Play the role of a bridge to promote the transformation of innovative equipment
Release Date: 2020-06-16
Medical devices and drugs are necessary to protect human health and important material basis of health industry.
In recent years, innovative medical devices have emerged one after another, and research technologies and inspection methods have been changing with each passing day.
How to recognize, evaluate and supervise the new products under the condition of new science and technology and ensure the safety and reliability depends on the scientific solutions provided by the regulatory science.
The new situation has brought about new developments
In recent years, with the rapid development of social economy and the continuous progress of modern science and technology, great changes have taken place in the medical device industry.
On the one hand, the scale of the medical device market continues to grow and has gradually become one of the pillar industries of the world economy and a new growth point of China's national economy.
On the other hand, the scientific technology and industrial structure of medical devices are undergoing revolutionary changes.
The collection of various cutting-edge achievements of modern science and technology promotes the continuous emergence of innovative medical devices and the rapid development of research and testing methods.
For example, the means of repair and replacement of damaged tissues or organs has developed from simple morphological and mechanical functional repair to in vitro regeneration of human tissues or organs, realizing personalized and minimally invasive treatment.
The methods of disease diagnosis have developed from histopathological observation to high-precision molecular imaging diagnosis, and from general biochemical examination to gene detection.
The development of nanotechnology and medical robots has opened up new space for the treatment of tumor, cardiovascular and cerebrovascular diseases and orthopedic diseases.
Additive manufacturing technology has been used in the manufacture of medical devices, and is gradually developing towards 3D printing of biological materials, making in vitro regeneration of human tissues and organs a reality.
The Internet, big data, artificial intelligence and other technologies have been comprehensively applied to the full life cycle supervision, risk prediction and assessment of medical devices.
The combination of real world data research and simulation technology is changing the scale and cycle of clinical trials of medical devices and accelerating the transformation of innovative product results.
Transgenic and DNA synthesis technologies are expected to alleviate the problem of limited donors for organ transplantation.
The combination of wearable flexible bioelectronic devices with smart phones and cloud software revolutionizes the traditional medical model...
New technologies face new challenges
With the deep integration of new technology and medical device industry, innovative medical devices emerge one after another.
How to achieve scientific evaluation and scientific supervision of innovative products is a common challenge for drug regulatory mode innovation and industrial product innovation.
For the determination of innovative medical devices and regulations need to be at the same time satisfy the following three points: first, in our country has product core technical invention patent, in accordance with the law or by the transferee in accordance with the law in our country invention patent right or right to use, or is the core technology invention patent application has been published by the administrative department for patent under the State Council, and by the state intellectual property office patent retrieval consulting center to issue the retrieval report, prove that product core technology scheme possess novelty and creativity;
Second, the preliminary study has been completed and the product has been basically finalized. The research process is real and controlled, and the research data is complete and traceable.
Third, the main working principle or mechanism of the product is the first of its kind in China, and the performance or safety of the product has been fundamentally improved compared with similar products. The product is at the international leading level in technology and has significant clinical application value.
Innovative medical devices usually adopt new materials, new designs, new functions and new technologies, and are characterized by innovation, frontier, crossover and transboundary, which bring certain challenges to technical review and scientific supervision.
Through its full life cycle design (including design verification related bench test and the biological evaluation, design, conversion and design confirming the animal experiment and clinical evaluation, etc.), application of registration, market marketing, scale production, quality control, market feedback, a lot of link such as renewal, how to ensure that the product is safe and effective in each link?
On the basis of ensuring the safety and effectiveness of the product, how to further optimize the process, improve the process, reduce the cost, improve the efficacy, and provide a reasonable basis for regulatory decisions?
How to establish a continuous monitoring and synchronous analysis method for the full background, total elements, full index system and full life cycle of medical device products to form regular values and extract abnormal signals...
The establishment of medical device regulatory scientific system will provide new ideas and new methods to solve the above problems.
New paths enable new products
Medical device regulatory science is the science of developing new tools, standards and methods to assess product safety, effectiveness, quality and performance.
The regulatory scientific research of medical devices covers the whole life cycle of products, including but not limited to the research on the interaction between products and human body, the development of test methods and test products for evaluating new technologies, and the development of universal methods for post-marketing research of products.
Different from traditional scientific research, regulatory science originates from the mission and needs of regulatory departments and is scientific research and activities that serve the regulation of the entire life cycle of medical products.
Medical device regulatory science is a new interdisciplinary discipline, which involves both natural science and social science. It is a basic discipline that serves to formulate regulations and standards related to medical devices.
Different from scientific research with scientific discovery and theoretical innovation as its core, medical device regulatory science is devoted to studying how to better apply these scientific discovery and innovative theories to regulation.
In addition, the medical device regulatory science to formulate specific product standards and regulations as the goal, but provide for the common principles and scientific basis, is the link between scientific research and regulations, is to promote medical equipment innovation and promote its rapid industrialization of Bridges, but also deepen the reform of the medical device review for examination and approval system.
The whole process from pioneering research to successful clinical transformation of innovative medical devices is inseparable from the strong support of regulatory science.
First of all, the innovative products need to be classified and defined to make it clear whether they belong to medical devices, drugs or drug device combination products. If they are medical devices, they also need to define which kind of medical devices they belong to.
The classification results of innovative products directly affect the way of review and supervision. Therefore, the classification definition standards need to be reasonable and clear.
Secondly, it is urgent to develop new tools, new methods and new standards for the performance research, safety evaluation and animal test of innovative products.
The design of new tools and methods, as well as the formulation of new standards, will have a profound impact on the development, production, registration, review, supervision and industrialization of innovative products.
Thirdly, the design, development and production of innovative products must be controlled by the quality management system.
Under a universal quality management system and production specifications, a set of rules shall be established to ensure innovative product features and reasonably control their potential risks.
Finally, the clinical transformation of innovative products needs to prove its effectiveness, that is, it has a significant clinical effect in the vast majority of the target population.
How to regulate clinical trials, ensure that products meet innovative use conditions, intended use and indications, as well as how to select a reasonable control group and the main efficacy indicators, all need to be answered by regulatory science.
In addition, after successful registration and listing of innovative medical device products, their post-listing management still needs to be based on regulatory science.
For example, deep research is needed on how real-world data can be synthesized through big data tools to form effective real-world evidence to support regulatory decisions.
It can be seen that the huge clinical demand and the rapid development of science and technology have accelerated the development of innovative medical devices.
The transformation of innovative medical devices shall comply with the provisions of laws and regulations, follow the corresponding paths and rules, and ensure the safety and effectiveness of the products.
Medical device regulatory science derived from regulatory mission and demand can provide new tools, standards and methods for evaluating the safety, effectiveness, performance and quality of innovative medical devices, and support and promote the successful transformation of innovative medical devices.
(Research Institute of Medical Device Supervision, Sichuan University)
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