Paper presented at MedTex 03, Bolton, 8-9 July 2003.
Abstract
The medical devices sector is critical both to the Nation's health and the UK economy. Life expectancy is increasing (1), giving an ageing population with attendant requirements for greater medical support for maintained independence. Government policy clearly aims to enhance the role of the National Health Service, requiring the effective introduction of new technological solutions.
The Medical Devices Faraday has been created with the aim of establishing a national framework, involving industry, academia, clinicians, RTOs and funding organisations, covering the Faraday Principles of research, training, people exchange and technology translation for the medical devices sector. The Partnership will complement and build on other UK initiatives and Faraday Partnerships concerned with many areas of research and technology including; biotechnology, medical electronics, textiles and plastics. Success will be achieved by focusing on delivery to the patient, through materials development, design and manufacture of medical devices and successful pre-clinical and clinical trials.
The following paper gives an introduction to the Medical Devices Faraday Partnership, outlining the structure of the Partnership, the aims and how they are to be achieved, along with deliverables already achieved. Particular attention is paid to describing what help and benefits this Faraday Partnership is intending to provide to organisations and individuals working in the textiles and healthcare fields.
Introduction
A Faraday Partnership is an alliance of organisations and institutions, which can include Research and Technology Organisations, Universities, Professional Institutes, Trade Associations and Firms, dedicated to the improvement of the competitiveness of UK Industry. Faraday Partnerships cover a wide range of disciplines and industry sectors. Each Faraday Partnership receives Core Funding consisting of:
- A grant from UK Government Departments (DTI, DEFRA, Scottish Executive etc.) to establish and operate the infrastructure of the Faraday Partnership.
- A ring fenced grant from UK Research Councils (EPSRC, BBSRC, PPARC etc.) for research projects that satisfy the twin criteria of excellent science and industrial relevance.
The Core funding establishes a platform from which the Partnership can bid successfully into other UK Government and EU funded schemes for research and technology transfer.
The four Faraday Principles, which provide the foundation for the operating models of the current 24 Faraday Partnerships, are:
- Promoting active flows of people, science, industrial technology and innovative business concepts to and from the science & engineering base and industry.
- Promoting the partnership ethic in industrially-relevant research organisations, business and the innovation knowledge base.
- Promoting core research that will underpin business opportunities.
- Promoting business-relevant post-graduate training, leading to life-long learning.
Faraday Partnerships strive to improve the interaction between the science and technology base and industry. Effective interaction requires the identification of industry needs and the subsequent synthesis of the knowledge and experience of those who can satisfy these needs. Faraday Partnerships use Technology Translators, people with broad experience of industry, academia and knowledge transfer, who can facilitate projects between Partnership members.
Faraday Partnerships are designated by a rigorous selection process following a national call for proposals. There are currently 24 Faraday Partnerships of which the Medical Devices Faraday Partnership is one of the newest, having formally started to operate in September 2002.
The medical devices industry
The medical devices sector is critical both to the Nation's health and the UK economy. Life expectancy has increased and mortality and morbidity at all ages have declined [2] , giving an ageing population with attendant requirements for greater medical support for maintained independence. Government policy clearly aims to enhance the role of the National Health Service, requiring the effective introduction of new technological solutions.
It is difficult to obtain consistent figures for the medical device market but it is substantial, with values of £2.4-2.7b for the UK (fifth largest in Europe). [3,4] The medical devices sector world-wide is heavily dependent on SMEs and the Healthcare industry sector in the UK employs over 3.3 million people. [5]
Current projections show that the UK Medical Devices industry will begin to fall behind both the rest of Europe and, more particularly, the Far East and the US - and even become a net importer - unless a concerted effort is made to bring some cohesion to the UK's exploitation activities.
Increasingly, medical device development is exploiting knowledge and advances in biotechnology and bioengineering, with the UK a lead player in this aspect of development. To deliver biologically rational therapeutic interventions to the marketplace in a cost-effective and reliable way will demand tailored devices based upon a multidisciplinary approach. This will require input across the science, engineering and medicine spectrum at the macro to molecular scale. The major challenge, which has been taken on by the Medical Devices Faraday Partnership, is to focus UK efforts into a coherent approach.
Mission of the Medical Devices Faraday Partnership
The Partnership mission is to 'provide the national infrastructure to facilitate the development and commercialisation of medical devices and biomaterials for new and improved patient treatment and increased competitiveness for UK healthcare industries'. This will be achieved by a programme of clinician and industry focused research, effective training programmes for post-graduates and students as well as major technology translation support direct to industry.
Scope of the Medical Devices Faraday Partnership
The term 'medical devices', in the scope of this Partnership, encompasses all devices which are implantable or non-implantable, which act in some way on the human body and may be either permanent or disposable. This spans the range of medical disciplines from orthotics, orthopaedics and ophthalmics, to cardiovascular, urology and dentistry, and includes active as well as passive devices. It encompasses therapeutic and preventative care, as well as devices, which aid self-help for greater care in the community.
Structure of the Medical Devices Faraday Partnership
The Faraday Partnership brings together a team of six leading academic institutions, including clinician representation, one experienced materials based RTO, two established biomaterials consultancy companies, and the national Medilink network. This powerful grouping has substantial delivery capability that, together with the industry, clinician and other research and professional organisation networks, is quickly establishing a national identity and strategic focus. The structure of the Partnership is shown in Fig.1.
The Management Group of the Partnership is responsible for the delivery of the Partnership mission and objectives and is led by TWI, with E-Tech, M4 Technologies, Medilink Yorkshire and Humber, the University of Cambridge and the University of Nottingham.
The Research and Training Advisory Group (RTAG) consists of the six universities shown in Fig.1 and reports to and advises the Management Group on all matters related to research and training.
The Partnership reports to and is guided by a Steering Group that is chaired by Professor Alan Suggett, Smith & Nephew. This Group has a bias towards end-user representation through direct industry involvement including large organisations, SMEs, the Association of British Healthcare Industries (ABHI), together with clinical representatives from the Royal College of Surgeons and the NHS.
The term network, shown in Fig.1, is intended to show the inclusive nature of the Partnership. In order to get a true feel for the needs of the medical devices industry, the Faraday Partnership must listen to and interact with representatives from all sectors of the industry. Fig.2 gives an idea of the scope of the term network, but it is by no means a comprehensive diagram.
Membership of the Medical Devices Faraday Partnership
There is no set format for membership of Faraday Partnerships, therefore the Medical Devices Faraday Partnership has taken time to identify the membership format that would provide optimum benefit to the medical devices industry in the UK. The medical device industry is very segmented and there are a lot of regional networks that provide invaluable local support. By offering membership of the Medical Devices Faraday to members of the regional networks, the Partnership aims to help these regional networks grow and provide a link between them all to give one national voice for medical devices.
The Medical Devices Faraday has surveyed the UK to identify appropriate regional networks. These networks have been approached and the following networks have approved the idea in principle:
- Medilink Yorkshire and Humber
- Medilink North West
- Medilink West Midlands
- Medilink East Midlands
- Medilink East
- Southern Medical Alliance
- MediWales
- Medical Devices in Scotland
- Medinet London
The first 'network of networks' meeting has been held and the process of setting up membership of the Medical Devices Faraday Partnership is under way. The list of networks included is expected to grow as other existing networks are identified and new networks are set up to cover areas previously unsupported. The intention is that people who would like to become members of the Partnership will do so via their local network. An announcement on membership of the Partnership will be made later in 2003.
Research
The Medical Devices Faraday Partnership has embarked on a research programme, funded by EPSRC and BBSRC. The Research Programme is designed to meet challenges that face the healthcare sector by developing solutions that can be exploited on a five-year horizon. This programme involved a call for outline proposals that was announced in November 2002:
Summary of requirement for outline proposals
Topics for research were identified with prime aims of:
- Enabling more effective clinical and nursing care.
- Providing models and data for an informed selection of materials, device design and manufacturing processes.
- Developing new devices for modern medical practice.
Within this framework, three priority platforms for research projects were:
- Clinically robust devices.
- New approaches to device design and materials development to minimise variability in clinical practice.
- New pre-clinical testing techniques (e.g. durability) to assess performance and clinical efficacy, and the development of predictive models of clinical performance.
- Development of cost effective devices which can replace or minimise clinician or nursing involvement, and thereby increase healthcare efficiency.
- Improved materials and surface engineering concepts.
- Enhanced biofunctionality in existing and new materials.
- Validated models of device surface/tissue/cell responses at the nano-, micro- and macro-scales for rapid materials selection and device development.
- Biologically validated materials properties.
- Novel drug delivery systems.
- Effective medical device/pharmacological solutions to drug delivery.
- Customised drug release systems (tailored to patient).
- Minimally invasive devices, therapies and surgical techniques.
- Novel manufacturing solutions.
Other requirements for proposals included:
- Significant contributions (cash and/or in-kind) to the total cost of any project by industrial partners were required.
- Each project was expected to demonstrate multidisciplinary collaboration between academic researchers, ideally from more than one institution, and industry.
- The participation of SMEs was particularly welcomed.
- Proposals needed to demonstrate activities aimed at producing exploitable deliverables within a 3-5 year timescale, as well as scientific excellence.
Results of call
Twenty-six high quality outline proposals were received. Ten top quality proposals were selected to proceed to the next stage of full proposal. A number of other high quality proposals were also identified for submission to alternative funding sources, such as the Health Device Technology Programme.
The successful Core Faraday proposals will be announced in October 2003. The Medical Devices Faraday Partnership will appoint a Project Monitor to each successful consortium who will continue to play a supporting role, during and after completion of the research, to assist in the exploitation process.
Industrial CASE studentships
EPSRC's Industrial CASE are allocated to companies to enable them to take the lead in defining and setting up research projects with the academic partners of their choice. These CASE Studentships provide an excellent mechanism for engaging universities and industry in the Faraday Partnership.
Any UK university may be selected for one of these 'Industrial CASE Training Grants'. EPSRC funds will be allocated to universities who in turn pay the students. The Industrial Company will be expected to provide top-up funds, which should be a minimum of one third of the total EPSRC grant. More information about the specific requirements can be found on the EPSRC website: www.epsrc.ac.uk/
The Medical Devices Faraday Partnership will be supporting up to six industrial CASE Studentships for awards, which are due to start in the academic year 2003-04. A call for proposals was announced in April 2003 with a deadline for submission on 4 July 2003. The results will be announced to all applicants by August 2003.
Training
Training support for technical, sales and marketing staff has been identified as a key requirement if the UK is to maintain and extend its competitive position in the rapidly expanding field of medical devices. This is of particular concern in view of the fragmented nature of the UK medical device sector, in which over 90% of companies are SMEs, and it is particularly important that training provision is co-ordinated so as fully to address the industry's changing requirements.
The Medical Devices Faraday Partnership intends to develop a national skills-base to support the growth and competitiveness of the UK Medical Devices Industry by:
- Mapping of the sector's emerging skills requirements (Training Needs Analysis).
- Integration of training resources to meet emerging needs.
- Improvement of industrial and clinical relevance of training provision.
The Medical Devices Faraday Partnership has set up a Training Working Party (TWP) comprising of experts in the area of training related to medical devices. The TWP is performing a Training Needs Analysis and is using the results of this survey to formulate a proposal for new training activity. The aim of the training programme will be to develop a national skills base to support the growth and competitiveness of UK companies, using information from the ongoing Training Needs Analysis to provide guidance on the effective use of existing resources and on the development of new capabilities where appropriate.
Details of the programme of work will be made available when the programme has been formulated and agreed for funding by the Management Group later in 2003.
Technology translation
This term captures a range of activities that facilitates the commercialisation of innovative research and also communicates industry and clinical needs to the research community. As part of its technology translation programme, the Medical Devices Faraday Partnership will provide:
- Direct support to industry through Technology Translators.
- Technology Roadmaps.
- Audits/Reviews e.g. Product and Process Reviews and Intellectual Property Reviews.
- Information on market trends.
- Events and networking opportunities.
- New business ventures.
- Specialist interest groups.
- Technology Watch to pick up on emerging opportunities and threats.
Framework 6
The first call for proposals under the European Community Framework Programme was launched on 17th December 2002. The Medical Devices Faraday Partnership addressed the areas relevant to its field, and responded to specific proposals into this area. Under the Nanotechnologies and Nanosciences thematic area, a call for proposals addressing 'the interface between biological and non-biological entitities' was particularly relevant to biomaterials and implantable devices. The Medical Devices Faraday Partnership was involved in a consortium bidding into a Network of Excellence in this area.
For the thematic area of Information Society Technologies (IST), The Medical Devices Faraday took a more active role. Firstly, in participating in a submission for an Integrated Project related to implantable sensing devices able to measure certain specific properties required for respiratory, urology and cardiovascular needs. Secondly, a Network of Excellence was developed, in combination with the EPPIC Faraday Partnership, to provide a visionary network able to support medically related Integrated Projects, that was to communicate and respond to the ambient intelligence. This provided a far-reaching opportunity for Europe to lead in new healthcare developments with the body detecting its own needs and communicating with external support systems to administer therapeutic treatments.
New calls for further research will be launched in late 2003/early 2004, when biomaterials has been identified as a key theme for new activities. Interest in collaboration in future calls would be welcomed.
Conclusions
The Medical Devices Faraday Partnership is up and running and ready to help with the technology and commercialisation of medical devices. For more information about the Partnership or help and advice in the field of medical devices contact us at:
Medical Devices Faraday,
TWI Ltd, Granta Park,
Great Abington, Cambridge,
CB1 6AL, United Kingdom.
Tel: + 44 (0) 1223 891 162
Fax: + 44 (0) 1223 891 284
Email: helpdesk@medical-devices-faraday.com
References
- 'The Age Shift - Consultation Document and Task Force Report.' April 2002. www.foresight.gov.uk
- Foresight: Health and Ageing Population Panels. www.foresight.gov.uk
- Siebert M: 'Giving the industry a face'. Medical Device Technology, Dec 2001 pp. 36-37.
- ABHI. 'A Competitive Analysis of the Healthcare Industry in the UK.' CoMap II 2003. www.abhi.org.uk
- EPSRC Healthcare Sector Brief. April 2002. ISBN 1-899371-04-4.