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Supplier Stories for the Week of November 17

Here’s what was new in the world of medical device suppliers during the week of November 17.

  • Freudenberg Medical

    As part of a major innovation initiative, Freudenberg Medical, a developer and manufacturer of medical devices, components, and minimally invasive solutions, has introduced several products and technologies. “Our engineers and product development teams worldwide have been working on over-drive these past few years,” stated Dr. Max Kley, CEO of Freudenberg Medical, in a news release. “The result of this is a large number of innovative products and cutting-edge technologies that will greatly benefit our medical device customers all around the world.”

    For instance, Freudenberg Medical obtained 8 patents for minimally invasive technologies, such as the Composer Catheter Handle Platform, hemostasis valves with variable diameter seals, and expandable introducer sheaths. Just introduced were the next-generation Composer EPIC and Composer Toccata Catheter Handle platforms and the HyperSeal Mini hemostasis valve.

    The company also expanded medical balloon development, including introducing Rapid Response Prototyping for balloons. In-house capabilities are in place to develop, manufacture, and test high-performance medical balloons.

    Helix iMC, a new technology for continuously measuring the inner geometry of silicone tubes, aims to increase product quality for critical applications such as pacemaker lead insulation and to cut material usage, process time, and validation requirements.

    Another innovation is Twisted Lumen Tubing, which is multi-lumen tubing designed to provide equal balance of stress across the inner and outer lumens as the tubing bends. The technology offers a broad range in the degree of twist required for medical device applications such as pacemakers, breathing tubes, and other medical applications that require navigation through tortuous pathways within the human body, the company reported.

    Freudenberg Medical has also developed a proprietary conductive silicone compound used for smart therapeutic devices that deliver electrical currents and for ESD shielding of sensitive electronics. The silicone is suitable for two-shot overmolding applications. “Our extensive material knowledge helps us identify and modify state-of-the-art materials and enhance them for special requirements,” said Lars Gerding, technology director at Freudenberg Medical, in the release.

    Products recently launched by InHealth Technologies, Freudenberg Medical’s ENT division, include the Blom-Singer StomaSoft Laryngectomy Tube, the redesigned Katz Extractor Oto-Rhino Foreign Body Remover used globally by physicians, Blom-Singer FitSeries Adhesive Housing for stoma care, and Blom-Singer Post-Operative Care Kits for total laryngectomy post-op patients. 

    [Image courtesy of FREUDENBERG MEDICAL]

    Freudenberg Medical
  • The Detroit Free Press has honored PTI Engineered Plastics Inc. with a Top Workplaces 2019 award. The list is based solely on employee feedback gathered through a third-party survey administered by research partner Energage LLC.

    PTI Engineered Plastics provides custom injection molding and manufacturing of plastic components and assemblies. The company offers capabilities in design, engineering, tooling, low- to high-volume production, and a range of secondary services. ISO Class 8 Cleanroom services include molding, assembly, and packaging.

    “The Top Workplaces award is about much more than recognition and celebration,” stated Eric Rubino, CEO of Energage, in a news release issued by PTI. “Our research also shows that these organizations achieve higher referral rates, lower employee turnover, and double the employee engagement levels. It just goes to show that being intentional about culture delivers bottom-line results.”

    PTI Engineered Plastics CEO Mark Rathbone added: “I take great pride in being recognized by our employees as a 'Top Workplace' again. I appreciate the respect and loyalty shown PTI with this honor. A sincere thank you to our PTI family.”

    [Logo courtesy of PTI ENGINEERED PLASTICS]

  • OKAY Industries, a contract manufacturer that engineers components and subassemblies for original equipment manufacturers in the medical device and industrial markets, announces the addition of NexTech Labs. These prototyping and process development labs are dedicated spaces offering equipment, resources, and staff who work collaboratively with customers to solve complex engineering design challenges, OKAY Industries reported in a news release.

    Employing advanced robotic technologies, NexTech Labs offer multi-axis, high-speed CNC and LaserSwiss machining, laser tube cutting, laser welding, marking, and surface treating. The labs offer 3D printing for quick-turn feasibility testing, tooling, and fixtures. 

    “NexTech Labs bring our resources and expertise to a space where we can directly collaborate with customers,” stated Sean Stowik, director of sales and marketing at OKAY Industries, in a news release. “We can get products to market faster and solve issues early in the design stage, which ultimately lowers production costs and improves manufacturability. By working one-on-one with medical device OEMs early on, we create custom manufacturing solutions that deliver high-quality, reliable components and sub-assemblies with speed and cost efficiency.”

    OKAY Industries’s in-house tool and die design and development is available for customizing the manufacturing process.

    [Image courtesy of OKAY INDUSTRIES]

  • West Pharmaceutical Services Inc. has made several announcements at recent shows, with more planned. 

    At CPhI Worldwide, West launched two new elastomer products, the advanced elastomer 4040/40 and AccelTRA Select, a line extension of its AccelTRA component program featuring new configurations of stoppers and plungers. 

    "These new elastomer product offerings reflect West's deep commitment to innovation based on customer insights. Designed with the customers' challenges in mind, we aim to simplify their journey with drug packaging and delivery solutions and help bring much-needed injectable medicines to patients more quickly and efficiently," said Karen Flynn, West's senior vice president and chief commercial officer, in a news release. "CPhI also marks our first full year offering the Integrated Solutions program, our comprehensive approach to working by our customers' side to help reduce risk and regulatory complexity. Together with these new product offerings, West supports customers as they navigate the journey from early development to commercialization." 

    The elastomer 4040/40 features Westar Select quality and low particulate levels, offering optimal design, drug compatibility, and quality to protect drug stability and minimize fill-finish rejects. In the 4040/40 formulation, two LyoTec stopper designs are available: 13 mm and 20 mm, with a universal design for high functionality and reliability. It was developed through a Quality-by-Design (QbD) approach to material selection and component analysis.

    The new AccelTRA Select elastomer components include AccelTRA 13-mm and 20-mm serum and lyo stoppers in multiple configurations, along with a 1-3 mL uncoated plunger (see above image). The AccelTRA Select line extension leverages the Westar Select wash process to offer high-quality options for generic drug manufacturers. The AccelTRA program will continue to expand in 2020. 

    West's Integrated Solutions program unites primary packaging, device, analytical, regulatory and contract manufacturing expertise in a single-source approach to drug containment and delivery system development. Available in defined and customized packages, the program combines West's suite of drug packaging and delivery products with the company's service offerings to meet the needs of the drug product and its delivery system at any stage of development—across all injectable formats, West explained. 

    Also at CPhI Worldwide, West and primary packaging solutions provider SCHOTT announced a partnership to combine the SCHOTT iQ platform with West's Ready Pack system. The collaboration will begin by combining West components and SCHOTT's adaptiQ high-quality RTU glass vials and will expand to include other ready-to-use combinations of West and SCHOTT products, to be available on a small-quantity basis. The companies also shared plans to expand West's Ready Pack system to include additional SCHOTT glass offerings, such as including more vial formats as well as ready-to-use cartridges (cartriQ) and pre-fillable glass syringes (syriQ). Further product launch plans will be shared at Pharmapack Europe in 2020.

    At the 2019 PDA Universe of Pre-Filled Syringes and Injection Devices event, West announced two product offerings: the launch of NovaPure 3-mL Cartridge components, an addition to its NovaPure product line of plunger and lined seal components designed for consistent delivery for higher-volume injectable drug delivery systems; and the commercialization of SmartDose Gen. II 10-mL injector for subcutaneous delivery of a range of drug formulation viscosities up to 10 mL in volume.

    Flynn said of the offerings: "The launch of our NovaPure 3-mL Cartridge components line and the enhancements to our SmartDose platform are the first of many upcoming product launches and updates we'll be announcing in the coming months to address specific issues we know our customers are facing as they work to bring innovative, new injectable medicines to market."

    The new NovaPure components are specifically designed for 3-mL cartridges often used in autoinjectors and other drug-delivery devices. They incorporate West's premium quality enhancements: Westar pharmaceutical wash and sterilization, FluroTec barrier film, and a comprehensive data package, the company reported. They are suitable for sensitive biologic drugs coming to market.

    Part of the SmartDose portfolio of devices developed for patients with chronic health conditions, the SmartDose Gen. II 10-mL drug delivery system adheres to the patient's body so patients can remain hands-free during the injection, which may range from minutes to hours. West has now completed the development work to enable up to 10 mL of medication injection and is ready for commercialization.

    [Image courtesy of WEST PHARMACEUTICAL SERVICES]

  • Borealis and Borouge are launching a new service solution, Bormed InCompounds, in which Borealis collaborates with selected compounders to offer customers quality, reliability, and conformance in compounds and masterbatches. It also allows customization of compounds based on Bormed for use in a range of medical devices, pharmaceutical packaging, and diagnostic devices. Specific examples include IV bottles and pouches, pipette tips, syringes, and inhalers.

    The Bormed portfolio of high-quality polymers ranges from stiff polypropylene (PP) to soft PP, from low-density polyethylene (LDPE) and high-density polyethylene (HDPE), to plastomers. Each participating compounder has fulfilled stringent selection criteria as a precondition to collaboration, such as having a dedicated healthcare team composed of marketing and business development managers as well as application and regulatory experts, an established healthcare product brand, and compliance with ISO 13485-2016, among other criteria. Bormed InCompounds currently includes close collaboration with long-standing Borealis partners Clariant, Melitek and Wittenburg:

    • ­Clariant Business Unit Masterbatches is a provider of color and performance-enhancing concentrates and compounds with more than 80,000 live products manufactured in 50 production sites in 28 countries. 
    • Melitek is an ISO 13485 certified elastomer and polymer compounder with 20 years’ experience focusing solely on the healthcare market. 
    • ­The Wittenburg Group is a family-owned developer and manufacturer of a broad range of customized polymer solutions for medical, food contact, and other demanding applications.

    “We remain committed to offering our customers best-in-class service by promoting even more collaboration along the value chain,” stated Nina Ackermans, Borealis Head of Marketing Advanced Products, in a news release. “We are excited to collaborate with trusted partners, offering our customers an enlarged customisation potential based on Bormed quality, reliability, and conformance to help them manage the challenging requirements of their industry and develop their business further.”

    Borealis is a provider of solutions in the fields of polyolefins, base chemicals, fertilizers, and melamine. Borealis provides services and products to customers globally, in collaboration with Borouge, a joint venture with the Abu Dhabi National Oil Company (ADNOC) and with Baystar, a joint venture with Total and NOVA Chemicals in Texas, USA.

    Borealis and Borouge will exhibit at stand J68 at Pharmapack Europe February 6-7, 2020. 

    [Image courtesy of BOREALIS Group]

Daphne Allen

Daphne Allen is editor-in-chief of MD+DI. She previously served as executive editor of Pharmaceutical & Medical Packaging News, which serves as the pharmaceutical and medical device channel of Packaging Digest. Daphne has covered medical device manufacturing, packaging, labeling, and regulatory issues as well as pharmaceutical packaging and labeling for more than 20 years. She is also a member of the Institute of Packaging Professionals's Medical Device Packaging Technical Committee. Follow her on Twitter at @daphneallen.

 

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