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Supplier Stories for the Week of August 25

Here’s what was new in the world of medical device suppliers during the week of August 25.

  • Bimba has launched the BPVA, a compact pneumatic pinch valve that expands the company's pinch valve portfolio with a more cost-effective solution for industrial and medical applications. As with Bimba's other pinch valves, the BPVA is designed as an alternative to traditional wetted valves by opening and closing flexible tubing to control the flow of media so it never makes contact with the valve, the company reported in a news release. 

    According to Bimba, the BPVA:

    • Requires less maintenance and reduces the risk of contamination.
    • Offers high-performance life expectancy of 3 million cycles.
    • Features a compact design that enables operations in confined spaces.
    • Is available at a cost-effective price point.

    “The BPVA targets a wide range of applications needing a simplified design and a low price per unit for high quantities,” stated Sarah Manuel, product manager, in the release. “By offering four models with different sizes and options, the BPVA adds a versatile yet compact pinch valve design, all at an affordable price to our existing portfolio of pinch valve products. An electrical solenoid piloted version of the BPVA is planned for release in the near future, and will be announced as soon as it is available for ordering.”

    The BPVA is available in anodized aluminum or stainless steel and in normally closed or normally open configurations. A completely stainless-steel, corrosion-resistant option is suitable for washdown and sanitary environments. Additional options include mounting brackets, various seal materials, and magnetic position sensing.

    [Image courtesy of BIMBA]

  • Kraiburg TPE reports that its Thermolast M compounds meet the requirements of the 2017 guideline for medical-grade plastics (MGPs) passed by the Association of German Engineers (VDI) in July 2019. This guideline for manufacturers and users of plastics for medical products regulates the requirements qualified MGPs have to meet from basic requirements to formulation consistency and change management through to withdrawal terms.

    “The VDI 2017 is an important first step toward harmonizing the range of performance that a medical-grade plastic must fulfill, and it creates obligatory guidance in the communication between manufacturers of MGPs and OEMs and/or the manufacturers of medical, pharmaceutical, and in vitro products,” explained Oliver Kluge, a member of the guidelines committee and advisor for medical products at Kraiburg TPE, in a news release. “The new guideline explicitly provides scope for the respective materials suppliers and their customers to make broader arrangements.”

    Thermolast M compounds are free from heavy metals, latex, PVC, and phthalates and are manufactured exclusively on dedicated production lines, the company reported. Selected material types have been tested and certified according to USP Class VI (Chapter 88), ISO 10993-5 (cytotoxicity), ISO 10993-10 (intracutaneous irritation), ISO 10993-11 (acute systemic toxicity), and ISO 10993-4 (hemolysis). The quality assurance of raw materials used also covers full traceability of batches on the suppliers’ side, and Kraiburg TPE’s materials comply with REACH and RoHS requirements, it was reported.

    Kluge explained that the company's “established thermoplastic elastomers from the Thermolast M family – for medical use – have for a long time been complying with the requirements for MGPs that are now codified, so that we only need to flesh out some of the specifications. But we will continue to actively work on future revisions of the guideline in order to further enhance the secured profile of MGPs.” 

    [Image courtesy of KRAIBURG TPE]

  • EmbedTek LLC, a specialist in the design and manufacture of embedded computer systems, software, sensors, and integrated displays, will expand its manufacturing space by 20,000 square feet.  

    “We have progressed from supplying customers with a single subsystem to manufacturing entire products, which means we have an increased complexity in parts, production, and testing,” said Dan Aicher, CEO of EmbedTek LLC, in a news release. “Companies partner with us to help them invent a product, bring it to market at a pace that keeps up with technology developments, prove that it works, then manage the manufacturing and distribution moving forward.” 

    The expansion supports the company’s long-term growth plans in two strategic areas of embedded technology design and manufacturing, one of which is manufacturing finished medical devices. EmbedTek not only produces the device but manages the entire lifecycle and participates in subassembly design, the company reported.

    For instance, one OEM worked with EmbedTek to improve the design of a medical device for image-guided surgery, EmbedTek reported. EmbedTek has since registered with the U.S. FDA as a contract manufacturer of medical devices and builds the entire device at its Waukesha facility.  

    The expanded space will give EmbedTek the ability to add full-time and part-time positions across the company in engineering, manufacturing, operations, and administration. EmbedTek currently has 90 employees and anticipates its staff to exceed 100 in 2020. 

    [Image courtesy of EMBEDTEK LLC]

  • Thanks to a cooperative agreement, Siemens and Italian robot manufacturer Comau have jointly engineered Sinumerik Run MyRobot/DirectControl, which enables robot kinematics to be fully integrated into a CNC system. The Sinumerik CNC controls the articulated robot arm directly with through complex algorithms without the need for a separate robot controller. Potential industrial uses include additive manufacturing, fiber placement, metal-cutting, carbon fiber-reinforced polymer, and laser machining.

    Integrating control of the robot arm into the CNC helps improve path and positioning accuracy as well as reliability, the companies reported in a news release. It also enhances dynamic response during robot-aided machining tasks. 

    Complete configuration for all DirectControl-supported robot arms is stored in the Siemens engineering tool Sizer.  Data sets for the relevant mechanics are made available by the robot manufacturer Comau and imported on a channel of the Sinumerik CNC.

    There is also support for other engineering functions, they report. Digital twins are available for DirectControl-compatible Comau robot arms to enable work in Siemens NX CAM Robotics. The kinematic 3D robot model and the virtual NC kernel Sinumerik VNCK enable sub-programs generated in the CAD-CAM chain to be completely simulated offline. Additional benefits described in the release are the reduced footprint due to the elimination of hardware components, lower overall investment, reduced stocking costs for spare parts, and greater availability given improved MTBF (Mean Time Between Failures).

    [Image courtesy of SIEMENS and COMAU]

  • Concept Metals Group (CMG) has acquired Freedom Manufacturing Inc., giving CMG advanced precision machining capabilities and enhancing its engineering services. Freedom Manufacturing serves clients in the medical and medical devices, material handling, and other industries. It provides CNC machining, single and multi-spindle machining, assembly, kitting and packaging, and welding services.

    Company founder and president Robert Baker will remain with the company as president to transition his 40-plus years of knowledge and experience to the new leadership team, it was reported in a news release. 

    “The acquisition will strengthen our core competencies and provide more diverse and complete solutions to our current client base, which giving us an entry into new markets,” stated CMG CEO John Walton in the release. “Concept Metals Group and Freedom Manufacturing share a like-minded focus on providing quality products delivered on time, value-added engineering solutions and exceptional customer service. We are very pleased to welcome Bob and the team at Freedom Manufacturing to the CMG team. Working together, we will deliver a better value proposition for our customers by offering complementary products and services that allow us to be a single-source supplier.”

    Added Baker: “I had been looking for an opportunity to transition for several years, but never found the right fit – until John. He has the same belief in his people that I do. We have the same core values. While it will be hard to step away, I feel confident in the future of Freedom Manufacturing with John and his team at the helm.”

    Rick Williams will lead day-to-day operations as general manager, bringing 30 years of manufacturing experience.

    Concept Metals Group started in rollforming as Concept Engineering, but later expanded and now operates four facilities, including:

    • Concept Metal Products, which focuses on rollforming, stamping, welding, stretch bending, and other services for steels, brass, aluminum, coated materials, and high-strength materials.
    • Concept Metal Fabrication, which provides light gauge sheet metal fabrication, laser cutting, turret punching, welding, secondary operations and prototyping.
    • Integricoat, which delivers powder coating for carbon steels, aluminum, die cast and brass surfaces, with a special focus on high-end, class A visual surface coating.

    [Image courtesy of CONCEPT METALS 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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