Elsevier

Applied Ergonomics

Volume 45, Issue 3, May 2014, Pages 413-419
Applied Ergonomics

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

https://doi.org/10.1016/j.apergo.2013.05.009Get rights and content

Highlights

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    The aim was to understand the constraints under which medical device design and development take place.

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    A thematic analysis was conducted based on 19 semi-structured interviews.

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    Barriers to designing for safety and usability were identified. They included deficits in communication.

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    The barriers to communication were both internal and external to the development process.

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    We recommend the use of mediating representations such as personas and scenarios to address barriers to communication.

Abstract

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.

Introduction

Design can reduce the likelihood and consequences of error (Clarkson et al., 2004). Developing a system wide understanding of users, the tools that they use and the environments in which the live and work supports this approach (Carayon et al., 2006). For medical devices, such as infusion pumps, there are several examples of redesign that would reduce error rates (Lin et al., 1998; Thimbleby and Cairns, 2010). In these cases a valuable opportunity has been missed: once equipment has been deployed, it is difficult to update or modify it. There have been calls for an acceleration of the integration of Human Factors and ergonomics in patient safety, including the creation of “market forces for manufacturers to produce safer products that incorporate HFE [Human Factors Engineering] principles and techniques” (Gurses et al., 2012). HFE is a term applied to the application of theory, principles, data and methods to design in order to optimise human well-being and overall system performance. The European equivalent is Usability Engineering (UE), which is similar in principle. The aim of the work reported here is to better understand current practices in incorporating HFE into the design and development of interactive medical devices and, in particular, the challenges to doing so.

Section snippets

Background

In the European Union, the placing onto market of medical devices is governed by a number of European Council directives, implemented though national law. A medical device manufacturer is required to be: “reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used.” They should provide: “consideration of the technical knowledge, experience, education and training and where applicable the medical

Participants and data collection

We interviewed practitioners in order to build an understanding of current UE/HFE techniques and identify opportunities for support. Our definition of UE/HFE was not constrained by IEC 62366; rather, we allowed participants to define the terms as they wished. The topics for discussion are presented in Table 1.

We interviewed a range of professionals. The majority had an interest in the interactive properties of infusion devices (Table 2). Where possible, interviews were audio recorded and

Results and discussion

A high-level finding was that design and development was shared across multiple and sometimes independent functions. This resulted in challenges regarding shared ownership of the design space, and communication between disciplines. These themes are the focus for this paper. In the presentation of results below “#n” is used to indicate the use of evidence from participant n; where possible this is a direct quotation, but where it was not possible to audio-record the interview, the notes from the

Conclusions

In this study, 19 interviews were conducted across a range of individuals involved in the design and development of medical equipment. We found there was a lack of common ground between disciplines, meaning that communication was impeded by gaps in mutual understanding or shared reference points. It was as if the range of stakeholders internal and external to the development process were residing within disciplinary silos or walled gardens. This had the effect of blocking exchanges relating to

Competing interests

None.

Funding

This work is part of the CHI+MED: Multidisciplinary Computer-Human Interaction research for the design and safe use of interactive medical devices project, supported by the UK Engineering and Physical Sciences Research Council [EP/G059063/1].

Acknowledgements

We thank the participants and the reviewers for their input. The study obtained approval from the UCL research ethics committee.

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