REQUIREMENTS CAPTURE FOR MEDICAL DEVICE DESIGN - International Conference on Engineering Design - ICED 03 Stockholm, August 19-21, 2003

Sep 12, 2026

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Poor requirements-capture practice in medical device design has been linked to post-market failures, including patient morbidity and mortality, creating a clear need for improvement. This paper reports multi-year research by five investigators into requirements capture, using multiple research methods to study the problem and develop a workbook. The workbook provides guidance for designers through a functional analysis approach, a matrix-based checklist, and advice on regulatory requirements, refined over time and published for industry use.

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Requirements Capture for Medical Device Design

Why do more research on requirements capture?

Research methodology

INTERNATIONAL CONFERENCE ON ENGINEERING DESIGN ICED 03 STOCKHOLM, AUGUST 19-21, 2003 REQUIREMENTS CAPTURE FOR MEDICAL DEVICE DESIGN J Ward, S Shefelbine and P J Clarkson Abstract There are many examples from the medical device design industry where poor requirements capture practice has led to post-market problems, including patient morbidity and mortality. There is a clear need to improve this process. The purpose of this paper is to present the results of several years of study by five researchers into the requirements capture process in this area of industry and to highlight the need by industry for further guidance. Various research methods were used to investigate the requirements capture problem and to develop and evaluate a workbook which provides guidance for designers. The workbook consists of a package of methods: a functional analysis approach, a matrix-based checklist and advice on regulatory requirements. It has been refined over the years and is now published [1] . The matrix also forms part of a publication for the UK Department for Trade and Industry [2], anda web version is under development. Keywords: best practice, introduction of methods, medical devices, requirements capture 1 Introduction Medical device design involves the creation of healthcare products and the manufacturing and testing equipment used to produce them. It is a large and diverse industry, which often manufactures safety-critical products. Worryingly, however, device design-related problems can – and do regularly – cause serious difficulties for device patients and operators, ranging from near-misses to death. Since the mid 1990s, regulatory authorities world-wide have placed design controls on the design of medical devices and manufacturing equipment in order to identify such deficiencies before full production commences. Despite this, still all isnot well in the medical device design industry. Whilst design controls were being introduced, the Engineering Design Centre at the University of Cambridge, UK, began work to investigate current practice in medical device design, and to see why some of these design problems were occurring. Since gaining “good”requirements was identified consistently as a key area of difficulty for device designers, oneof the areas of focus for this “Good Design Practice” research was that of requirements capture (defined here as the identification and documentation of the requirements that the device must satisfy) . The objectives of this research were to investigate current and good practice in this area; to develop guidance for designers on how to follow a ‘good’ requirements capture process; to evaluate this guidance; to refine it and finally to disseminate it to industry. This paper reportson the findings from this research. Observations in this paper are based on the work of several individuals, in particular Sandra Shefelbine [3] . Acknowledgements are given at the end of the paper. 2 Why do more research on requirements capture? It is well established that requirements lay the foundation for the rest of the design, and that capturing them is therefore a very important process. Indeed, the Food and Drug Administration (FDA), which regulates medical devices in the US, states that gaining suitable requirements is the “single most important design control activity” [4] . Yet, capturing requirements can be a simple affair [4], partly due to the fact that comprehensive lists of recognised requirements are readily available, thanks to the existence of a multitude of general and device-specific standards. However, many medical devices are complex and/or innovative. In such instances “it is not uncommon” for the design requirements definition stage to take as much as 30% of the total project time [4] . In addition, even for more simple devices, standards rarely go far enough to specify all the details for the device as they tend to allow room for at least some device innovation and diversit

FAQs

Why is requirements capture critical in medical device design?

Requirements establish the foundation for later design work. Regulators also emphasize requirements as the single most important design control activity.

What problems arise from poor requirements capture practice?

Poor practice can lead to post-market issues and serious difficulties for patients and operators, including morbidity and mortality.

What does the guidance workbook include?

It includes a functional analysis approach, a matrix-based checklist, and guidance on regulatory requirements to support designers through a good requirements-capture process.

Sep 12, 2026

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