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Supplier Stories for the Week of December 17

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

  • This is a compilation of the latest news from suppliers in the medical device industry. If you have news you’d like to submit for potential inclusion in this weekly roundup, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”

    [Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

  • Sunlite Plastics Inc. has announced that it has officially obtained accreditation from MedAccred in plastics extrusion. A subsidiary of Diversatek, Sunlite specializes in PVC extrusion for producing custom medical tubing.

    “On behalf of Sunlite Plastics Inc., we’re thrilled to be recognized for our manufacturing expertise and quality assurance,” stated Diversatek Inc. Chairman and CEO Brant Stanford in a press release. “We have always operated as a partner to our clients, not a vendor. Process is central to this commitment and we pride ourselves on regular evaluation and refinement to ensure consistent product quality and efficacy. Our MedAccred 'first global' distinction is a testament to our team’s hard work and to seven decades of experience in high-volume manufacturing.”

    Established by leaders in the medical device industry and the Performance Review Institute (PRI) in 2013, MedAccred is an industry managed, consensus-driven approach focused on improving patient safety by preventing product defects through a critical manufacturing process audit, Sunlite explained in the news release. 

    [Image courtesy of Sunlite Plastics Inc.]

  • MAURO Usability Science provides a new suite of testing methods designed to help drug-delivery device developers meet FDA human factors guidance. These new techniques are intended to provide multi-dimensional and scientifically valid data on patient interactions with the entire drug-delivery experience, the company reports.

    New Data Capture Methods from MAURO Usability Science include: 

    • 3D spatial tracking
    • Newtonian force measurement
    • High Definition Electromyography
    • High-resolution eye tracking
    • Micro-facial expression analysis
    • Automated task analysis and data capture
    • Cognitive workload analysis
    • Information foraging theory

    MUS has developed proprietary and certified hardware/software systems that combine these new advanced testing methods into a unified data collection steam that provides unprecedented hard data on the human factors engineering performance of drug delivery devices, instructions for use, package design, and dosing information, the company explained in a press release.

    Types of Device Tested Using New MUS System

    • Single-action auto injectors
    • Complex-action auto injectors
    • Advanced fully electronic auto injectors
    • On-body injectors involving complex data presentation
    • Multiple entirely new drug delivery configurations and methods
    • PFS devices for common and high-viscosity drug delivery
    • Multi-use vials and related injection devices
    • Drug delivery monitoring Apps / software
    • Drug dosing (complex and simple)
    • Instructions for use (simple and highly complex data)
    • Reference Guides 
    • Drug device and drug package design
    • Pharmacist device interaction analysis
    • Threshold and learning transfer analysis

    [Image courtesy of MAURO Usability Science]

  • At MD&M West 2018, IBAG North America will showcase its expanded “Micro Line” spindles for Swiss turning. These compact and high-speed spindles in 20-, 22-, and 25-mm-diameter models operate up to 120,000 rpm, including the new easy-to-install High-Torque Back Working Spindle for multiple locations for back working and front and cross drilling with speeds to 60,000 rpm. IBAG North America offers a full line of machine-tool high-speed spindles with complete repair and rebuilding services as well as vacuum workholding systems to serve metalworking manufacturers and precision product and component applications.

    Visit IBAG North America at Booth #250 at MD&M West February 6-8 in Anaheim, CA.

    [Image courtesy of IBAG North America]

  • Phillips-Medisize, a Molex company, is expanding the capabilities of the 380,000-sq-ft Molex Little Rock, AR, facility to include an FDA-registered manufacturing Center of Excellence for connected health and drug-delivery devices. Construction of cleanroom suites as well as FDA registration and ISO 13485 certification are scheduled to be completed in Q2 2018, the company reported in a press release.

    “Phillips-Medisize is excited to align with Molex on the transformation of the Little Rock facility, which will be a Center of Excellence for Connected Health and drug delivery devices and manufacture products that fit in today’s world of innovative devices. This facility will also allow us to accommodate large programs requiring extensive assembly and molding operations, in clean room and other controlled environments, within a compressed timeframe. The facility will have a particular focus on mid- to high-volume diagnostics, medical device and drug delivery systems that integrate electronics and digital applications, and will provide us with the additional space needed to reach our growth objectives over the upcoming years,” stated Matt Jennings, CEO and President of Phillips-Medisize, in the release.

    This latest effort will be the company’s sixth expansion in the past six years to support long-term growth of its medical contract manufacturing business. 

    Please visit Phillips-Medisize at Booth #3119 at MD&M West 2018 February 6-8.

    [Logo provided by Phillips-Medisize, a Molex company]

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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