22 developed technical expertise that embodies so much more than what can be documented in technical drawings or quality management manuals. Their departure frequently heralds the end of an era in which decisions were made quickly, a long-term mindset was self-evident, and personal responsibility played a vital role in the company’s success. It follows, therefore, that business succession is emerging as one of the greatest strategic challenges for the entire medical technology industry, a sector in which experience is paramount. Today, modern surgical instruments are manufactured using high-precision CNC machines, laser technologies, and automated manufacturing processes. Nevertheless, their quality is still rooted in the expertise of seasoned designers, toolmakers, manufacturing specialists, and quality engineers. Many of the finer details are not created by machines alone, but by people who understand materials, continuously optimize production processes, and notice even the smallest changes. This applies equally to osteosynthesis products and implants, which must withstand extreme mechanical stresses while still meeting the most stringent regulatory requirements. Today, materials, surfaces, sterilization methods, biocompatibility, clinical evaluation, and risk management are interlocked like the gears in the movement of a watch. The European Medical Device Regulation (MDR) has significantly expanded the regulatory requirements. Significant resources are tied up in the areas of clinical evidence, post-market surveillance, UDI, EUDAMED, risk management, and extensive technical documentation, presenting significant challenges for small and medium-sized enterprises in particular. Meanwhile, digitalization, artificial intelligence, cybersecurity, sustainability, and increasing demands on supply chains merely compound the issue. Many companies are left facing a twofold transformation as a result: Firstly, they need to address the issue of succession planning; secondly, the market demands substantial investments in new technologies and skills. While earlier generations were often designers, toolmakers, or production managers themselves, the reins are now frequently passed to highly qualified engineers or business administrators. They bring fresh perspectives to the table, think globally, deploy digital tools with confidence, and increasingly view companies as interconnected platforms for innovation. Both have their merits. After all, successful business succession does not mean replacing a proven system. Instead, it involves pooling the strengths of past generations with the possibilities of novel technologies – and it is here that the immense opportunity for medical technology is found. Companies that retain the expertise they have established over decades while remaining open to digitalization, automation, and artificial intelligence ENGLISH
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