External Barriers to User-Centred Development of Bespoke Medical Devices in the UK

It is widely accepted that user-centred approaches to the development process produces better products and therefore brings commercial rewards. Despite such acceptance, the majority of manufacturers of medical devices fail to adopt such development principles. This paper will examine cases of manufacturers of bespoke medical devices, where one might perceive that the engagement with the end-user throughout the development process is critical to product quality. In a previous study undertaken by the author, interviews with manufacturers of bespoke medical devices indicated a perception that three external stakeholders to present barriers to the application of a user-centred design approach. This paper reports on a follow up study to understand the practice and agendas of the three external stakeholders, in order to draw a comparison with the manufacturers’ views. The findings revealed mismatch between the product development process that manufacturers of medical devices are encouraged to apply and the practicalities of complying with the needs of the identified stakeholders.