Development and demand for domestic surgical instrument manufacturing technology

I. Overview

As part of the broader medical device industry, the development of a self-sufficient surgical instrument sector in China began during modern times. Following the Opium War, the introduction of Western medical devices sparked the emergence of local production through family-run workshops and small-scale factories. From the founding of the People’s Republic of China until the reform and opening-up period, the government actively supported the growth of this industry. Today, there are over 200 surgical instrument manufacturers operating in China. Surgical instruments generally refer to a wide range of tools used in medical procedures. According to this broad definition, the variety of surgical instruments is extensive. However, this article focuses specifically on traditional surgical instruments such as knives, scissors, forceps, and suction devices.

II. Current Status

After decades of rapid development, China's surgical instrument manufacturing technology has made significant progress. Basic surgical instruments have gradually transitioned from plating to non-plated surfaces, while specialized instruments for fields like cardiothoracic surgery, microsurgery, ENT, neurosurgery, and orthopedics have also advanced (see Figure 1). According to incomplete statistics, there are now more than 7,000 types of domestic surgical instruments, with output growing from hundreds of thousands in the early years of the PRC to over 10 million units today. The application of alloy materials, insulation materials, coating technologies, and mosaic techniques has driven the trend toward refinement and standardization in domestically produced instruments. These products now largely meet domestic clinical needs. A single surgical instrument typically goes through dozens to over a hundred processing steps, involving both cold and hot working, machining, and clamping operations. Due to the high proportion of manual labor, surgical instruments have traditionally been considered handcrafted. However, machining remains essential for mass production, and its precision plays a critical role in final product quality. With technological advancements and rising labor costs, continuous improvements in machining and automation are expected to become the industry norm. Over the years, domestic manufacturing equipment has been upgraded, and mechanization and automation levels have improved significantly. CNC high-speed milling machines and multi-axis turning and milling machines are now widely used. Related technologies such as forging, heat treatment, and surface treatment have also seen major advances (see Figure 2), with some processes now aligned with international standards. Mold manufacturing technology has long been an area where China lags behind global leaders. In the past, mold production relied heavily on manual methods, resulting in poor size control and inconsistency in mass-produced blanks. Since the new century, domestic mold-making technology has made remarkable progress. The adoption of CNC machine tools has significantly enhanced precision (see Figure 3), laying a solid foundation for better product quality. Currently, CAD and CAM technologies are commonly used in mold design and manufacturing. For the unique appearance features of surgical instruments, software design uses a modular parameterization approach. Once the line parameters of the blank drawing are set, the computer can automatically generate the required 3D blank shape and corresponding engineering drawings. Based on the provided blank map, 3D modeling is completed automatically using the parameter equations defined by the template. This method reduces the complexity of 3D programming and greatly improves efficiency.

III. Existing Challenges

Despite the industry's rapid growth, it is clear that Chinese surgical instruments still lag behind foreign counterparts in terms of quality and internal performance. Most domestic products dominate the low-end market, while the high-end segment remains dominated by foreign brands. Several factors contribute to this situation: **Special Equipment** Modern surgical instruments emphasize safety and reliability. Many critical processing steps rely on specialized equipment. For example, foreign grinding machines and robotic polishing systems ensure high-quality results and improve efficiency. In contrast, many domestic machines are outdated, and since the 1990s, it has been difficult to acquire suitable equipment due to systemic issues. Importing expensive foreign machinery is often unaffordable, limiting the update of domestic special-purpose tools and affecting overall production quality. **Special Tools** In foreign countries, powder metallurgy or cemented carbide tools are commonly used for surgical instruments, enabling standardized and efficient production. In China, due to the industry's small scale and high processing demands, few manufacturers specialize in this field. As a result, most companies design and produce their own combined tools, using high-speed steel, which falls far behind in precision, consistency, and durability. **Processing Technology** The future of surgical instruments increasingly involves multidisciplinary knowledge. International research on medical alloys, polymers, bioceramics, functional coatings, and surface treatments has advanced rapidly. Surface hardening technologies like PVD are already well-established. In contrast, China's applied research in these areas was historically weak. Additionally, many original medical device research institutions have shifted focus, no longer engaging in surgical instrument development. This has led to poor coordination between production, education, and medical innovation. Meanwhile, manufacturers lack the technical capacity to conduct high-tech research. High-quality surgical instruments are the result of a perfect blend of traditional craftsmanship and modern technology. Top-tier foreign instruments are often compared to fine crafts. For instance, Germany has developed a complete industrial chain for surgical instrument manufacturing, with specialized equipment and molds designed and produced to maintain global leadership. It is evident that China still has a long way to go to catch up with international standards in this field.

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