Usability and user experience of medical devices: An overview of the current state,analysis methodologies,and future challenges

Improvements to the reliability and safety of medical devices are vital for healthcare systems. It is necessary to consider the user experience (UX) of patients and healthcare professionals at all the development stages of medical devices. Ergonomic design principles can also reduce the cost of medical device production. This study is a multilateral analytical literature review of UX and usability issues in healthcare and medical device design. The total number of literature sources presented is n = 88. The literature sources are classified according to the difference between UX and usability for various target products and services, including healthcare. The literature is reviewed with a focus on human-oriented aspects. This includes medical technology and device design, which are dependent on the user type, medical device scope, and area of use. A review of key medical device standards and regulation documents is presented. The main analysis methodologies for the UX and their advantages and disadvantages are discussed. The future challenges in healthcare and medical ergonomics are briefly highlighted. Above all, this study tried to examine the difference between usability and UX of general products and those of medical devices through the review of existing literature. Even standards do not reflect this well and need to be considered based on further research in academia and industry.Relevance to industryThe obtained results will help medical-device designers and healthcare professionals understand the main medical-research trends and improve the design process. Additionally, they will be helpful for increasing the satisfaction level among medical-device users and reducing user risks.     

A case study on applying formal methods to medical devices: computer-aided resuscitation algorithm

The design and functional complexity of medical devices have increased during the past 50 years, evolving from the use of a metronome circuit for the initial cardiac pacemaker to functions that include electrocardiogram analysis, laser surgery, and intravenous delivery systems that adjust dosage based on patient feedback. As device functionality becomes more intricate, concerns arise regarding efficacy, safety, and reliability. It thus becomes imperative to adopt a standard or methodology to ensure that the possibility of any defect or malfunction in these devices is minimized. It is with these facts in view that regulatory bodies are interested in investigating mechanisms to certify safety-crictical medical devices. These organizations advocate the use of formal methods techniques to evaluate safety-critical medical systems. However, the use of formal methods is keenly debated, with most manufacturers claiming that they are arduous and time consuming.In this paper we describe our experience in analyzing the requirements documents for the computer-aided resuscitation algorithm (CARA) designed by the Resuscitative Unit of the Walter Reed Army Institute of Research (WRAIR). We present our observations from two different angles – that of a nonbeliever in formal methods and that of a practitioner of formal methods. For the former we catalog the effort required by a novice user of formal methods tools to carry out an analysis of the requirements documents. For the latter we address issues related to choice of designs, errors in discovered requirements, and the tool support available for analyzing requirements .     

The scenario‐based usability checklist development for home appliance design: A case study

In the past decade, home appliances have been rapidly developed to satisfy the various requirements of users. Thus, there are increases in requirements to explore appropriate evaluation methods that reflect the usability of home appliances quickly and comprehensively. This study aims to develop a scenario‐based usability checklist for product designers early in the design process. In this study, the scenario‐based usability checklist consists of two parts: 1) a heuristic evaluation checklist, and 2) a scenario evaluation checklist. In heuristic evaluation checklist development, usability factors of home appliances are extracted and then coupled to user interface (UI) elements. In scenario evaluation checklist development, scenarios are developed through brainstorming by focus group interview (FGI), and then evaluation elements are extracted from previous scenarios analysis. The proposed scenario‐based usability checklists can enable designers to evaluate product design quickly and comprehensively early in the development process with users' viewpoints. © 2010 Wiley Periodicals, Inc.     

7 Themes for guiding situated ergonomic assessments of medical devices: A case study of an inpatient glucometer

There is relatively little guidance on the situated ergonomic assessment of medical devices, and few case studies that detail this type of evaluation. This paper reports results of a detailed case study that focuses on the design and use of a modern blood glucose meter on an oncology ward. We spent approximately 150 h in-situ, over 11 days and 4 nights, performing observations and interviews with users. This was complemented by interviews with two staff with oversight and management responsibility related to the device. We identified 19 issues with the design and use of this device. These issues were grouped into 7 themes which can help guide the situated study of medical devices: usability, knowledge gaps and mental models, workarounds, wider tasks and equipment, the patient, connection between services, and policy.     

A framework for evaluating the usability of mobile phones based on multi-level, hierarchical model of usability factors

As a mobile phone has various advanced functionalities or features, usability issues are increasingly challenging. Due to the particular characteristics of a mobile phone, typical usability evaluation methods and heuristics, most of which are relevant to a software system, might not effectively be applied to a mobile phone. Another point to consider is that usability evaluation activities should help designers find usability problems easily and produce better design solutions. To support usability practitioners of the mobile phone industry, we propose a framework for evaluating the usability of a mobile phone, based on a multi-level, hierarchical model of usability factors, in an analytic way. The model was developed on the basis of a set of collected usability problems and our previous study on a conceptual framework for identifying usability impact factors. It has multi-abstraction levels, each of which considers the usability of a mobile phone from a particular perspective. As there are goal-means relationships between adjacent levels, a range of usability issues can be interpreted in a holistic as well as diagnostic way. Another advantage is that it supports two different types of evaluation approaches: task-based and interface-based. To support both evaluation approaches, we developed four sets of checklists, each of which is concerned, respectively, with task-based evaluation and three different interface types: Logical User Interface (LUI), Physical User Interface (PUI) and Graphical User Interface (GUI). The proposed framework specifies an approach to quantifying usability so that several usability aspects are collectively measured to give a single score with the use of the checklists. A small case study was conducted in order to examine the applicability of the framework and to identify the aspects of the framework to be improved. It showed that it could be a useful tool for evaluating the usability of a mobile phone. Based on the case study, we improved the framework in order that usability practitioners can use it more easily and consistently.     

A survey of usability capability maturity models: implications for practice and research

Improving the position and effectiveness of user-centred design (UCD) in software and product development is a challenge in many companies. One step towards improvements is to carry out a usability capability maturity (UCM) assessment to evaluate the strengths and weaknesses of a development organisation in UCD. While several diverse UCM models have been introduced, little research has been published in the public domain on these models. The paper aims to fill this gap by analysing the main features of the models. The results show that most models represent different approaches – although some of them have the same roots – meaning that understanding one model is not enough to understand the basics of another model. All models can be used for examining the status of UCD in individual development projects. In addition, models provide various means for assessment of the status of UCD in other organisational areas. The level of documentation of models varies a lot, and very few empirical research results exist. Based on the results, implications for practice and research are suggested.     

The influence of design aesthetics in usability testing: Effects on user performance and perceived usability

This article examined the effects of product aesthetics on several outcome variables in usability tests. Employing a computer simulation of a mobile phone, 60 adolescents (14-17 yrs) were asked to complete a number of typical tasks of mobile phone users. Two functionally identical mobile phones were manipulated with regard to their visual appearance (highly appealing vs not appealing) to determine the influence of appearance on perceived usability, performance measures and perceived attractiveness. The results showed that participants using the highly appealing phone rated their appliance as being more usable than participants operating the unappealing model. Furthermore, the visual appearance of the phone had a positive effect on performance, leading to reduced task completion times for the attractive model. The study discusses the implications for the use of adolescents in ergonomic research.     

Exploring the wiki user experience: The effects of training spaces on novice user usability and anxiety towards wiki editing

With the advent of Web 2.0, the number of IT systems used in university courses is growing. Yet research consistently shows that a significant proportion of students are anxious about computer use. The quality of first experience with computers has been consistently mentioned as a significant contributor to anxiety onset. However the effect of users’ first experience on system related anxiety has not to the authors’ knowledge been researched using controlled experiments. Indeed little experiment based research has been conducted on the wiki user experience, specifically users’ evaluations and emotional reactions towards editing. This research uses usability engineering principles to engineer four different wiki experiences for novice wiki users and measures the effect each has on usability, anxiety during editing and on anxiety about future wiki editing. Each experience varied in the type of training spaces available before completing six live wiki editing tasks. We found that anxiety experienced by users was not related to computer anxiety but was wiki specific. Users in the in-built tutorial conditions also rated the usability of the editing interface higher than users in the non-tutorial conditions. The tutorial conditions also led to a significant reduction in wiki anxiety during interaction but did not significantly affect future editing anxiety. The findings suggest that the use of an in-built tutorial reduces emotional and technological barriers to wiki editing and that controlled experiments can help in discovering how aspects of the system experience can be designed to affect usability and anxiety towards editing wikis.     

A Cognitive-Affective Model of Perceived User Satisfaction (CAMPUS): The complementary effects and interdependence of usability and aesthetics in IS design

Affective dimensions of human–computer interaction design have the potential to elicit emotions and behaviours. However, there is little research into which affective treatments are systematically tested, let alone assessed in light of additional cognitive dimensions. In this study, we formulate and empirically test a Cognitive-Affective Model of Perceived User Satisfaction (CAMPUS) that displays high explanatory power (R² = .69). CAMPUS offers a comprehensive framework for assessing both direct effects of perceptions of cognitive and affective dimensions on satisfaction and the complex interplay between these two in terms of system design and use. Implications for theory and practice are discussed.     

A study of usability principles and interface design for mobile e-books

This study examined usability principles and interface designs in order to understand the relationship between the intentions of mobile e-book interface designs and users' perceptions. First, this study summarised 4 usability principles and 16 interface attributes, in order to conduct usability testing and questionnaire survey by referring to Nielsen (1993), Norman (2002), and Yeh (2010), who proposed the usability principles. Second, this study used the interviews to explore the perceptions and behaviours of user operations through senior users of multi-touch prototype devices. The results of this study are as follows: (1) users' behaviour of operating an interactive interface is related to user prior experience; (2) users' rating of the visibility principle is related to users' subjective perception but not related to user prior experience; however, users' ratings of the ease, efficiency, and enjoyment principles are related to user prior experience; (3) the interview survey reveals that the key attributes affecting users' behaviour of operating an interface include aesthetics, achievement, and friendliness.     

Playing stupid, caring for users, and putting on a good show: Feminist acts in usability study work

As a feminist HCI agenda develops, feminist analyses of behaviour must venture beyond the dominant liberal feminist approach to include other feminist approaches. Using the personal narrative or auto-ethnographic method, this article explores the role of gender in usability work, a common research practice in HCI. In this article, the author interprets three gendered behaviours that occur in usability work - playing stupid, caring for and about users, and putting on a good show - demonstrating that while these behaviours appear anti-feminist in a liberal feminist framework, they appear feminist in alternative feminist frameworks, such as relational/care-giving, sex-positive, multicultural, post-colonial and Third Wave. The article demonstrates how a feminist HCI agenda that embraces the multiplicity of feminisms necessarily forces a re-examination of usability work’s relationship to both feminism and HCI research methods.     

The impact of distractions on the usability and intention to use mobile devices for wireless data services

Mobile technology has quickly become ingrained in society due to the flexibility of anywhere/anytime usage. However, factors associated with and that impact mobility, mobile users, and mobile use of products and services are still poorly understood. For example, even though distractions are ever present during everyday use of mobile devices, the nature and extent to which user perceptions and performance are affected by their presence is unknown. An empirical study was undertaken to investigate the impact of distractions and confirmation of pre-trial expectations on usability and its subsequent effect on consumers’ behavioral intention toward using a mobile device for wireless data services. Distractions were simulated in this study in the form of either user motion or environmental noise (i.e. background auditory and visual stimuli). A Structural Equation Modelling (SEM) analysis confirmed the impacts of distractions on efficiency and effectiveness, and in turn the users’ satisfaction and behavioral intention to use a mobile device for wireless data services. Support was also obtained for a mediating effect of post-trial confirmation of expectations between perceived performance and satisfaction. Implications of these findings for theory, practice, and future research are outlined.     

The influence of prototype fidelity and aesthetics of design in usability tests: effects on user behaviour, subjective evaluation and emotion

An empirical study examined the impact of prototype fidelity on user behaviour, subjective user evaluation and emotion. The independent factors of prototype fidelity (paper prototype, computer prototype, fully operational appliance) and aesthetics of design (high vs. moderate) were varied in a between-subjects design. The 60 participants of the experiment were asked to complete two typical tasks of mobile phone usage: sending a text message and suppressing a phone number. Both performance data and a number of subjective measures were recorded. The results suggested that task completion time may be overestimated when a computer prototype is being used. Furthermore, users appeared to compensate for deficiencies in aesthetic design by overrating the aesthetic qualities of reduced fidelity prototypes. Finally, user emotions were more positively affected by the operation of the more attractive mobile phone than by the less appealing one.     

Interpretation of a cross-cultural usability evaluation: A case study based on a hypermedia system for rare species management in Namibia

We present the results of a usability evaluation of a locally developed hypermedia information system aiming at conservation biologists and wildlife managers in Namibia. Developer and end user come from different ethnic backgrounds, as is common to software development in Namibia and many developing countries. To overcome both the cultural and the authoritarian gap between usability evaluator and user, the evaluation was held as a workshop with usability evaluators who shared the target users’ ethnic and social backgrounds. Different data collection methods were used and results as well as specific incidences recorded. Results suggest that it is difficult for Namibian computer users to evaluate functionality independently from content. Users displayed evidence of a passive search strategy and an expectation that structure is provided rather than self generated. The comparison of data collection methods suggests that questionnaires are inappropriate in Namibia because they do not elicit a truthful response from participants who tend to provide answers they think are “expected”. The paper concludes that usability goals and methods have to be determined and defined within the target users’ cultural context.     

Exploring interactive style and user experience design for social web of things of Chinese users: A case study in Beijing

This study designed an interactive IoT (Internet of Things) service on mobile devices based upon the concept of Social Web of Things (SWoT), with which users can interact with IoT in the same way they use the social network services. In order to integrate IoT into Chinese daily use, this study also investigated how Chinese users interact with things and IoT technologies. A four-phase study among users living in Beijing was conducted with a lifecycle of user-centered design. Results revealed that SWoT could activate users׳ intuitive understanding of social network services, and make the interaction with SWoT natural in their own ways. Users living in Beijing tended to be utility-oriented and highly emphasized efficiency; they were distinctive in uncertainty avoidance and preference of hierarchical way of managing things. Our results suggested implications for the design of user-centered IoT systems in China, and shed light on improvements for the performance of IoT systems and balance of requirements between users and system design.     

Integration of human factors and ergonomics during medical device design and development: It's all about communication

Manufacturers of interactive medical devices, such as infusion pumps, need to ensure that devices minimise the risk of unintended harm during use. However, development teams face challenges in incorporating Human Factors. The aim of the research reported here was to better understand the constraints under which medical device design and development take place. We report the results of a qualitative study based on 19 semi-structured interviews with professionals involved in the design, development and deployment of interactive medical devices. A thematic analysis was conducted. Multiple barriers to designing for safety and usability were identified. In particular, we identified barriers to communication both between the development organisation and the intended users and between different teams within the development organisation. We propose the use of mediating representations. Artefacts such as personas and scenarios, known to provide integration across multiple perspectives, are an essential component of designing for safety and usability.     

A case study of the occupational stress implications of working with two different actuation/safety devices

A case study was conducted using an automatic sphygmomanometer to compare the stress encountered by workers using two different machine actuation/safety devices. The experiment took place in a small metal stamping plant as part of a government authorised comparison of the devices. Six experienced female workers separately performed the same task on the same power presses using either a photo electronic or a two-hand button device. These two devices perform dual duty as both machine actuators and machine safeguards. Blood pressure at the ankle and heart rate were measured periodically and a questionnaire was administered.

The case study approach to this experiment was necessitated by government restrictions which limit the population of workers experienced with both devices. The results of the case study are twofold: (1) For the small population tested no significant difference was found in the stress measures examined for machine operators; and (2) A feasible in-plant methodology is demonstrated for unobtrusively monitoring worker populations exposed to machine related stress.     

Information provision for challenging markets: The case of the accessibility requiring market in the context of tourism

The paper investigates the requirements of users with disabilities and the implications that these tourists have for developing accessible tourism information systems. A series of focus groups and interviews revealed the informational needs of people with disabilities, as well as the relevant technical difficulties involved in addressing these needs. The results indicated that the indispensable requirements include the following: (1) the veto or absolutely minimal prerequisites principle; (2) an indication of holistic accessibility paths; and (3) door-to-door access maps. The technical challenges identified focus on interoperability, content integration and personalization. The paper concludes by demonstrating how the tourism industry can overcome these challenges and address disabled travelers’ needs.     

The contribution of apparent and inherent usability to a user's satisfaction in a searching and browsing task on the Web

Previous research found that apparent and inherent usability had big influences on user's acceptance of computer systems. This research extended these findings to the area of user's satisfaction. The study investigated the impact of inherent and apparent usability on user's satisfaction of Web page designs while the two main tasks on the World Wide Web, searching and browsing, were performed. The results indicated that inherent usability was the main factor contributing to user's satisfaction in both searching and browsing. General principles and specific recommendations for the design and evaluation of Web page designs are derived from these findings.     

Requirements analysis for customization using subgroup differences and large sample user testing: A case study of information retrieval on handheld devices in healthcare

Requirements analysis defines the goals and evaluation criteria of system design. We introduce a methodology for requirements analysis for customization based on large sample interactive testing, with the premise that analysis of user behaviour with prototypes leads to requirements discoveries. The methodology uses a relatively large sample (1) to identify relevant user subgroups, (2) to observe significant empirically determined group differences in the context of task and tool use and (3) to estimate the groups’ different requirements and derive design implications. Between 20 and 50 participants are used per test, rather than the three to five often recommended for user testing. Statistical relationships are investigated between subgroups in terms of background variables, questionnaire items, performance data, and coded verbal statements. Customization requirements are inferred from the significant differences observed between empirically determined groups. The methodological framework is illustrated in a case study involving the use of clinical resources on handheld devices by three groups of physicians. The groups were found to have different needs and preferences for evidence-based resources and device form factor, implying opportunities and necessities for group customization requirements.

Relevance to industry

In safety-critical domains such as health care, it is essential to assess user needs and preferences regarding devices and systems to inform appropriate customizations. We present a methodological framework and case study that demonstrates how large sample user testing can supplement typical methods of requirements analysis to provide contextualized, quantitative accounts of group differences and customization requirements.