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Supplier Stories for the Week of February 2

Here’s what was new in the world of medical device suppliers during the week of February 2.

  • At Medical Design & Manufacturing (MD&M) West 2020, FOBA will showcase its M2000 laser marking workstation with an integrated vision-assisted UDI laser marking solution and its new Titus vector scan laser marking head described as the smallest and lightest on the market. 

    “Our U.S. sales team will take the opportunity to demonstrate laser marking on a M2000 laser marking workstation live at the booth,” explained Letizia Caselle, regional sales manager Americas, in a news release. “FOBA’s customers can rely on an integrated marking solution to make their medical devices compliant with the UDI-requirements according not only to the FDA but also to the new European MDR.”

    While most FDA deadlines for direct-part UDI marking of medical devices have passed, laser-marking systems will be of interest to medical manufacturers seeking to comply with the European Medical Device Regulation (MDR), which takes effect on May 26, 2020, the company shared.

    FOBA’s laser marking solutions enable precise marking results and maximum operating efficiency, the company explained. Laser marking can be used for stainless-steel surgical instruments, titanium implants, or plastic single use items.

    FOBA's three-step marking process enables precise mark alignment along with pre- and post-marking validation of parts and marking results. An optionally integrated camera situated directly in the laser head allows automated part detection. 

    FOBA’s Titus scanning head comes with the laser system Y.0200-xs / Y.0300-xs and is incomparably small and equipped with additional clamp-and-go laser head brackets forfitting into tight production environments.

    Also happening at MD&M will be a workshop on Thursday, February 13, 2020 (9:00 to 10:30 AM, room 201D) featuring FOBA’s Business Manager Software & Vision Faycal Benayad-Cherif Ph.D and two other expert speakers. Manufacturers who join the workshop will benefit from tips and tools and learn more about the current laser marking technology for meeting actual international UDI parts marking regulations.

    FOBA will be exhibiting in MD&M West Booth #771 February 11-13.

  • Pro-Tech Design & Manufacturing, a full-service medical device contract manufacturer and packager, is celebrating its 40-year anniversary in 2020. The company will be exhibiting at MD&M West Booth #2147, marking its 16th consecutive year exhibiting at the show.

    The family-owned and -operated firm was founded in Southern California in 1980 and has grown by 600 percent over the last 15 years. The firm started by focusing on corrugated products and then became one of the only companies to deliver sewn products compliant with ISO 13485 standards. In 2001, Pro-Tech expanded into the biomedical business with sterile cleanroom assembly and production. It expanded its footprint with redundant facilities in Arlington, TX, in 2012.

    “Pro-Tech got its start in my family room, and today we have over 130 employees and deliver 6.5 million units per year to some of the industry’s most influential players,” explained CEO and founder Pamela McMaster (featured above) in a news release. “Forty years ago, I was a young woman with big ideas for breaking into a largely male-dominated industry – and today, I’m proud to celebrate the success we have achieved with many of our original employees and my family working by my side.”

    The woman-owned small business was joined by McMaster’s late husband in 1985 and is presently led by McMaster and her two sons, Aaron and Jeff Swanson. Aaron Swanson, president of Pro-Tech, joined the company in 2001; he established Pro-Tech’s bio-medical packaging division and continues to oversee all aspects of medical device assembly, packaging and sterilization. Jeff Swanson joined in 1995 and currently serves as the executive vice president overseeing the Midwest region.

    Pro-Tech now operates in 75,000 sq ft of manufacturing and warehouse space and 6000 sq ft of certified Class 10,000/ISO 7-rated cleanroom space, providing complete medical device assembly and packaging as well as laboratory and sterilization services for nearly all sectors of the medical device market. It currently serves 140 customers, a huge leap from 2005’s customer count of 20, Pro-Tech reports.

    [Image of PRO-TECH CEO and founder Pamela McMaster courtesy of PRO-TECH DESIGN & MANUFACTURING]

  • The Polyplastics Group will exhibit its latest material for the medical/healthcare market, Duracon polyoxymethylene (POM) PM series for drug contact and delivery applications, at MD&M West Booth #440.

    The first grade under the PM Series, Duracon POM PM09S01N, meets regulatory compliance requirements including ISO10993 and USP Class VI biocompatibility/cytotoxicity, FDA Drug Master File (DMF) and Device Master File (MAF), and EU 10/2011 and FDA food-contact 21 CFR 177.2470.

    Polyplastics reported that the material adheres to strict quality management systems including conformity to VDI guideline VDI 2017 medical-grade plastics. It also provides full traceability of processes and products and production management based on GMP principles. 

    The company will also feature the latest for its TOPAS cyclic olefin copolymer (COC), a high-purity material for a range of medical applications complementing the PM series. TOPAS COC is a glass-clear and highly pure plastic that offers stiffness and barrier resistance, biocompatibility, and drug compatibility for wearables, drug delivery, medical devices, pharmaceutical blisters and trays, and diagnostics and microfluidics. 

    The group’s product portfolio includes POM, PBT, PPS, LCP, GF-PET, and COC. 

    [Image courtesy of THE POLYPLASTICS GROUP]

  • Qosina will showcase its Build-It-Yourself Assemblies and new adhesive product line at Booth #2021 during MD&M West 2020 February 11-13. The company has teamed up with H.B. Fuller, a manufacturer of medical adhesives, to offer solutions for bonding assemblies together.

    H.B. Fuller will join Qosina at the booth to present live component-bonding demonstrations throughout the show. Attendees who are present for the live demos will receive a free adhesive sample, Qosina reported in a news release.

    H.B. Fuller’s instant and light-cured adhesives featuring low, medium or high viscosity offer hassle-free bonding, it shared.

    Build-It-Yourself Assemblies was developed to help customers easily find and order components for their next design project.

    Qosina offers thousands of single-use components to the medical and pharmaceutical industries. The company is ISO 13485, ISO 9001, ISO 22301, and ISO 14001 certified and operates in a 95,000-sq-ft facility with an ISO Class 8 cleanroom. 

    [Image courtesy of QOSINA]

  • TE Connectivity will showcase its portfolio of sensor solutions at MD&M West 2020 Booth #3219. The company designs and manufactures sensors to exacting specifications for the rigors of medical applications, with ISO 13485 certification and FDA registration for various sensors and assemblies, it shared in a news release.

    TE described its upcoming series of booth demonstrations including:

    • Liquid Medical Systems Demo - Witness TE’s sensors can perform in a liquid medical system simulating an infusion pump or dialysis system. Temperature, force, pressure, humidity, ultrasonic, and other medical sensing technologies will be showcased in this demo collecting real-time data as fluid circulates through this system. This live sensor data will be displayed to demonstrate how TE sensors are used to track vital aspects of a medical system.
    • FX29 Compact Load Cell Demo - Showcasing the FX29, this demo will allow visitors to use the mallet and hit the force sensor. There will be an electronic peak detector connected to a sample and hold circuit with a digital display to capture the peak impact.
    • Cath Lab Simulation - TE Connectivity offers MD&M West visitors an opportunity to deploy a stent, replace a heart valve, and save a life in a simulated Cath Lab experience.

    Also at the show in Booth #701 will be Silicon Microstructures Inc. (SMI), recently acquired by TE Connectivity, which will highlight its IntraSense product line featuring biocompatible sensors that fit into 1-French tubing. Potential applications include minimally invasive surgical procedures given the sensors' ability to perform pressure measurements directly in many spaces throughout the anatomy.

    “TE Connectivity is pleased to join MD&M West again this year as we continue to work toward our goal of building a legacy of innovation and teaming with customers to revolutionize healthcare,” stated Bill Irwin, TE’s senior manager, medical business development. “TE has a broad range of offerings including sensors, connectors and cables, catheters, metal shafts and shrink tubing that continue to meet the needs of next-generation medical devices and we are thrilled to showcase them this year.”

    [Image courtesy of TE CONNECTIVITY]

  • Bourns Inc. will highlight its MEMS-based environmental sensors at MD&M West 2020. Its line of pressure and humidity sensors is designed to meet the sensitivity, accuracy, and long-term reliability requirements of certain medical market applications such as medium/low-risk medical designs, the company reported in a news release. 

    Highlighted at Booth #963 will be:

    • High accuracy, ultra-low pressure range capabilities
    • New digital output features to help reduce processor workloads
    • High reliability operation over a broad -40 °C - +150 °C temperature range
    • Demonstration of ultra-low differential pressure sensors
    • Non-contacting rotary position sensors for diagnostic equipment

    Bourns products have not been designed for and are not intended for use in "lifesaving," "life-critical," or "life-sustaining" applications nor any other applications where failure or malfunction of the Bourns product may result in personal injury or death, the company reported

    [Image courtesy of BOURNS INC.]

  • Herrmann Ultrasonics will unveil in the United States its HiQ ultrasonic welding product line at MD&M West 2020. The HiQ G2 is the first series-produced premium ultrasonic welding system to also possess the flexibility of a customized machine, the company shared in a news release.

    All machine components, connected devices, and their behavior are easy to access via comprehensible visualizations and can be directly experienced, the company shared. The user is guided through more complex situations quickly, safely, and comprehensibly. 

    The controller software’s modularity permits simple expansion and also adaptation to future tasks. This controller software truly brings the HiQ to the digitalized production of the future. Herrmann designed the new controller platform to accommodate future needs such as predictive maintenance and data mining, which can be easily added.

    Product highlights described include:

    • Functional, appealing design
    • Precise electrical height adjustment
    • Automatic tool clamping system (ACS)
    • Modular controller platform
    • Clever tool change system
    • Simple, safe, and fast tool change

    The system is able to select the weld program according to the tools used. The machine ensures that the stack used, the equipment, and the selected weld program are all compatible with one another. The user is informed about problems and suggested changes and can act immediately. A sophisticated, automatic tool clamping system additionally facilitates the change (automatic clamping system/ACS).

    The weld process and the complete machine cycle can be modeled in the controller platform and monitored, controlled, and optimized using the process data provided, the company reported. Adding additional sensors, actuators, and entire complex devices into the machine cycle can be carried out via simple user interface configuration.

    Herrmann will be at MD&M West in Booth #2811.

  • Cambus Medical, a Freudenberg Medical company, debuts Velona Custom & Specialty Needles suitable for minimally invasive needle-based devices used in diagnostic and therapeutic interventions for internal medicine. The needles are inspired by Cambus Medical’s Hypotube and Micro-Component business. “Our Velona Custom & Specialty needle business is modelled on our very successful Navigate R&D program,”explained Barry Comerford, CEO of Cambus Medical, in a news release. “This innovative approach to the DFM process calculates and mitigates the risks involved in delivering cutting-edge components to the medical device industry.”

    The Velona team offers design and product development support, manufacturing services, and assembly for needle devices in the clinical areas of fine needle aspiration, fine needle biopsy, minimally invasive delivery systems, and structural heart applications.

    The company described some of the available features as:

    • Lancet, Menghini, Whitacre, Closed Point, Backcut Bevel, Trocar, Franceen, Crown Core cut, and many more
    • Custom features for structural heart and delivery applications
    • Integration into a finished medical device 

    Cambus Medical offers advanced hypotubes, specialty needles, device assembly, and micro-component solutions to manufacturers of catheters, stent delivery systems, and other minimally invasive devices used in diagnostic and therapeutic interventions.

    Freudenberg Medical will be exhibiting at MD&M West 2020 Booth #2413.

    [Image courtesy of CAMBUS MEDICAL, A FREUDENBERG MEDICAL CO.]

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