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

Future bathroom: A study of user-centred design principles affecting usability, safety and satisfaction in bathrooms for people living with disabilities

Research and development work relating to assistive technology 2010-11 (Department of Health) Presented to Parliament pursuant to Section 22 of the Chronically Sick and Disabled Persons Act 197

Multimodal and ubiquitous computing systems: supporting independent-living older users

We document the rationale and design of a multimodal interface to a pervasive/ubiquitous computing system that supports independent living by older people in their own homes. The Millennium Home system involves fitting a resident’s home with sensors – these sensors can be used to trigger sequences of interaction with the resident to warn them about dangerous events, or to check if they need external help. We draw lessons from the design process and conclude the paper with implications for the design of multimodal interfaces to ubiquitous systems developed for the elderly and in healthcare, as well as for more general ubiquitous computing applications

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

Facilitators and barriers to the integration of healthcare service and building design

Service design research recognises the importance of infrastructure design in the achievement of streamlined service delivery. Although research about service design and building design is abundant, very little is known about the integration of these processes. Therefore, this research aimed at identifying facilitators and barriers to the integration of service and building design processes. To this end, the initial results from a historical investigation of the redevelopment of a hospital in Salford, UK were used to identify facilitators and barriers to the integration of service and building design. Data was collected through interviews, document analysis and a workshop. Initial results present internal and external factors related to the design process generating barriers to integration of service and building design

Using System Analysis and Personas for e-Health Interaction Design

Today, designers obtain more central roles in product and service development (Perks, Cooper, & Jones, 2005). They have to deal with increasingly complicated problems, like integrating the needs of various stakeholders while taking care about social, ethical and ecological consequences of their designs. To deal with this demanding design situation, they need to apply new methods to organize the available information and to negotiate the stakeholder’s perspectives. This paper describes how systems analysis supports the design process in a complex environment. In a case study, we demonstrate how this method enables designers to describe user requirements for complex design environments while considering the perspectives of various stakeholders. We present a design research project applying cybernetic systems analysis using the software ''System-Tools'' (Vester, 2002). Results from the analysis were taken to inform the design of an electronic patient record (EPR), considering the particularities of the German health care system. Based on the analysis, we developed a set of requirements for every stakeholder group, detailing the patients' perspective with persona descriptions. We then picked a main persona as reference for the EPR design. We describe the resulting design sketch and discuss the value of cybernetic systems analysis as a tool to deal with complex social environments. The result shows how the method helps designers to structure and organize information about the context and identify fruitful intervention opportunities for design. Keywords: E-Health; System Analysis, Cybernetics; Personas.</p

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

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

A Community-Driven Validation Service for Standard Medical Imaging Objects

Digital medical imaging laboratories contain many distinct types of equipment provided by different manufacturers. Interoperability is a critical issue and the DICOM protocol is a de facto standard in those environments. However, manufacturers' implementation of the standard may have non-conformities at several levels, which will hinder systems' integration. Moreover, medical staff may be responsible for data inconsistencies when entering data. Those situations severely affect the quality of healthcare services since they can disrupt system operations. The existence of software able to confirm data quality and compliance with the DICOM standard is important for programmers, IT staff and healthcare technicians. Although there are a few solutions that try to accomplish this goal, they are unable to deal with certain situations that require user input. Furthermore, these cases usually require the setup of a working environment, which makes the sharing of validation information more difficult. This article proposes and describes the development of a Web DICOM validation service for the community. This solution requires no configuration by the user, promotes validation results share-ability in the community and preserves patient data privacy since files are de-identified on the client side.Comment: Computer Standards & Interfaces, 201