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MAISI

MAISI
Facility for the Manufacture of Active Implants and Surgical Instruments

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
 

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

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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 and clinical trial 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 and Clinical Trial support for compliance to the requirements of the UK MHRA and new Medical Device Regulation.

MAISI was established by King’s College London School of Biomedical Engineering & Imaging Sciences, in partnership with UCL and Newcastle University, with the support of a Wellcome grant of £5.2 million.

Products & Processes

Silicone Encapsulated Ceramic Enclosure System (1)

Silicone Encapsulated Ceramic Enclosure

The Silicone Encapsulated Ceramic Enclosure is an active implantable medical device which provides a flexible platform for device connectivity, communication and control.

 
Micro Titanium Ceramic Enclosure System (1)

The Titanium Ceramic Micro Enclosure

The Titanium Ceramic Micro Enclosure is an active implantable medical device which provides a flexible, minimally invasive platform for device connectivity, communication and control.

 

MAISI Technologies

The MAISI Centre is a new 120sqm facility embedded within St Thomas’ MedTech Hub at St Thomas’ Hospital. It operates two Grade ISO-7 Cleanrooms within a certified QMS, with Grade ISO-5 Laminar Flow and Grade ISO-8 prep room. 

 

Two micro-machining laser units offer flexibility to execute sophisticated parts in different materials (metals, polymers and ceramic). Working area of 300 x 300 mm2, motion range of ± 100 mm, and equipped with high precision rotary chuck for small tubes (1.27 mm and a wall thickness of 0.15 mm).

A unique process capable of joining dissimilar materials like ceramic to titanium that delivers both high levels of hermetic performance and RF transparency. Working volume of 8 litres (200 x 200 x 200 mm3) and motion range of ± 50 mm.

Furnaces and oven for nitinol shape setting, annealing, tempering, ceramic sintering and firing. Chamber size for high temperature (1,600 C) of 7.5 litres, and 30 litres for lower temperatures. RTP (Rapid Thermal Processing) furnace has a chamber size of 0.4 litres and controlled atmosphere.

  • Micro-milling EDM (Electrical Discharge Machining) executes high precision and complex parts
  • The electrode removes material by spark erosion, drilling holes as small as 45 microns in diameter and as large as 3 mm, in a working area of 0.04 sqm (300 x 150 mm2)

Wide range of coating deposition system for both metals and organics/polymers using sputter, e-beam and thermal evaporation sources.

A hydraulic hot press with a platen area of 200 x 200 mm2 will laminate HTCC and multilayer hybrids in a continuous temperature (maximum of 250 C). The complete production on printed circuits is inside cleanroom grade ISO-7, including firing and sintering of ceramic components.

    Flexible and high-performance equipment to populate the circuit boards:
  • Pick and place (semi-automatic)
  • Fine Placer System (for precise positioning and reflow)
  • Wire-bonder
  • Parallel gap welder

Micro-milling EDM (Electrical Discharge Machining) executes high precision and complex parts. The electrode removes material by spark erosion, drilling holes as small as 45 microns in diameter and as large as 3 mm, in a working area of 0.04 sqm (300 x 150 mm2).

State of the art 3D printing system using different technologies, aiming to manufacture high-quality parts focusing our process in small sizes (maximum of 0.7 litres) using PA2200 Nylon, Ti64 titanium alloy, alumina ceramic and high performance polymers.

 

Our 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.

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 Manager 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 as well as 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 Associate. 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.

Kam Kahlon joined MAISI in 2022 as Manufacturing Quality Assurance Lead to provide quality support in designing and establishing a new cleanroom facility for the production of first-in-patient medical devices. Kam transferred from another flagship clinical manufacturing facility within KCL where she spent 20 years working in various roles.

 

Contact us

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

 

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