Whilst it is well established in theory that considering users and their requirements is an important aspect of medical device development, in practice there is little evidence of how this is done, how the results of this are incorporated into the product development process, or indeed of the difficulties of doing both of these things. Buckle et al. [1
] makes the point that more case studies that document the whole spectrum of success and failure in terms of integrating the results of user needs research are essential. As a preface to presenting a case study of user involvement in medical device development and an analysis of the barriers to incorporating the resultant knowledge in the device development process, we will outline the imperatives to user involvement and provide a brief overview of the barriers to achieving this.
It is well accepted that medical devices should be designed to fulfil the requirements, needs and capabilities of their users. User involvement in medical device development has been the focus of much recent research [2
]. The benefits of a user-centred approach to design include improved patient safety [5
], better health outcomes [6
] and increased user satisfaction [7
]. It has also been suggested that products that have been designed in this way are more likely to be commercially successful and less likely to require post-market alterations or recalls [8
]. To increase the likelihood of producing such a device, developers must have a clear and thorough understanding of, as appropriate, the clinicians, patients and carers who will use the device. The range of physical and organisational environments within which device use will be embedded must also be considered.
There are three main factors that encourage and motivate developers to conduct user research during the medical device development process (MDDP). The most notable is the regulatory imperative; there are a range of requirements that must be met before a device can legally be placed on the market. Both the US Food and Drug Administration (FDA) and the European Union require developers to demonstrate, normally through compliance with standards, that they have adopted human factors engineering processes (also known as human factors, ergonomics or user-centred design) throughout development [9
A second imperative is located in the requirements of funders of healthcare technology research, whose funding decisions are, in part at least, contingent on developers promising to consult and actively involve device ‘users’ and ‘stakeholders’. This is particularly relevant for Small and Medium Sized Enterprises (SMEs) who are often dependant on this type of funding to support new product development. In the UK in particular a significant proportion of medical device development is undertaken by SMEs, for example small engineering firms and university spin-outs. These types of companies will typically have less access to in-house expertise in user research and are therefore likely to be especially reliant on securing external funding to allow them to conduct this work.
Thirdly, there is a substantial literature on methods for accessing user needs that is, in theory at least, available to device developers who wish to respond to these imperatives and conduct user centred research as part of the MDDP. This literature describes the theory behind this approach [11
]; how and when to conduct the work, and with what groups of people [2
It is also well-established, however, that there are barriers to the involvement of users in this process. Drawing on other areas of product development, it is clear that some barriers are located in relation to the user. Van der Panne et al. [13
] note that users have limited ability to envision novelty and thus involvement is likely to be biased toward imitative products and incremental innovation. Other barriers are located at the organisational level. Developers may limit user engagement due to resource constraints [3
] or the belief that the investment required to conduct user research is not an effective use of limited resources [14
]. The way in which user needs data is delivered to the organisation may not dovetail with their decision-making process about the product [15
]. Indeed the perspective of the user provided by formal methods may not chime with the representations of the user held by developers themselves [17
]. In sum, such factors may limit the extent to which user information is appropriated within the product development process.
Any new product development project is a complex process, regardless of the industry it is located in. In recognition of this, considerable research has been conducted on how to effectively manage product development projects, and how to use the information collected during the project to make good business decisions. The question here is, how can user data be effectively collected, represented and utilised during the product development process?
Empirical research has consistently shown that that the factor most strongly associated with successful product development is “the existence of a high-quality, rigorous new product process: one that emphasizes up-front homework, tough Go/Kill decision points, sharp early product definition, and flexibility” [18
]. The ‘stage-gate’ model is the most frequently used such approach [19
] and aims to take the product from concept all the way to market. At the beginning of a project the development process is divided into ‘stages’ that consist of related and parallel activities. At the end of each of these stages there is a decision point or ‘gate’, when the management team reviews progress across all the different strands of development and then takes a decision on how the project should progress, or indeed, whether it should progress. The ultimate aim of such an approach is to ensure that objective and informed decisions are made at each and every stage of product development, based on careful consideration of all the information available at that time. It has recently been suggested by Pietzsch et al. [20
] that the complex nature of medical device development necessitates a formal stage-gate approach to development as this industry is characterised by high technology development, strict regulatory requirements and complex reimbursement processes.
In summary then, although human factors engineering methods are potentially of value at every stage of the MDDD process and documenting user involvement is increasingly mandatory, in practice, manufacturers may have good reasons not to extensively involve users in the MDDP process. If the full benefits of involving users are to be realised, more primary research is needed to better understand manufacturers’ perspectives and motivations and also how the results of user research can be effectively incorporated into the product development process.
This paper presents a case study of a medical device development project. The results are used to recommend strategies for effective user involvement in medical device development. We also examine the wider implications of these findings for medical device manufacturers, research funders and policy makers.