Medical device development: The challenge for ergonomics
Section snippets
Introduction to the role of ergonomics in medical device design
To provide safe and high quality care for patients the health care industry requires clinically effective and well-designed medical devices. The design of devices should take account of the environment in which they are required to function and should support the working patterns of professional users and the lifestyles of patients and carers. Medical devices are a diverse group of products that ranges from simple items such as sticking plasters to complex devices such as heart by-pass machines
Medical device regulation
To ensure the safety of patients, clinical users and associated third parties, medical devices are subject to complex regulations. Conformity assessment is conducted before and after a device is placed on the market, and devices are also subject to post-market surveillance once they are in use. It is the responsibility of the medical device manufacturer to ensure device conformity.
Medical devices are a diverse group of products and are divided into specific Classes of device, for which the
Review of ergonomics methods in medical device design
A structured literature review was performed to identify, summarise and appraise the published evidence on the methods and tools used for the capture of user requirements and to determine their potential for use within medical device development. The aims of the review were to:
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Map the extent of ergonomics research in the domain of medical devices and health care.
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Assess the usability of the reported methods, either by professional ergonomists or by the medical device industry.
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Identify the type,
Factors affecting user requirements research
We identified a number of themes that will affect the choice of method for a particular application. Many of these factors will be common to all product development such as the point in the product life cycle the device is at, the type of users that are to be studied and the cost, time and expertise available for the user research. Many principles that apply to general product development also apply to medical device development such as the use of open-ended scoping methods during the concept
The role of ergonomics
Should a role of ergonomics be to make its methods accessible to product developers and designers to ensure ergonomics principles are applied as widely as possible, or should we be concerned over the rigour with which these methods could be applied by those with limited human factors training? This is a topic which has been identified as a key challenge for ergonomics, as Wilson (2000) states, “consistency on the balance between professionalism and protection on the one hand, and growth and
Conclusion
Apart from the recent focus on usability of devices, in particular of infusion pumps, little published work exists on the ergonomic aspects of medical device development. In particular there is little advice available to developers on which issues to consider during design and development or recommendations for good practice in terms of the methods and approaches needed to capture the full range of user requirements. Industry needs guidance to help apply the most appropriate methods at the most
Acknowledgements
The authors acknowledge support of this work through the MATCH Programme (EPSRC Grant GR/S29874/01), although the views expressed are entirely their own. We would also like to acknowledge and thank our MATCH colleagues: Mala Bridgelal Ram, Natasha Campling (nee Browne), Dr. Patricia Grocott and Heather Weir from Kings College, London; and Professor Ian Robinson and Dr. Sarwar Shah from Brunel University.
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