Medical Devices


OVERVIEW

The ‘medical technology’ sector includes companies whose major business activity involves the development, manufacture, or distribution of medical devices as defined by the European Union Medical Devices Directive (93/42/ECC) and companies who have significant activity in supplying specialist services to the medical technology sector.

Of the 207 life science companies based in Wales, 146 (71%) are medical technology companies. This figure represents around 5% of the companies based in the UK. The Welsh medical technology sector has a turnover of around £1,017m (6% of UK turnover) and employs around 6,367 people (8% of UK employment). The sector has experienced significant growth in employment, with 2012-13 showing a growth of 8.6% in a single year. Annual turnover has increased since 2009 by a compound annual growth rate (CAGR) of 2.2%. The global market is expected to continue to grow at a rate of 4.5% per annum reaching global sales of £291bn by 2018.

A wide variety of medical technology products are produced in Wales. In-vitro Diagnostics is the largest sub sector with 16 companies (7% of the UK total). Assistive Technology is the second largest sub sector with 13 companies (4% of the UK total). The ICT and eHealth sub sector has 11 companies (6% of the UK total). Hospital hardware and single use equipment each have 10 companies (6% and 4% of the UK totals respectively). 16 companies provide specialist business services to the medical technology sector. Anecdotal evidence suggests that most medical products made in Wales are sold abroad.

 

STRENGTHS

Given the importance of access to clinical markets and expertise the key strength identified by the Medical Technology Focus Group is the role played by the NHS in Wales. One Focus Group member remarked, “They share the desire to see Welsh companies thrive.” A strong home NHS market is a prerequisite for UK and export sales. The Welsh NHS is recognised as being generally approachable and willing to help. Health Boards are increasingly more receptive to ideas that save time, reduce risk or increase capacity.

 

CHALLENGES

It is felt that navigating the NHS procurement landscape is complicated, with numerous different routes for different products and companies who may use different tactics. Support for companies to navigate and take advantage of these opportunities is considered a priority for the sector. The Welsh NHS Shared Services Partnership is recognised for helping and guiding Welsh SMEs. Sell 2 Wales is also regarded as an excellent tool for accessing UK wide contracts.

It is noted by the Medical Technology Focus Group that a significant barrier to selling to the NHS is getting products to the approved vendor list. It is felt that there needs to be a mechanism for reducing the cost burden of approvals by the NHS so that it can undertake this
activity faster and more often.

The unique roles of The Surgical Materials Testing Laboratory in Bridgend (SMTL) and CEDAR (NICE Evaluation Centre) are recognised and it is felt that these facilities could be further enlisted to help with assessment and approvals, which would also enhance the quality and perception of the Welsh medical technology sector.

Health Research Wales is recognised as presenting a significant opportunity to promote a strong clinical base for trials and testing to benefit both the population of Wales and indigenous businesses. The newly established Welsh Wound Innovation Centre may also contribute to the technology evaluation challenge.

 

OPPORTUNITIES

1. NHS TECHNOLOGY EVALUATION AND ADOPTION

There is an opportunity for the Welsh NHS to introduce a clear and appropriate access point for new technology appraisal and adoption and to use procurement to encourage adoption of innovations where better patient outcomes or reduced costs can be achieved. Clinical specialists could be helped to engage with suppliers specific to their clinical specialty in order to address unmet technology needs.

 

2. LIFE SCIENCE ‘KNOWLEDGE’ EXCHANGE

Many of the needs expressed by the Medical Technology Focus Group concern access to information, specifically the need to map the route to market for medical technology in the NHS; a directory of qualified regulatory and QA consultants; information about international markets and data that demonstrates the extent and value of international trade carried out by Welsh companies; regular and timely notifications of regulatory changes; and more up-todate, timely, specific funding information.

 

3. COLLABORATION

Wales has a highly collaborative life science community. A number of novel suggestions were made by the Medical Technology Focus Group aimed at transforming this collaboration into tangible benefits. Closer interaction and a ‘bridging of cultural differences’ can be achieved between industry and NHS staff through a ‘job exchanges’ or an ‘embedded staff’ programme intended to facilitate NHS and industry staff spending time together in manufacturing and clinical settings.

Wales also has a strong industry base across a number of advanced manufacturing sectors with expertise that can translate into the medical technology sector. Cross sector collaboration between these groups should be facilitated and encouraged. Greater collaboration between the medical technology sector, commercial property agents, architects and builders to generate new mixed ‘fit for purpose’ facilities and support the projected growth in the sectors also proposed.

Each of these opportunities could be progressed through the continuation of a sub-sector Special Interest Group tasked with improving collaboration between academia, industry and the NHS.

 

4. SKILLS

The need for graduates whose skills meet the needs of the life science sector was expressed across all Focus Groups. In the Medical Technology Focus Groups, it was felt that there is a growing need for staff to be trained in cGMP and that this could be delivered through engineering degree courses and bespoke courses for small businesses.