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What’s New in Medtech Materials

Several new material developments were announced at Medical Design & Manufacturing (MD&M) West 2020.

  • Teknor Apex Co.

    Medalist MD-34900 and MD-36975 Medical-Grade Thermoplastic Elastomer (TPE) Compounds
    Teknor Apex Co.

    Medalist MD-34900 series compounds, available in 50, 60, and 70 Shore A grades, are for general medical overmolding applications, while the MD-36975 grade is a 75 Shore A TPE designed specifically for overmolding in wearable devices, offering resistance to lotions and disinfectants typically encountered, explained Teknor Apex. The medical-grade TPEs are made only with FDA-listed food-grade ingredients, are ISO 10993-5 compliant for biocompatibility, and are compliant with CONEG, RoHS, and California Proposition 65 requirements, the company reported in a news release. 

    “Medalist TPEs are excellent alternatives to liquid silicones used in overmolding because they do not require the use of a primer, have a shorter cycle time (avoiding the lengthy curing process), and can be processed on conventional injection molding equipment,” explained Ross van Royen, senior market manager for Teknor Apex, in the release. “We’ve made substantial investments in adhesion-modified technologies for TPEs, increasing our understanding of adhesion, developing more cost-effective formulations, and improving the bonding capabilities of these products in complex part designs.” 

    Teknor Apex collaborated with Covestro LLC to overmold these materials onto various medical grades of Makrolon PC as well as Bayblend and Makroblend PC alloys, using both insert and multi-shot molding. Peel strength data showed the Medalist compounds exhibiting excellent adhesion to Covestro’s engineering thermoplastics. The two companies presented a co-authored white paper with details of the experiments and product performance at MD&M West.

    Teknor Apex Co.
  • PolyOne

    Versaflex HC BT218 Medical-Grade Thermoplastic Elastomer

    PolyOne introduced Versaflex HC BT218 TPE for biopharmaceutical tubing applications. Offered as a silicone alternative, the new grade features weldability, kink resistance, and tensile strength performance comparable to leading medical tubing materials, including silicone and TPEs, the company reported in a news release.

    “We’re excited to add the new Versaflex grade to our expanding set of solutions that enable customers to continue pursuing product innovation and meet market demands,” said Jim Mattey, global marketing director, Specialty Engineered Materials at PolyOne, in the release. “We are committed to leveraging our material science expertise to formulate alternative and customized solutions that meet regulatory demands and functional necessity for life-saving medical devices, especially in the face of market uncertainties.” (The company cited potential medical device shortages due to reduced supplies of siloxane, a key ingredient in silicone, and the closure of multiple EtO sterilization facilities.)

    Versaflex HC BT218 is available in the United States and has been submitted for USP VI and ISO 10993-4,5 certifications.

  • Epoxy Technology Inc.

    MED-OG198-55 and MED-730-110 Medical-Device-Grade Adhesives
    Epoxy Technology Inc.

    The newest products in the MED line products from Epoxy Technology Inc., MED-OG198-55 and MED-730-110, are suitable for use in critical design challenges.

    MED-OG198-55 is a special cationic-based, translucent, highly thixotropic gel with significant UV shadow curing capabilities and enhanced performance when thermally post cured, the company reported. It could prove useful in microfluidic designs, where its thixotropic nature helps to prevent flow to specified areas, or in staking electrical and optical components, reinforcement, feed-through, and sealing selected areas in drug-delivery products.

    MED-730-110 structural adhesive offers low- or room-temperature curing capability. It adheres to plastics, catheter tubing, and many difficult-to-bond materials, especially PEBAX, the company reported. It is provided in 1:1 mix ratio dual-cartridge packaging.

    “We, at Epoxy Technology, Inc., are pleased to further expand our line of specialty MED adhesives for medical device manufacturers and remain dedicated to the highest quality manufacturing and testing of our products,” stated Joan Bramer, global director of sales & marketing, in a news release.

    All of the company's 25 EPO-TEK MED line adhesives have successfully undergone ISO10993-5 cytotoxicity testing, and 9 products have undergone extensive additional testing passing ISO 10993-4,5,6,10,11 testing.


    Epoxy Technology Inc.
  • Clariant Plastics & Coatings Healthcare Polymer Solutions

    New Compounds in the MEVOPUR Family of Medical-Grade Polymers
    Clariant Plastics & Coatings Healthcare Polymer Solutions

    Clariant offers new compounds in the MEVOPUR family to resolve challenges faced when using polyether block amides (PEBA) or certain thermoplastic polyurethanes (TPU) that contain metallic fillers like tungsten or tungsten carbide so that doctors and technicians can see catheter position under X-ray fluoroscopy. “The problem is when these devices are exposed to heat and humidity over time, the polymer chains responsible for developing critical physical and mechanical properties become broken and the functionality of the device – and patient safety – may be seriously compromised," explained Steve Duckworth, global head of marketing & business development in a news release. Such hydrolysis effects can occur even with very small quantities of moisture trapped on the surface of the polymer, filler ingredients, or on the pellets of the compound, he added.

    Clariant combines proprietary processing techniques and additives that together help to make the polymer resistant to hydrolytic degradation. Accelerated aging tests conducted on both extruded tubing and injection-molded test samples show significant improvement in resistance compared to unmodified materials, the company reported. “The final quality and reliability of catheter components relies on the stability and predictability of polymer material properties over a wide range of conditions,” Duckworth stated. “Our testing on the new MEVOPUR radiopaque compounds shows the risk of polymer degradation from hydrolysis can be significantly reduced so predictability can be restored."

    The MEVOPUR portfolio has included PEBA, TPU, PA12, along with various radiopaque fillers, for more than 10 years. Fluoropolymers were recently added to the portfolio.


    Clariant Plastics & Coatings Healthcare Polymer Solutions
  • PAXXUS Inc.

    StreamOne R – Retortable Recycle-Ready Polyester (PET)
    PAXXUS Inc.

    At MD&M West PAXXUS highlighted its new StreamOne R – Retortable Recycle-Ready Polyester (PET), which offers the same benefits of its parent StreamOne PET along with being suitable for retort or autoclave sterilization while providing barrier properties.

    PAXXUS reports that seal and barrier integrity are maintained even after the sterilization process, and hermetic pouch seals provide security during distribution.

    StreamOne R is designed for recycling in the #1 polyester stream. The Stream family also offers StreamOne - Recycle-Ready PET (for the #1 Polyester recycle stream first launched over 10 years ago), StreamTwo - Recycle-Ready HDPE for the #2 high-density polyethylene recycle stream, and StreamFive - Recycle-Ready PP designed for the #5 polypropylene recycle stream.

    “The Stream product family now makes it easier than ever for medical device and life sciences companies to access the right recycle-ready packaging for their applications,” explained Dwane Hahn, chief strategy officer of PAXXUS, in a news release. “These visionary companies can distribute with the utmost confidence that their products are saving lives today with packaging that protects tomorrow for future generations.”

    PAXXUS Inc.
  • Eastman Chemical Co.

    Tritan MXF Flame-Resistant Copolyesters
    Eastman Chemical Co.

    Eastman's Tritan MXF product line now includes products that feature a UL 94 V-2 flame resistant rating for electronic medical device housings and hardware.

    “Eastman brings over 40 years of medical industry expertise to our latest iteration of Tritan MXF copolyesters,” explained Brad Potter, marketing director, Specialty Plastics-Medical. “We worked with OEMs to identify the attributes needed for specific product requirements and processing characteristics to enhance manufacturability.”

    The flame-resistant polymers offer chemical compatibility with a wide range of disinfectants used to combat HAIs as well as improved durability and higher impact strength, the company reported. The materials are also designed for eased processing thanks to lower ejection force for easier de-molding. 

    “Switching to Tritan MXF adds value throughout product design and commercialization and ultimately lowers the cost of ownership,” added Potter. “Most importantly, using Tritan MXF polymers in medical device housings enables healthcare workers to clean those devices more thoroughly with proper disinfectants, ultimately reducing the incidence of HAIs and positively impacting patient outcomes.”

    Eastman hosted two Lunch & Learns at MD&M West: “Critical Material Performance Considerations for Successful Development, Design and Validation of Medical Device Packaging: A Global Perspective” and “An Emerging Certification for Medical Device Cleanability and Durability: How Material Testing and Selection Help.”

    Eastman Chemical Co.
  • DuPont Transportation & Industrial

    Delrin SC698 Acetal Resin
    DuPont Transportation & Industrial

    DuPont launched a new Delrin acetal resin that features the lowest coefficient of friction (COF) in the company’s portfolio of materials for medical devices. With integrated lubrication, Delrin SC698 resin promotes smooth actuation of high-load drug delivery devices like inhalers, injectors, and pumps. In addition, its high strength and dimensional stability could help increase the injection precision of wearables and inserter devices, the company reported.

    “Healthcare sectors like home-based care and chronic disease management call for drug delivery devices that patients can use easily and comfortably,” explained Jennifer Gemo, global strategic marketing leader, DuPont Transportation & Industrial, in a news release. “Our new Delrin SC698 resin can help manufacturers improve the smoothness and precision of device operation to encourage patient compliance. Its ultra-low friction, strength and stability help reduce effort and improve consistency when patients self-administer their medications. Further, Delrin SC698 resin can be custom-colored to make devices more visually appealing to patients and to emphasize features and functionality. This innovative material is the latest example of DuPont’s ongoing investment in new solutions for changing industry requirements.” 

    As a highly crystalline homopolymer, Delrin SC698 provides strength, stiffness, and fatigue resistance, resulting in wear performance over time as well as high impact resistance. Such properties enable designers to create thin-walled, complex, and miniaturized designs without sacrificing performance.

    The SC designation in Delrin SC698 resin stands for “special control,” meaning that the resin has been subjected to extensive testing to offer manufacturing control and broad regulatory compliance. 

    DuPont Transportation & Industrial
  • Solvay Specialty Polymers

    Xencor LFT (Long Glass fiber-Reinforced Thermoplastic) Compounds
    Solvay Specialty Polymers

    Xencor LFT compounds offer high strength and enhanced impact resistance for structural applications such as chassis, gear systems, and components needing high mechanical properties and load-bearing capabilities. These long glass fiber-reinforced thermoplastics (LFT) offer healthcare designers and OEMs new opportunities to replace metal and traditional short fiber thermoplastics used in structural medical components, Solvay reported in a news release. 

    Solvay’s pultrusion manufacturing process produces continuous and highly aligned glass fiber-reinforced Xencor LFT compounds that provide better retention of mechanical properties at elevated temperatures along with very low creep, outstanding fatigue resistance, and excellent surface finish. Depending on the polymer and grade, Xencor LFT compounds can contain between 30 to 60 percent long fiber reinforcement, it was reported.

    “Xencor LFT compounds enhance our already robust metal-to-plastic replacement product portfolio for medical equipment,’’ stated Jeff Hrivnak, global business manager for Healthcare at Solvay Specialty Polymers global business unit, in a news release. “As is typical with our portfolio, Xencor LFT products stand up to aggressive disinfectants needed in healthcare and can reduce overall manufacturing costs through the use of high-speed injection molding.’’ 

    Other benefits to using Xencor LFT compounds over metals include lighter weight, expanded design freedom, chemical resistance, and streamlined processing. the company reported.  

    Solvay Specialty Polymers
  • Covestro LLC

    Low Friction Makrolon M204 LF, Makrolon M402 LF, and Makrolon M404 LF Polycarbonates
    Covestro LLC

    Covestro launched three new medical-grade polycarbonates that offer reduced coefficients of friction: Makrolon M204 LF, Makrolon M402 LF, and Makrolon M404 LF. The new low-friction Makrolon polycarbonates are described with the following benefits for drug-delivery devices:

    • Lower deployment forces.
    • Durability and biocompatibility according to ISO 10993-1.
    • Sterilizable with various methods, including autoclave, ethylene oxide, and radiation (e-Beam, gamma).
    • Elimination of the need for external lubricants.

    “We built on the superior performance of polycarbonate to formulate low-friction grades that offer consistency and versatility which, in turn, help OEMs design devices that address emerging drug delivery trends,” explained Doug Hamilton, global healthcare marketing leader, Covestro, in a news release.

    Covestro LLC
  • Covestro LLC

    Glass-Filled Makrolon M810 GF, Makrolon M820 GF, Makrolon M830 GF,  Makrolon M410 GF, Makrolon M420 GF, and Makrolon M430 GF Polycarbonates
    Covestro LLC

    Covestro has also developed two series of new glass-filled polycarbonates for surgical and drug-delivery applications that demand stiffness and strength, such as load-bearing internal components for drug-delivery devices and handles for minimally invasive or laparoscopic surgical tools, the company reported.

    The two series represent varying levels of reinforcement. The high-performance series includes Makrolon M810 GF, Makrolon M820 GF, and Makrolon M830 GF polycarbonate. The high-flow series includes Makrolon M410 GF, Makrolon M420 GF, and Makrolon M430 GF polycarbonate are used for filling larger or thinner parts with improved productivity.

    Covestro described the following advantages of Makrolon GF polycarbonates as:

    • Biocompatibility according to ISO 10993-1 for applications less than 30 days
    • Superior rigidity and strength
    • High-gloss surface achievable with rapid heat cycle molding
    • Higher tensile modulus and tensile strength, and improved dimensional stability under stress when compared to unfilled polycarbonate.

    “Our expanded materials offering gives healthcare OEMs access to a wide range of glass-filled polycarbonate products that deliver performance tailored to fit their applications,” stated Doug Hamilton, global healthcare marketing leader, Covestro, in a news release. 

    Covestro LLC
  • Biocoat Inc.

    Biocoat Inc.

    Biocoat Inc. launched HYDAK UV, a new version of the original HYDAK coating designed to be cured using ultraviolet (UV) light. 

    "Biocoat is the only hydrophilic coating provider that can provide industry-leading performance in lubricity, durability and particulates for both UV and thermal hydrophilic coatings," explained Dr. Bob Hergenrother, Biocoat's Senior Director of Research & Development, in a news release. "Our proprietary, internally developed UV coatings are built on the same bi-laminar coating platform currently being used on leading neurovascular, cardiovascular, and ophthalmic devices in over 160 countries around the world." 

    Added Jim Moran, Biocoat's president and CEO: "Biocoat is at the forefront of developing coating solutions to meet the increasing demands of our customers who are developing cutting-edge medical devices.  The introduction of HYDAK UV positions Biocoat as the premier provider of hydrophilic coatings. By working directly with our customers to understand their needs, we've developed a UV coating that maximizes device performance, and we've designed a manufacturing process that allows them to use their current in-house equipment. In addition, Biocoat will extend our in-house coating services to offer both UV and Thermal Coating Services."

    And Scott Cramer, chairman of Biocoat, said: "We believe that the future growth of Biocoat will be a direct result of simplifying the development process for our customers.  The introduction of HYDAK UV and the launch of the Contract Coating Services Unit were strategic initiatives specifically designed to improve Biocoat's complete service offering."

    Biocoat Inc.

    LNP ELCRES CRX Polycarbonate (PC) Copolymers

    SABIC introduced its new family of LNP ELCRES CRX polycarbonate (PC) copolymers to offer improved chemical resistance over existing materials such as traditional PC, acrylonitrile-butadiene-styrene (ABS), and polyester and co-polyester resins and blends. The new LNP ELCRES CRX copolymers can help prevent stress cracking and mitigate crack propagation, the company reported in a news release. 

    “Our new LNP ELCRES CRX copolymers offer device manufacturers an easier, drop-in alternative to conventional resins that experience challenges in withstanding repeated cleanings with extremely harsh disinfectants,” stated Darpan Parikh, global product management leader, LNP Specialty Compounds at SABIC, in the release. “By adopting our new copolymers, which offer robust resistance to crazing, cracking and discoloration, customers can help enable longer device life and avoid premature replacement. Based on the exceptional performance of these new materials in healthcare applications, SABIC is actively exploring additional grades for other industry sectors where chemical exposure is a challenge.”

    Added Ashir Thakore, global segment leader, Healthcare at SABIC: “To measure a polymer’s potential compatibility with chemical disinfectants, SABIC devised a quantitative ESC test that evaluates retention of both tensile stress at yield and tensile elongation at break. Our efforts to develop materials with improved chemical resistance that meet these standards can help extend the useful life of plastic medical devices and support repeated application of strong disinfectants aimed at preventing HAIs.”

    For instance, LNP ELCRES CRX grades demonstrate property retention after exposure to PDI Healthcare’s Sani-Cloth AF3 wipes and other aggressive healthcare cleaners, combined with excellent impact performance (ductile notched Izod at 23°C) and mitigation of crack propagation.  

    Also at MD&M West, SABIC experts Manish Nandi, SABIC business development manager for Specialties in the Americas, and Nithin Raikar, SABIC senior business manager for LNP Resins and Compounds, presented, “Keeping Medical Equipment Clean and Durable: PC Copolymer Technology Innovations that Improve Chemical Resistance against Hospital Disinfectants.” 

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