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Supplier Stories for the Week of October 21

Here’s what was new in the world of medical device suppliers during the week of October 21.

  • 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]

  • Resonetics has acquired STI Laser Industries Ltd., a company based in Or Akiva, Israel, that provides laser processing, nitinol shape setting and electropolishing, and cleanroom assembly and packaging for the medical device industry. Founded in 1987, Resonetics provides laser micro manufacturing and contract manufacturing services to the life sciences industry. STI was founded in 1998 by Tovy Sivan, President & CEO; the company has customer relationships in Israel as well as in the United States, Japan, China, and Korea.

    “Israel is recognized around the world as an important medical device center, and we are very excited to gain access to these customers with STI. Tovy’s entrepreneurial spirit and the strong management team he assembled have created an impressive business serving the structural heart, neurovascular, and minimally invasive surgery markets. The acquisition also broadens Resonetics’ nitinol processing capabilities, an important capability to serve our growing interventional business,” said Tom Burns, President and CEO, Resonetics, in a news release. 

    “I am very proud of the position STI has built in the industry over the past 20 years,” added Tovy Sivan. “By joining forces with Resonetics now, we can offer our customers a broader set of manufacturing capabilities with the resources necessary to support best-in-class prototyping and high-volume production options in Israel, the United States, Europe, and Costa Rica. We are uniquely positioned to service a growing list of industry leaders, and I look forward to continuing to build this business with Tom, Chip, and the team at GTCR.” 

    STI is doubling the size of its operations in Or Akiva, it was reported. Building 2 is under construction and will open in early 2020 to increase the Israel operation to 60,000 sq ft to accommodate the company’s growth and new manufacturing capabilities. 

    Resonetics will be exhibiting at MD&M Minneapolis October 31-November 1 at Booth #1940.

    [Image courtesy of RESONETICS]

  • Hoffmann + Krippner offers flexible input systems such as custom membrane switches and membrane switch keyboards for medical technology. The systems have no moving parts so there is no mechanical wear of the contacts. A sealable design protects against water or chemical fluid ingress into the switch area. Self-healing features can repair damage without user action (see GT Technology, which also offers raised or domed keys). Some models use gold-plated electrical contact surfaces to increase longevity.

    The customizable systems can be made with and without tactile feedback and either rigid or flexible; tactile feedback can be replaced or enhanced with optical and/or acoustic signals. They can be mounted on printed circuit boards, allowing for more compact designs. The systems can take up less space than other input devices, increasing options for designers.

    Other features the company reported include:

    • Double contact switches for enhanced security.
    • Optimal ergonomic operation of user interface.
    • Compact and safe to operate.
    • Graphic overlay visible in a 180° radius.
    • Easy to clean with a variety of cleaning materials, including fluids.
    • Excellent solution for hygiene-critical environments, including antimicrobial surface preparation.
    • Developed antimicrobial film for sustained protection against bacterial contamination.

    Hoffmann + Krippner will be exhibiting at MD&M Minneapolis October 31-November 1 at Booth #2338.

    [Image courtesy of HOFFMANN + KRIPPNER]

  • Dunn Industries, a Tekni-Plex business, will showcase its acetal Catheter Core technology used to manufacture minimally invasive catheter shafts at MD&M Minneapolis, October 31-November 1 Booth #1819.

    Catheter Cores help retain critical lumen tolerances during extrusion, braiding, coiling, and jacketing processes. Low-friction material properties and ultra-smooth surfaces allow these cores to be easily removed after catheter shaft assembly, the company reported in a news release. They are available in precise diameters from 0.020 to 0.250 in. with tolerances as low as +/- 0.0005 inches.

    Dunn’s proprietary process can be used to precision extrude a solid acetal rod, which is supplied on continuous spools for ease-of-use during catheter processing operations. The cores maintain critical inside-wall dimensions during initial extrusion of the inner polymer layer, application of the reinforcing fiber layer, and extrusion or ”jacketing” of the outer layer. Reinforced tubing is frequently used for diagnostic and guide catheters, high-pressure contrast injection tubing, and other minimally invasive devices.

    Natvar, another Tekni-Plex business, will join Dunn Industries at the show. The company will highlight its recently launched microextrusion and silicone tubing solutions, which can be made from cost-effective thermoplastics and other highly engineered materials. 

    Visit Dunn Industries and Natvar at MD&M Minneapolis Booth #1819.

    [Image courtesy of DUNN INDUSTRIES, A TEKNI-PLEX BUSINESS]

  • Gresham Power Electronics offers medical equipment designers and OEMs a wide range of fully approved medical power supplies for applications such as medical instrumentation, ultrasound equipment, clinical and cosmetic lasers, hospital and home patient monitoring systems, and IT equipment.

    The micro-footprint, Ultra High Density OF(M) range of open frame power supplies are available with output power of 120, 225 and 550W and output voltages of 12, 15, 24, 30, 48 and 58VDC over an operational temperature range of -40°C to +50°C (+70°C with derating), the company reported in a news release. All models feature an auxiliary output to power a cooling fan and an optional cover kit may be supplied to order.

    The MUI310-A Series of desktop power supplies is also available for medical applications. The universal AC input product range offers a wide selection of output voltages from 12 to 44 Vdc and up to 310W output power. The high efficiency, high reliability device meets IEC 60601-1 3rd Edition and offers 2 X MOPP protection.

    [Image courtesy of GRESHAM POWER ELECTRONICS]

  • TÜV SÜD's experts at Medica (Hall 10, Booth C12) will be available to discuss the EU Regulation on Medical Devices (MDR) and the EU Regulation on In Vitro Diagnostic Medical Devices. The new regulations introduce stricter requirements for medical device manufacturers and extends the responsibilities of notified bodies, the company reported in a news release. “Under the new MDR, for example, manufacturers must update the clinical evaluation and their pertinent technical documentation throughout the entire life cycle of a medical device, using systematically and actively collected data”, explained Dr. Bassil Akra, Head of the Clinical Centre of Excellence at TÜV SÜD Product Service. 

    The company explained new expectations for reporting. "Manufacturers of Class IIa, IIb and III devices must prepare periodic safety update reports for each certified product and, where applicable, each product category or product group, and update these reports at regular intervals--biennially for Class IIa or annually for Class IIb and III products," the company stated. "Reports of implantable medical devices (Classes IIa and IIb) and Class III devices must be uploaded to EUDAMED and assessed regularly by the responsible notified body. Manufacturers of Class III medical devices and implantable devices, except custom-made devices, must draw up and annually update summaries of safety and clinical performance which are publicly available."

    The company also explained how the IVDR differs from the previous IVD Directive. “When drawing up the IVDR, the European Union did not include a grandfathering clause,” said Dr. Thomas Theisen, Department Manager IVD at TÜV SÜD Product Service. “Given this, all in-vitro diagnostic medical devices that are already sold in the EU also need to be evaluated and, if necessary, certified in line with the new requirements.” By May 2022, IVD manufacturers must furnish evidence that their devices are in compliance with the requirements of the IVDR.

    Medica will be held in Duesseldorf November 12 to 15.

    [Logo courtesy of TÜV SÜD]

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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