Functional coatings can not only meet clinical needs, but are also key technologies and means to promote functional innovation of high-end medical devices. With the rapid development of my country's medical device industry, the medical device coating market is expanding rapidly. Currently, hydrophilic lubricating coatings account for the largest share of the domestic market and have been widely used in interventional devices such as intravascular catheters, guidewires, and delivery systems.
For high-risk blood contact devices such as intravascular catheter guidewires, the safety and effectiveness of hydrophilic coatings is crucial. Among them, the firmness of the combination between the hydrophilic coating and the device surface is an important influencing factor. In the FDA's 'Coronary, Peripheral, and Neurovascular Guidewires—Performance Testing and Recommended Labeling Guidance' 'Intravascular Catheters, Guidewires, and Delivery Systems with Lubricant Coatings—Labeling Requirements' According to the 'Guiding Principles for Registration Review of Vascular Interventional Devices with Lubricating Coatings' issued by the Medical Device Technical Review Center of the State Drug Administration , it is clear that the hydrophilic and/or hydrophobic coating may fall off the surface of the interventional device and may cause serious harm to the patient; warnings need to be given in the instructions and labels about various operations that may reduce the stability of the coating and cause the coating to fall off. Today, as the medical device market becomes increasingly standardized, more and more related medical device companies regard the firmness of hydrophilic coatings as a key issue that must be paid attention to in product development.
However, there was previously no domestic industry standard for evaluating the firmness of medical coatings. Regarding the important issue of the firmness of the hydrophilic coating of intravascular interventional devices, medical device R&D ports often need to invest a lot of time and labor costs in exploring evaluation methods, which slows down the overall design and development progress of the product, resulting in low innovation input and output efficiency.
Recently, the State Food and Drug Administration officially released the industry standard YY/T 1898-2024 'Test Method for Hydrophilic Coating Firmness of Intravascular Catheter Guidewires' . The standard will be implemented on March 1, 2025. This standard describes the coating firmness test method for medical catheter guidewires with hydrophilic lubricating coating used in blood vessels, including four methods: appearance inspection method, friction test method, insoluble particle test method, and chemical performance test method. Companies can choose the appropriate method according to the clinical use of the product and the purpose of the test. This standard is in line with the guiding spirit of the previously released 'Guiding Principles for Registration and Review of Vascular Interventional Devices with Lubricating Coatings', provides a specific and standardized testing method, and is an important supplement to the research on coating performance in the guidelines.
Taking the four test methods mentioned in the standard as an example, when medical device developers are in the product development process, they can choose simple and convenient visual inspection methods and friction test methods for rapid screening. If the test results have found that the coating is peeling off or has a tendency, it is not necessary to conduct the next step of testing insoluble particles and chemical properties, which has the effect of saving resources and labor costs. It can also help the R&D port respond promptly and quickly during the product design and development stage to better control risks.
As a professional coating company in the drafting unit of this standard, Baisaifei leverages its advantages in research accumulation and transformation of coating base technology to solve problems in the research and development process of medical device products, starting from the source and based on principles, selecting the correct coating materials and evaluation methods to form a complete set of solutions. The use of this testing method standard will help more medical device R&D personnel get through the 'blocking points' caused by coating evaluation in the product development process, save time investment in coating-related testing during the product design and R&D stages, and effectively help medical device companies improve product development efficiency.
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Jiangsu Baisaifei Biotechnology Co., Ltd. is the leading domestic technical service platform for the entire industry chain of medical functional coatings, and is a leading enterprise and leader in the field of medical coatings. Based on the founder's more than 20 years of professional accumulation in the field of biomaterial surface interfaces and academic influence at home and abroad, it focuses on innovative research and development of biomaterial surface modification technology, and develops high-end functional coatings and related products with independent intellectual property rights and international competitiveness. Since its establishment in 2017, the company has gone through several expansions and four rounds of financing, and now has nearly 30,000 square meters of R&D and production space. It has cooperated with hundreds of medical device companies, including domestic and foreign listed companies and group companies, and assisted companies to obtain a large number of Class II and Class III medical device registration certificates, covering neurological intervention, cardiovascular intervention, non-vascular intervention, drainage, intravascular implantation, extracorporeal life support and other fields. Coating equipment and high-capacity coating production lines are sold at home and abroad.
Coating categories include hydrophilic lubricating coatings, anticoagulant coatings, hydrophilic lubricating antibacterial coatings, hydrophobic coatings, anti-crystallization coatings, anti-fouling coatings, drug-releasing coatings, etc. The cooperation model includes coating liquid sales, coating equipment and coating testing instrument sales, coating ODM, coating inspection and testing, and coating customized R&D services.
According to public data from the State Intellectual Property Office, Baisaifei has become the company with the most applications and authorized patents in China in the global medical coating industry. It has also participated in a number of regulatory scientific research and the establishment of inspection and testing standards related to coated medical devices. It has formed a biomaterial surface modification technology as the core, integrating the research and development and production of coating materials, A comprehensive technical service and innovative product platform integrating advanced manufacturing of coating equipment, coating process development and customization, coating quality analysis instrument development and inspection and testing services, and research and development of new coated products, to create an internationally leading brand of independent and controllable biological functional coatings and related products, and promote the high-quality development of the health industry.
