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Supplier Stories for the Week of April 21

Here’s what was new in the world of medical device suppliers during the week of April 21

  • Phillips-Medisize, a Molex company, is reporting that its Little Rock, AR, facility is fully compliant with Current Good Manufacturing Practice (CGMP) regulations. Described as 21 CFR part 820 compliant, the 380,000-sq-ft facility enhances Phillips-Medisize’s medical manufacturing services with such capabilities as molding, stamping, plating, and assembly, thus enabling vertical integration of manufacturing, electronics, and connected device solutions all in one site, the company reported in a news release.

    The facility combines the innovative solutions and knowledge of Molex’s existing electronics production operations with Phillips-Medisize’s expertise in drug delivery and medical devices. For decades, Phillips-Medisize has been designing, developing, and manufacturing drug delivery devices. “We believe most drug delivery devices will benefit from being part of a connected health system. For that reason, we diligently pursue opportunities for lowering the cost of adding connectivity modules to drug delivery devices,” said Matt Jennings, CEO and president of Phillips-Medisize, in the release. 

    The facility also leverages existing dedicated white space along with Class 8 cleanroom space for medical manufacturing, the company reported.

    [Image courtesy of PHILLIPS-MEDISIZE, A MOLEX COMPANY]

    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.”

  • Specialty Coating Systems announces that it will co-host the Reliability of Circuit Assemblies Workshops that will begin touring in May 2019. Providing Parylene conformal coating services and technologies, SCS has more than 45 years of experience and expertise. The company also offers liquid coating systems including spray, spin, and dip coating systems and ionic contamination test systems. 

    The workshops will be held in Rockville, MD (May 21); Melbourne, FL (June 25); and Tampa, FL (June 27). Experts from across the circuit assemblies community will discuss topics such as cleaning, conformal coating, soldering materials, failure analysis, new IPC cleanliness testing standards, and more. Speakers will include industry thought leaders from Aqueous Technologies, ZESTRON, Foresite, Specialty Coating Systems, and FCT Solder.

    [Logo courtesy of SPECIALTY COATING SYSTEMS]

    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.”

  • In March, West Pharmaceutical Services Inc. opened its new Digital Technology Center (DTC) in Bengaluru, India, to serve as a global center of excellence for the company's Digital and Transformation (D&T) team, alongside teams based in Exton, Pennsylvania, and Eschweiler, Germany.

    "Our team at West appreciates and understands the important role that technology plays in our business and the tremendous opportunity it has to enhance the way in which we operate, both externally and internally," said Silji Abraham, chief digital and transformation officer, West, in a news release. "This Digital Technology Center will allow our team to create compelling digital experiences for our global customer base across hemispheres, source talent from India's fast-growing technology industry, and bring forward the latest digital advancements to create insights and value for our customers and team members—ultimately delivering better business results."

    The center is part of West's ongoing efforts to enhance customer engagement through digital marketing, digital manufacturing, and automations to accelerate internal and external business processes. Last year, West launched its online Knowledge Center to provide scientific insight and detailed technical information in the form of scientific reports, bulletins, presentations, and literature from its skilled team of professionals. West also launched its e-commerce platform earlier this year to provide a one-stop solution for small-quantity containment and delivery products and services from West.

    West has had a presence in India since 2004 with a commercial office in Hyderabad and established a manufacturing plant in Sri City in 2014.

    [Image courtesy of WEST PHARMACEUTICAL SERVICES INC.]

    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.”

  • GreenSoft Technology Inc., a provider of environmental compliance data services and software, has released a software solution to address the challenges presented by the EU REACH “Once an Article, Always an Article” (O5A) process of substance calculations. According to a 2015 European Court of Justice decision, companies need to evaluate Substances of Very High Concern (SVHCs) at the article level of a component or product rather than at the component or product level.

    GreenSoft Technology's updated GreenData Manager (GDM) software allows users to dynamically apply article designations for each material present in a part and can process complex articles made of multiple materials within a part. These changes give users the flexibility to decide the level at which to calculate articles so that users can comply with the EU REACH O5A ruling, the company reported.

    After what the company called a successful beta-test period with select customers, the wide release of this update has now been made available to all existing customers and is a standard part of all GDM software purchases going forward.

    [GREENSOFT TECHNOLOGY INC.]

    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.”

  • Grant Thornton LLP has launched the cloud-based assessment and project management tools SmartMDR and SmartIVDR for medical device and diagnostics companies working to comply with the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). To achieve or maintain CE marking, companies must assess their technical files and quality documents against the EU’s MDR and IVDR in a consistent, structured way, the company stated in a news release.

    “A number of factors are combining to create a perfect storm," explained Marty Zuzulo, compliance risk director at Grant Thornton, in the release. "The regulations themselves are sweeping – almost a doctrinal shift in certain areas from previous directives. On top of that, the regulations diminish the number of notified bodies, or third-party agents, certified to conduct compliance assessments and audits. The more stringent regulatory environment and the throttling of the review and approval ‘supply chain’ is creating significant challenges for affected companies.

    “Our SmartMDR and SmartIVDR tools allow for rigor and consistency in what is a program management challenge within many organizations,” continued Zuzulo. “They establish a structured, repeatable way for companies to conduct and capture technical and quality document assessment data – and to estimate costs and levels of effort to remediate gaps identified in product compliance assessments.” 

    For instance, the tools allow companies to prioritize remediation efforts by focusing on their most important products and documents. They also provide near real-time project tracking of all critical remediation efforts and a flexible dashboard with holistic progress reports toward identified target dates. 

    “The bottom line is that without overhauling ad-hoc approaches to product compliance assessments, companies’ revenue is at risk, and they need a robust way to protect it. These tools can help companies stay compliant and preserve revenue,” concludes Zuzulo. 

    [Logo courtesy of GRANT THORNTON LLP]

    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.”

  • Startup Sidhu Laboratories is introducing a class of 100% solid-state, high-performance polymer electrolytic membranes called SiLyte that offer numerous advantages over standard liquid electrolytes used in traditional batteries. They are void of any ionic liquids, low-boiling point solvents, or low-viscous oils and gels, the company reported. 

    Manveer Sidhu, president, Sidhu Laboratories, who serves as founder, materials scientist, and principal researcher, told MD+DI that this technology can be used as a power source for medical devices. It is not flammable and has a wide temperature operating range, and it works as a replacement to failing battery sources, he said.

    “Our energy storage technology serves as the basis for higher energy/power density, more economical and safer cell designs,” stated Sidhu in a news release. “SiLyte represents a scientific breakthrough that moves the concept of solid-state batteries from the laboratory to real-world applications – now and not in a decade.”

    Reported characteristics include:

    • Safe: enables the development of non-flammable, chemically-inert and safe batteries.
    • High-thermal stability.
    • Non-toxic components.
    • No outgassing of hazardous chemicals at high temperatures and nonflammable.
    • High Performance: outlasts conventional storage systems.
    • Room temperature ionic conductivity up to 1.4 mS/cm.
    • Lithium-ion transference number of 0.60.
    • Electrochemically stable up to 5 volts.
    • Mechanical strength.
    • High elastic modulus.
    • Nanofiber-reinforced component structure.
    • Flexible and resistant to deformation upon bending.
    • Flexible manufacturing enabling construction of unique battery designs.
    • Roll-to-roll processable.
    • Easily scalable into a variety of shapes.
    • Soluble in acetonitrile and NMP.
    • Economical: lowers manufacturing and shipping costs.
    • Low materials cost.
    • No sophisticated synthesis requirements.

    [Image courtesy of SIDHU LABORATORIES]

    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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