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Supplier Stories for the Week of March 17

Here’s what was new in the world of medical device suppliers during the week of March 17.

  • Zirconium-based Amloy alloys and copper-based materials from Heraeus could be injection molded into components in a fully automatic production process using Engel’s newly developed AMM injection molding machine from its hydraulic victory series. Very small wall thicknesses are possible, Heraeus reported in a news release. Cycle time can be up to 70 percent shorter than with previous amorphous metal injection molding solutions, and the required heating power can be reduced by 40 to 60 percent.  Thanks to a surface fineness of 0.05 µm Ra, manual reworking or further surface finishing are not necessary for most applications. 

    Injection molding of amorphous metals is described as superior to MIM (Metal Injection Molding) and CNC machining. MIM processing of metal-plastic powders requires further work steps such as debinding and sintering. CNC machining requires considerably more time and generates a large amount of waste, it was reported.

    At the Hannover Messe 2019 April 1-5 at Booth E32 in Hall 3, Heraeus and Engel will demonstrate the Amloy brand’s potential for delivering components that combine high mechanical durability with high reliability, low wear, scratch resistance, and reproducibility.

    Amorphous metals are named such because of their randomly arranged – amorphous – molecular structure. Amloy components are hard yet highly elastic and have a low wall thickness while remaining durable, light, and robust, it was reported. Amloy is biocompatible in line with ISO 10993-5. Applications could include durable instruments for minimally invasive surgery. 

    [Image courtesy of HERAEUS]

    Editor's Note: If you have news you’d like to submit for potential inclusion in future weekly roundups, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”

  • The Vector Hammertoe Correction System from Nvision Biomedical Technologies has been cleared by the FDA for use in the United States. It is the first foot and ankle implant to be made from PEEK-OPTIMA HA Enhanced from Invibio Biomaterial Solutions.

    "Hammertoe correction is one of the most common foot and ankle procedures, but we realized there are opportunities to improve outcomes," said Tom Zink, Nvision senior vice president of product development, in a news release. "We have seen real patient success with our interbody fusion product line using Invibio’s PEEK-OPTIMA Natural polymer. Now with our Vector Hammertoe Correction System, we are utilizing the PEEK-OPTIMA HA Enhanced material to translate and expand this innovation in foot and ankle surgeries.”

    Invibio worked with Nvision to develop testing and optimize the manufacturing process, while providing support regarding regulatory requirements for the FDA 510(k) submission to obtain clearance for the new implant. "To date, devices made from PEEK-OPTIMA HA Enhanced have been used exclusively for spinal interventions. Nvision's Vector system is the first time we've seen such a device cleared by the FDA for other than spinal applications," noted John Devine, medical business director, Invibio Biomaterial Solutions, in a news release. "What we've achieved here, with Nvision and Invibio working as project partners, is a solution for a relatively common but curiously challenging problem, the curled up, calcified toe. The result is a very small device, but one that for many hammertoe patients could literally shape a better future."

    The Vector Hammertoe Correction System is also the first lower extremity implant to incorporate Structural Encoding, a patented technology platform licensed from Watershed Idea Foundry that enables the unique identification of medical devices through direct part marking.

    [Image courtesy of INVIBIO BIOMATERIAL SOLUTIONS]

    Editor's Note: If you have news you’d like to submit for potential inclusion in future weekly roundups, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”

     

  • PTI Engineered Plastics (PTI) is celebrating 35 years in plastic injection molding and tooling. Founded originally as Proto-Tech Industries by CEO Mark Rathbone, the company has evolved into a successful custom injection molder and manufacturer of plastic components and assemblies in the industry with a 165,000-sq-ft state-of-the-art facility in Macomb, MI. 

    In the early days Rathbone "wore all the hats," he shared in a news release. "I was the bookkeeper, salesman, estimator, program manager, production supervisor and janitor!” Today the company has more than 325 employees servicing the medical, automotive, defense/aerospace, consumer products, and electronics industries.

    “Over the last four years we have been training the next generation of workers through our PTI Technical Academy," Rathbone reported. "There is a shortage of skilled labor in manufacturing, so the Academy was developed to help strengthen the region’s workforce and industry. The Academy provides a pathway for students who have a passion for creation and exposes them to the high-tech, innovative world that manufacturing is today.

    “PTI has had much growth both in business and workforce, and with this growth come greater challenges, but also many rewards," he continued. "I can proudly say that I still have many employees that have been with me for 30 years, and more. I’m also honored to say that about some of my customers. In any business, a relationship with your employees and customers is the key to success; without those, you have an empty building.” 

    [Image courtesy of PTI ENGINEERED PLASTICS] 

    Editor's Note: If you have news you’d like to submit for potential inclusion in future weekly roundups, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”

  • Sensor manufacturer Sensirion AG and medical technology cable and connector specialist Nicolay GmbH have cooperated to introduce flow sensor solutions for ventilators that include connectors and cable interfaces.  The sensor-connector-cable solution offers accurate, patient-side measurement while delivering a reliable flow signal to the ventilator, the companies reported in a news release. Different options for cables and connectors transport calibrated and temperature-compensated output signals of the sensor back to the ventilator. The solution offers ventilator manufacturers an alternative to individually produced sensor connector and cable configurations. 

    The Sensirion Flow Meter (SFM) is available either in autoclavable and washable (AW) variants or as single-use solutions (D = disposable). The SFM3400 was developed for neonatal applications (very small volumes) while the SFM3300 was developed for adult ventilation. The SFM3200 is intended for expiratory applications. The performance of these gas flow sensors is based on technology developed and patented by Sensirion that combines the sensor element, signal processing and digital calibration on a single microchip.

    All sensor variants can be connected to the ventilator using the Nicolay Flow Meter Connector. When connected, the interface is leak-proof to protection rating IP54; when detached, it allows for wipe disinfection. Communication with the sensor I²C bus using short cable lengths requires nothing more than a connection with simple spring contacts. 

    [Image courtesy of SENSIRION]

    Editor's Note: If you have news you’d like to submit for potential inclusion in future weekly roundups, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”

  • Precision Micro, a supplier of photo-etched components, is now certified to ISO 13485, the internationally recognised quality management system for medical device manufacturers. The accreditation was achieved after a successful site audit conducted by the British Standards Institution (BSI), the national standards body of the United Kingdom, Precision Micro reported. The company has been working with an increasing number of customers coming from the medical device sector. 

    “Precision Micro has focused on obtaining the relevant quality management system for each of the core high-value engineering markets it supplies,” said Carl Smith, Precision Micro’s quality manager, in a news release. “Having already secured AS 9100 (aerospace) and IATF 16949 (automotive), securing ISO 13485 was the next step and shows our commitment to not only meet, but exceed the needs of a growing medical customer base. We are extremely proud to have attained this stringent and prestigious standard in less than 12-months.”

    Photo etching can be used to produce complex, burr- and stress-free metal components with very fine detail, the company reported. It is can be used to manufacture parts from medical-grade metals and alloys characterised by their high strength-to-weight ratio, biocompatibility, and corrosion resistance.

    In 2015 the company invested in titanium etching and has since seen increasing demand for medical implants, including craniomaxillofacial meshes and components used in pacemaker batteries, the company shared.

    [Logo courtesy of PRECISION MICRO]

    Editor's Note: If you have news you’d like to submit for potential inclusion in future weekly roundups, please send a press release and any related images to [email protected] with the subject line “Supplier Stories.”

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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