Medical Devices Testing and Evaluation Centre

The NIHR Trauma MIC works closely with the Medical Devices Testing and Evaluation Centre (MD-TEC). The NIHR Trauma MIC is co-located with MD-TEC within University Hospitals Birmingham NHS Foundation Trust (UHB). Aligned activity alongside the shared oversight of Clinical Director Professor Tom Clutton-Brock means that the Trauma MIC and MD-TEC are ideally placed to support SMEs navigate the complex journey of medical technology development. MD-TEC forms part of the flourishing life science and digital ecosystem within the West Midlands.

The state of the art facility includes :

  • a near replica operating theatre
  • intensive care, emergency department, ward and clinic areas
  • a simbulance which carries medical equipment used to meet most emergencies and scenarios
  • high fidelity patient simulators that manifest vital signs, clinical signs and symptoms

Usability testing involves the latest technology patient simulators and phantoms, minimising study requirements and allowing companies the ability to test product iterations whilst avoiding costly design mistakes and condensing the design time frame. Clinical scenarios to test medical device usability are simulated and involve healthcare professional’s specific to the product’s end user and market.

  • MD-TEC conducts both formative and summative usability studies to ISO 62366
  • Usability testing informs design to ensure human factors engineering is considered at all stages of product development along with clinical need
  • User experience and feedback is captured using multi-angled AV analysis
  • Usability study reports support medical device technical files for regulatory approval.