In ageing societies, the need for innovative products and clinical procedures for fracture treatment is increasing. Clinical and epidemiological registries are an important backbone for the improvement of fracture care. The NFCC project is aiming at accelerated and effective transnational collaboration for innovation within fracture management in the NSR based on a transnational fracture registry (developed in BSR project BFCC) and hospital-indus

Clinical and epidemiological registries are an important backbone of the research and innovation infrastructure for the improvement of fracture care relevant to clinicians, hospitals, primary care, health authorities, pharmaceutical and medical technology industry. They allow for the analysis of the prevalence and incidence of different fracture types in a population and region. They can provide a benchmark of the quality of treatment in different hospitals, quality and safety of medical devices such as implants, the health outcome or the cost-effectiveness of treatment across regions and countries.In the Baltic Sea Region programme a transnational fracture registry platform will be developed within the recently approved project Baltic Fracture Competence Centre (BFCC). Within the BFCC project, this platform will be implemented in 6 hospitals from countries within the Baltic Sea Region.In the NFCC project additional new fracture registries should be implemented at several hospitals to be integrated into the transnational BFCC registry platform. This platform should be implemented, tested and enhanced in the North Sea Region to accelerate and enable effective transnational collaboration for innovation within fracture management in the NSR. This transnational R&I infrastructure fosters the evidence-based identification of clinical best-practice and needs for innovation. NFCC establishes a transnational collaboration platform between hospitals and industry in the NSR. The transnational fracture registry platform will be transferred into practical use within the NFCC project though innovation pilots between hospitals and companies from the NSR.The project partners Gothenburg University Hospital (as lead partner) and the implant manufacturer Stryker Trauma should be partners in both projects NFCC and BFCC to ensure synergies between the two projects. The project activities of these partners will be strictly complementary avoiding any overlapping. In addition partners from hospitals and companies from the sectors medical technology, pharmaceutical, imaging or wound care from the North Sea are project partners.Thus the partners in the North Sea region would benefit directly from the investments to be done in the BFCC projects in the transnational fracture registry platform as well as from the good practice in setting up clinical fracture registries and triggering innovation collaboration between hospitals and industry.

TRANSNATIONAL RESEARCH AND INNOVATION INFRASTRUCTURE: New fracture registries implemented in participating hospitals in the NSR Integration of registry data into Transnational fracture registry platform integrating data from hospitals including existing registries North Sea Fracture Competence Centre: Transnational organisational platform for research and innovation collaboration between hospitals, health authorities, companies from the pharmaceutical, medical technology and biotechnology industry in the NSRCAPACITY BUILDING: Providing access to fracture registry data for clinical research Analysis of transnational registry data and public reporting Innovation potentials of complete pathway of fracture treatment based on registry data Education and training of fracture clinicians and other health professionals Research and innovation pilots with hospitals and companies

In ageing societies, the need for innovative products and clinical procedures for fracture treatment is increasing due to more age-related fractures and comorbidities such as osteoporosis or postsurgery complications like infections. Innovations must reduce the total cost of care or clearly improve the quality of care at a justifiable cost and bring new solution to outstanding medical challenges. The industrial sectors for innovation are broad covering implants, imaging, pharmaceuticals, wound care or single-use surgery devices. These trends already led to a rising demand for innovation and investments e.g. by the European medical technology industry which increased their R&D spend 11% from 2012 to 2013.At the same time, research and innovation (R&I) within fracture management is facing various challenges in understanding clinical needs and effectiveness, reducing costs of innovation and time to market. Clinicians and companies often lack insight into the total costs of care, the effectiveness of treatment and the causes of adverse health outcome in hospitals. To overcome these challenges, clinical fracture registries can provide evidence in the clinical “real world” and reveal needs and potentials for innovation. Further, clinicians and hospitals are important actors in the innovation process helping to identify needs and to ensure user oriented products. Around 50% of new products are initiated by clinicians. Accordingly, companies in the NSR need direct access to hospitals and clinicians for collaboration within needs assessment, preclinical research, product development, clinical trials, postmarket follow up studies or health technology assessment.Moreover, an intensified collaboration between clinicians across hospitals and countries benefits the innovation of clinical procedures through the exchange of best practice, influenced by different national, organisational and regulatory conditions. Finally, successful innovation is driven by fast market access across countries which can be facilitated by collaboration between clinicians and companies, which is especially relevant for start-ups and SMEs in the NSR.The challenge is to improve the outcome of fracture treatment regarding functioning, co-morbidities and health as well as socio-economic costs. A key is a better understanding of fracture healing and of the benefits of personalised implants, optimised treatment and management of fracture care in North Sea Region countries.

Sahlgrenska University Hospital, Sweden• Stryker Trauma GmbH, GermanyBoth partners are participating in the approved BSR project “BFCC”, but with different functions compared to the NFCC project. While the BFCC project focuses on the development and implementation of a transnational fracture registry platform, the NFCC will transfer this platform into practical use.