and technical aspects of RWM that has been evident within the technical expert community by providing stakeholders and experts of all kinds with a better understanding of the processes that shape the challenges which confront them. The report brings together insights for RWM that have been generated within the different research strands of the project and offers observations on their implications for practice, addressing in particular the processes of research and development, public and stakeholder involvement in RWM, and long-term governance of geological disposal of higher activity radioactive wastes

Land re-use, complexity and actor-networks: a framework for research

This paper will present a conceptual framework for the examination of land redevelopment based on a complex systems/networks approach. As Alvin Toffler insightfully noted, modern scientific enquiry has become exceptionally good at splitting problems into pieces but has forgotten how to put the pieces back together. Twenty-five years after his remarks, governments and corporations faced with the requirements of sustainability are struggling to promote an ‘integrated’ or ‘holistic’ approach to tackling problems. Despite the talk, both practice and research provide few platforms that allow for ‘joined up’ thinking and action. With socio-economic phenomena, such as land redevelopment, promising prospects open up when we assume that their constituents can make up complex systems whose emergent properties are more than the sum of the parts and whose behaviour is inherently difficult to predict. A review of previous research shows that it has mainly focused on idealised, ‘mechanical’ views of property development processes that fail to recognise in full the relationships between actors, the structures created and their emergent qualities. When reality failed to live up to the expectations of these theoretical constructs then somebody had to be blamed for it: planners, developers, politicians. However, from a ‘synthetic’ point of view the agents and networks involved in property development can be seen as constituents of structures that perform complex processes. These structures interact, forming new more complex structures and networks. Redevelopment then can be conceptualised as a process of transformation: a complex system, a ‘dissipative’ structure involving developers, planners, landowners, state agencies etc., unlocks the potential of previously used sites, transforms space towards a higher order of complexity and ‘consumes’ but also ‘creates’ different forms of capital in the process. Analysis of network relations point toward the ‘dualism’ of structure and agency in these processes of system transformation and change. Insights from actor network theory can be conjoined with notions of complexity and chaos to build an understanding of the ways in which actors actively seek to shape these structures and systems, whilst at the same time are recursively shaped by them in their strategies and actions. This approach transcends the blame game and allows for inter-disciplinary inputs to be placed within a broader explanatory framework that does away with many past dichotomies. Better understanding of the interactions between actors and the emergent qualities of the networks they form can improve our comprehension of the complex socio-spatial phenomena that redevelopment comprises. The insights that this framework provides when applied in UK institutional investment into redevelopment are considered to be significant

The evolution of pedagogic models for work-based learning within a virtual university

The process of designing a pedagogic model for work-based learning within a virtual university is not a simple matter of using ‘off the shelf’ good practice. Instead, it can be characterised as an evolutionary process that reflects the backgrounds, skills and experiences of the project partners. Within the context of a large-scale project that was building a virtual university for work-based learners, an ambitious goal was set: to base the development of learning materials on a pedagogic model that would be adopted across the project. However, the reality proved to be far more complex than simply putting together an appropriate model from existing research evidence. Instead, the project progressed through a series of redevelopments, each of which was pre-empted by the involvement of a different team from within the project consortium. The pedagogic models that evolved as part of the project will be outlined, and the reasons for rejecting each will be given. They moved from a simple model, relying on core computer-based materials (assessed by multiple choice questions with optional work-based learning), to a more sophisticated model that integrated different forms of learning. The challenges that were addressed included making learning flexible and suitable for work-based learning, the coherence of accreditation pathways, the appropriate use of the opportunities provided by online learning and the learning curves and training needs of the different project teams. Although some of these issues were project-specific (being influenced by the needs of the learners, the aims of the project and the partners involved), the evolutionary process described in this case study illustrates that there can be a steep learning curve for the different collaborating groups within the project team. Whilst this example focuses on work-based learning, the process and the lessons may equally be applicable to a range of learning scenarios