The December 2006 report of the Scottish Science Advisory Team (SSAC) on medical imaging highlights that advances in genetics, pharmacology and medical imaging technology bring the prospect of understanding diseases at a cellular and of molecular level, which is critical to both prevent diseases and improve treatments. Further, the recent Scottish Executive Rehabilitation Framework (2007) “coordinated, integrated and fit for purpose: A delivery framework for adult rehabilitation in Scotland” clearly highlights the need for advanced technology to improve rehabilitation services, particularly in the community setting for people with long-term conditions.
The objectives therefore are clear. However, in the field of biomedical devices, innovation beyond incremental advancements is impeded by the lack of integration of research and development in the NHS, academic and commercial sectors active in healthcare research and delivery. There have been a number of regional efforts made to address this issue, and these include:
- The Institute for Medical Science and Technology (IMSaT) a joint venture of universities of Dundee and St Andrews
- The Strathclyde Institute of Medical Devices (SIMD) at the University of Strathclyde
- The Medical Devices Doctoral Training Centre (DTC) Based at the University of Strathclyde, the only UK doctoral training centre in medical devices funded by EPSRC
- The Translational Medicine Research Collaboration involving Aberdeen, Dundee, Edinburgh and Glasgow universities, Wyeth Pharmaceuticals, Scottish Enterprise and the NHS
- The Clinical Research Centres, Aberdeen, Edinburgh, Dundee, Glasgow
- Researchers within the ERP, along with other academic researchers and four recently appointed RCUK fellows in the School of Engineering and Electronics and College of Medicine and Veterinary Medicine at Edinburgh.
- The SFC/NHS funded HealthQWest Research capacity and capability building consortium for nurses, midwives and allied health professionals (NMAHPS) involving Strathclyde University, Glasgow University, Glasgow Caledonian University, Stirling University, University of West of Scotland and the NHS in the West of Scotland.
A related, but specific, need is an improvement in the NHS/academic interface which would encourage and enable clinicians to become part of multi-disciplinary research teams, expanding on the nascent NHS scheme to develop the strengths of clinicians.
Finally, with current and projected growth in biomedical research, there is a need to both attract new skilled personnel to this field, and to develop and encourage the skills presently available within Scotland. Here, the graduate schools of the Engineering Research Partnerships can play a truly pivotal role.
Where Scotland Stands
Scotland has an excellent background of research in medicine and medical technologies. Clinical Research Networks are being established in cancer, stroke, diabetes, mental health, primary care and children’s medicine through the Chief Scientist Office (CSO). Regional collaborations have been developed with both academic and active hospital-based scientists and clinicians from the requisite disciplines of surgery, orthopaedics, rehabilitation, geriatric medicine, radiology and cardiology, many of whom are drawn from 5* RAE departments (e.g. surgery and molecular oncology and cardiology at Ninewells Hospital and Aberdeen Royal Infirmary). Other hospitals such as the Glasgow Royal Infirmary, Gartnavel, Glasgow Southern General and Glasgow Western Infirmary with long established reputations in research have embraced new initiatives at the interface with engineering and the life sciences. For example the Glasgow Research Pooling has led to a new initiative between the National Spinal Injuries Unit at Glasgow Southern General and neuroprothetics and mechanical engineers at the Universities of Strathclyde and Glasgow.
The EPSRC established the only UK Postgraduate Doctoral Training Centre (DTC) in medical devices at the University of Strathclyde in 2003. The DTC has active research collaborations across Glasgow and other NHS hospitals including Ninewells, Addenbrookes and the Hammersmith Hospital. The aim of the DTC was to form a fluid network between engineering, the life sciences and the clinical interface to allow some of the unresolved problems in the field of medicine that relate to medical devices to be addressed by innovative, interdisciplinary thinking. Currently there are thirty-four interdisciplinary research projects in medical devices, all with clinical or medical company advisers, being pursued by graduate students in the DTC. The DTC shares some common resources with the Strathclyde Institute of Medical Devices (SIMD). SIMD capitalises on existing University expertise in medical devices with collaborative research involving academic, NHS and industrial partners. This is a truly specialist research institute, dedicated to developing and exploiting expertise in this, one of the most dynamic and fastest growing sectors in the global healthcare industry. The Institute provides opportunities for the NHS, healthcare companies and the Life Sciences Intermediate Technology Institute to engage in high-level, multi-disciplinary, near-market research collaborations. A strong engineering-life sciences- NHS network underpins the interdisciplinary approach of the institute and ensures the clinical relevance of its projects
Similarly, the Institute for Medical Science and Technology (IMSaT) recently created as a joint venture of the Universities of Dundee and St Andrews, binds together research in medicine, biology, computing, engineering and physics with clinicians, health service providers, biomedical device companies and funding agencies. In common with other regional initiatives, there are existing strengths in physics and engineering which already interact with clinical and life sciences research, and such links must be expanded and coordinated on a pan-Scotland basis to optimise outcome deliveries. These collaborations include surface and materials science, bioengineering, tissue engineering, image analysis and surgical technology. Already strong links exist with SUPA between medical photonics at St Andrews and the schools of medicines, life sciences, computing and engineering in Dundee within IMSaT and between Bioengineering at Strathclyde and Glasgow universities and the allied health professionals through HealthQWest. A unique asset of IMSaT is building an “end-to-end” standardized and certified commercialisation process that will accelerate the most promising opportunities towards exploitation of medical product development. IMSaT plans to underpin its commercialisation activity with a commercially- development process based on regulatory rules of ISO 9000 13485 and GLP. This process is considered for long term funding through Scottish Enterprise National.
These various initiatives demonstrate that Scotland has recognised the scientific and clinical need in this sector, and possesses all of the skills, expertise and creativity at both the regional and national levels to effectively compete in the international arena, and these characteristics should ensure that Scotland continues to play a leading role in the field of biomedical science. The diverse specialist skills which exist within Scotland, coupled with the real clinical need of an aging population in which there is a high incidence of major diseases, such as cancer, coronary heart disease, and diabetes , suggests an enhanced significance for a truly Pan-Scottish approach in this field.
Challenges: Cross-Cutting Themes for Pan-Scottish Research
There have been a number of UK wide task forces and government committees which have reported in recent years on the need for interdisciplinary research and improved interfaces to engineering for the life sciences.
By 2006 the UK Technology Strategy Board (TSB), tasked with ensuring a cohesive approach to research and technology development in the UK and with synthesising the views of the research councils, industry and the research community into policy, had identified six Key Areas for the UK. These were;
- Bioscience & Healthcare
- Advanced Materials
- Information and Computer Technology
- Electronics & Photonics
- Sustainable Production & Consumption
- Design Engineering and Advanced Manufacturing
In the first priority area, Bioscience and Healthcare, the TSB gave particular priority to Medical Devices and further proposed the following as particular imperatives:
- Converging technologies – convergence of the physical with the biological leading to new and combined functionalities.
- Diagnosis and screening technologies together with the development and monitoring of more targeted therapies.
- Regenerative medicine – methods to induce the body to regenerate healthy functional tissue and to provide replacement parts.
- Assistive technologies – devices and technologies that aid rehabilitation and support for independent life in the community.
These four research imperatives seem to fit very well with the needs of the aging Scottish population, which represents a significant challenge to the social, clinical and technological sciences in this new century. Presently, approximately 18% of the Scottish population is over 65 and more than 380,000 are aged over 75. In 2006, the rise in population aged over 75 was 13%. Coupled with this is a decline in all age groups <44 years. The age profile of the population of Scotland is therefore becoming dominated by a growing absolute number and proportion of people in the older age groups. This will be further exacerbated by the cumulative effects of the 1947 and 1960s baby booms which will contribute to a continuation of this trend (http://www.gro-scotland.gov.uk/files1/stats/mid-2006-population-estimates-scotland/j852700.htm). With this aging population come a number of significant social and clinical challenges that supplement those already prevalent in the Scottish population. These include diabetes, cancer and cardiovascular diseases, together with the challenges associated with maintaining mobility and independence in an aging population. It is clear therefore that age related health and welfare problems are of critical importance to the Scottish economy and its future social landscape.
To optimise the impact of research in this area in Scotland it is essential to focus on interdisciplinary research in the medical science/clinical interface sector. The Health Industries Task Force Report in 2005 and the Cooksey Report in 2006 both pointed to a need for more academic-NHS collaboration and greater support for applied and translational research at this interface between engineering, science and medicine. Thus in informed studies throughout the UK, involving the NHS, academia and industry, important needs have been signalled for the UK. Scotland is well placed to lead research and development in many of these areas.
The challenges in this field call for themed research programmes. This was discussed by participants at the pan – Scottish Meeting of the SRPe. Themes that were identified in a pan-Scottish context are:
- Tissue Engineering and Regenerative Medicine.
- Assistive and Interventional Health Care Technologies.
- Analytical and Computational Modelling
- Biomaterials, Bioengineering and Biomechanics
- Diagnostic and Therapeutic Imaging.
These themes represent both the broad range of expertise available across Scotland as demonstrated by the number of regional initiatives, and those specialist areas most pertinent to the current clinical and social imperatives. There is considerable cross-thematic interaction in terms of the disciplines involved in addressing these various needs. However, the role of individual themes are quite clear, but most can be viewed as being mutually enabling. Tissue engineering and regenerative medicine (1) is associated most closely with the treatment of disease, for example the development of novel wound healing and tissue correction technologies, whereas imaging and, sensors (6,5) are most closely aligned to the screening, diagnosis and continued monitoring of diseases, medical devices and conditions, but cross over in many ways with all other themes. Analytical and computational modelling (3) may be considered to be a generally enabling theme and represents the important and continually developing discipline of modelling of complex and simple mathematical interactions in population, biological and device environments. The assistive and interventional health theme (2) relates principally to the development of treatment technology, for example improvements in minimally invasive surgery, targeted drug delivery, neuroprosthetics and the rehabilitation and maintenance of mobility in the general and aging populations. The biomaterials and biomechanics theme (4) is also of cross-thematic importance insofar as it focuses on the development of new materials and components which enhance the design, efficiency and delivery of technology technologies resulting from other themes, and may be employed in treating recognised clinical conditions, for example the production of novel adsorbent materials for the treatment of inflammatory conditions (2,3,4,5,6) or in the production of improved cardiovascular stents and heart valves (2,3,4,5,6). Novel Image guided procedures such interventional and intraoperative MRI hybrid imaging such as MRI compatible Ultrasound and optical based imaging carry a great potential to revolutionize minimal access surgery and taking imaging from a diagnostic to a therapeutic dimension. The Scottish Life Sciences and the Translational Medicine Research Collaboration would benefit from novel technologies such as nano particle based molecular imaging marker and PET ligands as well as targeted drug delivery using microstructured drug carriers. As these examples demonstrate, in suggesting these themes, it was important to recognise that they are to be considered as being inclusive and complimentary rather than exclusive in terms of motivating and enabling pan-Scottish research in this field.
A number of significant outcomes can be expected from a successful pan-Scottish initiative, including:
- Low-cost, non-invasive imaging and sensor screening and diagnostic tools, especially in relation to diabetes, cancer and cardiovascular diseases (ref themes: #2, 3, 5, 6)
- Improved understanding of the mechanisms underlying major diseases including cancer and diabetes(ref themes: #2, 6)
- Continue development of 3-dimensional scaffolds for tissue engineering (ref themes: #1, 3, 4)
- Novel wound care technology (ref themes: #2, 3, 4, 5)
- New “active” materials for the treatment of major diseases such as diabetes, cancer and inflammatory conditions(ref themes: 1,4,5)
- Remote sensing technology for monitoring of implanted devices such as cardiovascular stents, and for the aiding in the treatment of diabetes and other significant clinical conditions. (ref themes: # 3, 4,5).
- Bioprocessing for human cells and tissues (ref themes 1, 4)
- Novel rehabilitation and assistive technology (ref theme 2)
- Enhanced and extended knowledge of the factors effecting physical rehabilitation and mobility in for example Stroke, Orthopaedics and Diabetes (ref theme 2)
- Clinical trials and other proof of concept studies to support the evidence base for the use of rehabilitation technology in Healthcare (ref theme 2)
- Advanced multimodality image guided diagnostic and interventional procedures
- MRI compatible devices and implants
- Preclinical and clinical trials for safety approval of new medical technologies
Integrating Non-Technical Subjects
Integration with non-technical subjects will be most apparent in the assistive healthcare theme, where strategies for administering treatment and assistance to patients must consider psychological and behavioural issues, calling for interaction with suitable specialists, such as social care workers, support workers and family members. Examples of such work exist in the collaboration between the computing and medical researchers at Dundee, for instance to help dementia sufferers in everyday tasks. Similar integration currently exists between staff at the Bioengineering Unit and Allied health professionals and nurses involved in rehabilitation in both the academic and clinical settings across Scotland and within IIS (part of the Edinburgh Research Partnership) where collaborative work involves Engineers and Physicists working with biologists in 3-dimensional live-cell imaging. HealthQWest and the other regional NMAHP research consortia offer ready access to relevant clinical and academic NMAHP’s and HealthQWest shares many of the Engineering consortia objectives set out in this document, but related to Healthcare and NMAHPs.
Further integration with non-technical specialists is required to engage with health economists and statisticians to adequately model the potential impact of medical devices and novel treatments- this may be crucial for gaining NHS/social services adoption of new technologies
Graduate School Activities
The need for training skilled personnel in the many subjects allied to medical technologies has been recognized by the Scottish Executive as a “critical shortage” of medical imaging specialists, medical physicists, life scientists, bioinformaticians and technicians. The SRPe graduate school (GS) can play an important role by raising the visibility and profile of Scottish research, attracting high-quality young researchers and supplementing Scottish research and industry with trained, highly skilled personnel.
The SRPe should encourage initiatives aimed at creating interactions between medical and technical students, to enable clinicians to become part of research teams, and to foster training and collaboration across the regional partnerships, especially in the themes identified above.
However, at the Life Sciences Interface where engineering, the sciences and medicine must converge, there will be a need for specialised research training centres. Such centres need to provide well-integrated approaches to the selection of appropriate interdisciplinary research projects to train young engineers at the clinical and life sciences interface. This is not a trivial issue as the area of medical technology and medical devices is heavily regulated and projects, procedures and trials must be led or monitored by academics who are aware of the issues. There is a clear need therefore, in any graduate school with aspirations in biomedical engineering, to provide opportunities for engineers and physical scientists to receive instruction in the life sciences and suitable interdisciplinary medical device research training. This must take place within centres which have the appropriate clinical and medical industry links. As this document has already demonstrated, such centres already exist at the regional level, but an integration and coordination of the activities of these very successful centres on a pan-Scottish basis would considerably enhance and focus these activities. With this in mind we suggest a number of strategies which may help focus the activities of the Graduate School:
- A strategy to monitor and identify key research topics across the engineering partnerships, and promote collaborative opportunities through joint supervision of graduate students.
- A biennial pan-Scottish SRPe GS conference with visible international speakers. There is sufficient critical mass in Scotland to turn this into an event with official proceedings published by a visible publisher and attracting international attendance.
- As part of the above conference, an associated workshop dedicated entirely to postgraduate research students, with ample opportunities of networking and technical discussion with peers.
Key Performance Indicators
The key performance indicators for this initiative include the following:
- Research quality, i.e., the volume and quality of scientific publications, and RAE-like esteem indicators.
- Sustainability, i.e., the volume of independent (public and private) funding attracted, especially for collaborative projects spanning regional partnerships.
- Training, i.e., collaborative, added-value training initiatives like cross-partnerships schools, workshops and degree-related teaching.
- Technology transfer, i.e., the successful migration of proof-of-concept systems to market distribution via the involvement of suitable industrial partners, the participation in innovative applied research with companies through schemes like DTI KTP, the translation of research results into clinical practice.
- Translational research, i.e., the migration of results of investigative researchinto viable products and process for use in clinical trials
- Public Engagement/Dissemination Events. To ensure that the public in general are aware of the progress and success of this initiative.
- Research capacity building, reflecting the number of academics and clinicians involved in projects and the numbers of research degree students, research assistants and post doctoral fellows employed on such projects.
Value-Added Research at the Life Sciences Interface
- Graduate destinations, the successful placement of PG students into industry, health science and academia.