Under the combined effects of economic development, urbanization, population aging, and other factors, medical demand is continuously being released, which has created a huge growth space for the medical device market. According to EvaluateMedTech data, global medical device sales are expected to exceed $ 520 billion by 2022.
Medical devices are mainly used in areas closely related to human life and health, and have high requirements on quality, accuracy, and stability. Therefore, in the process of product development, the use of new materials, new processes, and new technologies is more prudent. We must not only pursue the improvement of technology, but also ensure the quality.
Taking advantage of the end of the year inventory season, New Materials Online® has summarized 10 new materials for medical devices, so that everyone can understand which new materials are made of medical devices with better performance and quality and safety.
Now, let's take a look at what forces BASF, Dow, Covestro, Solvay and other companies have contributed to the health cause this year.
* The following is in descending order of product release time, and there is no ranking.
1.Solvay introduces innovative solutions for orthopedic devices
On November 19th, Solvay launched a series of innovative solutions for orthopedic devices. Among them, Ixef® GS-1022 PARA has excellent mechanical properties, is easy to form, and can withstand gamma rays without discoloration. It is a compact Redi-SpineTM surgical instrument package (designed for minimally invasive spinal fusion) Convenient surgical instrument solution) provides an ideal alternative to stainless steel, which not only has great processing and cost advantages, but also eliminates the risk of cross-infection caused by repeated use of stainless steel instruments.
Solvay Ixef® polyaramid (PARA) not only has excellent strength, toughness and biocompatibility, but also can withstand high-energy gamma-ray sterilization. It is an ideal choice for disposable surgical instruments. MEDIANTM (a single-use instrument kit specially developed for anterior cervical fusion) is easy to use, does not require on-site disinfection, and greatly improves the operating efficiency of the operating room. In addition, he assisted ECA Medical Instruments in developing Cervical-One ™, a disposable cervical spine instrumentation kit for primary and secondary cervical spine implantation.
2.Carbon launches medical grade resin 3D printing material MPU 100
September 12 news, Carbon announced the launch of its first medical-grade resin 3D printing material-Medical Polyurethane 100 (MPU 100), a medical-grade two-component resin that can use Digital Light Synthesis to produce isotropic rigid Quality plastic. The material's main functions include: engineering-grade materials with excellent abrasion resistance; tested to meet USP VI and ISO 10993-5 and -10 biocompatibility; compatible with ethylene oxide, electron beam, and gamma sterilization methods Can maintain its biocompatibility after sterilization; Compatible with common disinfectants; Certificate of analysis can be provided; Master file provided by FDA.
MPU 100 resin material is designed for medical system, skin contact device, drug contact device and disposable medical device application components. Its mechanical properties, biocompatibility, sterilization compatibility and chemical resistance provide medical device manufacturers New features to produce safe and reliable end-use products for patients.
3. SABIC launches new materials for fused deposition manufacturing
On May 29, Saudi Basic Industries Corporation SABIC launched three new materials for fused deposition manufacturing. Among them, ULTEMTM AMHU1010F and LEXANTM AMHC620F filaments are suitable for medical and health applications. SABIC said that the new materials introduced this time have great potential in the field of medical equipment. From concept modeling to functional prototypes to the final product, it is especially suitable for custom applications such as surgical tools, disposable instruments, castings and splints and other product solutions.
According to reports, ULTEM AMHU1010F polyetherimide material is made of ULTEM HU1010 medical grade resin, which has high heat resistance and uncolored filaments are biocompatible (evaluation standard is ISO 10993 or USP Class VI). Parts can be sterilized with gamma rays, ethylene oxide or steam autoclave. LEXAN AMHC620F polycarbonate (PC) material also has excellent biocompatibility. It is available in white and can be sterilized by gamma-ray or ethylene oxide.
4. CHIMEI released the new generation of medical grade plastic WONDERLITE® PC-115P
On April 26th, CHIMEI released the new generation of medical grade plastic WONDERLITE® PC-115P which can be used in contact medical equipment during CHINAPLAS 2018. It is understood that WONDERLITE® PC-115P complies with the ISO 10993 biocompatibility test. It is suitable for sterilization of ethylene oxide, gamma rays and electron beams, and can be used in medical equipment such as hemodialyzers and infusion components.
5.Eastman showcases a new generation of polyesters resistant to medical disinfectants
On April 23rd, Eastman demonstrated the new generation Eastman MXF221 copolyester product that can withstand a variety of medical disinfectants at CHINAPLAS 2018 This product has excellent chemical resistance, can withstand strong disinfectants used to reduce hospital infections, and has higher durability and impact strength. It is a medical grade copolyester used in medical device housings and hardware.
MXF221 is produced through extrusion blending. It has inherent characteristics of resistance to discoloration and cracking. It is suitable for electronic medical equipment casings and hardware. It has excellent chemical resistance to a variety of strong disinfectants and can retain 90% after contacting strong disinfectants The above original impact strength is far superior to similar materials such as polycarbonate mixtures.
6.Trinseo has developed high-quality medical-grade ABS resin
On March 23, Trinseo brought to the medical device industry high-quality, high-quality medical-grade ABS resin MAGNUMTM 8391 MED, which has complete regulatory support and biocompatibility. MAGNUMTM 8391 MED is different from traditional emulsion method ABS. It is produced by bulk polymerization technology. This technology makes ABS highly consistent in color, rheology and physical properties, and has less and less residual volatiles, so it can achieve batch-to-batch. The quality is extremely consistent.
The consistency of batch-to-batch quality makes the key performance of Trinseo MAGNUMTM 8391 MED's other medical equipment products relatively stable, including low volatile content, biocompatibility, and medical disinfection. It is particularly excellent in processability, including spray coating, plating, solvent bonding and ultrasonic welding.
7.BASF launches high-performance applications based on TPU to meet the functional needs of medical devices
On March 15th, BASF showed a batch of new applications of Elastollan® thermoplastic polyurethane elastomer (TPU) at CHINAPLAS 2018 to meet the needs of high performance and durability. Elastollan is resilient and can be used to meet the functional requirements of medical devices.
In the sensitive medical field, Elastollan enhances safety and health protection for more patients. For example, in an oxygenator used for cardiac surgery, hollow fibers made of Elastollan film are connected at the ends by a small polyurethane system to build a solid stent to ensure accurate oxygen supply to the blood. BASF's thermoplastic polyurethane materials generate almost no static electricity and do not hinder surgery. Thanks to the properties of the Elastollan material, it is possible to safely build ultra-high-precision fibers with a thickness of only 70 microns.
8. Dow Chemical develops ViviOn ™ (CBC), a medical grade plastic with high cleanliness and low fluorescence sterilization
News from March 13th, Dow Chemical Co., Ltd. has developed a new cyclic block copolymer polymer, ViviOn ™ (CBC), which is made by fully hydrogenating styrene and conjugated olefin copolymers based on a highly efficient catalyst full hydrogenation technology. The plastic has the advantages of extreme cleanliness and ultra-high visible and ultraviolet light transparency (including deep UV light), as well as excellent chemical resistance, resistance to gamma and electron beam irradiation sterilization.
ViviOn ™ (CBC) has passed a number of ISO10993 biocompatibility inspection projects and complies with USPClassVI, USP and Japanese Pharmacopoeia inspection standards. The potential applications of this material in medical materials products include the following four categories: pre-filled syringes, vials / ampoules, detection consumables-UV cuvettes, UV microplates, high-throughput microplates, and fluorescent labeling micro Orifice plate, microfluidic chip.
9.Covestro releases new solvent-resistant and detergent-resistant medical polycarbonate products
News from March 9th, Covestro released Makrolon Rx3440, a material that is resistant to solvents in tumor treatments and cleaning agents. Its durability and chemical resistance help prevent cracking, allowing medical professionals to make cancer patients safer for cancer patients. Inject drugs. Makrolon Rx3440 has been developed to meet the high requirements of IV connectors. Its biocompatibility and toughness can avoid improper handling, and the material can also be used in thin-wall applications.
Covestro has proven that Makrolon Rx3440 polycarbonate products have better chemical resistance and tumor resistance than other transparent resins that make IV connector parts. Also. The material also exhibits the best stress retention capabilities to provide a more reliable IV connection.
10.Teknor Apex company introduces a new series of medical grade thermoplastic elastomers
January 12th news, Teknor Apex company introduced two new series of medical grade thermoplastic elastomers (TPE) for injection molding masks at MD & M West exhibition, one of which is anti-deformation series products for flexible masks, the other one A gel series that provides an air-tight liner for injection-molded polypropylene rigid masks. These new materials meet FDA requirements for food-grade ingredients, ISO 10993-5 biocompatibility standards, and the REACH SVHC directive. They are free of DEHP and other phthalates, BPA and latex. ADM is not included in the standard grade.
Medalist® 50100 series TPEs for flexible masks are more resistant to deformation than PVC and, as thermoplastics, offer a more economical alternative to silicone. The product is as transparent as PVC, making it easy to monitor patient conditions. Medalist® 10100 Series TPE gels for hard mask liners adhere tightly to the polypropylene in the insert or can be used for overmoulding, a traditional inflatable PVC "balloon" that must be bonded to rigid components Pads provide a lower cost alternative. This ultra-soft cushion fits the patient's face shape, which can ensure a stronger air-tight fit than the PVC cushion and appear smaller on the face.