How does the medical device industry innovation system in Shanghai evolve?

How does the medical device industry innovation system in Shanghai evolve?

Abstract: In recent years, China has gradually formed a medical device industry innovation system under the guidance of the government, and its industrial innovation capability has gradually improved. Under the guidance and control of the government's macro-policy, the participating entities of the innovation system – enterprises, universities and research institutes, financial institutions, and science and technology service institutions – interact to promote the creation of innovative technologies and products. Taking the Shanghai medical device industry as an example, the article will elaborate on the formation and evolution of the medical device industry innovation system from three aspects: policy, industrial park and collaborative innovation mechanism of production, education and research.

introduction

The medical device industry is a multi-disciplinary high-tech industry involving many industries such as medicine, machinery, electronics, materials, etc. It is a concentrated expression of the country's cutting-edge technology development level and technology integration application capabilities. Since the country officially established the discipline of biomedical engineering in 1978, after more than 30 years of development, China's medical device industry has developed from a small group of productive small enterprises with public ownership under the planned economy to a coexistence of multiple ownership systems. Operating enterprise group. After years of accumulation, China's medical device industry has established a complete system and formed a good medium and low-end medical device production base. In 2013, China's medical device enterprises totaled about 15,000, with sales revenue of 188.9 billion yuan, becoming the third largest medical device market after the United States and Japan. However, China's medical device market only accounts for 14% of the entire pharmaceutical market, and there is still a certain gap with 42% of foreign countries, indicating that China's medical device industry has huge room for development. At the same time, the independent innovation of medical devices is receiving increasing attention from all walks of life. The number of medical device patent applications increased from 10,616 in 2003 to 41,633 in 2011. China's medical device industry is gradually being realized by “Made in China”. The transition to "Created in China."

Shanghai medical device industry has always been in the leading position in the country. In the early 1960s, in the development stage dominated by single imitation, Shanghai began to have engineers and medical workers to combine medical workers and jointly develop medical equipment and equipment. The concept of independent innovation has taken shape. In 1979, Shanghai took the lead in setting up the Shanghai Biomedical Engineering Society. After years of accumulation and development, Shanghai has become a leader in the field of medical device innovation in China with its outstanding industrial base, talents, research and development and clinical research. Especially in recent years, Shanghai medical device enterprises are gradually moving towards independent innovation, innovative products are constantly emerging, and innovation capabilities are gradually improving. For example, Shanghai Weichuang Medical Devices Co., Ltd. has developed the first drug-coated stent product in China and the world's first single-sided grooved process bracket, the Fire Eagle bracket. At present, MicroPort has applied for or owned more than 300 patents. In 2012, R&D expenditure accounted for more than 15% of sales revenue, reaching the foreign average. Established in 2011, Shanghai Lian Ying Company, after three years of research and development public relations, first launched 10 high-end medical imaging products covering the entire product line at the end of last year, and has the only domestic molecular imaging (PET-CT) production capacity. In the field of in vitro diagnostics, the proprietary CDA detection (cancer differentiation analysis) technology developed by Apex Biomedical Technology Co., Ltd. enables one-time screening of at least 16 types of cancer, and sensitivity and specificity of more than 80% for lung cancer and liver cancer. For the domestic high incidence of esophageal cancer, there is no early detection of effective detection markers in the world, and it can achieve more than 80% sensitivity and specificity, and has made breakthroughs in the field of early detection of tumors. These innovative products not only fill the gap between the international and domestic, but also mark the improvement of Shanghai's medical device innovation ability, and greatly reduce the cost of medical treatment for domestic patients.

In fact, in recent years, the improvement of China's medical device industry innovation ability has benefited from the gradual establishment and improvement of the medical device industry innovation system under the guidance of the government. Under the guidance and control of the government's macro-policy, the participating entities of the innovation system – enterprises, universities and research institutes, financial institutions, and science and technology service institutions – interact to promote the creation of innovative technologies and products. This article will take the Shanghai medical device industry as an example to elaborate the formation and evolution of the medical device industry innovation system from three aspects: policy, industrial park and collaborative innovation mechanism of production, education and research.

1 Gradually improved policy system

In 1978, China formulated the first medical device development plan "Development Plan for Biomedical Engineering (Draft) from 1978 to 1985". Later, in the scientific and technological development plans of different periods, the development of new medical devices and medical new materials was also proposed, but It was not until 2006 that the national medium- and long-term science and technology development plan was explicitly proposed to accelerate the establishment and improvement of the national medicine creation technology platform and promote the independent innovation of major new drugs and medical devices. The introduction of the new medical reform program in 2009 has enabled the medical device market to increase in volume, which provides an opportunity for the development of China's medical device industry. The "Special Plan for the Development of Medical Device Technology Industry (2011-2015)" promulgated in 2010 initiated and implemented the "Special Project for Medical Devices" and vigorously promoted technological innovation in the medical device industry. So far, it has invested about 1.2 billion yuan. The "Special Approval Process for Innovative Medical Devices" promulgated in February 2014 aims to further accelerate the industrialization of innovative products. The new edition of the Regulations on the Supervision and Administration of Medical Devices, released in June 2014, has undergone major adjustments in the connection between product registration and production licenses. The supervision mode for “first product registration and post production license” for medical devices has been clarified. It is stipulated that the production enterprise may apply for a medical device production license if it has a medical device product registration certificate. This change in the regulatory model will reduce the company's investment in the pre-registration of products, and help the research and innovation of medical device companies.

Based on its own development characteristics, Shanghai has also formulated a series of related policies and plans. For example, the “Shanghai Biomedical Industry Development Action Plan (2009-2012)”, which was formulated in 2009, focuses on promoting the industrialization of domestic blank products, such as drug stents and insulin pumps, in the field of medical devices, and vigorously develops diagnostic reagents and supporting instruments. Molecular imaging fusion CT, digital integrated operating room, large CT / X-Ray Machine, B-ultrasound and other medical imaging equipment, choose to develop blood purification and wound repair materials, and promote the application of artificial bone materials. In 2014, the Shanghai Municipal Government formulated the second round of “Shanghai Biomedical Industry Development Action Plan (2014-2017)”, which will promote high-end medical devices as a priority development field, promoting 3T magnetic resonance, 64-row CT, and pacemakers. The research and development and industrialization of 50 three types of medical device products, such as biological valves, foster a group of biomedical leading talents and innovative teams, and continue to maintain the leading position of Shanghai biomedical innovation capability in the country.

At the same time, a series of related supporting policies such as “Several Policy Provisions on Further Promoting the Development of Shanghai Biomedical Industry” have also been introduced. By encouraging the development of industrial M&A investment, cultivating leading enterprises in the industry, improving the policy of land for industrial project construction, accelerating the industrialization process of innovative products, perfecting market policies that encourage enterprise innovation, and promoting the demonstration application of innovative products and other policies and regulations, vigorously promote the Shanghai biomedical industry. Development, as shown in Table 1.

Table 1 Shanghai Biomedical Industry Policy Examples

How does the medical device industry innovation system in Shanghai evolve?

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