Trevor Lewis

Trevor has provided training of national regulatory authorities and senior officials in European Union (EU) medical device directives, MDR 2017/745 & 2017/746 especially in India, China, Egypt, Turkey, and all the MEDA countries on behalf of the European Commission over a 20-year period.

He has provided guidance and advice on medical regulation implementation to Canada, the Republic of Moldova, Hong Kong, and China. This has included working with the European Commission and Chinese Government via BSI on the comparison of clinical evaluation in both jurisdictions to inform the European Commission (EC) and Chinese Food and Drug Administration (CFDA) on their regulatory approach.

Trevor has also worked very closely with ECRI Institute throughout his medical device career. ECRI provides world leading and truly independent Health Technology Assessment (HTA). Understanding HTA is a crucial component of success with medical devices.

Trevor has provided specialist knowledge, guidance, and expert advice to individual entrepreneurs, small companies, multi-nationals, universities, and governments all around the world to help take innovative medical device concepts to market. Naturally quality systems, regulatory affairs, business development, and HTA are all key to his approach.

Trevor has an in-depth unique mix of technical, financial, business, and regulatory skills, which coupled with his experience gained from working in all aspects of medical device innovation have made him a well-known and sought-after professional.

Trevor has experience of large-scale international collaboration. He is a former Partner for Exploitation and Regulatory Affairs in TheraEDGE an €8 million EU Framework (FP7) Project. He was a consultant to RAPP-ID a €14.7 million Innovative Medicines Initiative (IMI). Both projects were concerned with molecular diagnostics.

Trevor’s early career was in the Royal Air Force (RAF: 1974 to 1979) initially as an Apprentice and Technician working in Air Communications and Air Radar, then as a Flying Officer (student pilot). Trevor left the RAF to study Physics, Electronics, and Mathematics at Reading University. He first worked with medical devices during 1980, whilst still at university, working in the quality assurance department of an electronics company.

After graduating Trevor worked at Smiths Industries as a Development Engineer working on the Digital Engine Control Unit (DECU) for the Pegasus engine used in the Harrier ‘jump jet’ and various related test equipment used in production of the DECU. This design and development work included both analogue and digital multiplexers.

Trevor then became a High Technology Securities Analyst (North American) for stockbrokers Grieveson & Grant – where he met and interviewed some of the greatest technology entrepreneurs of the 1980s.

He joined Vickers Medical in Basingstoke during 1985 initially as a Design and Development Engineer working on patient monitoring products. He was rapidly promoted to Product Manager and then Marketing Manager working in Hatboro, PA, USA on neonatal products for global markets. A significant product he helped to create was the ‘Quiet Time’ incubator that was developed by recognizing the importance of human factor issues for the baby, parents, nurses, and clinicians.

Trevor joined Huntleigh Healthcare in the USA during 1989 and returned to the UK. He led projects that resulted in Queen’s Awards for Innovation and Export. He was promoted to Director, Corporate and New Business Development for the Group.

After leaving Huntleigh during 1993 he was a Director at Innovation Wales and then General Manager at Ferraris Medical, a respiratory device business, in London.

He was invited to tender for a major national strategic medtech project to work as a consultant for the Welsh Development Agency (WDA) during 1995 and beyond. This led to the founding of the Medical Device Consultancy (MDC).  The project objective was to

“To provide the Welsh Development Agency with the relevant research, strategy, sales arguments, supporting analysis and personal commitment to create a foundation for Wales as a world renown centre of excellence for medical devices.”

The project was a complete success and Trevor went onto provide expert research for the ‘Medical Technologies Cluster Research Project’ for Advantage West Midlands (AWM).

Trevor’s initial regional development consultancy work was concurrently complemented by work in quality systems and regulatory affairs. This was the start of MDC as it is today.

Trevor is particularly pleased that over the years several previous clients, initially engaged with at the start-up stage, have grown and developed into successful businesses that have been sold and provided substantial returns for their founders and investors.

Please contact MDC for Trevor’s CV and Training Record if you wish to know more.

Should you require any further information simply call us on +44 (0)7739 733 177