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.     

Coping with defective software in medical devices

Embedding defective software in medical devices increases safety risks. Given that all software is inherently defective, how can medical device manufacturers identify and manage risk? An effective, tailored risk management process can make the task less daunting. Developing complex, software-based medical devices is a challenging business. Device manufacturers must understand the inherent differences between hardware and software components and establish robust software development processes that are based on recognized engineering principles appropriate for safety-critical systems. At the heart of such processes, they must incorporate risk management - from early development through product retirement. Manufacturers have a responsibility to train development and risk management teams in the use of recognized software engineering practice that promote software safety. Only then can they minimize the risk of including inherently defective software in their products.     

Training software developers and designers to conduct usability evaluations

Many efforts to improve the interplay between usability evaluation and software development rely either on better methods for conducting usability evaluations or on better formats for presenting evaluation results in ways that are useful for software designers and developers. Both of these approaches depend on a complete division of work between developers and evaluators. This article takes a different approach by exploring whether software developers and designers can be trained to conduct their own usability evaluations. The article is based on an empirical study where 36 teams with a total of 234 first-year university students on software development and design educations were trained through an introductory course in user-based website usability testing that was taught in 40 h. They used the techniques from this course for planning, conducting, and interpreting the results of a usability evaluation of an interactive website. They gained good competence in conducting the evaluation, defining user tasks and producing a usability report, while they were less successful in acquiring skills for identifying and describing usability problems.     

Breaking away from the conventional 'usability lab': the Customer-Centered Design Group at Tektronix, Inc.

The conventional usability lab is primarily responsible for testing prototypes and products to determine if customers will accept a new design. Often this testing comes too late in the development cycle to allow major design or product changes to occur. In the Customer-Centered Design Group at Tektronix Labs, the usability lab is a small part of our group's involvement in the entire design life cycle of a Tektronix product. We work with design groups to bring the benefits of a usability lab to all phases of design, beginning with understanding our customer's current system and work processes to assessing the competitor's strengths and weaknesses to simulating and evaluating design alternatives. Our 'lab' is often on the road; meeting with customers where they work, working with design teams to simulate and prototype designs, and evaluating designs with our customers. To keep in touch with customers and to keep product development focused, we feel a usability group must break down the barriers inherent in a conventional testing suite. By breaking these barriers we can better determine what customers need and how these needs are addressed throughout the entire product life cycle.     

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.     

Breaking away from the conventional ‘usability lab’: the Customer-Centered Design Group at Tektronix,Inc.

Abstract

The conventional usability lab is primarily responsible for testing prototypes and products to determine if customers will accept a new design. Often this testing comes too late in the development cycle to allow major design or product changes to occur. In the Customer-Centered Design Group at Tektronix Labs, the usability lab is a small part of our group's involvement in the entire design life cycle of a Tektronix product. We work with design groups to bring the benefits of a usability lab to all phases of design, beginning with understanding our customer's current system and work processes to assessing the competitor's strengths and weaknesses to simulating and evaluating design alternatives. Our ‘lab’ is often on the road; meeting with customers where they work, working with design teams to simulate and prototype designs, and evaluating designs with our customers. To keep in touch with customers and to keep product development focused, we feel a usability group must break down the barriers inherent in a conventional testing suite. By breaking these barriers we can better determine what customers need and how these needs are addressed throughout the entire product life cycle.     

Reconciling usability and interactive system architecture using patterns

Traditional interactive system architectures such as MVC [Goldberg, A., 1984. Smaltalk-80: The Interactive Programming Environment, Addison-Wesley Publ.] and PAC [Coutaz, J., 1987. PAC, an implementation model for dialog design. In: Interact’87, Sttutgart, September 1987, pp. 431-436; Coutaz, J., 1990. Architecture models for interactive software: faillures and trends. In: Cockton, G. (Ed.), Engineering for Human-Computer Interaction, Elsevier Science Publ., pp. 137-153.] decompose the system into subsystems that are relatively independent, thereby allowing the design work to be partitioned between the user interfaces and underlying functionalities. Such architectures extend the independence assumption to usability, approaching the design of the user interface as a subsystem that can designed and tested independently from the underlying functionality. This Cartesian dichotomy can be fallacious, as functionalities buried in the application’s logic can sometimes affect the usability of the system. Our investigations model the relationships between internal software attributes and externally visible usability factors. We propose a pattern-based approach for dealing with these relationships. We conclude by discussing how these patterns can lead to a methodological framework for improving interactive system architectures, and how these patterns can support the integration of usability in the software design process.     

“Today I Tell” A Comics and Story Creation App for People with Autism Spectrum Condition

ABSTRACT

This article describes the design, development, and evaluation of an application to help people with autism spectrum condition (ASC) express themselves through the creation of stories and comics. The intended platform of the application is touchscreen devices. The design process follows a human-centered design approach involving caregivers, teachers, usability experts, primary school students, and people with ASC. The characteristics considered are explained to design and implement the application, as well as the different evaluation steps. The prototype design was evaluated with 36 experts (teachers, caregivers, and usability experts). Next, 14 primary school students and 10 participants from a special education institution tested the application. Among all the participants, five students of the primary school institution have attention-deficit hyperactivity disorder and five students of the special education institution had ASC. The feedback gathered shows the importance of multidisciplinary teams in developing an application aimed at people with special needs. Non-functional features such as usability and accessibility can be bypassed by developers and this is the point at which teachers, caregivers, usability experts, and even the end users of the application can provide their insights in order to improve the product during its development phase. This also reduces the costs that would be incurred if the final product had to be changed after its development.     

计算机软件可使用性设计的发展、标准及支持原则

一些重要交互技术的设计和应用曾对计算机可使用性设计的发展起了重要的推动作用,该文对此进行了回顾,并由此总结出可学习性、可记忆性、功效性、错误率和用户满意度等五项可使用性设计标准。一些支持可使用性设计的相关原则,包括可学习性原则、灵活性原则、可观察性原则、可恢复性原则和反应原则等,也被分析和讨论。     

Development of a method for evaluating accessibility of medical equipment for patients with disabilities

ObjectiveThe purpose of this study was to develop a method for evaluating accessibility of medical equipment for patients with disabilities.MethodsThe researchers reviewed videotapes of patient-participants with various physical and sensory disabilities using different types of medical equipment. For each of 11 videotapes, four observers independently identified and documented access and safety barriers, such as physical, sensory, cognitive, and environmental barriers. Inter-observer variability for identifying barrier presence was assessed with kappa statistics for pairs of observers.ResultsA list of 10 access and safety barriers was developed through an iterative consensus process, which identified design features of medical equipment that presented difficulties for participants with disabilities. The list is useful for identifying and categorizing accessibility problems found in equipment. While reliability of barrier identification was substantial or moderate for some barriers, reconciliation of barrier events identified by multiple video observers is recommended for optimal results.     

Model-Driven Interactive System Design for Therapy Robots

Physiotherapy using intelligent robots is emerging as a new approach to recovery for many stroke patients. Although therapy robots have a strong potential in dealing with therapeutic and other medical applications, they have not been fully utilized in everyday therapy activities due to concerns over safety and the lack of friendly robot user/patient interaction models. From the viewpoint of software engineering, a user-centred design based on UML (Unified Modelling Language) has been known to be one of the best solutions to satisfy usability since the design process relies heavily on the analysis of users and their tasks to reach their goals. Therefore, a model-driven approach to interactive system design via UML for therapy robots is needed to make them usable in the real world. This paper proposes such approach and introduces a new graphical notation that describes user interface elements and the methods of connection with hardware/software objects. With the proposed abstract interaction models, prototyping interactive systems can be made faster and allows for their evaluation by users and system developers before implementation in order to improve usability from the perspectives of users and system developers.     

Analysing interactive devices based on information resource constraints

Analysis of the usability of an interactive system requires both an understanding of how the system is to be used and a means of assessing the system against that understanding. Such analytic assessments are particularly important in safety-critical systems as latent vulnerabilities may exist which have negative consequences only in certain circumstances. Many existing approaches to assessment use tasks or scenarios to provide explicit representation of their understanding of use. These normative user behaviours have the advantage that they clarify assumptions about how the system will be used but have the disadvantage that they may exclude many plausible deviations from these norms. Assessments of how a design fails to support these user behaviours can be a matter of judgement based on individual experience rather than evidence. We present a systematic formal method for analysing interactive systems that is based on constraints rather than prescribed behaviour. These constraints capture precise assumptions about what information resources are used to perform action. These resources may either reside in the system itself or be external to the system. The approach is applied to two different medical device designs, comparing two infusion pumps currently in common use in hospitals. Comparison of the two devices is based on these resource assumptions to assess consistency of interaction within the design of each device.     

To twist or poke? A method for identifying usability issues with the rotary controller and touch screen for control of in-vehicle information systems

In-vehicle information systems (IVIS) can be controlled by the user via direct or indirect input devices. In order to develop the next generation of usable IVIS, designers need to be able to evaluate and understand the usability issues associated with these two input types. The aim of this study was to investigate the effectiveness of a set of empirical usability evaluation methods for identifying important usability issues and distinguishing between the IVIS input devices. A number of usability issues were identified and their causal factors have been explored. These were related to the input type, the structure of the menu/tasks and hardware issues. In particular, the translation between inputs and on-screen actions and a lack of visual feedback for menu navigation resulted in lower levels of usability for the indirect device. This information will be useful in informing the design of new IVIS, with improved usability.

Statement of Relevance: This paper examines the use of empirical methods for distinguishing between direct and indirect IVIS input devices and identifying usability issues. Results have shown that the characteristics of indirect input devices produce more serious usability issues, compared with direct devices and can have a negative effect on the driver–vehicle interaction.     

Virtual design of multiengineering electronics systems

The authors describe a virtual reality prototyping (VRP) and virtual product design approach that uses a modeling strategy to design, test, and evaluate concepts and products in advance-before creating any physical design models. Their design decisions reflect solutions and practices derived from systems engineering and software engineering research. Close competition has forced companies to focus on tailoring technological products to meet customer preferences in user interface design, usability, and appearance. Often, implementing new features has assumed less importance than creating an optimal product variation for different customer segments in international markets. Modern computer-based systems result from a multidomain development process, and organizing this work requires developers to communicate, cooperate, and coordinate effectively with nonengineering teams. Early linking of product development to other company operations supports this activity. Geographically dispersed development teams must communicate and coordinate effectively. Extending the use of interactive, functional, and photorealistic 3D product models into other company domains can facilitate effective business practices that cover the entire value chain, from simulated product idea to Web-based customer support of the final product. This wider adoption of the VRP technology and process offers ample scope for further research     

A comparison of location and token-based interaction techniques for point-of-care access to medical information

This paper compares the usability of some location and token-based interaction techniques for systems that provide point-of-care access to medical information. The investigation is based around a scenario from clinical work—administration of medicine to patients. Four interaction techniques that match the scenario are identified. We demonstrate how these techniques can be concretized through functional prototypes. The prototypes were tested with health workers in a full-scale model of a section of a hospital ward. The usability issues emerging from the tests were related to required user attention, predictability of system behavior, and integration with the work situation. We found that the usability of the interaction techniques to a large degree depended on specific physical and social conditions of the use situation. This result is an incentive to consider a broad set of sensor-based interaction techniques and devices for such systems, and to select the best few of these for implementation.     

A review of medical error reporting system design considerations and a proposed cross-level systems research framework

OBJECTIVE: To review the literature on medical error reporting systems, identify gaps in the literature, and present an integrative cross-level systems model of reporting to address the gaps and to serve as a framework for understanding and guiding reporting system design and research. BACKGROUND: Medical errors are thought to be a leading cause of death among adults in the United States. However, no review exists summarizing what is known about the barriers and facilitators for successful reporting systems, and no integrated model exists to guide further research into and development of medical error reporting systems. METHOD: Relevant literature was identified using online databases; references in relevant articles were searched for additional relevant articles. RESULTS: The literature review identified components of medical error reporting systems, error reporting system design choices, barriers and incentives for reporting, and suggestions for successful reporting system design. Little theory was found to guide the published research. An integrative cross-level model of medical error reporting system design was developed and is proposed as a framework for understanding the medical error reporting literature, addressing existing limitations, and guiding future design and research. CONCLUSION: The medical error reporting research provides some guidance for designing and implementing successful reporting systems. The proposed cross-level systems model provides a way to understand this existing research. However, additional research is needed on reporting and related safety actions. The proposed model provides a framework for such future research. APPLICATION: This work can be used to guide the design, implementation, and study of medical error reporting systems.     

无人物流车的车外屏人机界面设计研究

随着智能汽车和物流行业快速发展,产业结合促进了无人物流车的出现。为了提 高无人物流车的安全、效率和用户体验,对无人物流车的车外屏人机界面设计进行研究。首先 提出了基于无人物流车的人-车-环境关系理论,并且结合物流车的运行场景流程对车外屏人机 界面的设计需求进行了研究。在此基础上,对无人物流车的车外屏人机界面的信息架构、多通 道交互模式及界面设计进行了探讨和设计实践,并且对物品回收功能的初步原型设计进行了可 用性测试评估。测试结果显示初步的无人物流车车外屏交互原型逻辑流畅,可用性较高。调查 结果显示用户希望无人车定位准确,并且可以利用积分制来兑换物质奖励。研究表明车外屏人 机界面设计可以提高无人物流车的安全、效率和用户体验。对无人物流车的车外屏设计进行修 改和完善,并且经过测试迭代后,将会不断提升车外屏设计。     

3D sound interactive environments for blind children problem solving skills

Audio-based virtual environments have been increasingly used to foster cognitive and learning skills. A number of studies have also highlighted that the use of technology can help learners to develop effective skills such as motivation and self-esteem. This study presents the design and usability of 3D interactive environments for children with visual disabilities to help them solve problems in Chilean geography and culture. We introduce AudioChile, a virtual environment that can be navigated through 3D sound to enhance spatiality and immersion throughout the environment. 3D sound is used to orientate, avoid obstacles, and identify the positions of various characters and objects within the environment. We have found during the usability evaluation that sound can be fundamental for attention and motivation purposes during interaction. Learners identified and clearly discriminated environmental sounds to solve everyday problems, spatial orientation, and laterality.     

‘Representing the User’ in software development—a cultural analysis of usability work in the product development context

It is widely accepted that users should be involved in the development of interactive systems. However, involving users in interactive systems development is challenging, especially in product development. The organizational culture is a key factor affecting the successes and failures of organizational change and development efforts. This paper shows how user involvement is intertwined with the organizational cultures in a case study of five software development organizations. User involvement is indirect in the case organizations, and labeled as usability work. Using cross case analysis, four ‘cultures of usability work’ are identified. The cultures have distinct cultural characteristics, employ different approaches to usability work, and have different preferences and strategies for the prospective facilitation of usability work. Sensitivity to the cultural context is identified as an important consideration in the facilitation of usability work, and culturally compatible strategies for usability work in different cultural settings are identified. The paper concludes that there might not be one ‘best, universally valid, context free way’ of introducing and carrying out usability work in software product development organizations.