According to the sample survey conducted by the branch of China Pharmaceutical Materials Association, the total size of China's medical device market in 2016 was about 370 billion yuan, an increase of 62 billion yuan or 20.1% over 2015. Medical device products have high requirements on the quality of raw materials and manufacturing Sophisticated and diverse varieties of needs, the scientific and technological progress of the upstream industry directly affects the technological trend of medical devices The 13th Medtec China Exhibition was opened at Shanghai World Expo Exhibition Center from September 20 to September 22, 2017. As a leading focus in China In the exhibitions on medical device design and R & D, raw materials, components and parts, processing technology and manufacturing services, what are the most popular materials and applications delivered by Medtec China? Limited, we selected Gold Medal, Interview with Lubrizol, Solvay, and DuPont to highlight readers.
Gold Medical: Interventional Catheter
With the development of minimally invasive surgery and implantable interventional medical technology, the market demand for interventional catheters has increased significantly, and the requirements for catheter processing technology, material selection, precision and customization services have also been increasing. , Various types of catheter manufacturers have exhibited the latest products and technologies, each has its own strengths, dizzying. One from Suzhou Gold Wire and Telecommunication (Suzhou) Co., Ltd. Medical Business Division (hereinafter referred to as: Gold Medical) in China The market has been deeply involved in the type of catheter for many years, relying on high-precision processing technology and mature supporting services, in the interventional catheter production showed significant competitive advantage.
Various types of extrusion pipe braided tube
With more than 80 years of extrusion technology, Gold Med is able to integrate all in-house manufacturing processes, from extruding PTFE to knitting and then forming. At this Medtec show, Gold Medical mainly showcased its PTFE / + metal braid Tube and GC8.5Fr ~ guide catheter, and other interventional catheter products. Braided catheter is composed of three layers of material, the innermost layer of PTFE, PFA and other materials, greatly reducing the friction coefficient of the catheter inner wall and enhance the catheter lubrication; weaving process Let very thin catheter more tensile and bending resistance.
Gold Group has operations all over the world but its major markets are in the Asia Pacific region. Gold Medical's interventional catheters enjoy a high reputation in the Japanese market with products such as catheters for the abdomen accounting for 50% -60% of Japan's market share; and we Of the GC8.5Fr ~ catheter in Korea is to achieve 70% market share. 'Gold Medical Business Unit Manager Zhang Weihua said in an interview.' In the domestic market, we are working with Lepu, minimally invasive and other well-known Medical Devices Group to establish cooperative relations, such as contrast catheter, microcatheter projects, etc. Next year we will further open the South China market.
'We have established factories in China for more than 20 years and have a good understanding of the needs of the Chinese market. Compared to foreign suppliers, Gold Medical has factories in the country, so delivery is faster and service is better. Customer Resources From the point of view of R & D strength, our technical team will regularly go to Japan for training and study, and Japanese experts will regularly exchange ideas and share information. The Suzhou-based R & D team can quickly connect with suppliers all over the country. The point is that we have worked for many years in the field of high-precision catheter processing technology and have reached the industry-leading manufacturing process, such as the tolerance of the inner diameter to ± 0.01mm. For example, we combine thread weaving and mesh weaving for minimally invasive surgery Of the catheter products, etc., and, for example, our catheter hardness changes, internal and external diameter change control is very skilled. 'Zhang Weihua, director told us.
Zhang Weihua, Head of Sales Section, Gold Medical Business Unit
Gold Group started its business in Japan in 1932 and set up its factory in Suzhou, China in 1994. After more than 20 years of hard work and development, Gold Group has established good cooperative relations with hundreds of customers around the world and provides clients with brain, abdomen, heart and other parts Interventional catheters such as microcatheters, contrast catheters, guide catheters, etc. With over 80 years of extrusion technology, Metso Medical can integrate all in-house products such as PTFE • Weaving • Processing. Requirements, the production of various types of catheters in line with its standards.
'With the further integration of resources in China's healthcare market, suppliers with poor technology will be eliminated, and the only focus on the development of the company is to focus on sophisticated processing technologies and speed up localization. In the future, we will continue to use The latest and most advanced technology to produce the best and most secure products for the development of China's medical contribution to our greatest strength!
Deniptek: High-precision medical catheters and TPE particles
With three new products, the Natvar Medical Catheter Series and the Colorite TPE Particle Series, presented at Medtec China in Shanghai, Denipower delivers new product options and solutions to healthcare customers.
Medtec has been able to meet Tekni-Plex since 2006. As a global conglomerate, Denitel is dedicated to the development and manufacture of innovative packaging materials, medical particles and high-end precision medical catheters , And provide solutions to all major names in the medical, pharmaceutical, personal care, home and industrial markets, and food and beverage markets.Deni Pei is headquartered in Wayne, Pennsylvania, in the United States, Dozens of factories operate to meet the needs of global customers.
The Medtec China, Denipipe introduced three new products including medical catheters and medical particles:
◆ Natvar brand of high-precision micro-extrusion medical catheter
Micro extrusion of medical catheters addresses many of the challenges of minimally invasive surgery and the need for miniaturization of instruments. Natvar's new micro-extruded medical catheters based on thermoplastic meet the requirements of medical device companies for the expected performance of the product, while The cost is only a fraction of expensive materials such as fluoropolymers, glass, etc. Microfused catheters deliver consistent processing accuracy that drives product innovation and supports the development of smaller instrument applications.
◆ Natvar high-precision silicone extrusion medical catheters
Silica gel is an inert, well-biocompatible material with excellent strain recovery that makes it an excellent choice for pumps and other applications.With the support of a world-class engineering and engineering R & D center in the United States, The Natvar plant in China serves the global medical device market and supplies high-quality silicone extruded medical catheters in shorter lead times.
◆ Celite TM thermoplastic elastomer (TPE) particle series under Colorite
Clear, halogen-free and phthalate-free, nontoxic, easy-processing, flexible thermoplastic elastomer (TPE) particles designed for injection and extrusion applications in the medical and food industries CELLENETM is a thermoplastic elastomer (TPE) particle family combines the advantages of vulcanized rubber with the ease of processing of thermoplastics CELLENE ™ TPE particles are widely used in medical devices, packaging and other standardized markets CELLENE ™ particles are silicone-free, latex-free, Dicarboxylates or halogens and formulated using raw materials meeting FDA requirements for Category VI and ISO 10993.
For over 50 years, Colorite has been the world's leading manufacturer of medical-grade particles and has been used by world-class manufacturers of medical products and medical devices. With a wide range of PVC and thermoplastic elastomers TPE) medical-grade particle product line to meet specific product needs and provide customers with the ideal solution for a wide range of products including hemodialysis tubing, blood bags, endotracheal tubes and oxygen masks.
Natvar is an innovative global supplier of high-end precision medical catheter solutions dedicated to delivering solutions for a wide range of medical device products for use in hospitals, physicians, dentistry and home. Natvar has a portfolio of products in the United States, Asia and Europe Four manufacturing sites. Natvar's unique precision medical catheter solution has been adopted by some of the world's leading medical device companies for intravenous drug delivery, dialysis equipment, insulin infusion, cardiovascular surgery, drainage, catheterization and Many other applications, and these applications are particularly fast-growing in mainland China.
De Nipper has been focusing on technological innovation and equipment renewal investment, such as high-precision silicone pipe extrusion, custom injection parts, micro-catheter extrusion, etc. Continuous innovation to meet the special requirements of different customers.
Speaking about automated production, Mr. Paul Young, CEO of Dennipe Group, said: "Automation has always been the concern of the healthcare industry. The equipment used by Deni- pim minimizes interference from human factors such as using the world's most advanced automation equipment, Matching high precision instrumentation, online monitoring systems, etc., while good experience is still an integral part.
Mr. Paul Young, CEO of Denise Group
Earlier this year, Denipé announced that it has invested $ 15 million to build a new factory to meet the growing demand in the pharmaceutical and medical device markets in the Asia Pacific region. In September, Denizpea formally put into operation a new advanced manufacturing facility in Suzhou, China, 140,000 square feet (13,000 square meters) of products manufactured by Denniber's Natvar, Colorite and Action Technology business units, the new facility has three 100,000 cleanrooms that produce medical grade tubing and accessories, And a 10,000-level clean room that produces Natvar's pharmaceutical-grade lines.
"With this opportunity to relocate our new plant, we have added silicone tubing and microcatheter to the extrusion of pipelines and are planning to upgrade our technology and build new assembly operations for semi-finished products assembly. Next year we will continue our commitment to Product sales extend across the entire Asia Pacific region, "Paul said.
Lubrizol: Medical Grade TPU Experts Lead Material Innovation in Medical Products
In 1956, Lubrizol invented the thermoplastic polyurethane (TPU), the first of TPU's doomed medical applications since the birth of TPU.As a technology leader in the medical device and healthcare industry and a leader in specialty polymers, With more than 40 years of experience in the medical industry, Lubrizol is one of the oldest and largest TPU manufacturers.
Not long ago, Lubrizol Life Sciences debuted at 2017 Medtec China to demonstrate its comprehensive capabilities in medical device solutions. Lubrizol Life Sciences is the only medical solution partner to offer both polymer customization, drug delivery device development and contract manufacturing services Lubrizol Life Sciences Greater China Sales Manager Yan Ge introduced us to Lubrizol's key products and services at this show:
◆ Pellethane® TPU - the best replacement for PVC in medical device manufacturing
Although PVC is still common in the Asian medical device market, it is virtually eliminated in many other parts of the world because PVC-containing medical devices release harmful chemicals during routine use and disposal, In the treatment of PVC medical devices, phthalates (DEHP) migrate into medicinal fluids or blood in medical catheters or infusion bags and cause side effects on the human body such as reproductive system development problems, liver problems, etc. European harmless Medical organizations (HCWH) have taken steps to keep patients away from PVC and DEHP-containing medical devices.
Pellethane® TPU is a safe, stable, high-quality alternative to PVC and is now recognized by many manufacturers of IV infusions worldwide. Pellethane® thermoplastic polyurethanes are ideal for manufacturing a wide range of medical devices including infusion tubes, Transfusion Hourglass, Implants, and Other Short-Term Applications The main advantages of Pellethane® TPU include: excellent kink resistance, flexibility, flexibility, resistance to internal pressure much greater than PVC, superior transparency to PVC / EVA and TPO, Chemical resistance, low drug adsorption, sterilization with gamma rays and ETO, ISO-10993 and USP Class VI standards, and more.
◆ Medical product customization service
Vesta, now part of The Lubrizol Life Sciences Division, provides customized contract manufacturing services to the medical device industry, including precision thermoplastic extrusion, secondary processing, and silicone manufacturing and assembly. With decades of experience, Vesta's services and engineering expertise Knowledge and commitment to quality are recognized by customers worldwide. Vesta's extensive silicon production capabilities and deep expertise in precision thermoplastic extrusion complement Lubrizol's business. Some customized products include: Thermoplastic Tubing - Tubes, Tubes, Multi-lumen Tubes, Braided Tubes, Heat Shrink Tubing, Postprocessing - Cutting Edge, Flaring, Printing, etc .; Silicone Products - Extrusion, Compression Molding, Dip Molding, Silicone Sheets and Films, Assembly and Packaging .
Lubrizol Life Sciences Greater China Sales Manager Yan Ge
◆ Medical materials present and future
'Lubrizol is currently in Shanghai's Songjiang with laboratories and factories, whether it is the speed of the supply of products or customer service customized response speed, have been well guaranteed. This year we have just on the Chinese production line has been further optimized,' Yan The manager said: "Lubrizol has been a low profile in marketing, and next year the Life Sciences Division will increase our marketing efforts by participating in trade shows, conducting webinars, organizing various offline customer events, strengthening relationships with markets and users Of course, we will continue to introduce customized products.
Speaking of the future development of medical materials, Manager Yan shared his view: 'In the next five years, medical materials will surely be safer and more environmentally friendly. Especially in the infusion device manufacturing market, the replacement of PVC with TPU has become an inevitable trend. Biocompatible biodegradable materials will become a hot spot in the medical market; the functionality of materials will be paid more and more attention; new medical 3D printing raw materials will also become a hot spot for development.
Solvay: High-Performance Polymer for Medical Devices
Due to its rapidly growing market demand and great potential, China has always been one of the key markets where Solvay's development is under development. Since the 1970s, Solvay has been operating in China and reached 9.49 billion in 2015 Net sales of Renminbi Currently, Solvay has 18 manufacturing sites and four research and innovation centers in China.
Jeff Hrivnak, Global Business Manager, Solvay Healthcare
The medical industry has been the mainstay of Solvay, and for the past five years Solvig has focused on two of China's implants and medical devices. At 2017 Medtec, Solvay's global healthcare manager Jeff Hrivnak explains the latest Solvay advanced polymer solutions for medical device applications.
Solvay offers the healthcare industry the broadest selection of high-performance thermoplastics for implantable and non-implantable medical devices, as well as global technical and regulatory support. With more than 25 years of experience in the healthcare industry Solvay is able to provide medical device manufacturers with the commitment, experience and innovation they need, thanks to the combined experience of leading material suppliers. Solvay's materials comply with the biocompatibility standards defined in ISO 10993: 1 and Various specialized disinfection methods are compatible, including gamma rays, ethylene oxide, vaporized hydrogen peroxide and steam.
◆ high-performance medical grade plastic
Performance requirements for disinfection cassettes and disinfection trays and surgical instruments vary greatly from those for other non-implantable medical devices but require the high levels of performance that Solvay grade plastics offer. These materials are suitable for limited contact (24 Hours or less) Body fluid or tissue application
Solviva® Biomaterials for Implantable Devices
Solviva® Biomaterials are used in implantable medical devices, especially those that come into contact with bodily fluids or tissue for more than 24 hours. The specialized manufacturing facilities are located in Georgia, U.S.A., conforming to ISO 13485 and are operated in accordance with current relevant good manufacturing practices. All Materials are tested in an ISO 9001-certified laboratory accredited to ISO 17025.
'Solvay's materials are popular with our customers because we are able to meet the diverse needs of our customers. We have more than 1500 specifications in over 35 varieties of materials, medical grade used in equipment, appliances As well as body-implanted materials. Solvay's vast design and engineering team allows us to offer different solutions to our clients' needs, as well as additional resources including material recommendations, structural functional design, on-site process guidance , Simulation testing and failure analysis, regulatory support, etc. Jeff said, 'Solvay's high performance polyphenylene sulfones (Radel® PPSU) are tough, corrosion resistant and withstand thousands of steam sterilization Can maintain excellent mechanical properties.And for example, our series of polysulfone (Udel® PSU), has been 50 years of history, 50 years of plastic products actually still welcome now is certainly its uniqueness, its Applied to dialyzers, it is also used as a vital part of life-sustaining and life-saving products, such as anesthesia machines, ventilators and the like.
When asked by reporters about what the future of Solvay will focus on the medical industry, Jeff replied: 'We are concerned about many applications, such as China's fastest growing hemodialysis industry, China's hemodialysis center is currently only available to About 20% of patients, a large number of patients without access to treatment resources.Solivi two years and many companies to work together to provide more services in China's hemodialysis industry.Cardiovascular, brain surgery, dentistry, orthopedics, etc. are We focus on the development of the industry, Solvay has three kinds of materials can be applied to permanent implants, our customers around the world have a lot of registration card to market the product.
Speaking about the future direction of medical plastics, Jeff said: 'I can see two major trends: the first to test medical materials has become more stringent. With the increasing risk of cross-contamination and the gradual strengthening of regulatory regulation , The hospital disinfection of equipment and instruments will be more frequent and disinfectant disinfection capacity is also growing, so that the chemical resistance of the material will also be a corresponding increase in demand, which is the advantage of our specialty materials where we are helping equipment To upgrade the product, so as to improve product quality and service life.Another trend is design innovation, many medical devices are still made of metal, plastic in many areas is bound to replace bulky metal materials, compared to the old-fashioned metal products , Standardized design, plastic parts greatly enhance their design freedom and product aesthetics, the material itself has comparable with the rigidity of metal, look more beautiful, easy to distinguish a variety of colors, multi-functional and lightweight plastic equipment, energy band To bring a better doctor experience, the most important Overall, the material through the high-volume injection molding costs down A lot of the benefit of the patient, which is a great advantage of the plastic materials used in medical devices. '
Speaking of the benefits of plastic alternative metals, Jeff cites some specific examples: 'For example, the surgical instruments and trays made by our Radel® PPSU can be adequately designed as snap-in closures using very light and tough materials, Easy to clean, will not rust to cause bacterial nourishment, the whole can be repeated steam sterilization still maintain the original mechanical properties, and a variety of transparent color selection to facilitate surgical distinction.For another example, the joint implant current multi-purpose metal materials First of all, the strength of the metal is very high, which is much higher than that of the human body itself. Therefore, the weight load of the body is entirely supported by the metal, and the bone around the implant is not affected by the force. The academic name is Stress Blocking, but with Zeniva® PEEK materials that have a bone mass close to that of the human body, the bones need to be weighed and have the chance to exercise without loss of function. In addition, Zeniva® PEEK materials compare to metallic materials , With inherent bio-inertness, better abrasion resistance and fatigue resistance, thus improving the service life and improving the quality of life for patients. '
DuPont: World's First DuPont ™ TYVEK® 40L Medical Packaging Materials
This year marks the 50th anniversary of the DuPont ™ Tyvek® Tyvek® brand and in the meantime DuPont ™ Tyvek® unveils the world's first Tyvek® 40L medical packaging material at MEDTEC 2017. The new Tyvek® for medical packaging applications Material designed to provide a more cost-effective packaging option for lower weight and lower risk medical devices.It is reported that Tyvek 40L will be first officially on sale in China and is scheduled to be listed in other Asian countries, Europe and North America.
For years, Tyvek® has helped protect the health of millions of patients worldwide and effectively reduce the combined costs of health care facilities, a recognized example of the medical packaging industry that has been used in almost all forms of Aseptic medical packaging and related medical applications. Tyvek® 40L continues the many benefits of the Tyvek® range, such as low chip removal, clean stripping, breathability and excellent microbial barrier performance even in harsh environments; Handling, transport and storage (even in high humidity or cold conditions) and to adapt to all major sterilization methods, it is these advantages that have made Tyvek® Medical Packaging Of the industry benchmark for lighter, breathable, better performance over EO and gamma radiation sterilization Unique texture with unique textures that give packaging more design Sense and recognition. Compared with reinforced medical paper, Tyvek? 40L also showed more excellent physical strength and breathability. Relying on its lower basis weight, T yvek® 40L greatly reduces the use of packaging materials and promotes the sustainable development of the industry.
In addition to providing the medical packaging industry with a range of high-performance microbial barrier products such as Tyvek® 1073B, Tyvek® 1059B, Tyvek® 2FS ™ and the new Tyvek® 40L, the DuPont Medical and Pharmaceutical Packaging team is also committed to manufacturing medical devices worldwide Provide technical support to discuss issues such as industry standards, compliance information, technology and product quality, etc. Team members actively participate in the technical activities carried out by major standardization bodies and industry associations and contribute to the development of industry standards and technologies such as International Organization for Standardization (ISO), European Committee for Standardization (CEN), AAMI and SAC.
Two major Tyvek® plants in the USA and Europe, Shenzhen, China, have a processing center for the reprocessing of Tyvek®, and the Tyvek® 40L is manufactured at a U.S. plant in the future and does not exclude the possibility of DuPont's plant in China in the future.
When it comes to DuPont will launch what products, DuPont ™ Tyvek® / Typar® Global Business Director, Mr. Christian Marx said: 'Tyvek® is not just for medical device packaging, we are involved in a very large number of markets, we are in each Market segments will include the latest products to meet market needs such as our newly designed high-grade chemical protective clothing to help protect the safety and security of our workers at risk of dual hazards from toxic chemicals and deflagration, Confidently do the job at hand. Tyvek® is also widely used in the protection of medicines and fresh food transport and was developed to address the threat of cold chain disruption during shipping. Our recently launched Tyvek® cargo transport heat shield, To help keep the drug in transit at between 15 and 22 degrees Celsius, which is the effective temperature range for many drugs, the Tyvek® cargo transport heat shield effectively protects the drug from shipping it after it is shipped because Changes in ambient temperature lead to failure, has been around the world pharmaceutical companies, easy Product distributors, third-party logistics companies and airlines, and we also have a new Tyvek® IsoClean® brand that protects people and processes in cleanrooms from contamination. There have also been recent product launches. Tyvek® IsoClean® Clothing and accessories are commonly used in biotechnology, pharmaceuticals, medical device manufacturing, food processing, cleanrooms in the cosmetics and electronics industries, and other critical or controlled environments. In the future we will continue to provide better products and solutions To various industries.