Medical device precision components industry characteristics and the main barriers constitute.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
1, medical device precision components with capital-intensive characteristics.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Because the precision of medical device precision components has reached the micron level, so the mold, production equipment have high requirements, most of the current domestic production equipment can not meet the requirements of high precision, so they need to meet through imported equipment, and imported equipment is often higher unit price, the capital investment requirements are also higher. Therefore, precision structural parts belong to capital-intensive industry.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
2、Precision components for medical devices have the characteristics of customized production.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Medical device precision components, different users have different needs for components in terms of structure, appearance, performance, color and texture, and different brand manufacturers have their own unique industrial design, which requires component manufacturers to customize specialized component products according to the overall design of the machine manufacturer.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
3, medical device precision components enterprises to "service large customers" as the core of the profit model.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Medical device industry is often a few big brands occupy most of the market share, so once the medical device precision components companies become qualified suppliers of large brands, usually have a sustained and sufficient orders, can dilute the fixed costs at the same time, to achieve stable corporate profits. On the contrary, if the company is mainly a small customer, there will be a small number of single orders and a wide variety of orders, coupled with the inherent characteristics of the component products are non-standard parts, which will increase the workload of the enterprise mold development, while increasing the number of production line debugging and product switching frequency, thus increasing the cost of expenditure, affecting the profitability of the enterprise. Therefore, medical device precision components enterprises are generally "service large customers" as the core of the profit model.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
4、The customers of medical device precision components have high stability.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Medical device companies have high quality requirements, strict criteria and long time cycle for component selection and certification.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
5、Barriers to industry entry.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
(1) Qualification barriers to entry.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Medical devices are closely related to life and health, the regulatory requirements are very strict, countries have implemented different degrees of access to the production and operation of medical devices. In the United States, the owners or operators of medical device manufacturing and distribution enterprises must register with the U.S. Food and Drug Administration. Medical device products entering the EU market must comply with the relevant directives set by the EU and pass the corresponding conformity assessment procedures to obtain the CE mark. China has implemented a filing and licensing system for medical device manufacturers and operators, and a product manufacturing filing and registration system for medical device products.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Access to medical device qualification of the relevant laws and regulations on medical device production, business enterprise personnel qualifications, plant environment, equipment and facilities, business premises, storage conditions and other requirements are high. It takes about 4-5 years or even longer for new enterprises to apply for establishment approval, product development, clinical trials and successful completion of registration and market launch, and requires enterprises to have rich industry experience in talent building, R&D, production, sales and management, which is difficult to obtain, so there are high barriers to entry.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
(2) technical experience barriers.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Medical device is a knowledge and technology-intensive industry, product development and production involves electronics, materials, machinery, biomedicine and other technical fields, including mechanical technology, electrical technology, biochemistry and communication technology, etc., which requires high requirements for enterprises in the industry in terms of patent reserves of relevant technologies and accumulation of manufacturing processes, and requires enterprises to have a complete research and development and production system.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
The manufacturing of precision components for medical devices requires the ability of batch production from mold design, engineering technology, automated production to component assembly and functional testing of finished products. The accumulation of industrial know-how and the cultivation of scientific research and development capabilities is a long-term and lengthy process, and it is difficult for inexperienced new entrants to form experience in product transformation within a short period of time, and the threshold of technical experience to enter this industry is high.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
(3) Barrier of professional talents.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Medical devices are highly knowledge-intensive industries, and their industrial development involves electronics, materials, machinery, biomedicine and other industries, which require high-level professional and technical talents from multiple disciplines such as medicine, materials science, biomechanics and mechanical engineering to collaborate in R&D and innovation. Medical device precision component manufacturing enterprises through the operation of advanced equipment use and process technology research, in the process of processing and manufacturing of precision components for a long time, gathered and cultivated a large number of professional and technical personnel, accumulated professional process technology and R & D capabilities to ensure the safety of product manufacturing and yield rate. For this reason, it is necessary to have certain professional talents, technical reserves and R&D strength to enter this field.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
(4) financial strength barriers.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Relevant laws and regulations on the medical device manufacturing and operating enterprises of personnel qualifications, plant environment, equipment and facilities, business premises, storage conditions and other high requirements. Therefore, the R&D, construction of production lines and layout of sales network of medical device enterprises require a large amount of capital investment, and the capital investment is large.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
In addition, China's medical device enterprises are in a critical period of development from low-end to high-end medical devices, which requires medical device enterprises to layout forward-looking technologies and new usage scenarios in advance, conduct R&D, adjust production capacity and conduct sales promotion according to market demand. This requires medical device companies to have sufficient capital reserves, so the industry has formed a high capital barrier for new entrants.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
(5) Customer Barrier.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
Medical device precision components are essential basic accessories for medical devices, and stable product quality is very important for the safety and effectiveness of medical device products. Therefore, medical device precision component manufacturers can only become qualified suppliers of medical device brands through strict supplier qualification audits, and medical device brands will put forward stringent requirements for suppliers' R&D capability, manufacturing capability, production process, quality management system, working environment, business status, social responsibility, human resources and even brand image during the qualification process. Only after passing the audit can the customer become a qualified supplier. Therefore, the qualification audit of qualified suppliers constitutes a customer barrier for companies that intend to enter this industry.SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
SourceRare earth magnet-https://www.rare-earthmagnet.com/medical-device-precision-components/
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