MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Supplier Stories for the Week of January 26

Here’s what was new in the world of medical device suppliers during the week of January 26.

  • Quality Tech Services LLC (QTS)

    Quality Tech Services LLC (QTS) has received accreditation from MedAccred as the "Global First in Sterile Device Packaging."

    “Receiving the Global First in Sterile Device Packaging accreditation from MedAccred is testament to our commitment to being best-in-class,” stated Doug Wilder, QTS founder, in a news release. QTS provides such services as finished device assembly, validated cleaning, inspection, packaging, labeling, sterilization, and supply chain management. It manufactures in Class 7 cleanrooms, is ISO 13485 certified and FDA registered, and has certified microbiologists, packaging engineers, and cleaning specialists on staff.

    MedAccred accreditation allows subscribing member companies to ensure suppliers meet quality standards by adhering to global regulations and requirements, while reducing the number, cost, and resources needed for supplier audits, it was described in the release. QTS piloted the Sterile Device Packaging audit process and helped the MedAccred team develop certification criteria for packaging system assembly/filling and sealing of trays. Johnson & Johnson, Medtronic, Stryker, Philips, BD, and Boston Scientific leadership made up the MedAccred team that focused on the development of the audit criteria and process.

    “QTS has been audited many times by very experienced and knowledgeable auditors, but the MedAccred audit, focused specifically on sterile barrier packaging processes, was the most beneficial to enhancing this aspect of our business," stated John Klapperich, vice president of operations at QTS, who was a key facilitator in the audit process at QTS. 

    QTS's audit process began in early 2019, and the company received official accreditation in November 2019. QTS  is privately held by Cretex Companies. 

    [Image courtesy of QTS (QUALITY TECH SERVICES LLC)]

    Quality Tech Services LLC (QTS)
  • Miltec UV

    Miltec UV is celebrating 30 years in business in 2020. Over the years the company has evolved from being a distributor of industrial UV (ultraviolet) products to becoming an equipment manufacturer of UV curing equipment and spare parts provided to more than 30 markets globally.

    The company's portfolio includes microwave, arc, and led lamp technologies, and it provides consulting, training, and technical support. A customer applications laboratory open allows customers and formulators to work alongside PhD chemists, engineers, and UV experts on testing new processes, cost reduction, and process improvements.

    Miltec UV supports the community through various organizations, and its four principal owners serve various volunteer roles. In the above photo, the center of the photo features the four owners: Marilyn Blandford, CEO (holding the certificate); to her left is Charles Blandford, executive vice president; to her right is Robert Blandford, president; and behind Robert is Joe Blandford, vice president (with glasses).

    Miltec UV will be exhibiting at Medical Design & Manufacturing (MD&M) West Booth #958 February 11-13.

    [Image courtesy of MILTEC UV] 

    Miltec UV
  • Trelleborg’s healthcare & medical operation

    At MD&M West 2020Trelleborg’s healthcare & medical operation will showcase its GeoTrans geometric transition extrusion technology intended to improve part quality, device function, and longevity of medical devices using high-consistency rubber (HCR) silicone. It also removes the risks and labor of assembly and secondary processes, the company reported in a news release.

    GeoTrans technology eliminates the use of assembled joints that can be weak, creating failure modes or internal misalignments in which fluids can become turbulent or stagnant, Trelleborg reported. This could increase component strength and improve the medical device’s longevity and robustness.

    “HCR silicone’s unique green strength, the strength of rubber in its unvulcanized state, allows for highly complex geometries in continuous extrusion processes," stated Dan Sanchez, product manager at Trelleborg’s healthcare & medical operation, in the release. "In the GeoTrans process, tool components can be moved during extrusion to substantially change cross sections. This opens up new design possibilities in a wide range of medical devices, including wound drains and spinal and hemodialysis catheters.

    “A major advantage to the device manufacturer is that overall processing time and costs can be reduced," he continued. "Although running a simple extrusion is faster than running a geometric transition extrusion, overall manufacturing, assembly, and quality testing time can be significantly shortened with the GeoTrans process. For instance, the production volume of many long-term implants does not justify complex, automated assembly. However, a redesign to include a geometric transition can eliminate the need for manual assembly of a portion of the device. Additionally, with fewer components and secondary processes, the design validation step may be significantly shorter. The process for achieving compliance with international standards and regulatory requirements for a single part is also greatly simplified, due to risk mitigation.”

    Trelleborg offered the following examples of possible geometric transitions with GeoTrans technology:

    • Transitioning from a single lumen tube to a multi-lumen tube or splitting a multi-lumen tube into two or three single lumen tubes.
    • One or more lumen stops and restarts within a multiple lumen tube, eliminating the need for secondary operations, such as backfilling a lumen used for filling a catheter balloon.
    • A wound drain that comprises three separate pieces--an extruded tube, complex cross-section extrusion, and molded hub--can be created as a single extrusion with two or more distinct geometric cross-sections and a smooth, integrated transition instead of a hub.
    • Off-ration bump tubing, for applications requiring a variable outer diameter with either a constant or variable inner diameter, can be created with very short transitions down to fractions of an inch.
    • Bifurcated tubing, which traditionally has four components--a two-lumen tube, two single-lumen tubes, and a molded hub--can be produced in one extrusion process.

    The GeoTrans extrusion process has been used to manufacture products between 7 French and 24 French (on the catheter scale), it was reported.

    Visit Trelleborg at MD&M West Booth #2601 February 11-13.

    Trelleborg’s healthcare & medical operation
  • A partnership between Heraeus Medical Components and Myant Inc. will involve developing, testing, prototyping, and producing a solution using Heraeus’s Tecticoat coating for electrical-sensing textile applications. Tecticoat is a conductive polymer-based coating that can be applied to textiles to control electrical conductivity, electromagnetic shielding, and electrostatic dissipation, suiting it for integration into connected, on-skin textile applications.

    Flexible and robust, Tecticoat can overcome some of the challenges associated with electrodes interfacing with the human body via the skin. Tecticoat can be applied onto yarns such as the ones developed by Myant for its bioelectrical on-skin sensing (e.g., ECG, EEG, EMG) textile applications. 

    “The quality of data collected from the human body is highly dependent on the quality of the interface between the electrode and the skin,” said Tony Chahine, founder and CEO of Myant, in a news release. “This partnership with Heraeus to develop a solution using Tecticoat takes us another step closer to building a better bidirectional connection to the human body via textiles.”

    Added Heiko Specht, executive vice president of stimulation and sensing solutions and global innovation at Heraeus: “We are excited to enter into this partnership with Myant to develop solutions using Tecticoat. This partnership reflects our reputation and history as a leader in materials for advanced technological applications and we look forward to leveraging Myant’s experience in technology integration and yarn-based textile production to further explore Tecticoat’s use in wearables.”

    Heraeus will be exhibiting at Medical Design & Manufacturing (MD&M) West Booths #2101 and #700 February 11-13.

    [Image courtesy of HERAEUS MEDICAL COMPONENTS]

  • Covestro is introducing two medical-grade polycarbonate families for surgical devices and drug delivery. Covestro will exhibit at Pharmapack, February 5-6, in Paris, in Booth K46, and at MD&M West 2020, February 11-13, in Booth #2221.

    New glass-filled polycarbonates are developed for surgical and drug-delivery applications in need of stiffness and strength, such as load-bearing internal components for drug-delivery devices and for handles for minimally invasive or laparoscopic surgical tools. 

    These grades are divided into two series with varying levels of reinforcement. The high-performance series includes Makrolon M810 GF, Makrolon M820 GF, and Makrolon M830 GF polycarbonate. In the high-flow series, Makrolon M410 GF, Makrolon M420 GF, and Makrolon M430 GF polycarbonate are used for filling larger or thinner parts with improved productivity.

    Covestro offered the following advantages of Makrolon®GF polycarbonates:

    • Biocompatibility according to ISO 10993-1 for applications less than 30 days.
    • Superior rigidity and strength.
    • High-gloss surface achievable with rapid heat cycle molding.
    • Higher tensile modulus and tensile strength, and improved dimensional stability under stress when compared to unfilled polycarbonate.

    “Our expanded materials offering gives healthcare OEMs access to a wide range of glass-filled polycarbonate products that deliver performance tailored to fit their applications,” said Doug Hamilton, global healthcare marketing leader, Covestro LLC.

    To meet low-friction requirements for easing drug delivery, Covestro is launching three new medical-grade polycarbonates: Makrolon M204 LF, Makrolon M402 LF, and Makrolon M404 LF. These grades featuring reduced coefficients of friction and provide the dimensional and mechanical properties of polycarbonate while eliminating the need for external lubricants. Covestro offers the following benefits to drug delivery devices:

    • Lower deployment forces
    • Durability and biocompatibility according to ISO 10993-1
    • Sterilizable with various methods, including autoclave, ethylene oxide and radiation (e-Beam, gamma)

    “We built on the superior performance of polycarbonate to formulate low-friction grades that offer consistency and versatility which, in turn, help OEMs design devices that address emerging drug delivery trends,” said Hamilton.

    [Image courtesy of COVESTRO]

  • Davis-Standard LLC will run a TPE tubing and ABS filament line at Booth #4024 during MD&M West 2020 February 11 – 13, running TPE tubing on the first two days and ABS filament on day three. The TPE tubing will measure 0.145 in. OD by 0.0108 in. ID, and the ABS filament rod will be 1.75 mm OD. The line can process a variety of flexible tubing materials at speeds up to 300 feet per minute (91 mpm).

    “This line is an excellent example of a space-saving system that can be used for both medical and industrial tubing. We have numerous larger scale lines like this one in the field, capable of running in excess of 800 feet per minute,” said Kevin Dipollino, Davis-Standard’s senior product manager of pipe, profile, and tubing systems, in a news release. “For purposes of the show, we want to demonstrate a smaller foot print and functionality for line speeds up to 300 feet per minute when space is a limiting factor. The line also features a turn sheave to enable processing at a 90-degree angle to accommodate additional space limitations such as those found in clean room environments.”

    Line components include a Davis-Standard 2-inch (50mm) Super Blue Extruder with e-TPC-II controls, a Guill spiral crosshead die and tooling, a Conair 12-foot multipass vacuum sizing tank, a servo puller and automatic and transfer coiler, and Zumbach OD/ID wall gauge and control system. The TPE material will be supplied by Teknor Apex.  

    Every line component is engineered for tight tolerances, consistent quality, and output efficiency, the company reported in the release. The DS-eTPC II control has become a popular option for medical tubing processors, adding flexibility to support more applications at an attractive price point, it explained.

    [Image courtesy of DAVIS-STANDARD LLC]

  • Leapcure has expanded its suite of clinical trial services to help medical device companies with patient recruitment, enrollment, and engagement. Services in clinical feasibility, site selection, public awareness, and recruitment have all been shown to increase enrollment rates leading to successful trials, the company reported in a news release.

    Leapcure's public awareness service includes a network of 3500 health organizations, representing millions of patients. Its protocol-level feasibility service assesses whether a clinical trial’s goals are achievable and ensures that trial requirements are designed with patients in mind. Its site selection support incorporates recruitment viability, identifying sites that will be effective recruitment partners.

    Leapcure reported that these services along with its adaptive recruitment services when enrollment opens has led to an impressive average refer to enroll ratio of 10:1, five times more efficient than other recruitment offerings. 

    “Using a multi-pronged approach to recruitment, we find the right patients for clinical studies and guide them through the recruitment process so everyone’s expectations are met. This is critical for ensuring a trial meets timelines and stays within budget, ” said Zach Gobst, CEO of Leapcure, in the release. “Ultimately, we make enrolling in a clinical trial easier for every party involved so that research funding is optimized and innovation moves forward.”

    [Image courtesy of LEAPCURE]

Filed Under
500 characters remaining