Domestic orthopedics after 20 years of rapid development, the product has gradually broken the monopoly of foreign situation, but in the basic biomedical materials domestic still have some materials in the situation of the neck.
Medical implantable grade PEEK (polyether ether ketone) is one such material, in the past decades, implantable grade PEEK material has been the global monopoly of three manufacturers, so much so that we have to accept foreign high-priced raw materials, and even some foreign grades of materials are not sold to the Chinese market, the high purchase price is not possible, the collection with a price reduction is not to talk about.
Breakthrough foreign medical implant grade material monopoly has always been the goal and dream of domestic enterprises. However, why for so many years domestic enterprises are difficult to break through the foreign blockade, after long-term research and summary, there are four major difficulties: 1, production equipment and environmental updates are difficult.
1, production equipment and environmental updates difficult
Currently, there are about five domestic manufacturers with the ability to prepare industrial-grade PEEK polymerization, and almost all have formed a mature industrial-grade PEEK polymerization process and equipment. Due to the early development of these PEEK enterprises, the layout of the production environment, production equipment and related configurations are difficult to meet the production requirements of implant-grade PEEK.
Most domestic PEEK raw material suppliers are not qualified to produce medical devices, and the requirements and standards related to implantation-grade production lines are unclear, while changes to equipment and production lines by chemical companies are very cumbersome, with high capital pressure and a long lead time to figure out and establish new production lines.
2, the purification process of implant-grade PEEK is difficult
Industrial PEEK and implantable PEEK from the product, performance differences are not significant, the difference lies mainly in the purity of the material, to ensure that PEEK materials used in the human body for a long time biocompatible, need to ensure that some of the trace chemical elements and heavy metal ion content does not exceed the standard. Almost all of the PEEK produced by domestic companies currently have problems with trace elements and metal ions that exceed the standard.
Currently, this problem is only dealt with in the process of polymerization and refinement, and post-pelletizing is difficult to remove even with high-pressure melt filtration. To solve this problem, PEEK manufacturers need to actively work with domestic equipment manufacturers to develop equipment to meet the refining and purification of implanted PEEK, and research new purification processes. Only from both equipment and process breakthroughs together to ensure effective removal of metal ions and trace chemicals in purification.
3, the material process is difficult to comply with difficult
Make the product is just the first step, in line with YY/T 0660-2008 and 16886 related implant materials is only the basic requirements. As the domestic head of implantable PEEK material manufacturers, in the submission of product registration will certainly be subject to strict review by the reviewer, the FDA will even fly inspection of the entire production process, the manufacturer must have at least polymerization, refining, granulation, extrusion and other key processes.
How to show the review teacher the stability and reliability of the entire production process, how to show the entire production, processing and manufacturing process traceability, these are very important, but also difficult.
4、Acceptance of recognition still needs process
Government regulatory departments, medical device companies and hospital doctors need a process to accept the recognition of domestic materials.