ENGLISH 21 • Labor costs: Rising production and labor costs due to high quality standards. • Technological requirements: New and improved technologies require major investments in machinery and in the training of skilled employees. 1.2. Market fragmentation and competitive pressure The market for surgical instruments and osteosynthesis is highly fragmented and includes a large number of small and medium-sized enterprises (SMEs), along with a few large companies. This market structure has resulted in intense competition defined by the following factors: • Price competition: In the low-price segment, manufacturers from low-cost production countries are increasing the price pressure on established companies, which have then been forced to optimize their cost structures. • Pressure to innovate: The pressure to remain competitive requires high investments in research and development, which is particularly burdensome for smaller companies. 1.3. Globalization and supply chains Globalization has made supply chains more complex and vulnerable. Particularly in recent years, apparently distant events have shown just how sensitive global supply networks are. The following aspects are of importance for manufacturers of surgical instruments and osteosynthesis: • Reliability of supply chains: Ensuring a continuous supply of high-quality raw materials and components is essential. Delivery bottlenecks can delay production and jeopardize compliance with delivery deadlines. • Diversification of suppliers: To minimize the risks of being dependent on a particular supplier, companies are having to diversify their supplier base. However, this requires additional resources for management and quality assurance. 2. Regulatory challenges 2.1. Tightening of regulations The regulatory requirements for medical devices have significantly expanded, particularly with the introduction of the Medical Device Regulation (MDR) in the EU, which has made the process of both approving new products and monitoring existing ones more stringent. • A pproval procedure: The requirements for documentation and testing of products have become stricter. This has resulted in longer and more costly approval procedures, especially for innovative products. • Clinical assessments: The requirements for clinical assessments have in-
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