Supplier Stories for the Week of July 8

Here’s what was new in the world of medical device suppliers during the week of July 8.

  • 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]

  • Teel Plastics Inc. has received ISO 13485:2016 certification. Serving customers in the medical market for more than 20  years, the company reported that the certification is part of its long-term plan to expand its offerings in the medical market, such as flexible PVC and coextrusion, to a wider customer base. “We have had customers that have worked with us for years and kept auditing us to higher and higher standards, which we always maintained, and we wanted to certify that for new customers,” stated Mike Faust, Teel’s director of quality, in a news release.

    The certification covers Teel’s extrusion and injection molding operation at its headquarters as well as its laboratory sampling products division. “We think this demonstrates our commitment to our customers and the medical market,” stated Teel’s president, Tom Thompson. “We are excited for future possibilities and the challenge of continuing to improve.”

    Teel Plastics custom extrudes plastic tubing and profiles, producing high-quality custom tubing in a wide variety of sizes with tight tolerances and specializes in complex projects.

    [Image courtesy of TEEL PLASTICS INC.]

  • Greenlight Guru has provided startup medtech company Myolyn with a digital quality management solution and consulting services. Myolyn co-founders Matthew Bellman and Alan Hamlet established their company in 2013 during their engineering Ph.D. studies at the University of Florida.  After extensive research in biomechanics and applying functional electrical stimulation (FES), Bellman developed new stimulation techniques and control algorithms for a powerful and efficient cycling workout for people with paralysis. Myolyn's first product is MyoCycle, and it’s available in two models: one for home and one for professional settings such as physical therapy offices.

    Myolyn acquired Greenlight Guru’s system and full QMS templates, which Bellman customized to suit the company’s processes, Greenlight Guru reported in a case history shared with MD+DI. Myolyn co-founders as well as staff engineers use the software daily. They have found that using the document management module daily and the risk management module every couple of weeks or so helped them to stay on top of compliance requirements. It has also supported simple change control and easy collection of electronic signatures.

    Along with the Greenlight Guru software, Myolyn also used its consulting services, with the Greenlight Guru Customer Success Team giving input over a six-month period. This helped to ensure that the company stayed on track with setting up its procedures and preparing its 510(k). Myolyn applied for its 510(k) in January of 2017 and received it 93 days later in April. Greenlight Guru’s software eased the process by storing all documentation in one place. Greenlight Guru reported that Bellman was able to quickly and easily print out the design history file and risk management documentation to include with the submission.

    Moving forward, Myolyn is using Greenlight’s Grow software to input and monitor customer feedback, it was reported in the case history.

    [Image courtesy of GREENLIGHT GURU]

  • Molex has improved its best-selling PicoBlade connector to meet growing needs in the consumer, healthcare, and industrial markets. With four header options, the 1.25 pitch PicoBlade connector offers a reliable connection in both wire-to-wire and wire-to-board applications. 

    “For more than 20 years, Molex PicoBlade connectors have been a best seller and an industry standard,” stated Mariko Okamoto, product manager, Molex, in a news release. “These new improvements to the PicoBlade deliver the traditional reliability, but also meet the needs of several market applications including consumer, automotive, industrial, healthcare, and data communications.”

    The design features a two-point connection for a secure electrical connection, even under low-current, low-voltage, and high-vibration conditions. The crimp receptacle has two latching ramps to minimize uncoupling due to shock or vibration. The PicoBlade is offered in both vertical and right-angle connections in a variety of wire-to-board and wire-to-wire connections, and 2-, 8- and 15-circuit configurations. It also features an off-the-shelf assembly in a variety of cable lengths.

    [Image courtesy of MOLEX]

  • ITL Group, a designer, developer, and manufacturer of medical and diagnostic devices, has increased its in-house 3D printing capabilities. Last year, the company invested in two 3D printers that reduced design costs and timescales and contributed to better designs by enabling adaptations on the fly with multiple iterations in a matter of hours.  A recent purchase was FlashForge Creator Pro, a new 3D printer that will improve component quality and design flexibility. 

    Tom Haydon, mechanical systems engineer at ITL, describes the impact of 3D printing in a news statement: “3D printing continues to be an invaluable resource in R&D, allowing us to rapidly develop, prototype, and advance designs at a speed and cost not achievable with traditional manufacture methods.”

    Added Ollie Aylett, mechanical systems engineer at ITL: “3D printing gives an extra level of versatility to the R&D department and is a real asset to the mechanical design and development process. From prototype design variations in an instance to end use fixtures and fittings it has transformed the way we bring products to life.”

    The recent investment included upgrading to a FlexionHT dual-head extruder, which provides more freedom to experiment with different techniques and printing materials such as PETG filament, which is stronger, tougher and can withstand higher temperatures., the company reported. "The use of flexible materials such as TPU opens up the potential to produce previously unachievable features such as living hinges and flexible parts," it stated.

    [Image courtesy of ITL GROUP]

     

  • Packaging Compliance Labs, a medical device and pharmaceutical packaging engineering and validation firm, has opened a new office in Denver, CO, to support the area’s growing biotechnology industry and other markets. Headquartered in Grand Rapids, MI, Packaging Compliance Labs partners with medical device manufacturers, development firms, and entrepreneurs. Its ISO 17025 accredited facility is equipped to perform a full suite of transit, accelerated aging, and integrity testing in accordance with ASTM and ISTA standards.

    “The decision to expand our presence into Denver’s metro area was a logical step in our business growth strategy, as we bring on more clients on the West coast and expand our reach to better serve them,” stated Matthew Lapham, president, in a news release.

    Added Sarah Rosenblum, director of business development and marketing, who is heading the expansion in Denver and is the primary contact for PCL’s West location: “The Colorado area is currently booming with new biotechnology innovation, making it very exciting to be right in the heart of the action. We also now have the opportunity to be more accessible for the established medical device markets in San Jose – Silicon Valley, Los Angeles, and Salt Lake City, just to name a few. We also can further expand our sales, customer service, and marketing departments, as well as increase our ability to service current and future markets.”

    [Logo courtesy of PACKAGING COMPLIANCE LABS]

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 packaging, labeling, manufacturing, and regulatory issues as well as pharmaceutical packaging 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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