MPMN_Medical Product Manufacturing News

Medical Product Manufacturing News, November/December 2015

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Q M E D . C O M / M P M N M E D I C A L P R O D U C T M A N U F A C T U R I N G N E W S N O V E M B E R / D E C E M B E R 2 0 1 5 1 7 A Friction-Reducing Additive Compounding Solutions in September 2014 introduced its Mobilize lubricious, friction-reducing additive, which it boasts can produce a 20-40% reduction in friction. Such reduced friction can reduce the amount of force required to insert or retract a device. Mobilize can even allow the potential removal of FEP, PTFE, or HDPE liners during device processing, and can cut costs in half compared to traditional processes that utilize PTFE liners and hydrophilic coatings, according to the Lewiston, ME–based company. New Coating Could Enable Tinier Electronics in the Body Biotectix (Richmond, CA) claims it has found a more durable way to enhance electrodes with conductive polymer coatings. The development could further enable the miniaturization of implantable medical devices. The company in June announced a license with Acutus Medical for the use Biotectix's Amplicoat on their EP mapping catheter. "We're currently working with them towards regulatory approval and commercial launch of the coated devices," says Biotectix's co-founder and engineering director Jeff Hendricks, PhD. Biotectix has found that Amplicoat-coated electrodes can be up to 80% smaller than traditional metal electrodes that are several millimeters across, and still deliver the same amount of energy, Hendricks says. The company, which started in Michigan, moved in summer 2015 to a new, larger facility near Silicon Valley. The new facility has controlled, dedicated manufacturing areas, and Biotectix is in the process of getting ISO 13485 certification. An Affordable Professional-Grade Desktop 3-D Printer Formlabs—the four-year-old 3-D printer company that raised nearly $3 million in a Kickstarter campaign—is touting its new Form 2 stereolithographic 3-D printer as ideal for creating medical device prototypes. The Form 2 is a professional-grade desktop 3-D printer that costs only a few thousand dollars. The Form 2 excels at producing intricate parts, thanks in part to its ability to use laser light to cure resin, according to Formlabs (Somerville, MA). TechCrunch referred to the Form 2 as the first refined consumer-grade SLA printer. New Fibers for Drug Delivery TissueGen's ELUTE fibers, first commercially available in 2013, deliver a wide range of drugs and therapeutic agents from small pharmaceuticals to proteins (growth factors, enzymes, even viral particles) with retained biological activity directly to the surgical implant site. The Dallas- based company's patented drug delivery platform enhances the effectiveness of both the drug and provides a mechanical scaffold. ELUTE fiber's novel approach has far-reaching implications for many medical applications including, but not limited to, regenerative medicine, peripheral nerve and spinal cord repair, cardiovascular, orthopedic and dental applications, tumor remediation, and dermal wound healing. TissueGen R&D applications have included: • Anti-fibrillation devices. • Cardiovascular stents. • Coatings for cardiac stents. • Growth factor-loaded "smart" sutures. • Nicotine-induced angiogenesis. • Ocular drug delivery for diabetic retinopathy. • Scaffolding for peripheral nerve regeneration. • Urological stents. • VEGF delivery to induce angiogenesis in the retina. • Tumor remediation. • Root canal applications. • Nerve regeneration. Drug-delivering Fibers with a Host of Applications

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