MAISI

Anne’s research is in the field of neurotechnologies, from technological innovations to their interactions with the (human) nervous system. She develops technology for the next generation of implantable electronic devices to improve the quality of life of patients, through applications such as: neuromodulation and electrical stimulation for the restoration of movement in paralysed muscles; and biopotential recording for control of prosthesis and artificial organs. Anne is the Director of MAISI, a national facility for the Manufacture of Active Implants and Surgical Instruments housed at St Thomas' hospital. MAISI is not only a unique facility to manufacture the most complex medical devices, but the team also brings together engineers and experts in regulatory affairs to support researchers, whether in academia or SMEs, to bring their ideas to the first tests in humans. Anne trained as an engineer in Belgium (ULB) and the Netherlands (Eindhoven), then had the opportunity to undertake a PhD under the supervision of Prof Donaldson in the Implanted Devices Group at UCL. She has worked in Germany (IMTEK, Freiburg) and Australia (UNSW, Sydney), where she was fortunate to meet some of the most influential people in her career. Anne is also a keen teacher with a concern for Diversity Equality and Inclusivity, and actively seeks new strategies to develop more inclusive learning spaces and improve the university experience of non-mainstream students. She has been an active member of the International Microelectronics Assembly and Packaging Society (IMAPS-UK) since 2012. Opportunities to join MAISI or her research team as a PhD student or postdoc are regularly advertised through King's webpages and on LinkedIn. You can also view Anne's research profile.

Research profile

Professor Sebastien Ourselin FREng, is Head of the School of Biomedical Engineering & Imaging Sciences at King’s College London. He is also Director of the Wellcome/EPSRC Centre for Medical Engineering and Deputy Director of the London Medical Imaging and Artificial Intelligence Centre for Value Based Healthcare. He has over 20 years of experience within academia and research organisations across three countries. Alongside Guy’s & St Thomas’ NHS Foundation Trust, he is leading the establishment of a MedTech Hub, located at St Thomas’ campus. The vision for the Hub is to create a unique ecosystem, enabling academia, industry and the NHS to work in synergy and develop health technologies (including medical devices), workforce and operational improvements that will be of global significance. He has significant experience in translating and commercialising healthcare technology and is a co-founding member of two academic spin-out companies.

Dr Clare Heaysman is a Senior Lecturer in MedTech Regulatory Affairs based at the London Institute for Healthcare Engineering, King’s College London. She is a certified ISO 13485 Lead Auditor and Director of the Medical Engineering Quality and Regulatory Team. The Medical Engineering Quality and Regulatory Team offers a Quality Management System (QMS) and bespoke regulatory support for medical device development. They support projects with their technical file creation and adherence to medical device regulatory requirements. Clare’s experience also includes the manufacturing of complex medical devices and she holds the responsibility and authority for quality management of the national facility for the Manufacture of Active Implants and Surgical Instruments (MAISI) at St Thomas’ hospital. Clare has been working with academic groups on applying the required regulatory design control practices in translational research projects since 2014 on projects including; developing a novel intraoperative ultrasound probe for first-in-human transsphenoidal surgery, guided instrumentation for fetal therapy and surgery, digital mental health interventions and a unique implantable polymer-based glaucoma device. Prior to that she spent 10 years working in industry on the development of drug-device combination products for interventional oncology; generating intellectual property and technical transfer from academic and industrial partners.

Prof. Christos Bergeles received his Ph.D. degree in Robotics from ETH Zurich, Switzerland, in 2011. He was a postdoctoral research fellow at Boston Children’s Hospital, Harvard Medical School, Massachusetts, and the Hamlyn Centre for Robotic Surgery, Imperial College, United Kingdom. As a Professor at King’s College London, he directs the "Robotics and Vision in Medicine Lab" whose mission is to develop micro-surgical robots that deliver regenerative therapies deep inside the human body. Prof Bergeles has been awarded an ERC Starting Grant (2017 – 2023) and, among others, holds i4i NIHR funding (2017 – 2020, 2022 – 2025) for the development of instrumentation that delivers stem cells to diseased retinal layers. His active grant funding as PI is £2.5M. He has co-authored more than 100 articles in top-tier conferences and journals, and his research has been cited more than 3000 times. He was an Associate Editor of the IEEE Transactions on Robotics, and the IEEE Int. Conf. Robotics and Automation. His team and he are very active in public engagement and patient involvement activities, with examples including New Scientist Live (2019, 2023, 10,000+ participants), and Royal Society Summer Science Exhibition (2023, 10,000+ participants). He is an IEEE Senior Member.

Michael joined the School of BMEIS and the MAISI team in the early stages to lead the development of the cleanroom and establish the required manufacturing processes. With 10 years of experience in the medical device industry and a background in leading projects globally, he brings a strong foundation in both technical expertise and operational leadership. Michael heads the engineering team at MAISI.

Dominic Bailey has been working at MAISI since September 2024. He has an MEng in Mechanical Engineering with Mechatronics from Newcastle University and brings expertise from his time at CMR Surgical, focusing on surgical instruments and ISO 13485 compliance to ensure quality in medical device manufacturing.

Catherine joined the MAISI team in the spring of 2024 as the Operations Officer for the facility and the Director's PA. She is currently working on the MAISI’s communication strategy alongside supporting the team with projected timelines. She has a varied background in operations in university facilities, fringe arts and the NHS/public sector.

Hannah joined MAISI in early 2022 as Regulatory and Clinical Research specialist. Having previously worked for the Medicines and Healthcare products Regulatory Agency delivering post-EU exit regulatory change, she provides customers and internal project teams at KCL with expert advice on medical device regulations and assists with the clinical translation of research prototypes.

Hedley joined MAISI in 2024 as Manufacturing Quality Assurance Lead. Hedley has over 10 years’ experience in Quality management positions at leading pharmaceutical and ATMP organisations. Hedley has been involved in projects in establishing cleanrooms and manufacturing facilities and has led Quality in pharmaceutical and ATMP manufacture for clinical trials and commercial batch release.

Fintan joined MAISI in early 2023 as Quality and Compliance Officer providing quality support in establishing a new cleanroom facility for the production of first-in-patient medical devices. Fintan spent over 6 years in leading GMP Contract Manufacturing and Research Organisations where he held various Quality positions supporting release and manufacture of ATMP and Biologic products used in clinical trials and commercial batch release.

Pamela joined in March 2023 as the Cleanroom Manufacturing Technician to support the qualification and validation of the process equipment. She graduated with a degree in Biomedical Engineering from Lodz University of Technology and holds a degree in Applied Biotechnology from the University of Westminster. Prior to her current role, she worked in various part-time jobs that allowed her to adapt to different working environments.

Lauren joined the MAISI team in Summer 2024 as an Electrical Manufacturing Engineer. She is responsible for supporting the qualification, validation, and operation of the cleanroom equipment. She graduated from the University of San Diego with an undergraduate degree in Mechanical Engineering and from Queen Mary University of London with a Masters in Biomedical Engineering. Before joining MAISI, Lauren spent a few years working in the semiconductor manufacturing industry in Arizona, USA.