"Our team's independently innovated and developed world's first 'Multimodal Tumor Treatment System' officially obtained the Class III medical device registration certificate in June 2023. This system's treatment technology has a promising application prospect in many solid tumors such as liver and lung," said Sun Jianqi, Deputy Dean of the School of Biomedical Engineering at Shanghai Jiao Tong University and Chairman of Shanghai Meijie Medical Technology Co., Ltd., to Yicai. Currently, the team is developing iterative products adapted to more different application scenarios and meeting various clinical needs based on clinical applications and feedback, continuously expanding the indications, and carrying out innovative research on drug combination therapies.
"The team is mainly focused on the development of 'medical engineering' projects related to minimally invasive surgery with endoscopes, mainly Class II and Class III medical devices, with the number of projects exceeding 10, and almost all development inspirations come from clinical doctors," Xiao Liang, General Manager of Shanghai Kanglu Union Medical Technology, told reporters.
Xiao Liang said that currently, the enthusiasm in the field of technology achievement transformation is high, but there is still a lot of room for improvement in maturity. It requires a long period of market verification, and only after establishing some benchmark transformation projects and methods will this field gradually mature.
Advertisement
Recently, Shanghai issued the "Shanghai Action Plan for Promoting the Transfer and Transformation of Scientific and Technological Achievements (2024-2027)" (hereinafter referred to as the "Action Plan"), which sets a goal that by 2027, the city's technology contract transaction amount will exceed 800 billion yuan; the cumulative technology achievement transformation contract amount of scientific research institutions will reach 100 billion yuan, and the number of enterprises incubated by technology achievement transformation will exceed 2,000. The "Action Plan" also proposes to promote the connection of related elements within the Yangtze River Delta.
The "2023 Shanghai Science and Technology Achievement Transformation White Paper" released in late September shows that in 2023, the contract amount of biomedicine and medical devices reached 105.019 billion yuan, a year-on-year increase of 117.84%. At the same time, in 2023, Shanghai absorbed an increase in the number and amount of technology contracts from the three major economic circles, with the most contract amount coming from the Jiangsu, Zhejiang, and Anhui regions, reaching 34.455 billion yuan, a year-on-year increase of 62.16%.
The reporter's research found that although there is a large demand for transformation in the biopharmaceutical field in the Yangtze River Delta, there are some difficulties and bottlenecks, including: weak protection of intellectual property rights in technology achievement transformation projects, insufficient prediction of the market and commercial prospects of projects, single financing and investment channels for projects, and certain obstacles in the later stages of registration and market sales. How to break these barriers?
High "threshold" for transfer and transformation
The flow of elements is the key to cross-regional technology transfer and achievement transformation in the Yangtze River Delta, involving intellectual property rights, concept verification, registration approval, market sales, and other sub-segments. Industry insiders said that taking the biopharmaceutical field as an example, due to the special attributes of technology transfer and achievement transformation in this field, the transformation difficulty, complexity, and challenges it faces will also be relatively large.
As the "prototype" of medical science and technology achievement transformation, the element of intellectual property rights plays an important role. Pan Xi, the person in charge of the National Intellectual Property Operation (Shanghai) International Service Platform, explained to the reporter that compared with other industries, intellectual property rights in the biopharmaceutical field have some differences, which are reflected in: first, reflecting the complexity and high specialization of technology, and its protection usually involves various forms such as patents, data exclusivity rights, and trade secrets. Second, the regulatory and approval processes for intellectual property rights in this field are strict and closely related to compliance and market access. Third, the flow of intellectual property rights not only needs to consider market demand but also reflects a certain social responsibility because it is directly related to public health.
"The cross-regional flow of intellectual property rights in the biopharmaceutical field requires the construction of a more perfect policy coordination mechanism within the Yangtze River Delta region, supporting the deep integration of the industrial innovation chain, and promoting the rapid transformation of technology and achievements into market value," Pan Xi said. For a patent, what should be provided is not only the traditional patent protection and transaction services. "We are holding events such as the Yangtze River Delta High-Value Patent Operation Competition and the G60 Science and Technology Innovation Corridor Achievement Auction to reflect the 'operation' of intellectual property rights, helping more patents to connect with the international community."The key to whether medical technology成果转化 can form a "prototype" lies in engineering verification. Song Chengli, a professor at the University of Shanghai for Science and Technology and the executive deputy director of the Engineering Research Center for Minimally Invasive Medical Devices of the Ministry of Education, stated that unlike other industries, the biomedical field has a high technical threshold, involving professional knowledge in various aspects such as clinical medicine, engineering technology, business operations, and laws and regulations. "Among them, there is a lack of interdisciplinary and cross-professional talents, and there is an even greater scarcity of talents who can integrate knowledge and lead innovation and entrepreneurship."
Song Chengli further stated that the early investment in the biomedical field is large, scientific research investment is insufficient, and there are not enough exit paths for industrial funds. Compared with other industries that can quickly create wealth, it is difficult to attract outstanding talents and investment.
How do investment and financing professionals understand the "particularity" of medical technology成果转化?
"Medical-engineering transformation projects involving doctors and university professors have an additional process of two-way feedback and verification of clinical needs and health policies compared to transformation projects in other fields," said Tang Haofu, managing partner of Chuangrui Investment Group. The technical threshold in the fields of biomedicine and medical and health is usually very high, requiring individuals with a high level of knowledge reserves to interpret. "At the same time, some 'inventors' in medical-engineering transformation projects cannot fully represent the group of doctors. The engineering development of the project often needs to return to the clinic for verification, but doctors usually find it difficult to arrange extra time, which is very different from consumer and electronic projects."
In order to improve the quality and speed of "engineering," a senior person from a medical school revealed that the overall patent transformation rate of domestic medical schools is around 10%, and some medical institutions with strong advantages in scientific and technological achievements can approach 20%, but this is still a gap compared to the 40% level of developed countries. The reporter also learned during the research process that the success rate of a patent being developed into a "prototype" is less than 50%, and there are many difficulties in "engineering."
Wu Jiajun, the person in charge of the incubation of Aipeng Medical Devices, told the reporter that "medical-engineering transformation" projects mainly refer to some technological innovations based on clinical use, from the technical pre-research of clinical products to those that can be registered and marketed. The most common problem encountered by medical-engineering transformation projects is that the "prototype" of technology development cannot meet the standards of medical devices and there are production and use risks, and it cannot become a product for industrial mass production. "There are also projects that failed to fully identify the relevant standards and guide requirements at the time of project initiation, which makes the product need to be redeveloped during the clinical verification stage."
As the "operator" of several cross-regional medical achievement transformation projects, Wu Jiajun told the reporter that, especially in terms of data resources and sharing, on the one hand, because medical-engineering transformation projects require a large amount of medical and engineering data in the analysis and verification links, but the data sharing mechanism in the Yangtze River Delta region is not perfect, and the project development progress is inevitably affected. On the other hand, medical-engineering transformation projects need to use advanced medical equipment and engineering experimental equipment, but these devices are expensive and unevenly distributed. Some small enterprises and research institutions may not be able to bear them, and the equipment utilization rate of large medical institutions and enterprises is not high. There is a lack of an effective equipment sharing platform, leading to resource waste.
In addition, in terms of profit distribution, the transformation of medical-engineering transformation projects involves the interests of multiple parties. How to establish a reasonable profit distribution mechanism is a difficult problem. If the profit distribution is unreasonable, it may affect the enthusiasm of all parties involved in the cooperation or lead to the breakdown of project cooperation, seriously hindering the marketization of medical-engineering transformation projects.
How to solve the "engineering" problem? Song Chengli told the First Financial Daily reporter that in the past five years, the Minimally Invasive Center of the University of Shanghai for Science and Technology has carried out more than ten "medical-engineering cross" scientific research cooperations with enterprises and hospitals in the Yangtze River Delta region, including specific projects such as minimally invasive surgical instruments, minimally invasive medical surgery simulators, 3D intelligent laparoscopes, and insulin blood collection needles.Song Chengli stated that, in reality, the graduates in engineering and science fields currently cultivated by domestic universities cannot yet be called "research engineers" in the true sense. They are severely lacking in capabilities such as scientific research innovation, hands-on practice, clinical exploration, and international cooperation. At the same time, "research engineers" from the industry sector lack systematic integration capabilities, professional quality, and research ability. "Therefore, it is particularly important to build a public service platform that can gather, cultivate, and empower research engineers, which can further promote the flow of medical-engineering translational talents in the Yangtze River Delta region."
"In addition, we must also pay attention to long-term international cooperation," Song Chengli believes that only by drawing on international experience and keeping up with the international frontier can biopharmaceutical technology and industry keep pace with the times. "We can make use of established international cooperation relationships and platforms, including deepening cooperation with Stanford University's Biodesign Center in the United States, the Imperial College London Innovation Center in the UK, and the Singapore A-Star Center, while avoiding some high-risk areas."
As for how to improve the success rate of medical achievement transformation projects, Tang Haofu analyzed that the first step is to confirm clinical needs; the second is to achieve efficient engineering, which can be completed by technical service providers, manufacturing service providers, proof-of-concept centers, and contract manufacturing platforms with vertical capabilities; the third is to estimate the overall capital investment and timetable for the project, "These three elements are iterative."
How to collaborate? Sharing and openness are key.
Under the background of a unified large market, how should the advantages of cross-regional medical technology achievement transformation in the Yangtze River Delta be reflected?
Pan Xi suggested that in the next phase, on the one hand, a unified intellectual property transfer and transformation online platform can be established in the Yangtze River Delta to achieve information sharing, technology supply and demand docking, and policy collaboration through this platform, promoting efficient allocation of resources within the region. On the other hand, gradually improve supporting policies and measures, promote policy collaboration on tax incentives and financial support for patent transfer within the Yangtze River Delta region, and encourage cross-regional intellectual property cooperation and transactions.
Zhu Tongyu, Vice Dean of the Shanghai Medical College of Fudan University, stated that the Yangtze River Delta region has a very strong and irreplaceable policy advantage, and there are no policy obstacles to the transformation of medical technology achievements. However, there are still some difficulties in the specific operation and implementation process.
Zhu Tongyu said that for an "idea" to become a "product," elements such as capital, research and development, production plants, and sales teams are indispensable, but the operation of the entire chain is not so smooth. For example, some cities have made restrictions on the investment scope of industrial funds and the landing choices of scientific and innovation teams (for example, stipulating that industrial funds can only be invested in local or regional projects, etc.), and some cities have failed to fulfill the original reward commitments after project introduction, which is not conducive to the growth and development of scientific teams.
For this reason, Zhu Tongyu suggested that first, in addition to research institutes and industrial funds, the Yangtze River Delta region needs a platform for the convergence of scientific and innovation achievement elements. Second, the Yangtze River Delta region also needs a platform for the recommendation and selection of incubators, where different scientific and innovation entities can match incubators for their own development.
Third, the Yangtze River Delta region needs to study related transformation and landing assessment mechanisms; the "origin" of patents and projects and the "location" where they are transformed, applied, and settled into enterprises can share the rewards and performance benefits brought by the enterprises.Liu Xinzhong, Deputy Director of the Technology Transfer Center at Fudan Science Park, has experience in operating several "flying territory" science and innovation parks in the Yangtze River Delta region (Haiyan, Zhejiang and Kunshan, Jiangsu). He told reporters that whether it is the research and development transformation from universities and research institutions, or the product transformation from enterprises and industries, a multi-chain, multi-link, and full-process "openness" is required to widely obtain external innovation resources, optimize the science and innovation industry ecosystem, and gather and stimulate development momentum.
He suggested that through "openness," innovation resource elements can fully flow and share, allowing innovation entities to activate each other and promote each other. Various methods such as "R&D outsourcing," "implantable innovation," and "custom innovation" have the best efficiency and the lowest trial and error costs, which are important means used to promote the construction of science and innovation industry centers.
Leave A Comments