King's College London - Senior Project Manager

Annual Report on Widening Participation and Outreach (WP&O) | 2013–14

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Surgical and Interventional Engineering (SIE) Laboratory Space

MAISI (Manufacture of Active Implants and Surgical Instruments)

The newly created surgical interventional research facility has been delivered at St Thomas’ Hospital for the School of Biomedical Engineering & Imaging Sciences. It is located in the basement of Block 7 – one of the original 19th century hospital buildings - and was an incredibly complex construction project in a challenging environment, led by KCL with the support of GSTT – an example of our deeply inter-twined development programme. The new SIE department will develop new surgical technologies for a range of indications, cultivate a robust translational strategy, demonstrate impact through clinical trials, and shorten bench-to-bedside time so research reaches the clinic and impacts patient care faster. The core laboratory space delivered by KCL is the first of its kind in the UK. The overall infrastructure allows engineers and clinicians to work collaboratively to translate technology into the NHS. State-of-the-art multi-disciplinary facilities to support research spanning from core technology development to cadaver studies will help avoid the pitfalls into which many novel technologies fall due to poor understanding of the challenges surrounding clinical workflow, good manufacturing practices and regulations. Early career researchers who train and work in this fully-equipped environment will be able to identify limitations in interventional practices, discover innovative solutions, and navigate the translational pathway of healthcare, delivering patient-centric solutions. Further, the SIE facility will be an enabler of future research activities and attract both multinational & new medtech companies to King’s College by providing a clinically realistic testbed. This will give major industry companies the confidence to follow through with the commercialisation of healthcare technologies. The new facility provides a new mock operating theatre alongside dedicated optical research labs and 3D workshops to allow King’s to complete both research and teaching of Surgical Interventional Engineering within St Thomas’ Hospital.

Work is about to start on the development of a unique and dedicated cleanroom facility for the Manufacture of Active Implants and Surgical Instruments, which will be fully staffed and equipped to build and certify advanced Class II & III medical devices (e.g., aortic and mitral heart valves, brain implanted devices for epilepsy) for first-in-patient clinical studies. An innovative and novel manufacturing facility (cleanrooms), this project will also allow the production of medical devices for named patients who require bespoke devices that are not commercially available, and in this way, will support academic research to develop and deliver life-saving products to patients of our partner NHS hospital onsite. Such facilities to enable this research are currently lacking in the UK. The SIE facility including the mock interventional provides an environment where novel medical devices can be tested before they become manufactured within the cleanrooms. The new cleanroom facility will be embedded within the 4th Floor envelope of the Lambeth Wing at the St. Thomas’ campus and therefore involves close collaboration with GSTT colleagues to ensure disruption is minimised. The facility is expected to be fully operational by November 2022.

Hydra MRI Replacement The Hydra MRI project was a recent life-cycle replacement of redundant MRI technology with a new machine to support both NHS clinical activity and NHS and University research. The facility is embedded in the emergent Imaging Centre at St Thomas’ Hospital which will see continual investment in new MRI scanning technologies, by both the University and GSTT, for the foreseeable future. Theoriginal scannerwas adedicatednon-CEmarked research system that was no longer feasible to support, although the research for which it was designed has continued and we have found a way to do that as an add on to otherwise standard MRI systems. Because of its non-standard, non-CE marked status, the old system was of limited general utility, but it still cost the same to maintain as a standard MRI system. The project sought to replace it with a modern Siemens system as part of a developing strategic partnership. Providing amodern scanner certified for healthcare use allows the School to support the continued growth in clinical MRI demand from the NHS, whilst supporting the university’s research and development initiatives.

University of Surrey

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surrey.ac.uk

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