Medical Devices Testing and Evaluation Centre (MD-TEC)
The Medical Devices Testing and Evaluation Centre has been supported through the European Regional Development Fund to establish support for small to medium sized companies* located in the Greater Birmingham and Solihull Local Enterprise Partnership area. The facility will provide business support and access to 1048 sq. m of refurbished innovation facilities and expertise for ISO accredited characterisation of devices in terms of safety and usability.
It will remove a regulatory blockage to the development of the local life science economy by providing a set of facilities that we have identified to be absent in the region. The project will accelerate the translation of novel innovations in the laboratory through to the clinic and commercial exploitation. In doing so, it will aid in the development of existing markets and stimulate new ones for Life Sciences SMEs, enabling them to bring products to market quickly, at less cost with reduced risk. MD-TEC will help develop a life sciences cluster around the University Hospitals Birmingham (UHB) / University of Birmingham campus and more broadly an innovation eco-system across the GBS LEP area
Liam Grover, Professor in Biomaterials Science at the University of Birmingham, will lead biomaterials development and Dr Tom Clutton-Brock, Clinical Director, NIHR Trauma Management Healthcare Technology Cooperative and Deputy Director of the ITM, will lead medical device usability and safety testing.
Dr Clutton-Brock said: “It is envisaged that up to 135 small and medium sized enterprises could benefit from the refurbished facilities in the ITM and expertise for ISO-accredited characterisation of devices in terms of safety and usability between May 2017 and Dec 2019. The project will build on the vision of the ITM to accelerate the translation of novel innovations in the laboratory and in simulated clinical environments through to the clinic and commercial exploitation.”
A med-tech Small/Medium Enterprise (SME) based in Bromsgrove approached MD-TEC with a new prototype blood pressure cuff that they believed was easier to use than the ones currently in use, saving time in emergency situations. The SME needed evidence that the device would provide significant improvements in acute care situations, which could be used in applications for regulatory approval (CE, FDA etc.) and promotional material.
MD-TEC and the SME discussed options for how to test their blood pressure cuff. It was decided that a usability test be undertaken to measure how doctors and nurses use the device in comparison to standard NHS blood pressure cuffs.
MD-TEC utilised simulation space to resemble an emergency department. Medical equipment and professional audio was arranged to provide appearance and ambient sounds to increase participants’ immersion. On-site hospital staff at University Hospitals Birmingham volunteered to take part as participants and a SimMan™ provided a mock patient to test the device on.
Each participant was fitted with a microphone and GoPro™ camera with chest harness. Along with cameras fitted in the simulation room, MD-TEC were able to record the doctors’ and nurses’ experiences using both the test and standard blood pressure cuff during a simulated emergency situation. After the simulation was completed each volunteer was interviewed to assess their personal experience using each device
The recorded data was used to examine participants’ experience using each device both quantitatively and qualitatively. This was included in an official report to the company and the audio visual recordings were edited into promotional material for the company to use in future. Using the official report, the SME were able to gain regulatory approval for use of their device.
- Trauma (NIHR)
- Edgbaston Medical Quarter (EMQ)
- University of Birmingham
- Birmingham Health Partners (BHP)
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*SME definition – companies with less than 250 employees