User involvement in medical device development: An empirical study

Abstract

Changes in population, medical interventions and new technology opportunities, as well as public and political expectations, are all contributing factors to the pressure facing the healthcare system to change. Healthcare in the UK is beginning to move away from its traditional boundaries, for example hospitals and towards patient empowerment and collaboration. Consequently the target users for medical devices have also changed, with new users and user groups emerging. Further to this user involvement is emphatically becoming a part of healthcare delivery in the UK, recognised for bringing improvement in the quality, acceptance and in turn success of a medical device. The changing target market has given rise to the need to understand the newly created user groups and finding new ways to elicit their requirements has become vital for the success of medical devices.

This research intends to draw upon and capture the importance of user requirements research, by investigating the early stages of Medical Device Development (MDD) giving particular attention to the conceptualisation of the user within this process. The research shall assess the possible links between user requirement elements, to benefit the healthcare system and investigate how user requirements methodologies that have been proven in other fields can be successfully deployed in the medical device development lifecycle. User requirements methodologies identified within the disciplines of information technology, ergonomics, psychology and design theories relating to medical device design, will be collectively assessed for their capacity to collaborate. The research methodology began with undertaking a systematic review of the literature, which facilitated the construction of a single theoretical conceptual framework of user involvement in medical device development, representative of a superior model of user requirements capture. To validate this framework empirical research followed. This was divided into exploratory, explanatory and interpretive data collection phases, with a view to extract; what the current process of MDD is in industry, why and how users are currently deployed in MDD, and the users perceived experience of involvement. The exploratory study showed that manufacturers were aware of their users and extracting the user requirements effectively was seen as the main competitive differentiator. However, manufacturers were not always aware of the best methods to capture user needs, especially with business objectives and obligatory requirements repeatedly taking precedence over optional user involvement methods. The explanatory study showed that not every department has an equal role to play in terms of user involvement in terms of methods to elicit requirements. However there was consensus across the departments to acknowledge their customers and their feedback to ensure they feel valued. Further to this communicating information to potential new devices users was carried out well in advance of the product coming to market. The customer focus was something not only addressed in the design of the device, but the service that followed. The interpretive study emphasised the importance of understanding the user’s needs and to understand that these needs do change over time. Educating users on disease and self-management was considered important, but realisation by patient user of their responsibility was vital in the successful use of a medical device.

The original contributions of this study include its endeavour in taking a multidisciplinary approach to account for users and user involvement methods, and apply to specifically the early stages of the medical device development process. The research developed naturally to transcend and collaborate between these theories, as well as represent various voices within the research to really emphasise the multidisciplinary and multi-user approach it took. This research made a further innovative contribution by developing a framework to the problem of inadequate user involvement in the medical device development process. This could prove very beneficial for medical device manufacturers considering user involvement may become a regulatory requirement, meaning all medical device manufacturers would need to incorporate and document user involvement by law.