Conducting Medical Technology Trials in the NHS

By Alan Lindsay

Strathclyde Institute of Medical Devices (SIMD) and the Glasgow Clinical Research Facility (CRF) co-hosted an event at the CRF’s Western Infirmary site on the 15^th November 2011. The aim of the event was to inform SMEs on doing medical technology clinical trials in the NHS. 

The event was attended by 40 people, primarily from Scottish SMEs and the NHS and was chaired by Mrs Shona McDermott (Assistant Director, Glasgow CRF). The event comprised of five presentations representing different facets and scales of medical technology clinical trials within the NHS.

The first presentation was by Richard Love, Senior Quality & Regulatory Consultant, Emergo Group who set the scene in his talk entitled, “Regulatory Framework of Medical Device Clinical Trials in the EU, with Emphasis on the NHS”. This presentation covered the various approvals that need be sought before embarking on a clinical trial, e.g. MHRA, REC, NHS R&D.

The next presentation was by Dr. David Heath, Bioengineering Unit, University of Strathclyde, who discussed, “Involvement in MedTech Clinical Trials – an Academic Perspective” in which he recounted his experience of taking a transdermal diagnostic device from an academic laboratory through to a small scale NHS clinical trial. The presentation covered the practical issues associated with conducting such a clinical trial from obtaining ethics approval at the beginning to recruitment and beyond.

Scott Johnstone, CEO, Scottish Life Science Association talked about, “The MedTech Road Map and Clinical Trials“. The MedTech Road Map is a document that signposts companies to appropriate sources of advice and support in the NHS during the different stages in the development of a healthcare product. The Road Map’s ultimate aim is to help companies bring products to market that meet clinical and service needs and, where these are clinically and cost effective, increase opportunities for their uptake into the NHS in Scotland. In his presentation, Scott Johnstone gave examples of companies that have used the MedTech Road Map and stressed the importance of considering health economics when developing a product.

In her presentation “Pros and Cons of Medical Devices Studies in the NHS”, Ann Reid, Senior Clinical Research Associate, ClinTec International Ltd represented the CRO perspective on larger scale clinical trials. Examples were given of a drug delivery device clinical trial that went well and another trial that didn’t. In the case of the latter important lessons were learned, many of which were sufficiently generic to be of potential benefit to attendees. These included issues with the study design itself and the perceived unwillingness of the sponsor to respond adequately to ethical concerns.

The final presentation was by Anne Gordon, Deputy Director of the Glasgow CRF. Her talk,             “Glasgow Clinical Research Facility - an Overview” described the types of activities in which the CRF engages – supporting trials across NHS Greater Glasgow & Clyde in primary and secondary care settings across the West of Scotland. The CRF undertakes both commercial and non-commercial clinical trials in medicinal products and devices. They are currently supporting phase I-IV trials and in addition to providing access to clinical facilities and laboratory facilities they can support the approval process and provide administrative and nursing support e.g. obtaining informed consent, study visits for assessments, measurements, data entry and recruitment.

Overall, the event showed that there is a lot of expertise and experience for SMEs to tap into in Scotland with regard to conducting medical technology clinical trials in the NHS. The event also provided an excellent forum for NHS clinicians who are interested in working on new medical technology development with SMEs.

To obtain a copy of some, or all, of the presentations please contact Mrs. Rena Currie (Strathclyde MedTech Administrator) on 0141 548 3038 or georgina.currie@strath.ac.uk.

Through Strathclyde MedTech, part of SIMD, support/funding of up to £5K, unmatched, in the first instance, is available to Scottish SMEs to work with the University in the medical technology field. This can be for activities such consultancy or research projects e.g. feasibility studies etc. However if a company can demonstrate a commitment to strengthen its relationship with the University, e.g. by jointly applying for further research and knowledge exchange funding, including KTPs, then higher levels of funding through other mechanisms may be possible.