Service Communautaire d'Information sur la Recherche et le Développement - CORDIS

Periodic Report Summary 1 - NEWBIOGEN (New Generation of orthopaedic Biomaterials)

Project Context and Objectives:
Biomaterials industry and especially the orthopaedics sector represent a large market globally with growth rates of 7-15%. Unfortunately current biomaterials are not optimal and cause pain and distress to a large number of patients. Particularly their life cycle is very small compared to the average starting age of musculoskeletal disorders. The raw materials used can cause neurological problems as Alzheimer disease due to metal ions released in the body and the stress shielding effect can lead to bone atrophy. Also the structural and mechanical properties of biomaterials used in implants are not optimal, chemical inhomogeneity and large distribution of porous dimensions are common factors in production process. There is a clear need for innovation in biomaterials production in terms of biocompatibility, mechanical, and surface properties. NewBioGen introduces a new biomaterial production process that will solve the current problems and provide a new generation of orthopaedic bio-implants. Beta titanium alloys, containing fully biocompatible elements, will be optimised and validated as raw materials for the biomaterial production. The new production process will be using powder metallurgy technology. Use of powder metallurgy for bio-implants production will allow increased control of the final characteristics and properties of the product. It is expected to significantly reduce the chemical and porous inhomogeneties - a source of stress and cause of mechanical implant failure. The next step in our novel approach is the application of Zr/ZrO2 coating on the implant using Laser Engineered Net Shape techniques to give better wear resistance and lower the possibility of interfacial separation under repeated loading condition.
Project Results:
The project is currently at month 9. During workpackage 1, the specs related to the orthopaedic biomaterials, industrial equipment and titanium alloys requirements were set. After reviewing what exists in the bibliography so far and then gather information based on the experience of each partner during several meetings, three reports were developed that include all the gathered material. The main results of the specs are mentioned below:
1. Mechanical properties of biomaterials: creep, fatigue, elastic modulus, ductility, tensile strength, surface hardness
2. Non mechanical properties of biomaterials
3. Design of the implant which will be developed (the design has not been included in D1.1. as it was developed from SOCINSER)
4. mixing equipment requirements
5. packaging system requirements
6. powder filler requirements
7. cold isostating press requirements
8. sintering furnace requirements
9. fabrication process for titanium alloy requirements
10. hardness rating, shear modulus rating and poisons rating for titanium alloys
More information about the performed work in WP1 can be found in deliverables D1.1., D1.2. and D1.3.

During work package 2 (Start M3- End M9), the investigation of production process parameters was implemented. In more details, several samples were developed combining the below mentioned parameters:
1. grain sizes: i)smaller than 40μm, ii) 40-80μm and iii) 80-125μm
2. several mixing times: 1 h and 2 h
3. different pressures: 200-450MPa
4. compaction times: up to 1 minute
5. sintering temperatures: 1000 and 1100oC
6. several sintering durations 3h and 6 h
All the aforementioned samples were characterized by SEM, XRD, hardness, Young Modulus, porosity and density. The characterization results were evaluated and it was concluded that the samples M15, L15 and L17 have the best properties according to NEWBIOGEN project requirements.
Additionally, a simulation model of powder metallurgy process was developed during WP2 using the data of tasks 2.1 and 2.2. In more details, a fuzzy rule based model was employed to develop the Newbiogen software prediction tool. More information about the results of work package 2 can be found in the deliverables D2.1 and D2.2.

During Work package 3 (Start M8-End M15), some initial designs of the following systems have been implemented so far: i) mixing equipment and ii) packaging equipment

During Work package 4 (Start M8-End M15), some initial designs of the following systems have been implemented so far: i) filling systems and molds, ii) development of cold isostatic pressing equipment, iii) demolding equipment development and iv) sintering system

The main aim of WP5 (Start M3- End M9) was to investigate the ZrO2/Zr coating process with LENS technology. During the implementation of this workpackage, pure zirconium was used as powder in LENS equipment for coating the samples with the best properties as defined in Workpackage 2. The samples were characterized by XRD, tribological tests and cytotoxicity studies. The results of these studies showed that the wear rate is 0.0015 mm3/NM, the Zr coatings are non toxic and biocompatible. Additionally, commercial stabilized and partially stabilized zirconia was used for the development of coatings. Several samples were coated with LENS technology and then submitted to XRD, SEM tests and cytotoxicity studies. The main result was that either TZ-3Y and TZ-8Y can be used for coatings in which high roughness is required. More information of the work performed in WP5 can be found in the deliverables D.5.1 and D.5.2

The main aim of WP8 is to disseminate and provide the required preparation of the exploitation of NEWBIOGEN results. So far a website of NEWBIOGEN project has been developed and is periodically updated. An interim PUDF has been developed mentioning the exploitation potential of the project, competitors and market analysis. An initial patent search has been implemented in order to identify potential competitors. Last the consortium has participated in many dissemination activities to promote the project’s results.

Last a consortium agreement was signed among the partners in month 2 (Deliverable D9.1)

Potential Impact:
NewBioGen is a project within the EU Seventh Research Frame Program (FP7) in the area of Research for the benefit of SMEs. NewBioGen aims to develop new biocompatible raw materials, design and manufacture a scale up production process for the development of orthopaedic hip implants and manufacture of implants with low modulus which will be near to the bone (50GPa), not toxic, lower price, enhanced wear resistance and will last more than the current solutions available in the market.

The long term objective of this two-year project is to develop innovative biocompatible orthopaedic implants which will address the public’s needs and will conquer very fast the market bringing great gains to the involved SMEs. Additionally, the novel production technology has a prominent potential to be used with limited modifications for the development of other biomaterials such dental and knee implants or for applications in other areas such as navy and aircraft manufacturing giving the IEMS more flexibility and market space for business development.

This will be done by using different raw materials such as Ti-35.5Nb-5.7Ta, which is not toxic as it contains fully biocompatible elements (Nb,Ta). An advanced surface treatment technology of Laser Engineered Net Shaping (LENS) will be used to apply a high quality Zr/ZrO2 coating on the moving parts between the implant and the bone that need high wear resistance (moving parts of the implant). Moreover, fully automated machineries will be developed for titanium alloy manufacturers and orthopaedic implant industries.

All intellectual property issues are formalized in a Consortium Agreement (CA) which deals with all aspects of ownership and use of Intellectual Property in addition to the management agreements for the project. The possibility of subsequent agreements among partners expanding the content of the first Consortium Agreement will be explored in order to exploit fully the project results, taking into account the results obtained and the exploitation aspirations of each industrial partner. It is envisaged that at the end of the project, a viable exploitation agreement, satisfactory to all partners, will be established to cover the exploitation of the project results

Considering that the global orthopedic sector is a dynamic component of the medical device industry, which can be broadly divided in two main categories: orthopedic devices, and orthotics and prosthetics. Orthopedic devices include joint reconstruction materials and biomaterials used in the reduction of fracture fragments, bone manipulation and joint replacement. Reduction can be non-invasive, as is the case with external splints and traction, or can involve surgery to implant and replacement artificial joints. In comparison, orthotics and prosthetics involve evaluating, fabricating and custom fitting braces and artificial limbs.

With increase in the percentage of aging population worldwide, the number of individuals suffering from physical disability is also increasing. Baby boomers born between 1946 and 1964 are the major consumers of the biomaterial products. Besides, more than 20% of the global population in 2050 is expected to be over 60 years and this segment (of the population) will be significantly high in developing countries. This increase in the aging population will drive the demand for biomaterial products.

Overall, the orthopedic market felt the effects of the economic crisis, with cuts in medical-care spending and patients more reluctant to undergo optional surgeries due to the lengthy recovery time out of work. Highly competitive and at maturity with a single-digit growth rate, the global orthopedic devices market is primarily driven by: 1) artificial joints, with a worth forecast of almost $17.5 billion by 2012; and 2) orthobiologics, estimated to reach $9.6 billion by 2016, according to Global Markets Direct. Segment growth is also boosted by increases in knee and hip implants, and knee and hip replacements. According to research from Global Industry Analysts, the world orthopedic prosthetics market is expected to hit $19.4 billion by 2015, with growth driven by rising degenerative joint diseases (osteoporosis and arthritis), an aging global population and the desire to keep up an active lifestyle.

The orthopaedic device market is being driven by rising cases of osteoporosis, which the International Osteoporosis Foundation (IOF) reports to affect 75 million people in Europe, the US and Japan. This number which falls in line with current orthopaedic device market shares that put the US in first place followed by Japan and Germany. The foundation forecasts a 310% increase in hip fractures in men and a 240% increase in hip fractures in women worldwide by 2050. Similarly, arthritis is set to continue driving the orthopaedic devices market, with 22% of 50 million adults in the US suffering from the condition, a figure that is predicted to reach 67 million by 2030. Emerging countries - such as China, India and Brazil - are seeing strong growth for orthopaedic devices, with revenue expected to reach $2.9 billion in 2016 for a compounded annual growth rate of 8%, according to GBI Research.

The NewBioGen project is going to produce a new generation of improved biomaterials by modifying the raw materials used, the production line and applying coatings that would provide orthopaedic implants with the following Unique Selling Points:

• non toxic
• long lifetime of at least 20 years
• elastic modulus up to 50GPa
• at least 40% lower cost
• enhanced wear resistance at least 20%
• improved tribological properties
• diminished interfacial separation of the coating
• reduced infections due to the use of biocompatible materials
• reduced risk of osteolysis due to the elimination of metal ions release

Since no current solution in the industry can equal these unique selling points, NewBioGen is going to be considered as a market differentiator and it will be easy for the potential buyers to drop solutions well established in the market. Thanks to the project’s disseminations plan, a major part of the orthopaedic market will be successfully claimed resulting in a reasonable return of investment for the EU and the consortium SMEs.

By analyzing the orthopaedic implants market and taking into account of the manufacturing cost of the NewBioGen products, the consortium SMEs have arrived at the prices for the new products. The novel implants will be sold for 3.000€ per implant, a price that is equal to the lower limits of the than existing solutions.

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