The second Guangdong medical device clinical trial resources docking meeting was

Medical enterprises come hand in hand

The second Guangdong medical device clinical trial resources docking meeting was successfully held in Shenzhen

Author: Yu Siming, Xu Fangzhou, Shenzhen Hospital, Peking University

In the warm winter, December 8 Under the guidance of Guangdong Drug Administration and Shenzhen market supervision and Administration Bureau, the second "Guangdong medical device clinical trial resources hospital enterprise docking exchange meeting" was hosted by Guangdong Medical Device Management Association and Shenzhen medical device industry association, and jointly organized by clinical trial Professional Committee of Guangdong Medical Device Management Association and Shenzhen Hospital of Peking University Shenzhen Hospital of Peking University was successfully held. More than 220 people attended the meeting, including leaders of medical device regulatory departments of Guangdong Province and Shenzhen City, clinical experts and managers of 33 clinical trial institutions in the province, representatives of 108 medical device production and R & D enterprises inside and outside the province, and relevant staff of industry associations.

一、Free dialogue between medical enterprises to discuss the innovation and transformation of medical device products.

Guangdong Province is one of the three major medical device industry gathering areas in China. The number of medical device manufacturers accounts for about one sixth of the total number in China, and the total output value of medical devices is nearly 200 billion yuan. As one of the cities with the strongest development of medical device industry in Guangdong Province, Shenzhen has 882 medical device manufacturers, with an annual total output value of more than 46 billion yuan, accounting for nearly a quarter of the province's total. In the chain of innovation and transformation of medical device products, clinical trial is the key link. In the past 20 years, with the continuous expansion of the number and quality, scale and efficiency of medical device enterprises in China, it has brought about a great desire for the growth of clinical trial resources. Since the implementation of the qualification filing of medical device clinical trial by the State Drug Administration, the number of medical device enterprises registered in Guangdong Province has been increasing There are 89 clinical trial institutions, ranking first in the country in terms of the number of records. Among them, there are 21 registered clinical trial institutions of medical devices in Shenzhen, accounting for nearly a quarter of the province's total. However, due to the lack of a platform for full dialogue between clinical trial institutions and enterprises, hospitals and a considerable number of enterprises are still in a state of being unable to hold hands. In order to bring convenience to enterprises and fully share the resources of medical institutions in Guangdong Province with enterprises inside and outside the province, Guangdong Province has held two sessions of medical device clinical trial resources docking meetings.
The meeting was presided over by Cai Qiaowu, secretary general and executive vice president of Shenzhen medical device industry association, Chen JIAYE, deputy director of administrative licensing department of Guangdong Drug Administration, Ding Bo, deputy director of medical device safety supervision department of Shenzhen market supervision administration, Zeng Hui, vice president of Shenzhen Hospital of Peking University, and Liu Shunli, Secretary General of Guangdong Medical Device Management Association Professor Hong Minghuang, chairman of Guangdong medical device clinical trial committee and Affiliated Tumor Hospital of Sun Yat sen University, respectively delivered a speech, placing high hopes on the goal of promoting the construction of an excellent and convenient R & D and transformation ecosystem of medical devices in Guangdong Province and the win-win cooperation between medical enterprises.

In line with the original intention that both medical enterprises and hospitals can have dialogue and learn from each other, Wang Tiancai, chief of the administrative licensing office of Guangdong Provincial Drug Administration, first introduced the "key points and common problems of clinical trial verification of medical devices". Wang emphasized that clinical trials of medical devices should be combined with their own characteristics and intended use, and follow relevant laws, regulations and guiding principles to ensure the quality of clinical trials Taking the example of "three nine exercises in winter and three Fu exercises in summer", we emphasize once again that the implementation of clinical trials should be steady and the quality should be strictly controlled.
Then, Tang Lei, executive vice chairman of the clinical trial Professional Committee of Guangdong Medical Device Management Association and director of the First Affiliated Hospital of Sun Yat sen University, gave a brief introduction to the related work of the clinical trial Professional Committee since its establishment. In less than one year, with the efforts of all members of the special committee, the special committee has made a number of innovative measures and achieved fruitful results . For example, to deliver services to enterprises, to take the initiative to enter enterprises, to hold docking meetings between medical enterprises, etc. in addition, in order to improve the quality of clinical trials of medical devices, the special committee has also formulated training courses on clinical trials of medical devices, etc., which will promote GCP Since its establishment, the special committee has carried out five training courses on clinical trials of medical devices.
In order to dispel the sense of estrangement between hospitals and enterprises and give both sides full opportunities for dialogue and collision of views, two round table forums were also designed. The themes of the two round table forums are "the main factors for enterprises to choose clinical trial institutions, how medical institutions help enterprises implement clinical trials of medical devices" and "how medical enterprises can work together more effectively in the innovation and transformation chain of medical device products". The guests of the two round table forums are outstanding representatives of the business community, and their respective regional characteristics and professional experience are fully taken into account when inviting guests from medical institutions.

The first forum was co hosted by Tang Lei, director of the drug clinical trial institution of the First Affiliated Hospital of Sun Yat sen University and Zeng Xiaohui, deputy director of the institutional Office of the General Hospital of the southern theater of the Chinese people's Liberation Army. Focusing on the theme of the forum, Shi Xiaoli, vice president of clinical registration of Peijia medical technology (Suzhou) Co., Ltd., Shen Chengliang, manager of the regulatory department of Shenzhen Zhongke Weiguang Medical Device Technology Co., Ltd., and Shen Xiaohui, manager of the regulatory department of Shenzhen Zhongke Weiguang Medical Device Technology Co., Ltd Zheng Lili, manager of regulatory department of Shenzhen Libang Precision Instrument Co., Ltd., Shangguan Hongxia, general manager of South China region of Wuhan Zhizhong Technology Co., Ltd., and Mr. Zou shouchang, head of strategic customer and banking channel Department of China Taiping Property Insurance Co., Ltd., expressed their own opinions on the current situation of pre marketing clinical trials of various enterprises. The core problems are as follows: (1) enterprises are selecting trials Research Center PI's industry influence, team ability and efficiency will be their considerations; (2) the quality of clinical trial research is very important in the process of product registration; (3) although Guangdong Province is a big province of medical device R & D and production, the business volume and business level of relevant departments of medical institutions are the constraints for clinical trials of high-risk medical devices such as implants It is an important factor in the choice of industry.
In view of the bottleneck problems and demands raised by enterprises, Dr. Sun Jian, head of quality management of institutional Office of Tumor Hospital Affiliated to Sun Yat sen University, Dr. Su Aishan, Secretary of institutional Office of Southern Hospital of Southern Medical University, Mr. Yang Hongying, director of institutional Office of Shenzhen People's Hospital, Mr. Zhou Wenjing, director of institutional Office of Shenzhen Hospital of University of Hong Kong, and Mr. Song Lin, head of quality management of institutional Office of Shenzhen Hospital of Peking University, etc According to their own work experience and experience, they expressed: (1) various institutions are very willing to provide perfect and high-quality clinical trial evaluation services for enterprises, and fully assist enterprises to ensure the quality of clinical trials; (2) in the early stage of trial scheme formulation, they are willing to provide a good communication platform for the docking and bridging between the sponsor and researchers; (3) medical institutions will be more competitive We should attach importance to the cultivation of GCP awareness of researchers, mobilize the enthusiasm of clinicians to undertake clinical trials through multiple channels and means, and also suggest that we should learn to organize practical training for researchers.

The second round table forum was co hosted by Wu Jianlong, director of institutional Office of Shenzhen Second People's Hospital, and Xu Fangzhou, director of institutional Office of Shenzhen Hospital of Peking University. Li Qiang, general manager of Guangzhou Jiutai Pharmaceutical Machinery Technology Co., Ltd., Cao Junwei, general manager of Shenzhen medical enterprise Wenqu Consulting Service Co., Ltd., Bao Yuting, product marketing director of Shenzhen Huada Zhizao Technology Co., Ltd., Xie Tao, R & D director of Shenzhen Anke Hi Tech Co., Ltd., and Huang Yucheng, medical director of Shenzhen Lixin Science Co., Ltd. delivered speeches as representatives of the enterprise, and put forward their opinions: (1) ）The innovation, design and application of medical device products are inseparable from clinical suggestions; (2) under the background of strong national policy support and fierce industry competition, enterprises will choose their own advantages and strive for the localization of cutting-edge equipment and the realization of the goal from imitation to innovation, and this process is inseparable from the intellectual support provided by researchers for enterprises (3) the current medical device industry is a deep integration of "medicine, industry and capital". We hope to promote the mode of this kind of clinical trial resource docking and exchange meeting between medical and enterprise to the whole country, become a model to promote the development of medical device industry, and create "Guangdong mode".
Hong Minghuang, former director of Tumor Hospital Affiliated to Sun Yat sen University and chairman of Guangdong medical device clinical trial committee, said that 90% of the large-scale medical devices currently used by various medical institutions are imported equipment. Therefore, our medical device enterprises have a long way to go. We must take the road of innovation and development, and hope that all enterprises can make progress Under the background of National Encouragement of independent innovation, more "Huawei" have emerged in the medical device industry. Subsequently, on behalf of Zhang Xintao, director of rehabilitation medical center of Peking University Shenzhen Hospital, Cui Dongzhe, deputy consultant of cardiovascular surgery department of Shenzhen Hospital of University of Hong Kong, Wei Hong, director of institutional Office of Shenzhen Children's Hospital, and Chu Yuguo, quality controller of institutional Office of Sun Yat Sen Memorial Hospital of Sun Yat sen University, guests from various medical institutions expressed that: (1) medical institutions are eager to undertake innovative and high technology connotation (2) in the process of intellectual property rights and transformation of R & D achievements of medical enterprise cooperation, it is necessary to communicate with each other in good faith, learn from each other's strong points, and achieve mutual benefit and win-win results. It is also expected that government departments and medical institutions will provide benign guidance, support relevant favorable policies, and encourage medical enterprise cooperation to achieve results. (3) Children are the future of our country, and the innovation of medical device products also needs to take children into account.
The medical and business guests of the two round table forums discussed freely, had a passionate dialogue, and the warm atmosphere infected all the participants. If it was a bit chilly outside, the inside was full of spring and full of vitality. The representatives of the two round table forums expressed that the medical and business enterprises had a full dialogue, had a collision of ideas, had a new look, and gained a lot.

二、The medical institutions set up the exhibition stand, and the partners took the initiative to come out.

In order to give each participating enterprise a full one-to-one communication opportunity with the intended medical institutions, the exhibition stage was set up at the end of the meeting. The medical institutions set up the exhibition stage and took the initiative to shake hands with the enterprises. All medical institutions have printed exquisite brochures, set up publicity shelves, even brought souvenirs of our hospital, spared no effort to publicize their clinical advantages, the management characteristics of specialty and experimental institutions, and even put up advertisements. Representatives of enterprises attending the meeting can freely choose their preferred medical institutions, sit down face-to-face for consultation and negotiation on the pilot project. The atmosphere of on-site communication is warm, and many booths are open to the public. This kind of medical institutions set up exhibition stands and took the initiative to come out to communicate with enterprises in a new and special way. It changed the old idea that "enterprises always seek experimental institutions". The representatives of participating enterprises gave a thumbs up one after another and received a lot of praise.
Under the background of the construction of Guangdong, Hong Kong and Macao Bay area, deepening the exchanges and cooperation between hospitals and enterprises in the bay area will inject more power and vitality into the innovation and transformation of medical equipment products. The interdisciplinary integration of medicine, engineering, science and other disciplines will surely produce more innovative products with "ground gas". As one of the key links in the innovation and transformation chain of pharmaceutical products, our clinical trial institutions also need to keep pace with the times, innovate ideas, serve as a good server for the development of China's pharmaceutical industry, pave the way for the healthy dream, and do our part in the Chinese dream.