• What to consider when manufacturing a silicone soft skin adhesive coating

    All stages of the manufacturing process are important to obtain the soft skin adhesive or wound contact layer that meets both the manufacturer’s productivity targets and the customers’ quality requirements. Teamwork among the silicone supplier, the manufacturer and the final product designer is key to ensure success. Clément des Courières, Elkem Silicones The proven biocompatibility… […]

  • Packaging: Not a last-minute decision

    Your new package design and related equipment are validated. Can you live with a hurried decision for the next 10 years? John Abraham, Atlas Vac Machine The packaging engineer is too often invited “late to the party” when a new medical device is being launched. The device packaging design process is no time for shortcuts… […]

  • FDA committed to studying breast implant safety

    By Dr. Binita Ashar, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health Choosing to obtain a breast implant, whether for augmentation or reconstruction, is a deeply personal choice, from the initial decision to undergo breast implant surgery to the size, material and surface texture. These types of… […]

  • The top 10 medical disruptors of 2019

    The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year. The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150.… […]

  • How to work with a third-party testing lab

    Clear communication is key to success when working with any test lab partner. Maintaining good communication and following these tips will help result in a positive testing experience for all. Kaitlin Bladl, DDL, Inc. A minor misstep in product development and testing can have devastating consequences. While testing is unavoidable for most all medical device… […]

  • 3D printing patient-specific models

    Patient-specific anatomical replicas are an invaluable resource for improving pre-surgical planning. Detailed patient scans translate into 3D files ready for export to additive manufacturers, enabling virtual exploration and optimization of implants for users. Jessica James, Synopsys, Inc. Radiology labs have traditionally relied on software that was designed for clinical diagnosis and measurement of imaging data… […]

  • How six-axis robots are transforming medtech manufacturing

    As industry 4.0 evolves, medical manufacturers are finding six-axis robots valuable all along the production line. Oliver Cremoux, Stäubli Corp. The increasing popularity of six-axis robots is part of the growing industry 4.0 trends. Robots help streamline production lines, increase productivity and optimize workflows. They can be used for a variety of medtech production processes including… […]

  • FDA clarifies human subject requirements for clinical investigations

    By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains how its clinical investigation requirements pertaining to human subject protection policies correspond to US federal policy on human subject protections enforced by the Department of Health and Human Services (HHS). Get the full story here at the Emergo Group’s blog.… […]

  • What are high-heat thermoplastics and how do they work?

    Jonathan Jurgaitis, Spectrum Plastics Group High-heat thermoplastics are a group of polymers that receive this designation because of their elevated processing temperatures, typically between about 550 °F to 750 °F. Some of the more common high-heat polymer types are PEEK, Ultem, PSU, PPS, but many other material types also fall into this category. These materials… […]

  • Mapping for meaningful solutions

    Delivering human-centered solutions in healthcare means thinking about the total user experience from start to finish. Each design decision lies within a deeply interdependent, complex system, and the process of creating a seamless experience is complicated, too. Ami Verhalen, Design Concepts Experience and system-level maps are powerful tools to help teams to design the right things.… […]

  • Vascular catheter construction: Reviewing the basics and what’s new

    Advances in catheter components are paving the way for improved, more sophisticated devices. A super-thin-walled PTFE catheter base liner presents new opportunities for smaller devices. MRI-compatible LCP braiding is stronger than previous non-metal braidings and rivals the strength of some stainless steel braidings.  Kevin Bigham, Zeus Vascular catheters are paramount for non-invasive surgeries, serving as the… […]



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