Supplier Stories for the Week of May 20

Here’s what was new in the world of medical device suppliers during the week of May 20.

  • 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]

  • BTG Labs has developed Surface Analyst, a handheld solution for inspecting flexible packaging film. In two seconds, the Surface Analyst can measure the surface energy level of a film surface and determine whether it is properly prepared for adhesion. Ensuring the surface condition and consistency of a film is a vital component for guaranteeing success when printing or sealing a flexible package or pouch, or when printing a film label, the company reported in a news release.

    BTG Labs will be exhibiting at MD&M East Booth #762 in New York City June 12-14.

    Dyne pens and inks have been the industry standard for inspecting film surface tension in recent years, given that they are typically inexpensive. However, one of the primary negative aspects of dyne inks is that they can be chemically destructive to the materials they inspect, resulting in wasted product, BTG Labs reports. They may also produce subjective results, and those results can vary from user to user.  

    With a push of a button, Surface Analyst quantifies the quality of the film surface. To acquire the measurement, the Surface Analyst uses patented ballistic deposition technology to deposit a highly purified drop of water on the surface of the film and measures the contact angle—a direct correlation to surface energy.

    [Image courtesy of BTG LABS]

  • Dunn Industries, a Tekni-Plex business, will showcase its acetal Catheter Core technology used to manufacture minimally invasive catheter shafts at MD&M East, June 12-14, in New York City. Dunn will be exhibiting in its sister business unit’s (Natvar) Booth #2039.

    Dunn’s proprietary process is 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, the company reported in a news release.

    Reinforced tubing can be used for diagnostic and guide catheters, high-pressure contrast injection tubing, and other minimally invasive devices. Adding reinforcement to the plastic tube wall improves torque transmission, kink resistance, column strength and internal pressure resistance, the company reported.

    Dunn also manufactures custom medical tubing for diagnostic and interventional devices from a wide range of thermoplastics.

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

  • BBI Solutions offers its Morffi signal enhancement technology to manufacturers of influenza tests who are working to boost the sensitivity of their rapid lateral flow influenza tests. FDA has issued new guidelines to improve the overall quality of testing for influenza and has reclassified rapid antigen influenza tests from Class I to Class II. Manufacturers need to  ensure their tests are re-optimised to identify the presence of influenza in potential sufferers, BBI Solutions reported. Its new technology boosts test sensitivity and provides an up to ten-fold improvement in the limit of detection, offering a faster time-to-result for situations where a quick diagnosis is critical to patient care, the company reported in a news release. 

    “Each year in the United States, seasonal influenza leads to between 140,000 and 710,000 hospitalizations and as many as 56,000 deaths. This is a devastating disease that has been a constant threat for hundreds of years," stated Morgan West, New Product Development Lead at BBI Solutions and one of the inventors of the Morffi technology, in the release. “Developing diagnostics that provide an accurate, rapid diagnosis of the virus is the first and most crucial step to tackling this global threat. Exploring and adopting new technology and approaches offers us the best possible chance of tackling influenza.

    “What many manufacturers have found is that although their assays may look good on paper, when they’re being used in the field they’re experiencing a high number of false negatives, which is putting people at risk and means their tests lack the sensitivity needed to meet the FDA’s new standards," West added.

    BBI Solutions has deployed the Morffi technology against multiple different targets using monoclonal and polyclonal antibodies and utilising both sandwich and competitive assay formats. Evaluations have taken place across the majority of diagnostic sectors where speed and improved sensitivity are crucial, showing some impressive results, the company reported.

    [Image courtesy of BBI SOLUTIONS]

  • Greenlight Guru is introducing Multi-Level Design Control, the latest version of its purpose-built medical device design traceability software.

    “Our original platform revolutionized the medical device design industry by moving design controls off of paper and into the cloud,” said Greenlight Guru co-founder and CEO David DeRam in a news release. “Now we are taking the next step and adding functionality to our platform for multi-level design controls for medical devices with multiple subsystems and components, as well as Software as a Medical Device (SaMD) products.”

    Multi-Level Design Control will allow medical device manufacturers to better manage components or sub-components by introducing hierarchical workflows, giving product development teams a more-structured, holistic view of their design’s components and providing a centralized workspace with real-time updates. It also incorporates Software as a Medical Device (SaMD) controls, allowing manufacturers to better visualize their hardware, firmware, and software components, including software-only offerings commonly found on smartphones and smartwatches.

    “The first release of our Design Control software was a game-changer for traceability,” said Greenlight Guru founder and VP of QA/RA Jon Speer in the news release. “Multi-Level Design Control takes advantage of the latest technologies to allow manufacturers to not only maintain FDA and ISO compliance but put their focus squarely on quality while developing the next generation of medical devices. Medical devices routinely have multiple components that have different design and production cycles that need to be managed separately. Multi-Level Design Controls allow for complete unity in digital workspaces to further expedite product quality.”

    Greenlight Guru is also updating “The Ultimate Guide to Design Controls for Medical Device Companies,” which incorporates the latest regulatory developments, workflows, and best practices.

    [Image courtesy of GREENLIGHT GURU]

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 pharmaceutical and medical device packaging, labeling, manufacturing, and regulatory issues 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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