UCL partners on new medical device manufacturing facility
6 February 2020
A new facility at St Thomas’ Hospital aims to accelerate the clinical translation of medical devices by providing specialised, regulated support for prototype development.
UCL has partnered on a £5.2million grant from Wellcome Trust which will establish the new Manufacture of Active Implant and Surgical Instruments (MAISI) facility, located in St Thomas’ Hospital. The development will be led by School of Biomedical Engineering & Imaging Sciences, King’s College London, with further collaboration from Newcastle University.
The facility will support the manufacture of medical devices for use in first-in-patient studies. Crucially, regulatory support and a Quality Management System (QMS) approach will be embedded within the environment. This will ensure compliance to the requirements of UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and increase the chances of clinical translation for complex medical devices.
Few facilities in the UK allow for the manufacture of medical device prototypes in a specialised, regulatory environment like this, so MAISI presents an exciting opportunity for the national research community. The facility has the potential to accelerate the translation of healthcare engineering research into clinical use.
UCL’s Dr Anne Vanhoestenberghe, Division of Surgery and Interventional Science, has been appointed Deputy Director of MAISI. Anne is an electronics engineer, with specialised expertise in packaging for implantable medical electronics devices. She is particularly focused on developing new techniques to produce miniature active implantable medical devices that will operate reliably in the patient’s body for their whole lifetime.
Anne commented, “Class II and Class III medical devices have huge potential for impact, however their complexity demands a need for new translational models for them to reach patients and clinical use. Translation is currently impeded by the lack of appropriate facilities within the UK to navigate the intricate regulatory environment and to facilitate first-in-patient studies. MAISI will help fill this gap and I am delighted at the opportunities that this will provide for translation.”
Find out more about medical devices development at UCL?
UCL’s healthcare engineering community has world-leading expertise in the development of medical devices and researchers are involved in a diverse range of activity. An epicentre for the development of medical devices at UCL is Wellcome / EPSRC Centre for Interventional and Surgical Sciences (WEISS). Through QMS support and physical co-location of engineers, clinicians and computer scientists, WEISS has enabled medical devices research to flourish.
Successes within WEISS include the CE certified SmartTargetsystem which enables precision targeting for prostate cancer treatment, has been clinically evaluated in over 300 patients at UCLH and which sold its technology to Miami-based Intuitive Fusion LLC for clinical implementation last week. Another WEISS-based example of fundamental engineering developed and spun-out is EchoPoint Medical Ltd. EchoPoint raised £2.8m at the end of last year developing optical sensing technology to improve the accuracy of heart disease treatment.
Another hub for medical devices research is UCL’s Aspire Centre for Rehabilitation Engineering and Assistive Technology(Aspire CREATe) based at Royal National Orthopaedic Hospital and led by Dr Rui Loureiro. The experimental and novel techniques being pioneered there incorporate medical devices ranging from robotic exoskeletons to brain-computer interfaces, and from smart wheelchairs to 3D-printed bionic limbs. A particular focus on electrical stimulation and electrophysiological interactions is lead by Dr Lynsey Duffell, and includes some of the implantable electronic devices spearheaded by MAISI’s Deputy Director, Dr Vanhoestenberghe.
Another major contributor in the field is Dr Steve Taylor. His work within the centre is focused on active implantable medical devices including remotely extendible implantsto develop ‘growing’ prosthesis for children with bone tumours and other orthopaedic implants. He has a significant experience in first-in-human trials.
Other exciting examples of translatable medical devices include a retrievable aortic valve replacementthat could improve patient safety developed by a team within UCL Cardiovascular Engineering Group, and much of the work produced by the Implanted Devices Group(IDG) led by Prof Nick Donaldson.
A notable programme within IDG, CANDO (Controlling Abnormal Network Dynamics using Optogenetics), will form one of MAISI’s flagship projects. CANDO is a collaboration between Newcastle, UCL, Imperial College London and the Newcastle NHS Foundation Trust, to tackle epilepsy with an innovative multi-modal approach by combining electrical activity detection and optical neuromodulation of brain cells with increased light sensitivity. The project’s goal is to create a first-in-human trial in patients with focal epilepsy and to ensure the reliability of the components and material that will be implanted in the brain.
Much of the medical devices activity at UCL will be supported by the newly launched Devices and Diagnostics Therapeutics Innovation Network (TIN), which is led by UCL Institute of Healthcare Engineering and UCL Translational Research Office. The TIN brings together an interdisciplinary research community and is currently focused on creating a workflow for the design and development of medical devices, as well as reinforcing functional lines with UCL Partner Hospitals.