一、Development Status of Chinese medical device industry
Since reform and opening up, especially in nearly a decade, Chinese medical device industry has made great advances. The average of compound growth rate keeps above20%. Many high-end medical devices can be developed and produced, like large X-ray device, CT, MRI device, Color B ultra, intravascular stent, joint prosthesis and so on. The exports of medical device is above 20 billion dollar in 2014.There are more than 16000 medical device manufacturing enterprise. Shenzhen Mairui, Shandong Xinhua, lepu medical, Shandong Weigao are outstanding companies. There are three medical device area which are Yangtze River Delta, Pearl River Delta and surround Bohai bay. It can manufacture 47 categories, 3500 kinds and more than12000 specifications products that satisfy treatment.
二、The problems of medical device industry in our country
1、The generic products of medical device are more, and innovative products are less.
2、The mid-and-low medical device are more and high-tech are less.
3、The homogenization phenomenon of some Chinese medical device is very serious.
4、The difference between Chinese medical device and developed countries’ is almost 10 years.
三、innovation and development way of Chinese medical device
 1、The scale of medical device enterprises in China are general small and weak competitiveness. If the output value is RMB 400 billion per year, the average of output will be RMB 25 million for each industrial enterprise. The largest medical device enterprises MR US ‘s annual output value is about 7 billion. The annual sales of Johnson and Johnson is 27.5 billion USD. The annual sales of Medtronic is 18.3 billion USD. There are seven American medical device manufacturing enterprises in the global top ten.
2、The capital investment is not enough for research and development in Chinese medical device enterprises. The investment for Chinese medical device development accounts for 3% of its sales. While the investment of developed countries or areas for medical device development accounts for 10%-15% of its sales. The investment for development of medical device accounts for 15%-20% in few large enterprises abroad of its sales. Johnson & Johnson invest about 2 billion USD for development per year. Medtronic invest about 1.7 billion USD for development per year.
3、The policy for purchasing and using domestic medical device is week. It is very difficult to enter into large hospitals for domestic medical device and high-tech medical device.
4、The industrial base is still week in China comparing with developed countries or areas. High-tech medical device is the integration of Multidisciplinary knowledge and technology, so the industrial base limit innovation and development.
 5、The difference of medical device industrial science and technology between Chinese and developed countries or areas is about 10 years. It is difficult to catch up with developed countries or areas by using present developmental speed. The high-tech medical device abroad will occupy three-level hospitals in China.
四、 Innovation, development and thinking of domestic medical device
1、sense of urgency for medical device development should be enhancing. Medical device manufacturers, related research and development organization, hospitals and government need to enhance sense of urgency. Innovation and development should put most important position according to request of the party central committee under the state council. Chinese medical device industry may have chance to catch up with developed countries or areas in ten years if the whole society pay attention to innovation and development.
2、the State Council need to make “13th Five Year Plan for Chinese medical device innovation and development”, which to clear goal of development and policy measure.It is not enough for enterprises, scientific research institution or colleges and universities to pay attention due to high-tech medical device and comprehensive subject. The government must make “13th Five Year Plan for Chinese medical device innovation and development” to concentrate power to overcome it.
3、increasing investment for innovation and development of medical device
So far as the status of present medical device industry, firstly medical device manufacturing enterprise should increase research investment. Secondly government should make medical device innovation and development fund and support enterprises’ research. The venture capital firm can invest into promising research and development projects and support innovative development of medical device.
4、The innovative development of medical device should have new idea
It is necessary to learn experience of foreign enterprises. It is hard to learn or copy high-tech technology because of patent protect. So we advise that look for innovation point and breakthrough point from medical establishment and medical staff to develop Chinese medical device. We need to know what they need and collect their advises and suggest for medical device.
5、pay more attention to talent team construction of innovative research and development of medical deviceThe key of Chinese medical device Innovative development is to encourage related team to build. And government should set medical device department or some kind of medical instrument and enterprises train related talents.
6、Complete and encourage innovation and development policy for medical device
China is doing industry transformation and upgrading. Medical device manufacturing enterprise should seize this chance and make good use of relevant policies. They can make themselves stronger by using merge and combination.
7、further improve examine and approve policy for medical device
State Food and Drug administration have introduced《Special approval process for innovative medical device》.The government give encouragement for examine and approve of innovative medical device. Specific operation process will be more improved.