In medical device development the effective employment of user centred design strategies are likely to reduce instances of user-difficulty; however, for medical devices, the potential impact extends beyond product success or failure, as inadequate operational performance has a potentially critical impact on user health. From a purely commercial point of view, not only do user-centred design strategies make for more appealing products, but there exists the potential to create more robust evidence of due diligence. The NHS has recognised that user-centred design is important for medical device development, and as such the NPSA has published guidelines on user-testing for medical device development. However, as yet companies have limited access to the required expertise to undertake relevant studies and input the results of the studies back into the development process. In addition, there is limited empirical enquiry into the application of user-centred design theory. PDR is developing a number of approaches to user-centred design that focus on industrial application, especially in medical device design. These approaches address the availability of expertise and the balance of investment against development risk, utilising strategies for early prototyping, continuous user-testing and simulated or quasi- contextual environments.