Supplier Stories for the Week of January 6

Here’s what was new in the world of medical device suppliers during the week of January 6.

  • Tek Pak Inc. has opened a new 35,000-sq-ft manufacturing facility in St. Charles, IL. The location is now the home of the company's consolidated thermoforming division, which provides products and packaging to the electronics, medical, and food industries. 

    The new facility features a 3000-sq-ft cleanroom that houses existing Kiefel equipment as well as a new Kiefel thermoformer delivered in December. In addition to supporting expansion, the facility and equipment will also enable Tek Pak to grow and streamline other areas of its business. For instance, carrier tape products and thermoform tooling will continue to be pillars of the company, and this expansion will create more capacity and manufacturing efficiencies for their customers, the company reported in a news release.

    “We see opportunities in developing and running products for the medical, food, and electronic industries that other thermoformers aren’t interested in running,” stated Tony Beyer, president of Tek Pak, in the release. “We pride ourselves on providing technically demanding thin and barrier solutions that can’t be matched in the industry.”

    Visit Tek Pak at Booth #1573 at MD&M West 2019 February 5-7 in Anaheim.

    [Image courtesy of TEK PAK INC.]

    Editor's Note: 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.”

  • Smalley is releasing a new Nested Spirawave Wave Springs series, marking the first standard series on the market. (Smalley has produced nested wave springs as customs for more than 30 years.) Nested Spirawave springs can be specified for many applications including heavy duty bearing preload, connectors, valves, and seals. 

    “Introducing a standard line of nested springs gives customers the ability to streamline production while meeting their high force requirements,” stated Dan Frank, research and development engineer, in a news release. 

    These multiple-turn, flat-wire wave springs are coiled in parallel to produce two to three times as much force as traditional single-turn wave springs, the company reported, and the springs can be used to replace stacks of single-turn springs, eliminating misalignment and inconsistent loading. They are available in sizes from 0.500 to 4 in. or 16 to 3000 mm in carbon and stainless steel. Stock parts are available for overnight shipping. 

    The springs' tangle-resistant design enables time-saving automated handling, and costs can be reduced through use of a single spring and a simplified assembly process. 

    If needed, Smalley has a team of experienced engineers capable of designing a custom nested spring. 

    Visit Smalley at Booth #3434 at MD&M West 2019 February 5-7 in Anaheim.

    [Image courtesy of SMALLEY] 

    Editor's Note: 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.”

  • Foster Corp. has been appointed as a North American distributor of Solvay’s KetaSpire PEEK and AvaSpire PAEK polyketone based polymers for the North American medical market. The arrangement includes unmodified polymers and standard color formulations currently offered by Solvay. Foster can also offer custom compounding of these polymers, including custom colors, for specific application requirements.

    “Solvay’s standard grades of PEEK and PAEK polyketone based polymers, along with their sulfone based polymers, are in high demand for reusable medical devices. Additionally, device companies are increasingly evaluating material formulations that provide differentiated colors and performance characteristics,” stated Larry Johnson, executive vice president at Foster Corp., in a news release. “Our expertise in polymer distribution of standard grades and custom compounding specialty formulations is unique and provides the most comprehensive polymer solutions in the industry.”

    PEEK and PAEK medical-grade polyketone-based polymers are high flexural modulus and high-strength polymers that offer extreme heat resistance and excellent hydrolytic stability, the company reported. Able to maintain their mechanical properties in reusable applications when exposed to multiple steam sterilization cycles as well as other sterilization techniques, these polymers can withstand more than 1000 steam sterilization cycles without significant loss of properties, for instance. Both polymers are biocompatible (USP Class VI and ISO 10993) and biostable. Common applications include surgical tools, tubing, and connectors as well as healthcare metal replacement applications.

    Visit Foster Corp. at Booth #2923 at MD&M West 2019 February 5-7 in Anaheim.

    [Image courtesy of FOSTER CORP.]

    Editor's Note: 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.”

  • Electronic contract manufacturer East/West Manufacturing Enterprises has achieved ISO 13485:2016 certification, an internationally recognized quality standard specific to the medical device industry. East/West also renewed its ISO 9001:2015 certification and reported that it is one of the only contract manufacturers in central Texas to have both quality management certifications.

    East/West Manufacturing Enterprises produces PCBs, custom cables, and electrical/mechanical assemblies for different industries. It provides materials management by offering full turnkey services to procure all parts, assemble and final test the product, program, and drop ship to the end user.

    "2018 has been another year of solid growth for East/West," stated Andy Salo, president of East/West Manufacturing Enterprises, in a news release. "We are working closely with our customers as their manufacturing arm to deliver high-quality products, while achieving reduced customer costs through our process efficiency and strong distributor relationships."

    In addition to achieving ISO 13485:2016 and ISO 9001:2015 certifications, East/West reported these additional developments in 2018:

    • Record Q4 2018 revenue increase of 50 percent over the same period last year.
    • Ten new customers during the year.
    • SMT equipment purchases enabling a capacity increase of 2X.
    • In-house Certified IPC Trainer and IPC-A-610 Certified Specialists to ensure compliance with IPC 610 Class II and III manufacturing.
    • ITAR registration renewal for continued work on defense-related technologies.

    [Image courtesy of EAST/WEST MANUFACTURING ENTERPRISES]

    Editor's Note: 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.”

  • Vidan Diagnostics LLC has entered into an exclusive distribution agreement with German diagnostic reagent manufacturer, Diasys Diagnostics Systems GmbH, to market in the United States Diasys Diagnostics’s liquid-stable, ready-to-use reagent kit for the measurement of beta-hydroxybuyrate (“β-Hydroxybutyrate 21FS”), Vidan Diagnostics reported in a news release.

    “This U.S. distribution agreement is a perfect fit to our diabetes portfolio and will complement our Lucidplus β-Ketone Plus Glucose Monitoring system," stated Gilbert Mejia, CEO of Vidan Diagnostics, in the release. "In addition, the agreement will create additional revenue stream and establish Vidan Diagnostics as a key player in diabetes diagnostics utilizing its existing distribution channels. We look forward to working with Diasys Diagnostics Systems to promote a new option in the U.S. for beta-hydroxybutyrate and other reagents in its pipeline.”

    Beta-hydroxybutyrate (BHB) is a marker used to improve the accuracy in diagnosing patients with diabetic ketoacidosis (DKA), and it is one of three sources of ketone bodies, the company reported. BHB's relative proportion in the blood (78%) is greater than the other two ketone bodies, acetoacetate (20%) and acetone (2%). As DKA is treated, serum BHB decreases more consistently than acetoacetate which is converted to BHB and does not change rapidly. The BHB/acetoacetate ratio is typically between 3:1 and 7:1 in severe ketotic states.

    Vidan Diagnostics also pointed out that the American Diabetes Association (ADA) recommends the use of blood ketone testing, based on the measurement of BHB, rather than urine ketone testing, for the diagnosis and monitoring of DKA.

    [Image courtesy of VIDAN DIAGNOSTICS LLC] 

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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