22 creased, requiring additional studies and evidence. This represents a significant challenge, especially for smaller companies. • Post-marketing surveillance: Increased post-marketing surveillance and vigilance by manufacturers is now required to ensure the safety and efficacy of products after they are launched on the market. This has made it necessary to develop corresponding structures and processes. 2.2. International harmonization of regulations For internationally operating companies, the harmonization of regulatory requirements is of crucial importance. The varying requirements in different markets, such as the US, the EU, and China, is making it difficult to develop and market globally uniform products. This has resulted in: • Duplication of tasks: Companies need to test and certify their products multiple times to meet different regulatory requirements, which increases costs and extends the time to market. • The risk of not fully complying with regulatory requirements can lead to recalls, fines, and damage to a company’s reputation, particularly in heavily regulated markets such as the EU and the US. 3. Future developments and strategies 3.1. Digitalization and Industry 4.0 Digitalization both offers opportunities and poses challenges to manufacturers of surgical instruments and osteosynthesis. Industry 4.0 technologies can increase efficiency and reduce production costs: • Automation: Using robots and automation technologies can optimize production processes and reduce error rates. This reduces costs while improving product quality. • Data analysis: The use of big data and artificial intelligence (AI) is enabling more precise monitoring and control of production as well as the early detection of quality problems. • Individualized medical devices: 3D printing and personalized procedures make it possible to manufacture customized implants and instruments that are specifically tailored to patient needs. 3.2. Sustainability and circular economy Requirements for the sustainability of products are continuously increasing. Manufacturers now have to grapple with issues such as environmental compatibility and recyclability: • Material selection: Choosing environmentally friendly and recyclable materials is increasingly proving to be a competitive advantage. However, this ENGLISH
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