Medical diagnostics are the technologies concerned with the determination of a disease or condition causing a person’s signs and symptoms. Technologies produced in Wales include in-vitro diagnostics, molecular diagnostics, medical imaging and eHealth. In-vitro diagnostic tests are typically used in health professional settings or for consumers to use at home. Molecular diagnostics are technologies used to analyse biological markers in the genome and proteome by applying molecular biology to testing. Diagnostic imaging covers the capturing and interpretation of images for the purpose of medical diagnosis. Diagnostic technologies in eHealth are concerned with the collection and aggregation of patient level health data for monitoring purposes. Companion diagnostics is a new field embedded in the strategy of personalised medicines and involves genetic tests which provide information on a person’s likelihood of developing a specific disease or if certain drug treatments work effectively. Of the 207 life science companies based in Wales, 33 (16%) are medical diagnostics companies. In-vitro diagnostic technology is the largest sub sector with 16 companies (7% of the UK total).
The devolved Welsh NHS is a unique and important asset to the diagnostics sector, as a research collaborator, a customer and as a supplier of clinical expertise. While most companies introduce their new products into global markets, adoption by the NHS can be an important reference site for demonstration, and stepping stone to achieving international sales. The work of NISCHR, NISCHR AHSC and specifically Health Research Wales is credited with playing an important role in improving engagement between industry and clinical experts. The Welsh Cancer Bank is also regarded as an excellent resource that has simplified the process of accessing tissue samples.
Close collaboration between academic institutions and manufacturers is an important feature of the Welsh life science sector. MediWales is the networking organisation that supports collaboration between Industry, academic and clinical professionals. The new Welsh Government Life Science Hub is intended to bring together the sector under one roof. Work is being carried out to address skills gaps in the diagnostics sector. In South West and Mid Wales the Regional Learning Partnership has carried out a survey to identify skills needs in the sector while Cardiff University is discussing the introduction of ‘Education for Industry’ courses. The Life Science Exchange has established an ongoing life science skills group to identify areas of need in the Welsh life science sector. Business incubator facilities are offered by Swansea University and the Cardiff Medicentre and industrial ‘grow on’ space is available at the Sony UK site in Pencoed.
Assessment and adoption of new diagnostic technologies by the NHS across the UK is a concern for diagnostics companies producing innovative solutions. There is currently no equivalent to the pharmaceutical assessment and adoption process for diagnostics. The general shift in the NHS market towards adoption of higher throughput diagnostic solutions and full service third party provision could become a barrier to adoption of niche technological innovations. Access to patient and infectious disease samples is an issue for R&D led diagnostics companies. An inadequate supply of UK clinical samples has created a bottleneck in the industry.
The sector suffers from skills shortages in regulation, intellectual property, project management and practical laboratory skills. Undergraduate students are often unaware of the range of roles available in the diagnostics sector including sales, marketing and regulation. Regulatory skills are an area of particular need for diagnostics companies. The regulatory burden on diagnostics technology companies is increasing. For new companies and SMEs, this regulation is a major barrier to market entry. Regulation is also a barrier to international trade. Given the international nature of the diagnostics sector, this is a priority issue. There is a feeling that current laboratory and manufacturing facilities that suit the needs of the diagnostics companies are inadequate to meet the growth aspirations of the sector. For many smaller companies another limiting factor to international trade is the cost of specialist cold chain logistics. Diagnostic tests are more price sensitive than drugs but drug distribution can dictate the pricing of specialist logistics.
1. TECHNOLOGY ADOPTION AND UNMET CLINICAL NEEDS
Wales has the opportunity to lead the UK in the implementation of a formal diagnostic technology appraisal and adoption process. Alongside this process the Diagnostics Focus Group would like to work with clinical colleagues to identify and address ‘unmet clinical needs’ in the diagnostics sector. To this end a Diagnostics Special Interest Group (SIG) is proposed, potentially as part of ongoing Life Science Exchange activity and with the support of MediWales.
The Diagnostics Focus Group would strongly support the provision of ethical and appropriate access to anonymous patient samples for research and testing. A ‘bio bank’ created using a similar model to the Wales Cancer Bank is proposed. This specific recommendation reflects a wider opportunity for close NHS / Industry engagement.
Given the proportion of business done outside of Wales, companies stress the need to support international activity as a priority. A specific action is for companies to collaborate, with a view to reducing the cost of international trade for smaller companies and niche products, to share capacity and to negotiate prices of specialist cold chain distribution.
There is a need to raise awareness of career options in the sector to undergraduates and to provide specialist training in subjects such as intellectual property, project management and practical laboratory skills. Companies can work together to create a critical mass of applicants required to make the provision of part time courses in these subjects. There is a specific need to develop the regulatory skills required for the future. Government assistance in the provision of regulatory support and training would be a valuable service to businesses. The continuation of the Life Science Exchange Skills Initiative could be an overarching forum for collaboration in this area.
There is a need for appropriate laboratory and mixed-use business accommodation for
diagnostic companies if sector growth is not to be curtailed by a lack of appropriate research,
development and manufacturing facilities.