Medical Devices Testing & Evaluation Centre (MD-TEC) provides the Med-Tech and Life Sciences sector access to the latest state-of-the art simulation facilities and medical technology development expertise. Aligned with the NIHR Health Tech Research Centre in Devices, Digital and Robotics, MD-TEC has extensive experience in delivering human factors usability testing in both pre and post regulatory products to IEC62366.

MD-TEC mirrors the clinical environment with a fully equipped operating room, a configurable ward area with set up for critical care, A&E, and general ward areas. Additional space easily adapts to primary health and social care settings with extensive HD/4K video recording and streaming capability throughout.

Usability testing involves high-fidelity patient simulators and speciality-specific clinical users, minimising study requirements. Product iterations can be easily evaluated at less cost and with reduced risk, to avoid re-engineering and re-evaluation caused by an initial lack of user testing.

So, what is usability and why is it so important?

Usability in medical devices is a process that aims to design a medical device in such a way that it is easy and intuitive to use, the interface is tailored to the user, and its use provides the highest possible level of effectiveness and safety. It is an essential aspect of the regulatory framework for medical technologies, including SaMD (software as a medical device).