Ge Junbo, academician of the Chinese Academy of Sciences: Medical-engineering integration casting ingenuity Innovation engine has been upgraded again

Editor's Note

From May 1, the Measures for the Supervision and Administration of the Production of Medical Devices and the Measures for the Supervision and Administration of the Operation of Medical Devices were officially implemented. As a supporting document of the Regulations on the Supervision and Administration of Medical Devices, these two management measures reflect the latest regulatory concepts in the production and operation of medical devices in the mainland.

Since the first anniversary of the implementation of the newly revised Regulations on the Supervision and Administration of Medical Devices, the development of China's medical device industry has been rapid and rapid, and the tide of medical device development in the new era has surged forward.

Recently, the supporting documents of the regulations "Measures for the Supervision and Administration of The Production of Medical Devices", "Measures for the Supervision and Administration of The Operation of Medical Devices", "Good Management Practices for Clinical Trials of Medical Devices", and "Opinions on Strengthening the Coordinated Supervision of Cross-regional Commissioned Production of Medical Devices" have been released one after another, and scientific supervision is comprehensively promoting the innovation and transformation of the medical device industry to a new stage of high-quality development.

In the new era of high-quality development of the medical device industry, we have specially planned the "Leading tide - the 14th Five-Year Plan" Blueprint for China's Medical Device Supervision and Development" to enthusiastically help the innovative development of the medical device industry. To this end, the Pharmaceutical Economic News specially invited Academician Wang Yingjun of the Chinese Academy of Sciences, Academician Ge Junbo of the Chinese Academy of Sciences, Director Liu Bin of the Greater Bay Area Branch Center of the State Food and Drug Administration for Medical Device Technology Review and Inspection, Chairman Li Xiting of Mindray Medical, Chairman Xie Yuehui of LifeGen Technology, Deputy Director of the National High-performance Medical Device Innovation Center Jiang Hongwei, Xu Yimin, Senior Executive Vice President of Minimally Invasive Medical Product Registration and Group Property, Liang Yi, Chief Commercial Officer of Zaiding Pharmaceutical and President of Greater China, Zhang Mingdong, Vice President of Boston Scientific (Shanghai), and Chairman Tang Liang of Aosheng Group , Shandong Weigao Zhang Huawei, Chairman of Lepu Medical Pu Zhongjie, Executive Vice President of Shenzhen Medical Device Industry Association Cai Qiaowu, President Wu Chusheng of Guangdong Medical Device Association, Secretary General Xu Shan of China Medical Device Association, Director Lu Zhong of southern Institute of Pharmaceutical Economics of the State Food and Drug Administration (the above ranking is not in any order) and other authoritative experts and scholars in the fields of medical equipment administration, production, learning and research, talked about the changes in the mainland medical device supervision system and the improvement of regulatory capabilities in recent years, and the new policy on promoting the high-quality development of the medical equipment industry. The far-reaching impact of stimulating market dynamism.

The first issue of the feature is now freshly baked, and the follow-up is equally exciting, so stay tuned.

In the nearly one year since the implementation of the new "Regulations on the Supervision and Administration of Medical Devices", its supporting documents "Measures for the Supervision and Administration of Medical Device Production", "Measures for the Supervision and Administration of Medical Device Operations", "Good Management Practices for Clinical Trials of Medical Devices", and "Opinions on Strengthening the Coordinated Supervision of Cross-regional Commissioned Production of Medical Devices" have been recently issued, reflecting the latest regulatory and development concepts in the production and operation of devices in the mainland.

Ge Junbo, academician of the Chinese Academy of Sciences and professor of Zhongshan Hospital Affiliated to Fudan University, pointed out that the mainland medical device industry is gradually moving from imitation to original innovation through imitation introduction, digestion and absorption to the industrial path of re-innovation. Facing the future, medical integration, specialty segmentation, portability and intelligence based on real clinical needs will be the inevitable trend of the development of the medical device industry in mainland China.

Dialogue >>>

Academician of the Chinese Academy of Sciences, Professor of Zhongshan Hospital Affiliated to Fudan University

Ge Junbo

“

Pharmaceutical Economic News: In your opinion, what are the characteristics of the current innovation and development of the medical device industry in mainland China? What other development pain points are there?

”

Ge Junbo: At present, the innovative development of the medical device industry in mainland China presents three major characteristics.

01

Medical-worker integration

Throughout history, the innovation process of medical devices is the process of mutual confirmation of scientific research and clinical, the process of medical and engineering integration, the whole process of device innovation is inseparable from the close cooperation between doctors and engineers, the mainland's previous device innovation is mainly imitation, medical integration is not enough, facing the future, promoting the deep cross-integration of medical engineering, and building a complete knowledge system of medical device innovation process is urgent.

02

Specialty segmentation

In the past, the innovation and development of medical devices in the mainland was mainly based on general-purpose and basic medical devices, and the refined innovation based on the subdivision of specialties still needs to be improved, except for some specialties such as cardiovascular, most of the specialty medical device innovation still has a lot of room for development.

03

The portability and intelligence of medical devices

The future medical device will no longer be a simple device, but based on the integration of data and intelligent systems, and with the forward movement of the mainland medical center of gravity (from treatment to prevention and treatment) and sinking (county grassroots), the trend of portable and intelligent medical devices is worthy of attention.

In the process of exploring the innovative development and innovation direction of medical devices, there are still some duplicate developments in the mainland, which make some device research and development homogeneous, resulting in innovation resources and waste and overlapping industrial chains. In the future, innovation and development should pay attention to the division of labor and differentiated development of the industrial chain, and it is necessary to use systematic policies to guide healthy competition and achieve dislocation development.

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Pharmaceutical Economic News: Where is the breakthrough in opening up the innovation industry chain at present? In the process of promoting scientific research innovation and transformation of clinical demand pain points, what needs to be paid attention to?

”

Ge Junbo: Running through the innovation industry chain and establishing a complete industrial ecology requires a good interaction between various elements in the chain, including the government, supervision, medical institutions, universities/research institutes, enterprises and capital. I think the breakthroughs are mainly as follows:

01

Medical innovation should aim at the source and start from clinical needs

As the proposer of clinical needs, the assistant and inventor of technological innovation, the executor of clinical trials and the user of products after marketing, the role and value of doctors in medical device innovation run through the whole process, and the mechanism for clinicians to participate in industrial innovation in the process of innovation in mainland China needs to be further established and improved.

02

To do a solid job in the integration of medical workers, we need standard path guidance

The early innovation of medical devices, most of the innovative projects from doctors are in the idea stage, the product technology realization is lacking, the innovation projects from universities and enterprises focus on technological innovation, and the clinical demand orientation is insufficient, so at the beginning of the project design, we should pay attention to the cross-integration of medical institutions and universities and enterprises, take product landing and achievement transformation as the main goal, establish a complete set of medical integration process and path support, and deeply integrate medical workers throughout the entire product cycle.

03

Establish a systematic support platform to support early project innovation

The innovation of medical device products needs to go through a series of processes of concept proposal, technological breakthrough, clinical trial, industrial follow-up, high-level clinical research verification, guideline recommendation, and industrial outbreak, and the process is long and complex. At present, many medical institutions and scientific researchers have limited industrial and capital resources, and too many early innovation projects cannot find engineering and material resource support, staying in the early concept and preliminary design stage. It is recommended to support a systematic support platform for the innovation and landing of early medical device projects, give systematic support in the process of clinical and industrial docking, proof of concept platform, etc. according to the innovation path of medical devices, help the project quickly link partners, make prototypes/samples, and promote the transformation process of achievements; establish an early financial support system and industrial innovation base, connect industrial resources such as parks, medical enterprises, and investment institutions, and provide landing support for project development.

04

Attach importance to the cultivation of innovative transformation talents, and strengthen the awareness of innovation and transformation

The process of transformation of achievements involves multidisciplinary interdisciplinary professional knowledge and skills, which requires professional innovation and transformation talents to be full-time promoted, but at present, due to the lack of innovation and transformation professionals, the project innovation and transformation are limited step by step. It is recommended to understand the importance of the construction of the talent team for the transformation of scientific and technological achievements from the strategic level, establish a training system for innovative transformation of talents, and consider the construction of the medical scientific and technological achievement transformation talent team from multiple angles such as funds, projects, and promotion systems.

05

The development of basic science is the underlying foundation of innovation

The innovative development of medical devices is inseparable from the development of basic disciplines such as materials science, machinery, optoelectronics, etc., and it is very important to attach importance to the development of basic disciplines and find points that can be applied to clinical practice in the development of basic disciplines.

Taking CCI as an example, in September 2015, I jointly launched the China Cardiovascular Doctor Innovation Club (referred to as CCI) together with a large number of medical experts, and since its inception, adhering to the original intention of "From the doctor, by the doctor, for the doctor", from the initial doctor innovation exchange platform to a systematic and professional medical innovation ecosystem, initially forming a covering innovative training, proof of concept, innovative research, Innovative system for project transformation.

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Pharmaceutical Economic News: At present, the Guangdong-Hong Kong-Macao Greater Bay Area, the Yangtze River Delta and other medical equipment industry clusters are developing rapidly, and industrial clusters and industrial transfers are parallel. What suggestions do you have on the road of leading the high-quality development of the medical device industry with innovation clusters?

”

Ge Junbo: The Yangtze River Delta and the Guangdong-Hong Kong-Macao Greater Bay Area have their own advantages in the industrial cluster of medical devices, the Yangtze River Delta is rich in medical resources and has a good industrial base, while Shenzhen, as a pioneering demonstration zone of socialism with Chinese characteristics and the core engine of the Guangdong-Hong Kong-Macao Greater Bay Area, has become one of the most influential medical device industry clusters in the mainland. In promoting the high-quality development of industrial clusters, there are the following suggestions:

01

In the top-level design and planning of industrial clusters, attention should be paid to avoiding homogeneous competition

The industrial clusters in the Guangdong-Hong Kong-Macao Greater Bay Area and the Yangtze River Delta have formed their own scale and characteristics, and in the subsequent layout, it is necessary to design different industrial priorities and innovation paths according to their respective advantages and characteristics, and at the same time promote the formation of benign interaction between the two industrial clusters through reasonable mechanism design.

02

Trend prediction and forward-looking layout should be carried out in the direction of industry innovation

As an important carrier for mainland medical devices to participate in international innovation, it is necessary to appropriately pre-study and pre-judge the disruptive innovations that may occur in the future, and carry out forward-looking layout for the future.

03

Attach importance to the construction of innovation ecology and support the development of platform institutions

The construction of the innovation ecosystem and hardware investment are equally important, and it is necessary to gradually build an innovative ecological microcirculation network to promote the connection and integration of various innovative elements; gradually build a new platform-based research and development institution, coordinate the overall innovation process, and integrate the development of basic scientific research, clinical medicine and industrial innovation, and effectively cooperate with innovative elements.

04

Support the construction of clinical research platforms and transformation institutions for innovative medical devices

Build a pilot unit for the clinical application of innovative devices similar to Hainan Boao Lecheng, set up pilot hospitals in the Greater Bay Area and the Yangtze River Delta to carry out the clinical application of innovative devices, promote the rapid transformation and landing application of innovative devices at home and abroad, and provide clinicians with a fast path for device transformation.

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Pharmaceutical Economic News: The "Report on the Development of China's Medical Device Industry (Status Quo and "14th Five-Year Plan")" was published and issued by the Southern Institute of the State Food and Drug Administration, which comprehensively analyzes the development status of the medical device industry and makes a prejudgment of the future industrial development trend. In your opinion, what is the significance of the publication of this report for the economic planning of the medical device industry, the healthy development of enterprises, and the scientific research of supervision?

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Ge Junbo: As a pharmaceutical economic research institution directly under the State Food and Drug Administration, the Southern Institute of the State Food and Drug Administration has a long-term research foundation for the macro trends and policy evolution of the medical device industry, has detailed industry data and resource integration capabilities, and is led by the Southern Institute to issue the "Report on the Development of China's Medical Device Industry (Status Quo and "14th Five-Year Plan")", which is of great significance for industrial development and regulatory scientific research. It is mainly reflected in the following aspects:

The first is to interpret the current situation of the industry based on data and provide a basis for policy formulation. Through detailed data research, the report accurately portrays China's medical device industry from multiple dimensions such as scale efficiency, innovation ability, industrial ecology, and international competition, accurately analyzes the current situation of the industry based on data, analyzes the current situation, and provides a strong basis and reference for the country's follow-up macro-control, dynamic management, and industrial development policy formulation and guidance.

The second is to integrate industry resources and provide effective ideas for industry supervision. On the basis of data accumulation and analysis, integrating feedback and suggestions from relevant resources from all walks of life such as government, industry, academia and research, a set of data standards and evaluation systems for the development degree of the medical device industry has been established to provide solutions for the monitoring of problems in the medical device industry and industry supervision.

The third is to point out the direction of industrial development and guide the orderly development of the industry. The report makes constructive and guiding industrial prospects from many aspects, such as industrial policy promotion, technological innovation drive, medical demand pull, international trade traction and overall industry trend forecast, etc., to ensure industrial development expectations and promote balanced, orderly and dislocated industrial development.

Layout Editor: Chen Shuwen

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【Source: Pharmaceutical Economic News】