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MAISI


Maisi logo - Manufacture of Active Implants & Surgical Instruments

Specialised and regulated facilities for the manufacture of Class II & III medical devices for first-in-human studies in the UK.

MAISI is a national facility for the Manufacture of Active Implants and Surgical Instruments, located at St Thomas’ MedTech Hub. We aim to streamline the clinical translation of healthcare engineering research and address the lack of specialised and regulated manufacturing facilities within healthcare settings. Our dedicated manufacturing cleanrooms and regulatory support services are deployed for small batch production of complex devices for use in human studies. The Class IIb and Class III devices we can produce include Active Implantable Medical Devices (AIMD) and complex surgical instruments. Our cleanrooms will operate under a certified Quality Management Systems (QMS), and we offer dedicated Regulatory support for compliance to the requirements of the UK MHRA and new Medical Device Regulation.

This support is provided through a team of over 10 experts with years of industry experience in Quality and Regulation. The MAISI experts are a crucial element of the executive support King's provides to promising spin-outs and SMEs hosted at the flagship London Institute for Healthcare Engineering (LIHE)

MAISI is a new 120sqm facility operating two Grade ISO-7 Cleanrooms within a certified QMS, with Grade ISO-5 Laminar Flow and Grade ISO-8 prep room.  

MAISI realises the vision of Profs Ourselin, Donaldson and Vanhoestenberghe.  It was established in 2023 by King’s College London School of Biomedical Engineering & Imaging Sciences, in partnership with UCL and Newcastle University, with the support of a £5.2 million grant from the Wellcome Trust.

 

 

 

With the support of Wellcome we are delighted to continue to build infrastructure that addresses the challenges to clinical translation of complex medical devices. This will ultimately contribute to our goal to accelerate the development and uptake of innovative technologies that improve health outcomes.

– Professor Sebastien Ourselin, FREng

 

Contact Us

For any queries you might have, please don't hesitate to contact us.

 

For any enquiries regarding QMS, please contact

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Products

Processes

Heat Treatment

Heat Treatment

Furnaces and oven for nitinol shape setting, annealing, tempering, ceramic sintering and firing.…

Coating

Coating

Wide range of coating deposition system for both metals and organics/polymers using sputter, e-beam…

Lamination and Firing

Lamination and Firing

A hydraulic hot press with a platen area of 200 x 200 mm2 will laminate HTCC and multilayer hybrids…

Populating

Populating

Flexible and high-performance equipment to populate the circuit boards:- Pick and place…

Micro-machining

Micro-machining

Micro-milling EDM (Electrical Discharge Machining) executes high precision and complex parts. The…

The Team

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 people page.

people page

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.

Gabriel joined the school of BMEIS and MAISI team in the early stages of the project to assist with the conceptualisation of the cleanroom and required manufacturing processes. He has a deep technical and operational process experience combined with a talent for data-driven innovation. Gabriel is a Mechanical Engineer with more than 15 years’ experience at a leading pharmaceutical and medical device company where he managed several projects in multiple countries.

Dr Clare Heaysman is the Medical Engineering Quality Systems Director in the Wellcome /EPSRC Centre for Medical Engineering. Clare started working with academic groups on applying the design practices adopted by regulated industries in translational research projects in 2014. She also has 10 years’ experience working in industry on the design and development of drug device combination products for interventional oncology, generating intellectual property and working on the technical transfer from academic and industrial partners.

Michael joined King’s College London in January 2021 as a Process Engineer for the School of Biomedical Engineering & Imaging Sciences. He is responsible for the development and delivery of the new facility for the manufacture of active implants and surgical instruments (MAISI) and the associated manufacturing equipment and processes. After graduating from the University of Hull with a first-class degree in Mechanical Engineering, Michael spent 5 years at a leading medical device company where he held various Engineering focused roles and developed several multimillion-dollar processes for new and existing medical device products.

Laurence joined King’s College London in July 2019 as the Research Administrator for The Centre of Medical Engineering supporting researchers and fellows with major projects. Laurence has been involved in some major grants and projects including KCL Check (research study on the impact of Covid-19). He joined the MAISI team in July 2021 as the Operations Officer for the facility and the directors PA. He is currently working on the MAISI’s marketing and branding strategy as well as supporting the team with the projected timelines.

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.