Dr Tom Clutton-Brock is the clinical director of the new Medical Devices Testing and Evaluation Centre (MD-TEC), based in the Institute of Translational Medicine (ITM) in Birmingham. He was also recently named as one of the “100 most influential drivers of the health technology revolution, globally”. MTI finds out more about his work and MD-TEC.
MTI: What are the major barriers to getting medical devices taken up into the NHS, and how can these be overcome?
TCB: There are numerous barriers to getting Medical devices taken up into the NHS. The NHS, through commissioning, funds services and not technology, making it very difficult for NHS Trusts to recover any additional costs associated with using new devices. For medicines, large amounts of clinical research evidence are required before regulatory approval; the same is not true for devices and so industry faces a huge task to collect evidence of sufficient quality and quantity to satisfy Health Technology Appraisal Bodies. Academics, clinicians and research support staff are much more used to undertaking medicines research than device research. Applying the rules around medicines to devices slows down both the regulatory and evidence gathering processes. The whole funding of device SMEs is a problem, with over 29,000 medical device SMEs in Europe alone; with an average employment of two people it is hardly surprising that one company is estimated to fold financially every 11 minutes.
MTI: Why is the new Medical Devices Testing and Evaluation Centre (MD-TEC), supported by the European Regional Development Fund, so important to the Life Sciences Economy?
TCB: There is a mass of evidence to support the view that the majority of device related adverse incidents are user related. The latest publications both from the Medicines and Healthcare products Regulatory Agency (MHRA) and the FDA highlight the importance of including usability testing in a device’s technical file. Many devices undergo significant re-design loops after introduction into clinical practice, which is very costly to the life sciences industry. The MD-TEC provides a dedicated test facility for med tech companies to test the usability of their technology in a realistic environment, using real clinical staff but without placing patients at risk.
MTI: How will the facility change how medical device companies approach product development and design?
TCB: The key factor here is engaging with clinical staff at a much earlier stage in product design and development than at present. Feedback from realistic testing sessions will be available well before the regulatory step allowing for much reduced development costs.
MTI: As a clinician what developmental errors are most avoidable? How would you approach medical device design?
TCB: User interface errors are very common and can lead to serious errors. We don’t need a new driving lesson each time we buy a new car, why should we need an extensive training programme each time we use a new device?
MTI: Human factors and usability engineering is becoming a bigger part of requirements for effective design of medical devices, how do you see this changing over the coming years?
TCB: I think it will be increasingly difficult to get a new device through the regulations without demonstrating that an effective usability-testing programme has been undertaken and has influenced device design. I believe that not to do so will require an extensive explanation.
MTI: If you could offer a piece of advice to any company developing within the med tech arena what would it be?
TCB: Come and talk to us as early as possible – or email: MDTEC@uhb.nhs.uk. A modest investment up front could save you a fortune in later re-design loops. For some SMEs we even have funded support available (eligibility criteria applies).
MTI: How is the industry changing to facilitate the use of more medical devices in healthcare? How are UK SMEs being supported nationally to facilitate this growing sector?
TCB: Industry is getting better at seeking help and advice at an earlier stage. The UK government, the NHS, the MHRA as the regulator and NICE all have programmes to facilitate the uptake of new device technology. Bodies such as the NIHR Healthcare Technology Cooperatives (Med Tech Cooperatives from January 2018) and the MD-TEC have all been created to help UK and other SMEs, make use of them.
