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Supplier Stories for the Week of December 9

Here’s what was new in the world of medical device suppliers during the week of December 9.

  • 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]

  • PrinterPrezz Inc. has announced the opening of its first Innovation Center in the Silicon Valley. With a multi-disciplinary team of medical doctors, engineers, and materials scientists in what is called a "Medifacturing ecosystem," the company combines metal 3D printing, nanotechnologies, and surgical expertise to design and manufacture next-generation medical devices. 

    “3D printing has the potential to revolutionize how the world thinks about developing advanced medical devices, but in the current ecosystem, it takes too long to go from concept to product,” said Shri Shetty, co-founder and CEO of PrinterPrezz, in a news release. “By combining proven metal 3D printing technologies with our proprietary nano-technology post-processing, we can further enhance new medical devices to improve durability, strength, and bone-in-growth while reducing the potential for infection, for example."

    The new center in Fremont, CA, offers medical device digital design services and access to an open innovation environment featuring software, scanners, and hardware to optimize 3D print design and prototyping for applications such as implants, surgical aids, and prosthetics. It also offers a complete additive manufacturing solution, including multiple onsite powder-bed metal 3D printers capable of printing in materials such as titanium and stainless steel as well as a suite of proprietary nanotechnologies including nano-metrology, nano-coating and nano-etching to enhance device performance.

    “We support innovators at every level, from the individual clinician all the way to multinational medical device companies," said Dr. Alan Dang, co-founder and chief medical officer of PrinterPrezz and board-certified orthopaedic spine surgeon, in the news release. "Some are looking to develop an initial prototype from a napkin sketch while others are already in production and need additional manufacturing capacity. We have offerings designed to help each group succeed. By bringing together experienced clinicians and innovative engineers with leading 3D printing equipment and software from around the world, PrinterPrezz decreases turnaround time from concept to manufacturing.”

    Photo Caption: By integrating imaging, design, modeling and 3D printing, PrinterPrezz seeks to create patient-matched devices for improved clinical outcomes.

    [Photo Courtesy of PRINTERPREZZ INC.]

  • At MD&M West Booth #2015 Teknor Apex Co. will introduce three new medical-grade thermoplastic elastomers (TPEs) for biopharmaceutical tubing as alternatives to widely used silicone. The company will also make a presentation on grades for peristaltic pump applications at the “Tech Theater” at 1:30 pm on Wednesday, February 6.

    Teknor Apex recommends the new Medalist compounds for challenging tubing applications in the biopharma industry for peristaltic pumps and extreme low temperature applications. Designed for peristaltic pump tubing, the materials offer the elasticity required to keep pace with rapid pump action and the durability needed for the tubing to retain shape and remain intact over time. They can be sterilized by means of e-beam, gamma irradiation, and ethylene oxide (EtO). And in comparison with the industry-standard TPE alternative to silicone, the Medalist TPEs exhibit lower levels of spallation—the shedding of particles from the inner and outer surfaces of the tubing caused by repeated compression and release during pump operation, the company reported. The three compounds are described as follows:

    • Medalist MD-12352 is a 52 Shore A translucent TPE designed for peristaltic pump tubing.
    • Medalist MD-50357 is a clear, slightly harder TPE (58 Shore A) for peristlatic pump tubing, which can be sterile welded and heat sealed.
    • Medalist MD-10353 is a clear compound used in biopharma tubing in extreme low-temperature applications. 

     

    “At a time when silicones are in short supply, Teknor Apex can provide an assured global supply chain for all Medalist TPEs, producing them at ISO-13485-certified facilities in the U.S, and Singapore,” said Ross van Royen, senior market manager of regulated products, in a news release. “As alternatives to silicone, our three new Medalist compounds provide better performance than the industry-standard TPE used thus far.”

    The new Medalist compounds are certified at a minimum to the ISO 10993-5 standard for biocompatibility, are REACH SVHC compliant, and are free of DEHP and other phthalates, BPA, and latex. Standard grades are ADM-free.

    [Image courtesy of TEKNOR APEX]

  • Through photo etching, Tech-Etch can produce many medical device component-level parts from thin metals. The company has published a design brief explaining the photo etching process and outlining the dimensions and thickness tolerances, heat-treatment options, and forming and minimum bend radii for various materials. It describes how the process can be used for prototype quantities and large production runs of intricate parts without the cost and lead times of hard tooling. Specialty materials that can be used in medical implants and implantable devices include nitinol for stents, titanium for maxillofacial and cranial reconstruction implants, Elgiloy for stiffener bands for valve replacement, tungsten for battery grids and opaque components for x-ray devices, and polyimide to produce haptics for intraocular lens implants, the company reported. Custom light-gauge parts can be produced with intricate patterns, precise tolerances, and burr-free edges, the company reported.

    Visit the web site at www.tech-etch.com/photoetch to download the Design Brief PDF.

    Tech-Etch will be in Booth #2183 at MD&M West February 5-7 in Anaheim.

    [Image courtesy TECH-ETCH]

  • Nelipak Healthcare Packaging has renovated its 67,250-sq-ft manufacturing facility in Humacao, Puerto Rico, adding a new control room and a Class 8 Cleanroom. Nelipak recently hosted an open house for invited delegates to tour the facility.

    “We are excited about the enhancements to our site in Humacao and continue to invest significantly in our operations in Puerto Rico because of the island’s proximity to our customers and the quality of the local work force,” said Mike Kelly, President and CEO of Nelipak, in a news release. “The Puerto Rico Industrial Development Company (PRIDCO) has been very supportive as we look to boost our operations in the region, and we look forward to being able to serve our customers even better from Humacao thanks to these latest renovations.”

    Manuel A. Laboy Rivera, secretary of Commerce and Economic Development (DDEC), added: “Nelipak’s new enhancements in Humacao will create jobs specific to the thermoformed healthcare packaging industry. The generation of employment opportunities for our work force represents new hope to continue our path to the economic development of Puerto Rico.”

    Headquartered in Cranston, RI, Nelipak has eight healthcare packaging facilities around the world and employs about 750 people in the United States, Netherlands, Ireland, and Costa Rica; there are presently about 65 workers in Puerto Rico.

    Nelipak will be in Booth #2070 at MD&M West February 5-7 in Anaheim.

    [Image courtesy of NELIPAK HEALTHCARE PACKAGING]

  • Offering medical device development and manufacturing support, Able Medical Devices has received ISO 13485:2016 certification from Ente Certificazione Macchine Srl. (ECM). ISO 13485:2016 is an internationally recognized standard that specifies quality management system requirements for medical devices.

    “ISO 13485 certification reflects our commitment to holding the highest standards. We achieved certification very quickly due to our experienced team," said Eric Baldwin, vice president and general manager for Able, in a news release. "Able Medical earns our customer’s trust every day and expects to be their most reliable partner. This milestone is another step that allows us to accomplish that goal.”

    Added David Surber, director of sales for ECM: “ECM’s Express Certification process was developed just for manufacturers like Able Medical Devices, which have quality system expertise and a short target timeline for gaining certification. Certifications don’t happen this fast without a highly competent and cooperative client. Able Medical’s commitment to quality was apparent throughout the process.”

    [Logo courtesy of ABLE MEDICAL DEVICES]

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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