User involvement in healthcare technology development and assessment: Structured literature review

Purpose – Medical device users are one of the principal stakeholders of medical device technologies. User involvement in medical device technology development and assessment is central to meet their needs. Design/methodology/approach – A structured review of literature, published from 1980 to 2005 in peer-reviewed journals, was carried out from social science perspective to investigate the practice of user involvement in the development and assessment of medical device technologies. This was followed by qualitative thematic analysis. Findings – It is found that users of medical devices include clinicians, patients, carers and others. Different kinds of medical devices are developed and assessed by user involvement. The user involvement occurs at different stages of the medical device technology lifecycle and the degree of user involvement is in the order of design stage > testing and trials stage > deployment stage > concept stage. Methods most commonly used for capturing users’ perspectives are usability tests, interviews and questionnaire surveys. Research limitations/implications – We did not review the relevant literature published in engineering, medical and nursing fields, which might have been useful. Practical implications – Consideration of the users’ characteristics and the context of medical device use is critical for developing and assessing medical device technologies from users’ perspectives. Originality/value – This study shows that users of medical device technologies are not homogeneous but heterogeneous, in several aspects, and their needs, skills and working environments vary. This is important consideration for incorporating users’ perspectives in medical device technologies. Paper type: Literature review

Medical device technologies: Who is the user?

A myriad of medical devices deployed by many users play an essential role in healthcare, and they, and their users, need to be defined, classified and coded effectively. This study provides definitions of terms frequently employed to describe the users of medical device technologies (MDT) as well as a classification of such users. Devices are widely used, developed and assessed by many others than clinicians. Thus, users of medical devices need to be classified in various relevant ways, such as primary and secondary users; user groups such as healthcare professionals, patients, carers, persons with disabilities, those with special needs, as well as professionals allied with healthcare. Proper definition and classification of MDT users is particularly important for integrating the users’ perspectives in the process of MDT development and assessment, as well as in relation to the regulatory, health and safety, and insurance perspectives concerning MDT

Virtual Integration Platforms (VIP) –A Concept for Integrated and Interdisciplinary Air Transportation Research and Assessment

The paper descibes a new methodology for a holistic development of air transportation concepts. The Virtual Integration Plattform (VIP) concept is based on an IT tool chain as well as human collaborative methods to deal with complex systems. As a result the definitions of future air transportation concepts for short range "Quiet and Clean", long range "Comfortable and Clean" and individual transport "Fast and Flexible" are presente

Designing a gamified social platform for people living with dementia and their live-in family caregivers

In the current paper, a social gamified platform for people living with dementia and their live-in family caregivers, integrating a broader diagnostic approach and interactive interventions is presented. The CAREGIVERSPRO-MMD (C-MMD) platform constitutes a support tool for the patient and the informal caregiver - also referred to as the dyad - that strengthens self-care, and builds community capacity and engagement at the point of care. The platform is implemented to improve social collaboration, adherence to treatment guidelines through gamification, recognition of progress indicators and measures to guide management of patients with dementia, and strategies and tools to improve treatment interventions and medication adherence. Moreover, particular attention was provided on guidelines, considerations and user requirements for the design of a User-Centered Design (UCD) platform. The design of the platform has been based on a deep understanding of users, tasks and contexts in order to improve platform usability, and provide adaptive and intuitive User Interfaces with high accessibility. In this paper, the architecture and services of the C-MMD platform are presented, and specifically the gamification aspects. © 2018 Association for Computing Machinery.Peer ReviewedPostprint (author's final draft

Systems level feasibility study for the detection of extra-solar planets. Volume 1: Infrared interferometer (IRIS) known as the Stanford Concept

A sensor system for the direct detection of extrasolar planets from an Earth orbit is evaluated: a spinning, infrared interferometer (IRIS). It is shuttle deployed, free flying, requires no on-orbit assembly and no reservicing over a design life of five years. The sensor concept and the mission objectives are reviewed, and the performance characteristics of a baseline sensor for standard observation conditions are derived. A baseline sensor design is given and the enabling technology discussed. Cost and weight estimates are performed; and a schedule for an IRIS program including technology development and assessment of risk are given. Finally, the sensor is compared with the apodized visual telescope sensor (APOTS) proposed for the same mission. The major conclusions are: that with moderate to strong technology advances, particularly in the fields of long life cryogenics, dynamical control, mirror manufacturing, and optical alignment, the detection of a Jupiter like planet around a Sunlike star at a distance of 30 light years is feasible, with a 3 meter aperture and an observation time of 1 hour. By contrast, major and possibly unlikely breakthroughs in mirror technology are required for APOTS to match this performance

Developing medical device technologies from users' perspectives: A theoretical framework for involving users in the development process

Objectives: The aim of this study was to suggest an acceptable and generic theoretical framework for involving various types of users in the medical device technology (MDT) development process (MDTDP).Methods: The authors propose a theoretical framework suggesting different routes, methods and stages through which various types of medical device users can be involved in the MDTDP.Results: The suggested framework comprises two streams of users' involvement in MDT development, that is, what might be called the end users' stream and the professional users' stream for involving these two groups respectively in the process of developing both simple and more complex and innovative medical devices from conceptualization through to the market deployment. This framework suggests various methods that can be used for users' involvement at different stages of the MDT lifecycle. To illustrate the application of the framework, several MDT development scenarios and device exemplars are presented.Conclusions: Development of medical devices from users' perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their caregivers. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users' requirements met. Developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users and professional healthcare staff directly in the MDTDP. The framework, the authors contend, is a step forward in helping medical device manufacturers plan and make decisions about users' involvement at different stages of the MDTDP

Benefits of and barriers to involving users in medical device technology development and evaluation

Objectives: This study investigated the benefits of, and barriers to user involvement in medical device technology development and evaluation. Methods: A structured review of published literature in peer-reviewed journals. Results: This review revealed that the main benefits of user involvement were an increased access to user needs, experiences and ideas; improvements in medical device designs and user interfaces; and an increase in the functionality, usability and quality of the devices. On the other hand, resource issues, particularly those of time and money were found the key impediments to involving users in the development and evaluation of medical device technologies. This study has categorised both the benefits and barriers to user involvement also. Conclusions: The involvement of users in MDTD&E requires resources, which are limited; however, it is essential from both users and manufacturers perspectives

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