Ethool, a tool to enable ethical and legal decision-making in research involving humans using new technologies in Europe: design and usability validation (original) (raw)
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Applied Ergonomics, 2017
This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were analyzed and compared using a multiple case study design. The results indicate that there are four main challenges in implementing international standards. These include a lack of direct access to users for the purposes of device development; a lack of understanding by users with regards to the impact of their feedback on the development process; contract formalities limiting user exchanges; and the perceived attitudes of clinical users which impact participation in human factors studies. The barriers presented in this research have the potential to be resolved but only with greater commitment by both medical device users and developers.
User involvement in the early development of assistive technology devices
2011
Objective The importance of user involvement in design, development and diffusion of all devices is widely accepted; however, the methods of achieving true user contribution to a design or development process are challenging. The challenges are increased when the target consumers for the device have disabilities that can make traditional methods of gaining user involvement at best difficult, and at worst impossible. The objective of this paper is to evaluate the effectiveness of a number of user involvement techniques employed on projects carried out by the authors.
Journal of Biomedical Informatics, 2017
This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a prevailing focus on cross-sectional validation studies, ignoring the issues of learnability and training. The U.S. Federal Drug and Food Administration's recent proposal for a validation testing protocol for medical devices is then extended to address these shortcomings: (1) a novel process measure 'normative path deviations' is introduced that is useful for both quantitative and qualitative usability studies and (2) a longitudinal, completely within-subject study design is presented that assesses learnability, training effects and allows analysis of diversity of users. A reference regression model is introduced to analyze data from this and similar studies, drawing upon generalized linear mixed-effects models and a Bayesian estimation approach. The extended protocol is implemented and demonstrated in a study comparing a novel syringe infusion pump prototype to an existing design with a sample of 25 healthcare professionals. Strong performance differences between designs were observed with a variety of usability measures, as well as varying training-on-the-job effects. We discuss our findings with regard to validation testing guidelines, reflect on the extensions and discuss the perspectives they add to the validation process.
2017
The human factor is often critical in the performance and safety of a large number of medical devices. To minimize risks to users and patients, health authorities have reinforced their requirements including human factors and usability testing during the development of new technologies. Human factors engineering (HFE) is an interdisciplinary approach to evaluating and improving use safety, efficiency, and robustness of work systems. The new device should be tested to show its safety and effectiveness for the intended users, uses and use environments. In order to fulfill these regulatory requirements, international standards suggest implementing the User Centered Design process during the technology design and development lifecycle. We would like to present here a case study of a HFE plan about an ongoing medical device development in order to illustrate how to practically process; then we will present some more general considerations on HFE development for medical devices. Manual ve...
Journal of the Brazilian Society of Mechanical Sciences and Engineering, 2020
The worldwide growing demand for assistive devices, due to the global trend of population aging and high rates of chronic diseases, creates design opportunities for study, optimization and clinical validation of these products, in search of quality products that promote quality of life and greater autonomy. The high abandonment rates of assistive devices, the low-quality and inefficient performance in many cases, in addition to the scarcity of options and the high prices, indicate possible failures in the initial design phases of these products. This paper presents the elaboration of an adaptive methodology focused on the "Design for Assistive Technology," considering user-centered design and 3D technologies. The AT-d8sign methodology presents an iterative and dynamic flux, divided into three main phases: (1) design cross-domain; (2) conception spiral; (3) evaluation and refinement. The study is based on three fundamental elements: an analysis of three designs developed in the area by the research group; a case study from one of these designs; a systematic review on the current scenario of the design methodology in this area. The preliminary results from the application of the methodology included: shorter design development time from informational design to clinical testing; effective insertion of the users and health professionals in the decision-making process throughout the conceptual design phase; better communication between the interdisciplinary research group due to the use of design techniques; gradual improvement of the conceptual and technical solutions supported by 3D printing, resulting in the refinement of fundamental attributes of assistive products: comfort, safety and functionality.
Benefits of and barriers to involving users in medical device technology development and evaluation
International Journal of Technology Assessment in Health Care, 2007
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 was conducted.Results:This literature 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 also has categorized both the benefits of and barriers to user involvement.Conclusions:The involvement of users in medical device technology development and evaluation requires resources, which are limited; however, this involvement is essential from both users and manufacturers p...
Applied Ergonomics, 2014
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.
BMC Medical Informatics and Decision Making, 2011
Background: Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD) process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods: In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any) they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results: A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process.