After 20 years of rapid development, domestic orthopedics has gradually broken the monopoly of foreign products. However, in terms of basic biomedical materials, some domestic materials are still in a bottleneck situation.

Medical implant-grade PEEK (polyetheretherketone) is such a material. In the past few decades, implant-grade PEEK material has been monopolized by three manufacturers in the world, so that we have to accept high-priced raw materials from abroad. Some foreign brands of materials are not even sold to the Chinese market, and it is not possible to buy them at high prices, let alone centralized procurement with volume and price reduction.

Breaking the monopoly of foreign medical implant-grade materials has always been the goal and dream of domestic enterprises. However, why has it been difficult for domestic enterprises to break through the foreign blockade for so many years After long-term research and summary, there are four main difficulties:

1. It is difficult to update production equipment and environment

At present, there are about 5 manufacturers in China that have the ability to prepare industrial-grade PEEK polymerization, and almost all of them have formed mature industrial-grade PEEK polymerization processes and equipment. Since these PEEK companies developed earlier, it is difficult for them to meet the production requirements of implant-grade PEEK in terms of production environment layout, production equipment and related configurations.

Most domestic PEEK raw material suppliers do not have the qualifications to produce medical devices, and the relevant requirements and standards for implant-grade production lines are not clear. At the same time, chemical companies are very cumbersome to change equipment and production lines, and they are under great financial pressure. It takes a long time to explore and establish new production lines.

2. The purification process of implantable PEEK is difficult

From the product point of view, there is little difference in performance between industrial PEEK and implantable PEEK. The main difference lies in the purity of the material. To ensure the biocompatibility of PEEK materials for long-term use in the human body, it is necessary to ensure that the content of some trace chemical elements and heavy metal ions in them does not exceed the standard. At present, almost all PEEK produced by domestic enterprises has the problem of excessive content of trace elements and metal ions.

At present, this problem can only be dealt with during the polymerization and refining process, and it is difficult to remove it even with high-pressure melt filtration in the subsequent granulation. To solve this problem, PEEK manufacturers need to actively work with domestic equipment manufacturers to jointly develop equipment that meets the requirements of implant PEEK refining and purification, and study new purification processes. Only by making breakthroughs in both equipment and process can we ensure the effective removal of metal ions and trace chemicals during purification.

3. Material and process compliance is difficult

Making products is only the first step, and complying with YY/T 0660-2008 and 16886 related implant materials is only the basic requirement. As a domestic head implant grade PEEK material manufacturer, when submitting product registration, it will definitely be strictly reviewed by the review teacher, and the Food and Drug Administration will even conduct a surprise inspection of the entire production process. The production enterprise must at least have key process flows such as polymerization, refining, granulation, and extrusion.

How to demonstrate to the judges the stability and reliability of the process throughout the entire production process, and how to demonstrate the traceability of the entire production and processing and manufacturing process are both very important and difficult.

4. Acceptance and recognition still requires process

It will take time for government regulatory agencies, medical device companies and hospital doctors to accept and recognize domestic materials.

As one of the earliest domestic companies engaged in the research, development, production and manufacturing of PEEK materials, Jiangsu Junhua pays great attention to the application of PEEK in the medical industry and has been committed to the research, development and production of medical implant-grade PEEK materials.

After 16 years of production and technology accumulation, the company started from the source of polymerization and established Shandong Junhao High Performance Polymer Co., Ltd. to polymerize implantable PEEK raw materials. According to the production standards of medical implant materials, a GMP refining production workshop was established, and professional refining and purification equipment for implantable AKSOPEEK polymerization was developed, which effectively solved the problem of excessive heavy metal ion content in implantable PEEK materials.

In order to further effectively realize full-process monitoring and traceability, the company selected a DCS central control system, which can effectively realize the control and detection of the main parameters inside the equipment during the production process, ensure that the production process is fully controllable, and the production data can be archived separately for subsequent traceability.

The company pilot-produced autoclave-grade PEEK materials in 2020. In the same year, third-party tests were conducted on various biological aspects of the materials in accordance with the ISO10993 test standard, and all test results met the requirements.

In 2021, the first batch of mass-produced implantable AKSOPEEK materials will be sent for testing of biological and physical and chemical properties in accordance with the YY/T0660-2008 medical industry standard. It is expected that all tests will be completed around September 2022, and the filing of the master file with the State Food and Drug Administration is planned to be completed in the same year.

Junhua PEEK uses an ICP (Inductively Coupled Plasma) instrument to test metal ions, and the lead ion content is extremely low, less than 0.002%.

In addition to the basic requirements for implantable products, the main concern of customers is the mechanical properties of PEEK products, which are related to whether patients can use them for a long time.

In response to the requirements of mechanical properties, Junhua PEEK has developed high-toughness AKSOPEEK, which guarantees the patient’s postoperative recovery with performance far exceeding the standards.

In addition, when we use implant-grade PEEK, there are also relevant medical industry testing specifications for certain specific uses, the most representative of which is the intervertebral fusion device.

Using the YY/T 0959 (ASTM F2077) spinal implant intervertebral fusion mechanical properties test method test standard, the AKSOPEEK  Natural intervertebral fusion device (H is 6.3mm) was subjected to compression fatigue testing at a load of 2000/4000N, a frequency of 5Hz, and a test number of 5 million times. No failure due to fatigue occurred. Static testing before and after fatigue also did not show any strength reduction, and this model of fusion device would only show compression yield at 12000N.