Innovation and the Medical Devices Faraday Partnership (June 2005)

Medical Devices Faraday, Partnership.
TWI Ltd, Great Abington, Cambridge, UK

Paper published in Medical Device Technology, June 2005.

Demand for development of new-generation medical devices has led many governments to support medical-sector research in the United Kingdom, the Medical Devices Faraday Partnership was created to establish a collaborative network that would enhance the transfer of good ideas into new products and processes. The services it offers medical device manufacturers are outlined here.

Going to the next level

The Medical Devices Faraday Partnership (MDFP) was created in September 2002 to establish a national framework of industry, academia, clinicians, and research and technology and funding organizations. It is sponsored by the United Kingdom's (UK) Department of Trade and Industry (DTI), the Engineering Physical Sciences Research Council (EPSRC) and the Biotechnology and Biology Sciences Research Council. The Partnership covers all medical devices that are implant able, semi-implantable, nonimplantable, permanent or disposable and act in some way on the human body. It gives support to develop clinically and industrially relevant research and assist industry and academia in the translationo technology into new devices. It does this by identifying funding sources and partners, facilitating the establishment of research consortia, helping with new intellectual property and commericalisation and having links with national and international networks. This article describes its structure and current research activities and how to access the resources that are available, including potential funding.

The network

Figure 1 shows the structure of the MDFP, its management team, steering group and Research and Training and Advisory Group (RTAG). The Partnership's Director and Programme Manager are based at TWI Ltd. Industrial membership isorganised through a network of regional support organization that now cover 11 out of 12 UK regions ( Table 1). This is currently evolving to form its own national entity, Medilink UK, with a prime focus to provide business support to medical device and healthcare companies.

 Technology facilitator. The MDFP has access to a number of Technology Translators (TT), who include many of the nonacademic members of the management team and a pool of known consultants. They offer a rapid-response service to industry through a helpdesk that provides contacts to a growing network of solution providers (e-mail: helpdesk@medical-devices-faraday.com) TT services include:

• technology road maps
• product, process and intellectual property reviews
• information on market trends
• events and networking opportunities
• new business ventures
• specialist interest groups
• a technology watch to puck upon on emerging opportunities and threats.

The special interest groups cover cell/materials interaction and tissue engineering; cardiovascular biomaterial; and dental, urology and orthopedic areas.

Sources of funding

A number of national and international funding sources are available to help UK industry, academics and clinicians. The MDFP receives regular updates on funding opportunities and is experienced in preparing bids to enhance the success rate of applications. Typical example are funding schemes offered by the UK's DTI, which include:

• Grants for innovative ideas
• Grants for research and development (R&Dmp;D) ( www.businesslink.org)
• Knowledge-transfer partnerships ( www.ktponline.org.uk)
• Small firm loan guarantees
• Knowledge-transfer networks
• Collaborative R&Dmp;D
• Best-practice networks
• Implementing best practice
• Small business investing companies
• Regional capital investment

Other sources of funding are available from organizations such as the EPSRC, charities, the European Commission and the UK Department of Health. Further links and associated programmes include:

• Health Technology Devices Programme ( www.healthtechnologyportal.org.uk)
• Framework Programmes 6 and 7 ( www.europa.eu.int/comm./research/fp6/index_en.html)
• EUREAK
• Doctoral Training Centre in Medical Devices ( www.strath.ac.uk/dtc
  Contact: Professor Patricia Connolly, e-mail: patricia.Connolly@strath.ac.uk)
• National Endowment for Science, Technology and the Arts ( www.nesta.org.uk)
• Global Watch ( www.globalwatchonline.com/static_intro.htm)
• Association of Medical Research Charities ( www.amrc.org.uk)
• Medical Research Council ( www.mrc.ac.uk)

The wider network

The MDFP also supports a number of national and international research programmes. Support here is in the form of identifying partners, linking to the experts for technical supports and providing an effective mechanism for dissemination of information. A typical example of this is the European Healthy Aims project, which is involved in ambient intelligent microsystems for medical implants and ambulatory measurement systems. For more information on the technology being developed, go to www.healthyaims.org

The MDFP network extends across national and international organizations (see Figure 2). The main objective is to support and set up joint collaborations, which benefit the UK's industry, academics and clinicians involved in research and clinical trials of medical devices and medical materials.

Research activities

The core research activities of MDFP are based on five major research projects, which were awarded in a competitive process in 2002/3. The information generated in the projects will, of course, initially be confidential to the participating companies. However, it is expected the new findings will eventually be released in the form of papers and presentations by the academics leading the projects. These projects and their participants are:

• Bone grafts for spinal fusion
  Professor Bill Bonfield of Cambridge University, Queen Mary/University of London, Grampian University Hospital Trust and ApaTech Ltd ( www.msm.cam.ac.uk)
• Aluminium-free glass-ionomer bone cements. Professor Paul Hatton of Sheffield University and Corinthian Surgical Ltd ( www.shef.ac.uktissue-engineering)
• Replication will hydrocolloids. Professor Gavin Pearson of Queen Mary/University of London, the Universities of Strathclyde and Brighton, Schottlander & David Ltd and Denfotex ( www.irc-biomed-materials.qmw.ac.uk)
• Tools to evaluate the preclinical performance of a novel knee hemiarthroplasty device. Professor John Fisher of Leeds University, University of Southampton and DePuy International Ltd ( www.leeds.ac.uk/imbe)
• Adsorption enhanced filtration device for fat removal in cardiac surgery. Professor Terry Gourlay of University College London and Hammersmith Hospital, Mast Carbon Ltd and University of Brighton ( www1.imperial.ac.uk/medicine/about/divisions/nhli/cardio/bhfsurgery/taylor/default.html)

Industrial studentships

There are several industrial studentships awarded each year in a scheme called Industrial Case, which is designed to encourage academics and industry to work together. It enables companies to take a lead in deining and arranging projects with an academic partner of their choice. The company provides a financial contribution to the project and the student must spend at least three months during the period of the award at the company's premises. There are currently 15 Case Studentiships. Some are described here, other are listed in Table II.

Table 2: CASE projects in progress.

Improved plasticised poly(vinyl chloride) This research is designed to produce a PVC product with reduced di-2 (ethyl hexyl) phthalate (DEHP) extraction when in contact with blood. The product will be based on the incorporation of a cyclodextrin (CD), or a CD inclusion complex that is formed between a CD and a substance selected to enhance diffusion of the complex to the PVC surface. This will alter the nature of the surface and prevent DEHPextraction. The Bioengineering Unit at the University of Strathclyde will produce suitable CD complexes and undertake initial studies of plasticiser extraction. The School of Pharmacy and Biomolecular Sciences at the University of Brighton will undertake biocompatibility assessment and monitoring of plasticiser extraction on optimized PVC formulations. Hydro Polymers Ltd will perform the PVC compounding to produce sheets and tubing for assessment. The deliverable would be a PVC product retaining the advantages of the long-established DEHP-PVC formulation, but avoiding the major drawback of plasticiser extraction. Contact: Dr John Gower, e-mail: j.d.s.gaylor@strath.ac.uk/bioeng/pg-info/engd/

Bioresorable nanocomposites for implantable medical devices. This project seeks to fabricate and characterise bioerodable nanocomposite materials for application in implantable medical devices. The project willinitially investigate a range of inorganic nanofillers in the form of fibres and particles that will be impregnated into bioresorable polymers. The influence of the fillers on degradation products and biocompatibility performance willbe investigated. The University of Nottingham is conducting this research and will target specific implant geometries identified by its industrial partner, Smith & Nephew plc. Contact: Professor David Grant, e-mail: david.grant@Nottingham.ac.uk
www.Nottingham.ac.uk/school3m/research/bioengineering/

Study of osteoblast response to modified phosphilipid polymers. Protein adhesion is the basic first step in a variety of biological processes that result in events such as thrombus, inflammation and fibrousencapsulation or bacterial adhesion and infection. Phosphorylcholine (PC) materials have been shown to significantly reduce protein adsorption because their hydrated surfaces are able to interact with proteins without inducing conformational changes in their three-dimensional (3D) structures, unlike many other hydrogel type materials. PC-based surfaces are therefore associated with less cellular adhesion, a reduced inflammatory response and lessened fibrous capsule formation. Recent studies have observed that human osteoblasts undergo an enhanced rate of mineralisation when grown on surfaces of phospholipid polymers modified with cationic groups. This research will focus on achieving a fundamental understanding of the mechanism of mineralisation induction with respect to changes in polymer composition and morphology. This will require expanding the range of currently available polymers to include other chargedentities with a range of compositions. A study of the effect of morphology will also be undertaken whereby the initial screening work on sample coatings will be extended to 3D structures. The participants are the University of Cambridge and Biocompatibles Ltd. Contact: Dr Serena Best, e-mail: smb51@hermes.cam.ac.uk
www.msm.cam.ac.uk

The future

In addition to the projects described, more research programmes are expected to be generated in the coming years. Much remains to be done in developing systems for easing people throughout the innovation pipeline and enhancing the methodologies for valuing the clinical and commercial benefits of new technological breakthroughs. The networks are now in place that can help link diverse areas of activity and ensure critical mass so that the UK is recognised as a leading country in commercializing new products and processes drawn from the UK knowledge base.

In just one specific area, the use of polymeric materials in many of the research programmes in this Partnership confirms growing interest in using these materials in health-care products. The unique properties of polymers thatcould be used as biodegradable as well as bioresistable materials have opened significant opportunities for these materials. MDFP welcomes contact from companies seeking assistance with developing technology. Contact from academics and clinicians is also encouraged with the aim of setting up new links with industry and identifying new funding sources. Manufacturers can contact the Partnership directly or through their regional support networks under the umbrella of Medilink UK.

Sue Dunkerton
Is the Director of Medical Devices Faraday Partnership and Group Manager of Advanced Materials and Processes Group at TWI Ltd,

Professor Mehdi Tavakoli*
Is Programme Manager and Consultant and Technology Manager of the Advanced Material and Processes Group at TWI Ltd, e-mail: www.medical-devices-faraday.com

*To whom all correspondence should be addressed