The risk problems and Management measures in the Research and Development of Medical device Project

At present, there is still a certain gap between the R & D technology of medical devices in our country and the developed countries, and we are faced with many scientific research risks, which has a serious adverse impact on the development of medical industry in our country. Therefore, it is urgent to strengthen the risk management of medical device R & D. This paper probes into the current situation of medical device research and development in China, and puts forward the corresponding management measures to promote the level of R & D and promote the steady development of medical industry in China. Since the reform and opening up, China's society, economy and science and technology have made great progress, making people's production and life have a good change, people gradually realize the importance of physical fitness and their own health. This kind of consciousness also promoted the development of medical service of our country. In this context, the research and development of medical device projects in China has become an important part of the high-tech industry. The research and development of the industry has a large span, a long time of research and development, high difficulty coefficient, strict legal requirements. The safety requirements are strict and so on, which increases the high risk of medical device research and development. Therefore, how to effectively avoid the research and development risks and improve the research and development quality is a problem that the medical industry and many medical device R & D personnel in our country are concerned about at present. It is necessary to understand existing risks and strengthen risk aversion and management of R & D projects.

  1. Research and development background and risk management of medical devices in china

    1.1 Research and development background as people improve their living standards, people pay more attention to their health, both physically and psychologically, This raises the demand and requirement of medical devices and various medical care products in the society, and the development prospect of medical device industry is good. As far as the development of medical device industry in our country is concerned, the number of enterprises with large scale or annual turnover of more than 100 million is relatively small, but the registration rate of medical device manufacturing enterprises is relatively high. At this stage, the application rate and occupation rate of medical devices made in China are on the low side at various levels of hospitals in China. Most of the large or accurate medical equipment and devices with high scientific and technological content are purchased abroad. On this point, we can see that the science and technology content of medical devices produced by our country is low, the R & D and production are lack of competitive power, and most hospitals have poor evaluation on the quality of medical devices and after-sales service of our country. The main reasons for this are the low R & D capability of medical devices in our country, the small scale of manufacturing enterprises, the lack of independent intellectual property rights, and so on. Therefore, if we want to change this situation, we must increase the independent intellectual property rights of medical device R & D enterprises. Strengthen R & D to enhance the core competitiveness of domestic medical devices.

1.2 status of risk management

     In order to improve the R & D quality of medical devices, the risk awareness and management awareness of the medical device industry and related R & D personnel were significantly improved. More and more people realize the important role and significance of medical device risk management in improving R & D quality. Some experts believe that the risk management measures and management procedures for medical devices should be based on the actual situation of the enterprise, mainly including the scale of the enterprise, the structure and organization of the enterprise, the characteristics of the product, and the function of the product, etc. According to the corresponding national or international standards, the risk procedure management documents are established in the enterprise, so as to identify the risk of R & D, to evaluate the method and to regulate the countermeasures effectively. In addition, professional risk management personnel should be trained or absorbed from the outside to ensure the smooth development of enterprise risk management. The industry standard of medical device risk management in China is "Medical device: application of risk Management to Medical device" (YY/T 0316-2008). On January 26, 2016, China issued the YY/T 0316-2016 industry standard and the YY/T 0316 Application Guide for Medical Devices (YY/T 1437-2016), which came into effect on January 1, 2017. In addition, the regulations on Supervision and Administration of Medical Devices and the measures for the Registration and Administration of Medical Devices are also the requirements and standards for R & D and risk management of medical devices in China at present.

2 .the risk of R & D of Medical device Project

2.1 risks associated with R & D characteristics of medical device projects

The contemporary world is a world with science and technology as the core of development. Due to the improvement of people's living standards and the popularization of science and technology related computer technology, medical devices are used in all aspects of society. For example, the prevention and control of diseases that are very common in people's daily life, the diagnosis and treatment of diseases in major hospitals, the recovery or rehabilitation intervention of patients' physical functions and various skills, etc., all have the participation of different kinds of medical devices. Medical devices play a great positive role in human health, and the application of medical devices is highly professional. If the wrong use of medical devices will not only cause huge economic losses to hospitals, It can also cause physical trauma to the user, so the research and development of the medical device is highly valued, and the requirements and standards of the law and medical safety are raised. The research and development of medical devices not only has the characteristics of unknown, innovative and uncertain, but also has the characteristics of high investment, long period, variability and so on, which brings great challenges to its R & D work.

2.2 risks associated with excessive R & D links in medical device projects

 As mentioned above, the R & D of medical devices has many characteristics, which cause a certain degree of hindrance for the smooth development of R & D, and the characteristics are relatively numerous and complex. Then problems in any aspect of the R & D process will have irreparable effects on the whole R & D work, or even R & D failure. For example, the R & D process of a new type of medical device is very complex and lengthy, requiring staff to conduct initial market research prior to R & D to understand the current market demand for products to be developed and other data. In addition, according to the survey data, the feasibility of the research and development of the project should be analyzed in detail. After the feasibility report is approved, it is necessary for professionals to verify the theory of the design scheme of the research and development project accordingly. To investigate the quality and usability of the pre-products and the effect of clinical trials, and to submit the results to the relevant standards after the results of the investigation are in accordance with the relevant standards. After the relevant departments have carried out the qualified examination and approval of the product, they can only carry out the final batch production and sales. Not only is the cycle long, but the research and development and production of the product also need a considerable amount of funds to support it. In any of the above links, even very minor errors, data errors, minor errors or substandard problems will lead to the overall R & D failure of the project.

2.3 risks associated with the dual nature of R & D of medical device projects

Each new product development process will face more difficulties, and also need R & D personnel in the process of continuous innovation and exploration of products, ordinary research and development of products has been a lot of difficulties. The R & D of medical devices not only has the characteristics of ordinary products, but also has its own characteristics. For example, the technological risks of R & D of medical devices, the changing market demand, This kind of change will bring the market risk to the medical device project research and development and the market policy risk that the government adjusts the relevant policy to the medical device project research and development according to the market demand; The financial risk caused by the shortage of R & D funds and the inconvenient turnover bring financial risk to the R & D of the medical device project and the quality risk caused by the defects or defective products in the production process after the successful R & D of the medical device project.

3. Research and Development risk response and Management of Medical device Project

The R & D of medical device project is a kind of market competition activity among medical device manufacturing enterprises, and it is also a research and development activity. This kind of benign competition among enterprises is also the manifestation of the fierce competition in the medical device market and the rapid improvement of the scientific and technological level in the contemporary society. At the same time, the upgrading of new products also provides a driving force for the R & D of the medical device production enterprises in our country. While providing impetus, it also brings risks and challenges to its R & D work. Therefore, risk avoidance and management of R & D of medical device projects in China has become the most concerned problem in medical device manufacturing enterprises. In the implementation of risk aversion and management, enterprises need to do the following four points:

3.1Raising the level of Science and Technology in Enterprises

Medical device manufacturing enterprises should strengthen their own study of international advanced science and technology and improve the level of scientific research technology. The application of science and technology in the research and development process of medical device projects in China is of great significance. Science and technology is the first productive force, and advanced science and technology are used to carry out project research and development. The integration of science and technology into products can effectively enhance the quality and technological content of products, increase the competitiveness of products in the market and the economic benefits of enterprises, in addition to the above advantages, The improvement of the level of science and technology can effectively reduce the quantity of quality and safety hidden danger caused by backward technology in R & D and avoid the risk of R & D. Therefore, the enterprise can learn advanced science and technology to promote the R & D of medical devices.

3.2 Establishment of an efficient organizational structure

In the process of R & D of new products, medical device manufacturing enterprises establish high quality and high efficiency organization structure, which can maximize the application rate of enterprise data. The establishment of an efficient organizational structure can make full use of the funds, human resources, data and information of the R & D center of the enterprise project. It can further enhance the ability of medical device manufacturing enterprises to deal with R & D risks and the quality of risk management. It is of great significance to establish an efficient organization structure according to the R & D situation in the medical device manufacturing enterprise.

3.3 Scientific Prediction of Medical device Market

The success of a scientific research project depends not only on the application, practicability and safety of the product, but also on good market acceptance. The practicability and validity have been officially recognized, but it does not prove that the product has been successfully developed, but it must also have a good market acceptance, that is, the product has market demand, meet the dual conditions to prove the success of the product development. Therefore, it is very important to forecast the market demand of the product before R & D, which requires R & D unit to set up market risk and demand forecasting group in order to reduce the market risk.

3.4 Policy risk response and management

Policy risk also has a great impact on the R & D of medical device manufacturing enterprises. Therefore, in order to ensure the smooth progress of R & D, enterprises need to attach importance to the policy risk and effectively avoid it. To do a good job of policy risk avoidance requires enterprises to pay close and sustained attention to the development of government laws and regulations, because medical devices are a special product, so the government has issued registration regulations and industry standards for them to ensure their safety. While avoiding policy risks, enterprises must have a thorough understanding of the laws and regulations of the product, ensure that the project is correctly established in the early stages of product development, and pay close attention to the development of relevant government policies. The new policy can be adjusted according to the requirements to ensure the smooth development of R & D.


In short, in the new period of continuous development and progress of science and technology, the number and scale of research and development of medical devices in the medical industry has increased dramatically, but this has also brought more R & D risks. Enterprises should make a thorough analysis of R & D risks and formulate risk aversion and management measures so as to improve the management level and economic benefits of R & D projects and promote the good development of medical services in China.

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