Medical device development: The challenge for ergonomics

Abstract

High quality, well designed medical devices are necessary to provide safe and effective clinical care for patients as well as to ensure the health and safety of professional and lay device users. Capturing the user requirements of users and incorporating these into design is an essential component of this. The field of ergonomics has an opportunity to assist, not only with this area, but also to encourage a more general consideration of the user during medical device development. A review of the literature on methods for assessing user requirements in engineering and ergonomics found that little published work exists on the ergonomics 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. The Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) is a research collaboration that is working in conjunction with industrial collaborators to apply ergonomics methods to real case study projects with the ultimate aim of producing an industry-focused guide to applying ergonomics principles in medical device development.

Review on Design for Medical Device

“…This standard is identical to the equivalent European standard (EN) and the British standard (BS) [7]. [50].…”

“…The main scope of these medical device regulations around the world is mainly on risk management to ensure that the device do not compromised with either clinical condition or safety of patient and its users. Medical device developers need to eliminate nor reduce as much as possible the risk associate with the device [7]. Taking decrease in non-renewable resource into measures, manufacturing sustainability is indeed a crucial issue.…”

“…They also do not consider user practicality first before manufacturing resulting the device did not reached customer's satisfaction [19][20] [21]. Ergonomic or widely known as human factor have contribute significantly in medical device safety have highlighted contribution which will improving safety in health care discipline especially on design [7][22][23] [24].…”

“…The awareness of the role played by the user in recognizing user error by the staffs and manufacturer have contributes in improving procurement decisions, scopes and selecting well-designed device. Thus, suggested by NPSA was to demonstrate safe design philosophies and guidelines for a more standardized device which suits user requirements, usage context and potential usage environment need to be taken into measures [7]. Table 1 shows the classification of incident according to their groups that is reported by NPSA in 2008.…”

Get moving: the practice nurse is watching you!

“…This strategy was based on several existing models for the design of medical devices ( Figure 2). [10][11][12] From November 2010 to September 2012 we conducted three substudies: (A) a user requirements study, (B) a usability test of the system in a laboratory situation and (C) a pilot study in two practices.…”