A new framework for the design and adoption of home and patient-use medical devices

In recent years the amount of medical equipment being used in non-healthcare environments has increased dramatically and, with the growing popularity of assisted living programmes such as telecare and telehealth, combined with an ageing population, this trend is set to continue. However, little research has been conducted on this issue and the many challenges that it presents for: Manufacturers: who must develop devices that are, not just clinical effective, but also usable and safe when used by people with a wide variety of characteristics, training, and capabilities and in environments that are varied, unpredictable and non-standardised. Healthcare Providers, who must supply not only the device but the accompanying service and all training, monitoring and maintenance. Patients: who are required to use these devices correctly, safely and in accordance with recommended regimens in order that they can obtain the maximum health outcomes. The many other people who will assist patients to use their devices correctly, for example partners, family members and carers (both professional and lay).