• The European Biomaterials Network Seminar at the European Society of Biomaterials' 14th Annual Conference 'North Sea Biomaterials'
• 1^st International Workshop on Tissue Engineering
• A Brief Report from the Second Intercontinental Meeting of Hair Research Societies
• The EBN Seminar – Industry Trends and Forecasts

The European Biomaterials Network Seminar at the European Society of Biomaterials' 14th Annual Conference 'North Sea Biomaterials', The Hague, 17th September 1998.

Meredith Lloyd-Evans opened the Seminar by describing the European Biomaterials Network, its aims and achievements, and some of its plans for the future. He then introduced the speakers: Professor Williams is a member of the Scientific Committee on Medicinal Products and Medical Devices, that advises the European Commission's DG XXIV, Consumer Affairs, on matters of public health and safety. His presentation was entitled 'The role of scientific opinion in matters relating to public health and safety'. Professor Jos Vander Sloten is Secretary General of the European Society for Engineering and Medicine and is a part-time Professor in Engineering Mechanics at KUL, Leuven. His presentation addressed the multidisciplinarity of projects in the biomaterials and devices areas, using a project and a network that focus on software integration with rapid prototyping as examples. Dr Alex Smeets is Manager of the Eastern England Innovation Relay Centre in Cambridge UK. His role is to bring together people at both sides of technology transfer. His presentation also covered the role that IRCs could have in helping construct suitable consortia for EC projects. Meredith Lloyd-Evans presentation closed the seminar by describing the way in which biomaterials and devices projects had become more complex and multidisciplinary, as a necessity, and talked about what was currently known of the 5th Framework Programme.

'The role of scientific opinion in matters relating to public health and safety' - Professor David Williams, University of Liverpool UK

The current perception amongst consumers and 'ordinary' people is that threats to society are entirely the result of abuses of science and technology. Although the EC has stated that high-quality science and scientific advice is vital for progress, for regulations and so on, the low level of public trust in scientists is a problem.

Professor Williams pointed to BSE (bovine spongiform encephalopathy) and the EC's response to it as the single biggest experience that has changed public attitudes. The perception by the EC that things were not being handled adequately or correctly led to a revision of the EC's approach to and use of scientific advice. In 1997, new committees for advising on consumer health and safety were set up, with up to 14 named experts per committee, in areas including Animal Health, Animal Welfare, Ecotoxicity, Medical products and so on. The terms of reference of these committees include the examination of methods of risk assessment and the development and application of new methods, particularly concerning transmission of new pathogens from animals to humans. The effect of this can be seen in the composition of the Medicinal Products and Medical Devices committee, which has 14 pharmacologists or toxicologists and 2 people experienced in materials.

An important role is therefore to anticipate risks to public health and devise advice and proposals for combating these. Currently, the committee is looking at a number of problematic topics, including:

Antibiotic use and resistance; BSE (Bovine spongiform encephalopathy) in sheep; Exposure to electromagnetic radiation; Diagnostic tests for TSEs (Transmissible spongiform encephalopathies); Phthalate plasticisers in toys; Safety of colorants in medicines; The evidence required for clinical efficacy of orphan drugs; Risk quantification for human CJD (Creutzfeld-Jakob disease), including new variant forms and transmissibility via, for example, blood transfusions; Mercury in dental amalgam; Latex allergies to rubber products; Impact of palladium and platinum in dental bridges; Oestrogenic activities of plasticisers; Reproductive impact of materials and devices, e.g. toluene diisocyanate from breast implants and risks to breast-fed babies; Safety of materials used in haemostasis such as collagens and thrombin; Should growth factors in devices be regulated as drugs, devices or combination products for the best effect on public health?; Ethical and scientific issues from tissue-engineered products; Validity of the European approach to use of Animal tissues in medical devices.

The heavy workload of the committee can be envisaged from this list. However, the committee has been discussing an additional topic that requires urgent action, that is whether the use of surgical sutures manufactured from materials of animal origin should be allowed to continue. The problem is complicated by the fact that, although usage of catgut sutures has fallen from 20% to less than 7% in Europe, usage is still high in developing countries. In view of the fact that the French Government has already banned the use of catgut and other sutures made from materials of animal origin, there is a need to advise the EC on what can be done Europe-wide. Although competing materials are well established and appear to be successful, so that there is no real reason to continue using catgut, a ban would have immediate implications of publicity and public alarm. The Committee is therefore likely to ask manufacturers to supply data confirming absence of risk for any catgut product and justifying continued sale and use. This opinion will go to the Commission and relevant bodies for review and response.

'Multidisciplinarity and trans-national collaboration: pathways to success in medical technology development' - Professor J Vander Sloten, KUL Belgium

The speaker first described ESEM - the European Society for Engineering and Medicine. This was established in 1991 as an initiative of the COMETT-BME programme of the European Commission. ESEM emphasises the involvement of the patient and the clinician with engineering and medicine. An important activity of ESEM is risk assessment, acting as a filter of new techniques and technologies before they reach the patient. ESEM has strong contacts with the EC's BIOMED programme.

The EC has a range of support measures for new technology in medicine including the research networks. These can act as generators of proposals for new research. Such proposals could be prepared in 2 stages, the first as an outline, for decision on attractiveness of concept and acceptability of consortium and general approach, then the second the detailed submission for full evaluation. For success, technology developers should be part of such multidisciplinary projects, plus patients, healthcare providers and researchers. At every stage from concept creation through prototyping and refinement, a clinical panel should be involved in an iterative, 'spiral' approach to ensuring that the end product is acceptable.

One such project, the PISA project, is developing Rapid Prototyping for spinal fixation methods. The end-product is a drill guide for placement of pedicle screws that is designed according to radiological assessment of each patient and built from acrylate photopolymer using stereolithography. Members of the consortium include 5 industrial partners involved in rapid prototyping, imaging, device development, metal membranes and surgical technology and 4 University departments involved in biomechanics and medical imaging. A matrix approach is applied to project management and development - in addition to the activity or technical work areas, there are also subject or application areas. The imaging and prototyping software has been developed using computer modelling, cadaveric studies and clinical cases.

Rapid prototyping is also the subject of the PHIDIAS network. Using modelling software to improve the accuracy and success of surgical decision-making is attractive. Unfortunately, at the moment the costs of such software and procedures are not reimbursable. Strategies for acceptance by social security agencies are important, as well as deciding what is technically feasible and exploring what other applications of the technology there might be. The network is holding meetings and preparing reports that address these issues. Different partners have taken on different tasks or aspects of the project, including a network newsletter produced by DTI Denmark (a partner in projects in the European Biomaterials Network), a web-site, a radiological analysis of 650 case reports to generate material for modelling, a report on all the medical device applications and examination of the clinical relevance issues.

Professor Vander Sloten finished by summarising what he knew of progress with the Fifth Framework Programme, and emphasised that he would like to see the concept of 2-stage applications adopted and the matrix approach to the project, that allowed definition of technical work areas and application areas.

'The Innovation Relay Centre Network and European technology transfer support' - Dr Alex Smeets, Eastern England Innovation Relay Centre, Cambridge UK

Dr Smeets described the Innovation Relay Centre (IRC) Network and its activities. The IRCs are jointly funded by the European Commission through the INNOVATION programme (DG XIII) and by the organisation that has agreed to host the IRC. The IRC Network really started about 3 years ago, and has recently been renewed. There are 53 IRCs in the EU, Norway, Iceland and Israel, and 10 associated FEMIRCs in Eastern Europe. Because of their situation, within a host organisation that is involved in Research and technology development, or in technology transfer, the IRCs are effectively part of a resource network of over 210 organisations.

Each IRC is involved in putting together technology providers and technology seekers, across the entire IRC network, based on requests from potential users. Depending on the funding set-up of each IRC, the initial assistance may be free or may attract a charge. Further assistance may extend to help in negotiations, and in obtaining relevant professional advice, for example for intellectual property management.

One aspect of IRC activity that Dr Smeets wishes to develop is the use of the IRC Network to help consortia find appropriate partners. Although we assume that most research groups will be aware of complementary groups elsewhere in the EU, and know about large companies that might be appropriate consortium members, it is a different matter when SMEs are considered. Often, it is very difficult to find out what SMEs exist in one's own country. To find appropriate SMEs for consortium membership on a trans-national basis is almost impossible. The IRC Network should be in a good position to assist in this and the new Framework programme 5 will be the ideal test for the system.

'The European Biomaterials Network and its aims and achievements' - Mr Meredith Lloyd-Evans

Mr Meredith Lloyd-Evans opened the Seminar by describing the European Biomaterials Network and its aims and achievements, and closed by commenting on the evolution of complexity and multidisciplinarity towards the Fifth Framework Programme as we currently understand it. Since one of the main aims of the EBN was to provide opportunities for interchange of ideas and discussion of shared issues, this Seminar itself is one of the achievements.

Last-minute posters of interest at the ESB conference included a report of a reasonably-successful series of repairs of bone defects and non-unions using a sea-coral scaffold onto which bovine bone morphogenetic protein was bound using type I collagen (Lindholm, Jalovaara and Marttinen, University of Oulu Finland); confirmation of crystalline particles in the hydroxyapatite coating of a joint prosthesis, that were released during accelerated degradation studies and could therefore contribute to surface wear; a study of the release of the potential carcinogen 4,4’-methyldianiline from steam- or gamma-ray-sterilised products made from aromatic polycarbonate urethane, as a result of which the authors recommend that steam-sterilisation is not used with such products.