Supplier Stories for the Week of February 4

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 daphne.allen@ubm.com with the subject line “Supplier Stories.”

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

Heraeus Medical Components has opened a new manufacturing facility in Cartago, Costa Rica, for supplying local and U.S.-based medical device companies with advanced component and sub-assembly solutions. For instance, the new operation will play a major manufacturing role in the company's Finished Devices business line, and it is expected to produce more than two million cardiovascular access guidewires in 2018 in addition to other medical device products.

"The expansion of the Heraeus company is a demonstration of the good conditions of Costa Rica as an investment destination, since it has qualified human talent, economic and political stability that guarantee strengthening of its operation. In addition, in this specific case the impulse to attract investment in provinces is fulfilled, which, like Cartago, has enormous potential to generate employment and well-being in specialized areas such as medical devices and technology," Costa Rica President Luis Guillermo Solís said at the February 1 grand opening ceremony, according to a press release issued by Heraeus. 

“Heraeus Medical Components employees here in Costa Rica and around the world are guided by a sacred mission: to produce medical components and solutions that extend and enhance the lives of patients. There is not a more noble purpose than that," stated Jan Rinnert, Chairman of the Heraeus Board of Management. "With Cartago’s skilled workforce and Costa Rica’s strong business climate and med-tech community, we are excited to expand our presence here.” 

The new site replaces Heraeus Medical Components's first Costa Rica location in San Jose, which began operations in 2012. 

[Image courtesy of HERAEUS MEDICAL COMPONENTS]

At MD&M West 2018, Datwyler Sealing Solutions debuted its new compound FM705 for blood collection stoppers. Offering low metal and sulphur extraction levels, FM705 was tested against four competitor compounds in a benchmark test over approximately three years and performed best in comparison to all tested compounds, Datwyler reported in a news release. Reducing such extractions "is essential for accurate test results and patient safety," the company stated.

The FM705 compound is ready to produce and offers high flexibility in design. Once the compound is production ready, customers can choose the design suited to their application.

[Image courtesy of DATWYLER SEALING SOLUTIONS]

Avantor's NuSil brand has developed a liquid silicone rubber (LSR) delivery system that allows for implantation of pre-sterilized materials for in-situ cure and forming within the body, the company reported in a press release. Implantable medical devices made from medical-grade liquid silicone rubbers (LSRs) are typically cured outside the body and then implanted via surgery, but NuSil's new delivery system makes it "possible for medical device manufacturers to customize the fit of implanted devices, as well as [enable] less invasive implantation procedures," the company stated.

The system is also designed to allow sterilization of uncured medical grade LSR via a gas sterilizable double-cartridge dispensing system that can be prefilled with specific uncured LSRs. Each cartridge features a plunger seal designed to allow ethylene oxide sterilant gas to permeate through it to sterilize the contents of the cartridge.

The disposable syringes are available in a variety of sizes: 5, 10, 25, 50, and 75 ml. They are adaptable to a variety of injection technologies.

{Image courtesy of NUSIL]

Qosina now offers single-use PenBlade safety scalpels in surgical blade sizes #10, #11P and #15. Ergonomically designed as well as tapered for blade visibility, the PenBlade features "intuitive" pen-style activation. The release button is positioned near the front of the scalpel, where it can be pressed without looking or repositioning the hand, the company reported in a press release. "When the blade is retracted, the end of the PenBlade forms a suture-trimming groove, which encourages the user to finish a procedure in a safe position. This unique patented feature is not available on any other surgical scalpel," it reported.

The rigid body is made of medical-grade ABS, and the blade uses high-quality British stainless steel for improved sharpness and durability, Qosina reported.

The PenBlade joins Qosina's offerings of more than 5000 products. Qosina is ISO 9001, ISO 13485, and ISO 14001 registered and maintains a 95,000-square-foot facility with an ISO Class 8 cleanroom.

[Image courtesy of QOSINA]

Clariant has started up a high-throughput twin-screw compounding extruder at its recently expanded facility in Lewiston, ME. This plant can now more quickly produce larger batch sizes of MEVOPUR pre-colored medical plastic compounds.  (A smaller line, installed last year, processes fluoropolymer resins such as, FEP, ETFE, and PVDF.) 

“Demand continues to grow worldwide for these specialized compounds and masterbatches, both of which Clariant markets for medical applications under its MEVOPUR brand,” stated Eric Rohr, who recently joined Clariant as North America Segment Manager, Medical & Pharmaceutical, in a news release. “Fluoropolymers, for instance, are being used with increasing frequency in medical catheters and other applications such as diagnostics that can benefit from their flexibility, lubricity, and chemical resistance. They can require special processing equipment and manufacturing techniques, however, and that’s exactly what we have put in place in Lewiston.” 

This plant is one of three Clariant sites designed and operated to produce materials used in medical devices and pharmaceutical packaging. The other two facilities are located in Malmö, Sweden, and Singapore. All are certified to EN:ISO13485 and can use the same validated raw-material ingredients and processes so that the same products can be produced at any of the sites, the company reported. 

[Image of the Lewiston, ME, fluoropolymer compounding line courtesy of CLARIANT]