Recently, the Medtec Medical Device Design and Manufacturing Summit was held at the Shanghai World Expo Exhibition and Convention Center. As a global integration test enabling platform, WuXi PharmaTech Testing Division participated in the forum, and its expert group focused on global pre-clinical testing regulations, medical device biology evaluation, medical device design material characteristics research, radiation dose verification survivors, etc. Hot topics have been wonderfully shared. After the meeting, Dr. Zhigu was fortunate to interview Dr. Liu Busan, Senior Vice President of WuXi PharmaTech and Chief Operating Officer of the Testing Division, to understand the layout of WuXi PharmaTech in the field of medical device testing in China.
Integrated testing services to accelerate the market launch of medical device products
In today's ever-changing regulatory environment, the successful introduction of medical devices to the market is a complex and difficult process, and WuXi PharmaTech has extensive domestic and international experience in this field. Relying on professional assessments, according to ISO, GB and other practical guidelines and test standards, WuXi PharmaTech can develop a comprehensive test plan to provide manufacturers or research institutions with the required medical device testing services and related tests and Guidance for reporting. In addition, it can be customized according to the needs of any stage of the new product development life cycle, accelerate the development of new products, and help it successfully pass the supervision and complete the declaration on a global scale.
Liu Kejun said that the Laboratory Testing Division (LTD), as the main business unit of WuXi PharmaTech, can provide world-class integrated testing solutions to help scientists turn their ideas into the best medical care. Health products truly bring science and technology from the field of experimental research and development to the clinic and benefit the majority of patients. “The main business of our testing division provides full process integration testing services for drug development, clinical testing and medical devices.†Liu said.
According to the interview, WuXi PharmaTech Testing Division is able to provide one-stop medical device testing and regulatory services from research and development to marketization. It is reported that its China Medical Device Testing Center in Suzhou City, Jiangsu Province is about to be completed and put into trial operation. The center will provide a full range of medical device testing services in line with international quality standards, covering biomaterial analysis toxicology, biocompatibility, risk assessment, product aseptic design microbiology, physical testing of packaging and shelf life, and product batch release. test. At the same time, the center also plans to establish an international level of doctor training center to achieve a close integration of production, education and research, and help China's medical device industry to develop steadily.
After years of deep industry cultivation, WuXi PharmaTech Testing Division has established long-term strategic partnerships with major domestic and foreign companies. “Today, more and more domestic customers are starting to use our high-level global service platform,†Liu said.
Directly hit the pain point and grasp the development trend of the industry
Nowadays, China's society is aging, and the incidence of major diseases such as cancer is increasing year by year. The corresponding medical device field is developing rapidly, especially in the fields of orthopedics, cardiovascular, dentistry, minimally invasive surgery and interventional therapy. Liu said that he is very optimistic about the prospects of China's medical device testing industry. He believes that the current developments in this field are mainly as follows:
First, the intensive application of new biomaterials, the analysis of new material components brings new challenges to the testing field.
Second, many medical devices require both active and passive detection. At present, domestic research on the passive aspects of medical devices, especially in animal experiments, is relatively scarce, with huge industry demand and broad development space.
Third, the demand for specialized and systematic training in medical device testing by domestic doctors is growing rapidly in the future, but there is a serious shortage of high-level training institutions.
Fourth, with the continuous improvement of product technology, the demand for domestic medical device manufacturers to enter the European and American markets has increased, and the demand for high-quality, internationally-adapted testing and regulatory services is growing.
In order to fully understand the needs of customers, we can provide the best service for our customers. In the process of communication with customers, Liu Kejun found that customers pay special attention to three aspects: first, test quality, new products from research and development to manufacturing process, products Whether the risk assessment is accurate, whether the final report of the test can be successfully declared at one time; the second is whether the test platform has all the required technologies. At present, the domestic ability for passive detection is rather weak, which restricts the development of the industry; the third is whether the test result is domestic. And recognized by international regulatory agencies.
“By effectively addressing customer pain points and difficulties, we are able to focus our customers on product development, production and launch, thus accelerating the process of commercialization. In the future, we look forward to deep cooperation with more domestic customers to help China's medical device industry. And jointly promote the big health industry." Liu Kejun said.
Laser Tape Measure 2 in 1, as its name, it is one product with traditional tape measure and digital laser distance measurer. Laser measure tape can measure 40m with laser measurement and 5m of the measuring tape. Convenient, smart, accurate, laser tape measure make every measurement simple in life!
Using a laser tape measure, one can measure short distance with stiff tape measure, while just put a single button to measure long distance up to 40m and the result will show on a small LCD screen.
No need to climb up and down, crawl on the floor, save your labor and time from now on! Laser tape measure, a simple device to change your life!
Laser Tape Measuring,Laser Distance Measurer,Distance Measuring Tool,Digital Laser Tape Measure
Chengdu JRT Meter Technology Co., Ltd , https://www.rangesensors.com