What we do at Mi3

Mi3 are the experts in contract medical device design, development and manufacturing. We bring medical innovations to life across the medical devices, IVD, Biotech and medical products sectors.

Bringing medical innovations to life

We take your ideas from consultation to concept to production through established medical device development processes with uncompromising excellence and integrity.

 

Our Services

Our extensive experience in medical device manufactureinjection mouldingextrusionsterilisation and regulatory services make us the ideal partner of choice for medical product manufacturers across the healthcare industry.

We believe that choosing the right medical device manufacturing partner should be a seamless process and we pride ourselves at being able to assist in any or all stages of the design, development or manufacturing process to ensure your product is robust and regulatory compliant for the markets they enter.

The Markets We Serve

Medical Devices

The medical devices sector provides an expansive breadth of instruments, appliances, implants or reagents for specific medical purposes in the prevention, diagnostics, treatment, monitoring or alleviation of diseases.

The process of designing and getting a medical device to market can be a complex one, and success can be masked by layers of regulations. At Mi3, we believe the decision to outsource the design, device development, the manufacturing or the entire process should be as easy as possible and provide you with a trusted partnership for the journey.

The design and development of a medical device at Mi3 follows 7 key phases. Moving between phases within a design project or complex design activity with a stage gated review at each step alongside detailed design inputs and deliverables throughout the entire process and resulting in a seamless collaboration between Mi3 and our clients.

The team at Mi3 work closely with you to ensure your medical device, be it simple or complex, is designed and developed to meet the scope of its intended use and the needs of the end user in a cost effective and timely manner.

Medical devices for marketing in the UK and EU are currently subject to regulation under the EU’s Medical Device Directive(93/42/EEC) which is soon to be replaced by the Medical Device Regulation(MDR) in May 2021. For more detail on the regulatory consulting services Mi3 can provide in conjunction with your design and development project click here.

In Vitro Diagnostics

In Vitro Diagnostic devices are a sub group within Medical Devices. The sector alone is an industry that is essential to improving outcomes for the NHS and other frontline healthcare services, and Mi3 is committed to partnering with diagnostic device companies in their development of new innovative IVDs.

The design and development of an IVD at Mi3 follows the same 7 key phases seen in our medical device development process. Moving between phases within a design project involves a stage gated review at each step with detailed design inputs and deliverables.

The team at Mi3 work closely with you to ensure your device, be it simple or complex, is designed and developed to meet the scope of its intended use and the needs of the end user in a cost effective and timely manner. The relevant IVD regulatory requirements are considered every step of the way.

In vitro diagnostic medical devices (IVDs) are subject to the European Directive 98/79/EC (IVDD). A subgroup of medical products, their market access, use, and market surveillance is regulated. The IVDD is implemented in the national laws of the member states and will soon become the IVDR in May 2022. For more details on how the UK’s departure from the EU will affect the regulatory requirements for IVD products being sold into the UK and/or EU click here.

Biotech

In general, biotechnology can be determined as technology that is based on biology or science. Harnessing the many cellular and biomolecular processes, and translating them into technologies and products that can help improve our lives, is the challenge of the thousands of biotechnology companies across the globe.

Mi3 can help remove some of the complexity involved in developing these new products, and make innovations happen. We help biotech equipment companies transform design concepts, lab-scale processes and technologies into robust, marketable devices.

Our experience and design insights are invaluable in specifying the appropriate product development process for you. Speeding up development and helping prevent costly mistakes, as well as precision testing and validation equipment.

Meet the Team

Guy Topping : Managing Director

Guy Topping Mi3Guy has over 20 years’ experience spanning the pharmaceutical, biotech, medical device and scientific industry.

Guy’s focus is on commercial sustainability by ensuring clients are provided with exceptional service and support in the design, development, manufacture and supply of their products.

His track record shows delivery against this objective at multinational and SME level. He is proud to lead a team at Mi3 which can repay the trust placed in it by our partners.

Patrick Duggan : Operations Manager

Patrick Duggan Mi3Patrick has over 10 years’ experience in the manufacturing environment spanning various sectors such as electro-mechanical design and production, medical packaging and medical devices.

Prior to moving into the Operations space he worked as a project manager where he has led multi million pound product launches from concept through to full scale production.

His main focus is to grow MI3’s manufacturing capabilities to ensure a cost competitive and quality product is delivered every time to our business partners.

Kelly Jackson : Senior Technical Manager

Kelly Jackson Mi3Kelly Jackson is the Senior Technical Manager at Mi3 with more than 25 years’ experience across the medical device, pharmaceutical and cosmetics industries and is our subject matter expert in research and development, product design and validation, specialising in Regulatory Affairs.

Kelly oversees the Engineering, Product Development and Quality teams at Mi3.

Ash Jeffrey : Quality Manager

Ash Jeffrey Mi3Ash has 10 years’ experience in medical device design, manufacture and supply including advanced wound care, IVD Instruments and now plastic medical and surgical devices here at Mi3.

His experience spans Operations, Technical and several Quality functions including Design, Manufacturing and Supplier Quality.

Ash brings a focus on continuous improvement with a wealth of experience in various process excellence methodologies.

Noel Marques-Neves : Production Manager

Noel Marques-Neves Mi3Noel has 8 years’ experience in manufacturing within the automotive industry before coming to Mi3, introducing new products and process to facilities, documenting and controlling launch plans, project management and implementing lean six sigma methodologies.

His experience includes production management, quality engineering and facilities management. He brings his experience of in process development to improve production efficiencies and drive lean manufacturing at Mi3.

Louise Sanders : Finance Business Partner

Louise Sanders Mi3Louise is a qualified CIMA Accountant, with over 10 years’ management accounting experience.

Louise’s finance career has spanned aerospace manufacturing, construction and legal consultancy and property management sectors, before bringing her to the medical device industry here at Mi3.

James Scorer : Human Resources Manager

James Scorer Mi3James has over five years’ experience working in Human Resources, having previously worked in multi-million pound businesses including logistics and housing.

Holding an MA in Human Resource Management, he is a Chartered Member of the CIPD, and has a wealth of experience in the many facets of Human Resources.

James believes that people are the key to success and his focus resides in helping to deliver the wider business objectives, through Human Capital maximisation. He ensures that Mi3 attract and retain the right people, and that colleagues are engaged and happy throughout their careers at Mi3.

Sara Yohn : Customer Experience & Marketing Manager

Sara Yohn Mi3Sara joins Mi3 with over 25 years commercial experience within the life sciences, diagnostic, biotech and medical devices industries. Sara's breadth of experience includes strategic planning, product management, branding and marketing communications.

Her passion is shaping and implementing the strategic direction of a business to ensure brand awareness and growth.

Prior to moving into a commercial setting Sara worked on the research and development of Immunological diagnostic tests. She is a CIM qualified Marketer.

Testimonials