Medical Devices Backup

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Topflight is recognized as a leading medical converter of components that require precise die-cutting, tight tolerances, and complex multi-layer laminations. With over 25 printing and converting presses, a full prototype lab, an in-line laser, and the strictest quality standards, Topflight works with both startups and established medical companies.

Our teams understand what it means to recommend materials and develop a product that works not only in the lab, but in full-scale production environments. Topflight is ISO 13485:2016 and ISO 9001:2015 certified, with a comprehensive testing lab to ensure that products are manufactured each and every time to exact customer specifications.

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Advanced Wound Care products are increasingly being used to treat chronic or severe wounds. As the demand continues to grow due to an aging population and a diabetes epidemic, new materials and capabilities are constantly being developed. Topflight’s wound care manufacturing capabilities include precision die cutting (steel rule, male-female, and rotary), laser cutting, prototyping, multi-layer laminating and assembly. In addition, delicate and low-tensile strength materials can be incorporated into designs with our precise electronic tension controls.

Topflight works with the leading medical materials and adhesives companies to design products that deliver premium performance and manufacturing efficiency. From skin-friendly adhesives, to breathable dressings and closures, Topflight can work with you to find the best material for your application. Some of our many key applications and products include hydrocolloids and hydrogels, island placement dressings, wound and suture closure strips, negative pressure dressings, patterned or zoned adhesives and IV site care.

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Manufacturing of diagnostic products requires unmatched precision, repeatability and materials knowledge. Topflight is recognized as a market leader and has worked with several Fortune 1000 companies in creating devices for blood/glucose monitoring; testing for pregnancy, HIV, drugs of abuse, and cholesterol; and for blood coagulation. Our extensive experience with a variety of converting techniques necessary for the medical field sets us apart from most printers or converters. ISO 13485:2003 and ISO 9001:2015 certification, Lean Manufacturing, and a host of our own mandated procedures ensure quality and confidence in every stage of product development.

Precision die-cutting with in-line laser cutting and punching gives Topflight maximum flexibility in designing and manufacturing parts economically. Some of the many products that can be produced on our wide variety of equipment include diagnostic test strips; microtiter plate lids, covers and adhesives; glucose monitoring devices; lateral & capillary flow assays and microfluidic tests.

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Manufacturers are increasingly adding conductive features to their medical devices, and have challenged Topflight to design components that are smaller and more advanced than ever before. Topflight has more than 30 years of experience producing printed circuits and other components for biosensors, antennae, heaters, transistors, blood coagulation devices and test strips. We have deep experience printing with both polymer thick films (PTF) and nanoparticle silver and carbon (graphene) inks. When higher conductivity is required, patterns can also be etched with copper or aluminum. Projects have been done on traditional polyester and polyimides, as well as thinner films, polycarbonate and paper.

Conductive tapes and adhesives can also be used to incorporate conductivity into product design. Topflight has built vendor relationships with the leading materials and adhesives manufacturers to have access to the latest developments in this area. As life sciences companies begin to incorporate more electronic components to their designs, Topflight is ready to assist with prototypes, design consultation and full scale production.

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The demand for products that help with patient safety, comfort and recovery is sky-rocketing as the population ages. At the same time, medical and surgical device manufacturers are under continuing pressure to reduce cost while adding features and value to their products. Having a manufacturing partner that will design products for efficient production is critical in today’s environment.

Topflight has over 40 years of experience in the medical industry, and brings a wide range of capabilities to the table for our customers. We can take your product from the prototype stage, to low-volume production, and then ramp seamlessly to high-volume manufacturing. Precision die cutting, laser cutting, multi-layer laminations, and up to 12 printing stations can all be combined to design the product you want, at the price you need. Some of our many capabilities include pulse oximeters, transdermal patches, EMI/RFI shielding, gaskets and spacers (Poron^® & other closed/open cell foams) and radiological markers.

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A variety of materials are available for delicate adhesive applications involving direct skin contact, including active ingredient delivery systems and indicating labels. Because Topflight also manufactures components for leading pharmaceutical companies, we have years of experience die-cutting and printing such materials successfully.

ISO 13485:2003 and ISO 9001:2015 certified, Topflight operates under stringent guidelines and strict confidentiality practices. Our outstanding research and development staff works with clients from the inception of an idea through commercialization of the product. We offer the broadest range of manufacturing capabilities available, specializing in precision die-cutting, silicone adhesives, adhesive-free zones, non-reactive materials, hydrophilic and hydrophobic adhesives, moisture barrier foils, and high MVTR films.

Shampoo Labels used in the Cosmetics & Personal Care Markets

Eat the Bear labels shown on supplements in the cosmetics section of the Topflight website

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When fully implemented, the FDA’s new Unique Device Identifier (UDI) system will improve the accurate identification of all medical devices on the market and the critical information that goes along with these devices. As labeling on most devices will now require a UDI in human- and machine-readable form, Topflight can print these for you, from the UDI and prime label to the barcode and shipping labels.

Topflight can help make this transition effortless, with our digital printing option providing perfect ink-to-ink registration, type down to 1 point, and incredible detail in images, all while contributing to a greener and more sustainable environment. Variable content and serialization are highly cost effective with database-driven print files and shorter runs with lower quantities are more economical when printed digitally.

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Medical Devices Backup

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