Patent Analysis and Suggestions for Promoting the Development of Zhejiang Bioactive Dressing Industry
Bioactive dressings have emerged on the basis of the development of biotechnology, new materials, modern medicine, and textile science and technology. They are a new type of medical device with symbolic significance in clinical medicine and have broad market prospects. In order to promote the creation of a highland of life and health innovation in our province, this article takes bioactive dressings as the research object, sorts out the current development status and future trends of bioactive dressing technology and industry, analyzes the opportunities, advantages and existing problems of developing the bioactive dressing industry in our province, and puts forward corresponding countermeasures and suggestions, providing decision-making reference for the development strategy and patent layout of the bioactive dressing industry in our province.
Many internationally renowned medical device companies, such as Conway from the United States, Schlieffen from the United Kingdom, and Buchmann from Germany, have invested heavily in the research and development of bioactive dressings, and have developed a series of high-tech products with excellent performance, occupying an absolute advantage in the research and production of bioactive dressings. China has undertaken the transfer of the traditional dressing industry chain from developed countries, gradually forming a group of medical dressing production enterprises engaged in OEM (Original Equipment Manufacturing) and mainly exporting, becoming the world's largest exporter of medical dressings. However, there is still a certain gap between China and developed countries in terms of product innovation, R&D investment, talent, and technological level. The products mainly focus on traditional dressings such as gauze and cotton pads, while bioactive dressings mainly rely on imports. In recent years, due to the increasing demand for bioactive dressings in the domestic market and the high prices of imported dressings from abroad, many domestic enterprises and universities have carried out related research and development work, focusing on promoting the import substitution of bioactive dressings. At the same time, the national "Healthy China 2030" plan proposes to strengthen the construction of innovation capabilities for high-end medical devices, and our province will include the medical device industry as a key development content of the "Eight Trillion Industries" health industry. In this context, it is of great significance to accelerate the research and development breakthroughs of bioactive dressings, which are iconic products of high-end medical devices, and cultivate a group of biologically active dressing advantage enterprises with international influence, in order to promote the transformation and upgrading of our province's medical device industry and the creation of a highland of life and health innovation.
1、 Development trend of domestic bioactive dressing industry
1. Bioactive dressing technology has entered a stage of rapid development
The patent applications for domestic bioactive dressings first appeared in the early 1990s. Since 2001, the number of patent applications has grown rapidly. After 10 years of technological accumulation, bioactive dressing technology entered the second stage of rapid development after 2011, and the number of patent applicants has also continued to increase, indicating that in recent years, the bioactive dressing industry has sparked a wave of technological innovation and entered a period of rapid development. From a regional distribution perspective, Jiangsu, Guangdong, Shandong, Zhejiang, and Shanghai
(Note: There is generally an 18 month delay from patent application to publication, and the data for 2017 and 2018 are incomplete for reference only.)
2. There is a gap in the production process control of dressing raw materials between China and foreign countries
In biomedicine, the biocompatibility, biodegradability, inhibition of bacterial proliferation, and antibacterial properties of dressings during wound healing have attracted increasing attention from researchers, and bioactive dressings with these properties have also become a research focus. The matrix materials disclosed in the patent for bioactive dressings mainly include chitosan, alginate, polyvinyl alcohol, gelatin, hyaluronic acid, carboxymethyl cellulose, polyurethane, polylactic acid, polyvinylpyrrolidone, collagen, etc. In the field of natural material dressings, animal derived chitosan and plant-based alginate are the focus of development. In the field of synthetic material dressings, polyvinyl alcohol is the most widely used material. In terms of efficacy, in addition to the traditional function of promoting wound healing, hemostatic and skin replacement effects have been the focus of research and development in recent years.
There is still a certain gap between domestic enterprises and foreign enterprises in the production process control of dressing raw materials such as chitosan and alginate, and the quality stability is poor, which affects the performance of the final product. For collagen based active dressings, the raw material collagen comes from allogeneic skin, such as pig skin or cowhide. Foreign companies strictly follow standards in the supply of allogeneic skin to ensure that the skin is harvested at the same growth time, while domestic companies usually determine the harvesting time based on market profit margins, which can also lead to differences in collagen properties and affect the performance of the final product. As a result, the lack of raw material sources and stability has constrained the development of China's bioactive dressing industry.
3. Enterprises are the innovative entities in the domestic bioactive dressing industry
From the analysis of patent applicant types, enterprises have the highest number of biologically active dressing patents, with 1283 applications, accounting for 50%, followed by universities, institutions, and individuals, accounting for 27% and 18% respectively. This indicates that enterprises are the main force in China's biologically active dressing technology innovation, and some universities and institutions have strong research and development capabilities in the field of biologically active dressings. Among the top 20 patent applicants, universities and institutions such as Donghua University, South China University of Technology, and Zhejiang University rank among the top in terms of patent application volume. Some foreign advantageous enterprises have begun to aim at the Chinese market and carry out patent layout in China. The layout focuses on chitosan based, collagen based, polyurethane based bioactive dressings. Johnson&Johnson Aixikang of the United States ranks in the top 20 patent applications in China, focusing on applications for oligosaccharide containing, aldehyde modified polysaccharide dressings, and related patents for hemostatic foam functional dressings.
4. Foreign bioactive dressing products occupy 80% of the domestic market
At present, the production of medical dressing products in China is mainly focused on mid to low end products such as cotton, gauze, and bandages, while high-end medical dressing products such as chitosan, alginate, polyvinyl alcohol, etc. are generally in the stage of technical reserves and research and development, and have not yet been widely industrialized. Foreign companies have an absolute advantage in the research and production of bioactive dressings. Relevant products were already launched in the 1990s, and after more than 20 years of development, the industry chain has become relatively mature, with products constantly upgrading and upgrading, and excellent performance. At present, imported products account for 28%, 34%, 51%, 22%, 58%, 48%, and 16% of the registered alginate based, polyvinyl alcohol based, gelatin based, hyaluronic acid based, carboxymethyl cellulose based, polyurethane based, and collagen based bioactive dressings, respectively, with a total market share of about 80% in China.
2、 SWOT analysis of developing the bioactive dressing industry in our province
1. Our province has the research and development capability and industrial foundation in the field of bioactive dressings
From the perspective of raw materials, the two main bioactive dressing matrix materials - chitosan and alginate - are extracted and processed from marine organisms. Our province has abundant marine resources and a group of advantageous enterprises in the utilization of marine resources, which gives us a resource advantage in the development of the bioactive dressing industry. At present, in terms of the number of registered products, our province ranks among the top five in the fields of alginate based dressings, carboxymethyl cellulose based dressings, and polyurethane based dressings in China (as shown in Table 1). In terms of patent application status, our province ranks fourth in the overall patent application volume of bioactive dressings in China (as shown in Figure 1). Zhejiang Yiding Medical Dressing Co., Ltd., Zhejiang Longtai Medical Technology Co., Ltd., Zhejiang Sanchuang Biotechnology Co., Ltd., Zhende Medical Supplies Co., Ltd. and other advantageous enterprises with emphasis on product substrate types have emerged (as shown in Figure 2), as well as key scientific research institutions represented by Zhejiang University. In terms of research and development carriers, Zhejiang Zhende Medical Dressing Enterprise Research Institute has been established with the support of Zhende Medical Supplies Co., Ltd., and Jingdi Medical Biopharmaceutical Dressing Provincial High tech Enterprise Research and Development Center has been established with the support of Jinhua Jingdi Medical Supplies Co., Ltd. At the same time, Zhejiang University has a Biomedical Polymer Research Institute, whose research directions include tissue repair and regeneration of medical polymer materials, self-assembled biomimetic interfaces and nano biomedical materials, natural biomedical polymer materials, etc. This has laid a solid foundation for the development of the bioactive dressing industry in our province.
(Note: The data is sourced from the website of the State Food and Drug Administration, as of December 2018)
2. There are relatively few key enterprises in our province, and the research and development level needs to be further improved
At present, there are nearly 200 enterprises engaged in the manufacturing of dressings in our province, but from the registered products, there are only more than 30 enterprises engaged in the manufacturing of bioactive dressings in our province. From the perspective of patent application volume, in the field of bioactive dressings, Jiangsu and Guangdong account for 16% and 14% of patent applications, respectively, which is significantly ahead of other provinces and cities and in the first tier. However, our province only accounts for 7%, which is in the second tier with Shandong, Shanghai, and Beijing. From the perspective of the depth and breadth of technological layout (as shown in Figure 3), Jiangsu has leading advantages in the analyzed popular dressing fields, especially focusing on the research and development of chitosan, alginate, polyvinyl alcohol, gelatin, and hyaluronic acid dressings; Guangdong Province focuses on the research and development of chitosan, polyvinyl alcohol, and alginate dressings; Zhejiang Province mainly focuses on the research and development of chitosan dressings, with less emphasis on the research and development layout of other material dressings. From the perspective of enterprise patent applications, compared to several companies in sister provinces and cities that rank among the top in patent applications, only Zhende Medical Products Co., Ltd. in our province ranks among the top 20 in patent applications. From the frequency of patent citations that can characterize the impact of technology, highly cited patents mainly come from enterprises or research institutes in provinces and cities such as Guangdong, Jiangsu, Beijing, and Shanghai, and no presence of Zhejiang institutions has been found. Therefore, in the field of bioactive dressings, our province's research and development level needs to be further improved.
3. There is a high demand for bioactive dressings in both domestic and international markets
Compared with traditional dressings, new types of dressings such as bioactive dressings account for about 60% of the global market and over 80% in developed regions. From the perspective of development trends, due to the advantages of reducing dressing pain, shortening healing time, decreasing dressing frequency, reducing labor intensity of medical personnel, lowering comprehensive treatment costs, and making dressing changes easy and feasible, the demand for bioactive dressings is becoming increasingly urgent. In the future, the proportion of bioactive dressings will further expand. At the same time, both the national and provincial governments attach great importance to the development of the medical device industry, including bioactive dressings. For relevant enterprises in our province, this presents significant development opportunities in the field of bioactive dressings.
4. Relevant policies and service support still need further improvement
During field research, many companies have expressed an urgent need for government guidance on policies such as medical device registration and evaluation conditions, registration and listing. Every year, the Provincial Medical Device Evaluation Center organizes two training courses for registration and application personnel of medical device manufacturing enterprises. However, due to the short course time and universal design of the courses, they cannot better meet the personalized needs of enterprises. Therefore, if government departments can conduct pre evaluation of the technical requirements and clinical trial plans formulated by enterprises, it will greatly enhance the enthusiasm of enterprise technological innovation and promote the process of enterprise product listing.
Three ,Suggestions for Promoting the Development of Bioactive Dressing Industry in Our Province
In order to better seize opportunities, accelerate the development of our province's bioactive dressing industry, seize the high ground of technological innovation and international competition, the following countermeasures and suggestions are proposed.
1. Strengthen government guidance and support, cultivate advantageous enterprises
We will focus on cultivating 5-10 advantageous enterprises, encourage them to introduce a group of large institutions with outstanding research and development capabilities in the field of bioactive dressings, such as Donghua University, South China University of Technology, Zhejiang University, etc., and guide and support cooperation between high-tech enterprises, universities, institutions, and hospitals to build an integrated development model of "industry university research application" for bioactive dressings; Guide relevant enterprises to conduct technological research and breakthroughs around the market of bioactive dressings with different substrates, develop in a differentiated direction, and accelerate the industrialization process; Further optimize the registration and evaluation procedures for medical device products, and conduct pre evaluation of some links such as product technical requirements and clinical trial plans formulated by the enterprise itself, in order to reduce the time and capital costs of the enterprise; Every year, a group of key enterprises are selected, and evaluation personnel are sent to the enterprises to provide comprehensive and in-depth guidance on product registration and listing.
2. Accelerate the research and development of core technologies for enterprises and promote industrialization development
It is suggested to set up a special project for bioactive dressings in the key research and development plan of our province. For the direction of chitosan based dressings, which are mainly distributed by foreign institutions, but currently have a relatively low proportion of imported products and have a good research foundation in our province, as well as the emerging technology directions such as nano spinning dressings, load proteins, growth factor dressings, porous fibers, gel filaments, porous sponges, porous foam dressings, we should increase research and development efforts, consolidate the foundation, and improve the overall technical level. Organize and implement a batch of medical grade polylactic acid, sodium alginate, chitosan, heterogeneous skin industrialization projects and large-scale application projects to meet the demand for high-end bioactive dressings. Actively promote the participation of our province's bioactive dressing enterprises in the formulation and revision of relevant international and domestic standards, enhance the role and status of our industry in the standardization field, improve the safety and reliability of our province's bioactive dressing products, enhance the market reputation of enterprises, and gradually occupy an important position in the international and domestic markets.
3. Implement patent navigation development strategy to enhance industrial competitiveness
In order to enhance the patent creation and application capabilities of innovative entities in our province's bioactive dressing industry, effectively avoid infringement risks, the government can target emerging products such as hemostatic dressings and artificial skin dressings in the development of the patent navigation industry, support and guide enterprises and universities to jointly carry out enterprise operation patent navigation, and fully play the leading and supporting role of intellectual property rights in enterprise scientific and technological innovation; Professional institutions can be commissioned to conduct research on the development strategy of patents in the bioactive dressing industry, focusing on analyzing and studying the patent applications of foreign companies such as Johnson&Johnson, Kaiser Permanente, Br ü cher, Bayer, etc. in various countries around the world, especially in China. This will provide intelligence support for our province's enterprises to track the technological development trends in the field of bioactive dressings.
Author Profile:
Wu Qiaoling, female, researcher at Zhejiang Science and Technology Information Research Institute, research direction: scientific and technological intelligence research, patent strategy research.
Shen Kai, male, Zhejiang Science and Technology Information Research Institute, PhD, research directions: scientific and technological intelligence research, patent strategy research, intellectual property analysis and evaluation.
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