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Project Presentation. Content. Aims Approach Problem statement & expected breakthroughs Envisaged radical innovations Scientific & technological objectives The Meddelcoat consortium Project structure & co-operation Project work plan Project milestones Expected impact
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Content • Aims • Approach • Problem statement & expected breakthroughs • Envisaged radical innovations • Scientific & technological objectives • The Meddelcoat consortium • Project structure & co-operation • Project work plan • Project milestones • Expected impact • Administrative information & contact
Aims of the MEDDELCOAT project To develop the next generations of multifunctional bioactive biocompatible coatings with biofilm inhibition and optimal implant fixation,eliminating the currently experienced need for implant revisions due to implant loosening and infections.
Approach of the MEDDELCOAT project • Design and engineer the structure of the implant surface to optimise implant fixation by osteointegration, • Promote osteointegration by the application of a bioactive top coating, • Incorporate a biofilm formation inhibiting function into the coating. Combinatorial approach
Problem statement & expected breakthroughs State-of-the-Art Problems How is this tackled in MEDDELCOAT Breakthroughs expected Bio-material Ti or Ti6Al4V substrates Limited biocompatibility of Ti6Al4V, to secure implant fixation until bone apposition Implant surface structuring or the application of a designed Ti mesh on the implant surface to secure implant fixation by osteointegration & development of new substrate materials New substrate materials, design coatings forfixation by osteointegration Bio- coatings Plasma sprayed Ti, HA or Ti + HA too low coating adhesion strength resulting in delamination, additional cost Design and application of new bioactive and resorbable top coatings with graded interfaces and tailored porosity on the structured implant surface. Tailored coatings with enhanced adhesion strength, mechanical fixation and an engineered stress distribution
Problem statement & expected breakthroughs State-of-the-Art Problems How is this tackled in MEDDELCOAT Expected breakthroughs Biofilm inhibi-tion Limited to bone cement impregnated with antibiotics The use of bone cement and limited controlled release possibility Investigation of bacteria-material interactions. Selection, incorporation and evaluation of biofilm inhibitors. Biofilm inhibiting coatings or coatings with incorporated antimicrobial releasing carriers Ortho-peadic & dental Implants 10-20 % revisions after 15-20 years for orthopaedic implants 15 % revisions for dental implants after 5 years Aseptic loosening, implant dislocation, and bacterial infection Multifunctional bioresorbable coating with biofilm inhibition Prolonged implant life time (> 25 %), reduced need for revision surgery, reduced infection rate
Envisaged radical innovations and major breakthroughs • Development of new substrate and coating materials with enhanced biocompatibility. • Development of radically new or improvement of existing coating techniques for the processing of bioactive and biocompatible coatings with a graded interface (adhesion strength) and tailored porosity (bone in-growth). • In-depth understandingof the implant substrate/coating/bone interfacial structure, the design, engineering and control for optimal implant fixation. • Novel knowledge on interactions between new coating materials and bacteria and effective biofilm avoidance/elimination routes • Evaluation of new biofilm inhibiting substances • A formulation for the incorporation of anti-infective substances into the coating
Project structure & partner co-operation Selection of implants (WP1) Selection of implants (LIMA, Helipro) (LIMA, Heli Pro) RTD-activities (WP1-WP5) all Innovation-related activities (WP6) all Demonstration activities (WP8) all LIMA, HeliPro, AALTO LIMA, Helipro, Substrates & powders (WP1) Substrates & powders KUL-MTM, ALHENIA, UoB KUL ALHENIA, AMES, Alhenia, AMES, Coating and sintering technology (WP2) Coating and sintering technology KUL-MTM, UoB, IJS KUL - MTM, UoB, IJS IMMG, KUL IMMG, KUL - - MTM, MTM, Characterisation and evaluation (WP2) Characterisation and evaluation UoB, IJS UoB, IJS Training activities (WP7) all partners Coating design & Engineering (all partners) Training activities (all partners) LIMA, AALTO, Coating design & Engineering (WP2) all partners Modelling and finite element analysis (WP2) Modelling LIMA, HUT, KUL - MTM, UoB KUL-MTM, UoB KUL-REGA, HEMOTEQ Bacteria Bacteria - - material interaction (WP3) material interaction KUL - REGA, OctoPlus LEMI, HeliPro, IJS, KUL-MTM Biocompatibility testing (WP4) Biocompatibility testing LEMI, Helipro, IJS, KUL - MTM Upscaling feasibility (WP5) all partners Dissemination and exploitation (all partners)
Project work plan overview WP 3: Bacteria-coating interaction Task 3.1: Bacteria-coating interaction investigation Task 3.2: Selection and incorporation of biofilm inhibitors Task 3.3: Evaluation of biofilm inhibiting coatings WP 2: Coating of implants Task 2.2: Coatings for implant fixation Task 2.3: Bioresorbable and bioactive coatings Task 2.4: Thermal treatments Task 2.5: Structural characterisation of coating/substrate systems Task 2.6: Mechanical characterisation of coating/substrate systems Task 2.7: Modelling and finite element analysis & thermodynamic and kinetic modelling WP 1: Substrates & bioactive powders Task 1.1: Selection & supply of substrates and implants Task 1.2: Selection & supply of bioactive powders Task 2.1: Coating engineering & design WP 4: Biocompatibility and activity testing Task 4.1: Cell culture of powders and coated implants Task 4.2: Bioactivity and resorbability testing of coatings Task 4.3: In-vivo testing of bone bonding WP 5: Upscaling feasibility WP 6: Innovation related activities WP 7: Demonstration activities WP 8: Training activities WP 9: Project management
Expected impact of the MEDDELCOAT project • Community societal objectives • The project aims at a drastic decrease of implant failures, concomitantly reducing the number of revisions, lowering the pain and suffer of the patients and decreasing the medical costs for patients and community. • The implementation of highly reliable implants definitely improves the mobility and quality of live of those among us who need it because of age, illness or accident. • SME-driven market ! Small and medium size companies together make up more than 80 % of medical technology business entities. This industry contributes significantly to saving life and improving the quality of life of the citizens of Europe. • SMEs are the main job creators of European industry. MEDDELCOAT will enhance the ability of the SMEs involved to improve their competitiveness, with an immediately positive effect in job creation.
Expected impact of the MEDDELCOAT project • Contribution to policy developments • The project addresses the integration of nanotechnologies, material science and advanced technologies to improve health and quality of life of European citizens and creating wealth through novel knowledge-based and sustainable products (biomaterials) and processes (coatings). • The project will contribute to a dynamic and competitive knowledge-based economy (“Lisbon” objective), sustainable development (“Göteborg” objective), and serves the needs of a traditional SME-intensive industrial sector. • The project contributes to the ERA by focussing on nanotechnologies, intelligent materials and new production processes; sustainable development; genomics and biotechnology for health; and citizens and governance in the European knowledge-based society (4 of the 7 research priorities for Europe) and especially enhances the participation of SMEs in ERA.
Expected impact of the MEDDELCOAT project • Biomedical implants are knowledge-based products with high added value. At present, about 60 % of the implant market in Europe is controlled by non-EU companies. The development of a technology, as envisaged in the IP-SME project, would give competitive advantage to European SMEs which is of high interest not only to conserve employment, but also to create new jobs in Europe. • The proposed research is of strategic importance to the EU in view of the massive impact on market share which would result from the development of the envisaged biomaterials with multifunctional bioresorbable biocompatible coatings with biofilm inhibition and optimal implant fixation.
Expected impact of the MEDDELCOAT project • Gender issues • The goal within this project is to reach a minimum of 25% of female researchers at the recruitment stage and encourage greater participation at senior level, which is significantly higher than the European average of 15% for industrial research. • Contribution to standards • The activities related to the bacteria-material interaction investigation, the development and evaluation of coating integrated biofilm inhibitors, and biocompatibility testing will result in an active participation in European and international standardisation committees.
Expected impact of the MEDDELCOAT project • Economic impact • The $80B medical device industry continues to grow at 9 % per year, driven by the aging global population and medical advances. • Less than 5 % of the medical device market now utilizes surface modification technology of any kind. As the demand for better, more advanced biomaterials accelerates in step with scientific breakthroughs, the market for surface modification of existing medical devices is expected to grow at approximately 80-90% per year for the next 5 years, as the market adopts "intelligent" coatings. • Early adopters will use the coatings to either improve device biocompatibility or reduce infection; later generations of coatings could conceivably employ a nearly infinite array of therapeutic agents. We anticipate that "intelligent" coatings for medical devices and biologic implants will become the standard of care.
Administrative information • Project • Type: IP-SME • Contract no.: NMP3-CT-2006-02651 • www.meddelcoat.eu • Project duration: 01/10/2006 – 31/3/2011 • No. of person-months: 674 • Budget: • Total project budget: 4706 k€ • EC funding: 3300 k€ • Project co-ordination: K.U.Leuven R&D (Leuven, Belgium)
Contact LEMI • For further information • Visit: www.meddelcoat.eu • Project coordinator: Prof. Dr. ir. Jef VleugelsKatholieke Universiteit LeuvenDepartement of Metallurgy and Materials Engineering (MTM)Kasteelpark Arenberg 44, B-3001 Heverlee (Belgium)phone: +32-16-321244, fax: +32-16-321992 E-mail: Jozef.vleugels@mtm.kuleuven.be