Analysis of Six Major Barriers in the Development of China's Medical Device Industry

Although the overall development momentum of China's medical device industry has been rapid in recent years, it still can not fully meet the needs of the domestic market, and there is still a small gap between the level of research and development and product categories in the world’s medical industry powers. At present, according to the statistics of the China Medical Device Association, China's medical device market accounts for 14% of the total pharmaceutical market size, and there is still a large gap compared to the global average of 42%. There is ample room for market development.

Market access barriers

The medical device industry belongs to the industry that is under the key supervision of the state. The use of medical devices will directly affect the patient's health and life safety. Therefore, China has adopted a strict access management system for the industry, which is in the product access, production access and management. Access to these three levels set a high threshold for supervision. The entire process of the development of medical devices, from laboratory development to product launch, requires a rigorous review at multiple stages. The registration of products is subject to a long period of time. There is a certain degree of uncertainty in the availability of new products for sale, and the risk of product development will increase. .

High-precision medical filters and functional infusion devices mainly belong to the state's three categories of medical device products, which require the approval of the State Food and Drug Administration, and their supervision is more stringent than those of Class I and Class II products. Enterprises obtain production and operating licenses for such products. The difficulty of registration and medical device registration certificates is relatively greater, so there are obvious market access barriers in the industry.

Since July 2012, the state has imposed the “Quality Management Practice for Medical Devices (Trial)” in the medical device industry, and has further improved the access threshold of the medical device industry by implementing the industry quality certification system.

Technology and talent barriers

As high-precision medical filters and functional infusion devices are directly applied to the human body, the country has put forward high requirements on its technology and production processes, and the final products often require a long period of development and testing from the production of parts to final assembly. In order to finally meet the requirements of relevant technical indicators and reliability. During clinical use, clinical staff and patients have higher quality requirements for their use.

The production of high-precision medical filters and functional infusion devices involves multiple technical fields and requires the interdisciplinary use of different disciplines such as medicine, materials science, and biochemistry. The accumulation of related professional technologies and the training of talents will take quite a long time. R & D personnel usually need to have a more comprehensive knowledge of multi-disciplinary knowledge, and then through a long period of time to accumulate practical technology development experience in order to gradually master the industry's product development capabilities. Therefore, it is relatively difficult for companies to quickly acquire a large number of excellent R&D talents, and a relatively clear barrier of skilled personnel is formed.

Dealer model barriers

Due to the distributor-based sales model unique to the medical device industry, it is difficult for new entrants to establish a sound market channel in a relatively short period of time. High-precision medical filters and functional infusion devices are sold in a wide area and require high post-sales technical support. In the industry, dealer sales models are often used to sell to hospitals. Companies that first entered the industry have developed a long-term channel expansion to cultivate a The high-quality distributors with strong market development capabilities, management capabilities, and professional service capabilities quickly seized channel resources, eliminated the competition from the latter, and formed strong channel barriers.

Technical Service Barriers

High-precision medical filters and functional infusion devices have a high technical content and are still in the promotion stage in China. In the process of product sales, medical device industry companies need to establish a technical service team with professional clinical nursing knowledge and professional product knowledge, provide technical service support for the clinical use of products, reduce the clinical misuse of product use effect and brand Influence of the image, improve the acceptance and popularity of products in medical institutions and patients, and continuously introduce new products of the company through technical services.

The establishment of a technical service team takes a long time, requires a lot of resources, and thus forms a clear barrier to entry for new entry companies.

Barriers to marketing capabilities

Medical equipment industry enterprises to establish a sound marketing network channel requires a lot of capital investment and a long period of time, after a long period of market accumulation can form a certain scale of marketing network, which formed a more significant marketing capability barriers.

Product exclusive barriers

During the clinical use of medical device products, medical institutions tend to purchase specific types of medical devices from a single or a few suppliers so that medical personnel can master the operating methods of such medical devices, improve work efficiency, and reduce operational risks. At the same time strengthen bargaining power and reduce procurement costs. Therefore, medical device products will have a strong exclusivity in the course of clinical use, and form barriers to entry for similar products that are intended to enter medical institutions. Although the overall development momentum of China's medical device industry has been rapid in recent years, it still can not fully meet the needs of the domestic market, and there is still a small gap between the level of research and development and product categories in the world’s medical industry powers. At present, according to the statistics of the China Medical Device Association, China's medical device market accounts for 14% of the total pharmaceutical market size, and there is still a large gap compared to the global average of 42%. There is ample room for market development.