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Supplier Stories for the Week of September 22

Here’s what was new in the world of medical device suppliers during the week of September 22.

  • Wind River has announced IEC 62304 medical standard compliance for the latest release ofVxWorks Cert Edition. The Wind River RTOS for medical is compliant for use in applications requiring up to IEC 62304 - Class C compliance, a standard for “Medical device software – Software life cycle processes,” according to a news release. 

    “From surgical robots to smart hospitals, new technology is revolutionizing healthcare, bringing new safety and security concerns that must be addressed with stringent industry regulations and standards,” said Amar Parmar, senior director of medical, Wind River, in the release. “Developing secure, safety-compliant medical devices requires a balanced blend of regulatory awareness, proven components, and efficiency of design practices; Wind River addresses each of these factors with the latest release of VxWorks Cert Edition.”

    Wind River has more than 20 years of experience in safety certification software products, and its software portfolio supports a wide range of medical device manufacturer journeys from design to development to deployment, whether teams require open source and need Linux, or an RTOS, or both, the company reported.

    [Image courtesy of WIND RIVER INC.]

  • Printing Industry Midwest (PIM) has certified AWT Labels & Packaging under PIM’s "Great Printer" environmental initiative for the eleventh straight year. To participate, printers must demonstrate a commitment to minimizing impact on human health and the environment while producing quality printed products. The companies also commit to going beyond Environmental Health and Safety (EHS) requirements for minimizing waste, recycling waste, maximizing energy efficiency, and creating healthier and safer workplaces.

    “We are proud to once again commit to the Great Printer initiative, and will continue looking for ways to operate in a sustainable manner,” said Doreen Praschak, director of quality at AWT, in a news release. “We’ve been an environmentally responsible manufacturer for many years, and the certification from PIM validates what we’ve been doing in the normal course of our business, and beyond compliance.”

    AWT also offers a line of sustainable label and flexible packaging materials, such as AWT’s ‘Terrene’ portfolio of materials consisting of paper and film stocks with a range of sustainable properties.

    [Logo courtesy of AWT LABELS & PACKAGING]

  • PolyOne's IQ Design team has received a 2019 IDEA Gold award in the Social Impact Design category from the Industrial Designers Society of America (IDSA). The award recognizes PolyOne’s work in designing and developing the USee self-refraction device for Global Vision 2020, a nonprofit organization founded by J. Kevin White, PolyOne reported in a news release.
      
    “As an inventor,” White stated in the release, “handing over your initial idea to a designer is like handing over your child and asking them to take it to college graduation. This award is proof that the USee device not only graduated, but was the valedictorian. I can’t thank PolyOne and its IQ Design team enough for donating their time, passion, and expertise to help change the world with the gift of clear sight.”

    USee is intended to help patients with blurred vision "dial in their best optical acuity while viewing an eye chart, thus determining their correct prescription," PolyOne reported. Trained local "refractionists" assist in the process, and it takes about 15 minutes to deliver prescription glasses for less than $5 per pair, it was reported.
     
    PolyOne’s team of industrial designers and design engineers utilized their expertise in materials science, manufacturing, and design to help overcome performance and production challenges. “Our IQ Design team sought to enhance the device’s simplicity in both design and production to facilitate larger-scale vision care that met low-cost targets,” said Cathy Dodd, vice president, corporate marketing at PolyOne. “Tackling a worldwide challenge like this one aligns well with our sustainability goals and commitment to our local and global communities, and we are honored by the recognition that this award from IDSA conveys.”

    As an IDEA-winning design, the USee device will be part of the permanent collection at The Henry Ford Museum of American Innovation, an IDSA partner.

    [Image of the USee device renderings in Moldflow courtesy of POLYONE]

  • Biocoat Inc. has launched an ISO-certified, full-service on-site facility for the application of its HYDAK coatings to its customers' medical devices. The company previously would work with companies to implement the coating process at their facilities or if necessary, recommend a third-party vendor.

    "The launch of our new coating facility helps extend Biocoat's vision of becoming a complete, turnkey coating service solution," said Jim Moran, president and CEO of Biocoat, in a news release. "The coating service unit allows us to expertly apply our unique hydrophilic coatings in a controlled environment, which enables us to consistently produce high quality results in an efficient and repeatable manner, while offering an unmatched customer service and best-in-market turn-around times."  

    Adds Senior Director of Operations Thomas Brugnoli, who was hired in January 2019 to lead the design and management of the unit: "The coating services unit allows us to fully support our customers by giving them options during their development process. For customers who are launching a new product, our facility can support commercial production volumes, and for existing clients, our coatings unit acts as a backup or overflow service for their existing coating process. We are proud to be able to accurately and efficiently process our customers' specialty devices in preparation for use by patients located around the world." 

    [Logo courtesy of BIOCOAT INC.]

  • Mack Molding has appointed Tory Peeler director of quality to oversee quality operations for the company's Northern Division. He reports directly to President Jeff Somple. 

    Mack specializes in plastics design, prototyping, molding, sheet metal fabrication, full-service machining, and medical device manufacturing.

    "Since joining Mack in December 2018 as Quality Manager for Medical and Regulatory Compliance, Tory has had a significant impact on the organization, leveraging his more than 30 years of quality experience to our benefit, and that of our customers," Somple said in a news release. "His expertise in process validation, design control, risk management, ISO requirements, quality systems, and continuous improvement will serve him well and is a great match for our growing business."

    Peeler previously served as director of quality and compliance at Adhesives Research, and he also had developed quality, engineering, and leadership experience within roles of increasing responsibility at Becton Dickinson Diagnostic Systems.

    Peeler replaces Wanda Knowles, who is retiring after more than 19 years with the company in IT and Quality leadership roles. "Wanda has been a major contributor to Mack's overall success," Somple said, "and we wish her all the best in this exciting new chapter of her life."

    [Image courtesy of MACK MOLDING]

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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