“We are pleased to demonstrate our commitment to our South American customers and especially Brazil’s growing healthcare industry by participating in the first MD&M show in the region,” said Ricardo Knecht, general manager, South America, Innovative Plastics. “Because SABIC has a global focus on our healthcare customers’ specific needs and circumstances, our South American customers benefit from our worldwide resources and innovations in materials and application development. At a local level, medical and dental OEMs can take advantage of our reliable supply of materials, industry expertise and services to help them bring products to market quickly and cost-effectively.”
To strengthen SABIC’s local offerings, manufacturing facilities in Campinas, Brazil and Tortuguitas, Argentina, have been certified to produce U.S. Food and Drug Administration (FDA) food contact compliant materials as well as materials needing ISO 10993 biocompatibility. These certifications can not only help South American customers shorten lead times, reduce inventory costs and increase flexibility in material purchasing, but can also support anticipated strong growth in healthcare spending in Brazil, which is expected to increase by a compound annual growth rate of 4.5 percent between 2011 and 2014.1
Innovative Materials Focus on Safety
Improving safety for patients and caregivers is one of the top issues in healthcare today. Replacing traditional materials with high-performance thermoplastics can enable greater protection, improve ergonomics and enhance usability. SABIC is exhibiting a variety of medical and dental applications that show the diverse ways that its materials can contribute to safety.
• A pill sorter cover molded from LNP Stat-Loy compound provides permanent anti-static properties to prevent medication from adhering to device walls, resulting in inconsistent dosages. The SABIC material replaced PC to provide better performance.
• To avoid the use of lead in its X-ray collimator, GE Healthcare turned to SABIC’s LNP Thermocomp HSG (high specific gravity) compound, which provides excellent shielding properties. This specialty compound also offers greater design freedom than lead because it can be injection molded – avoiding the time and cost of secondary operations such as machining and adding inserts.
• Sartori Instruments, Implants and Fixers chose a SABIC solution in lieu of traditional metal in sterilization boxes for surgical implants. Using biocompatible Ultem polyetherimide (PEI) resin, the company designed a box featuring a translucent cover that allows clinicians to check the contents without opening the box – and possibly introducing contamination. The expanded design freedom of a thermoplastic vs. metal allowed Sartori to minimize sharp corners and other features that can reduce cleaning efficiency and trap bacteria.
Thermoplastics Enable Portability, Usability, Consumer Appeal
To support the trend toward moving care to the outpatient and home settings and bringing care to the patient, medical devices are becoming smaller and more aesthetically appealing to consumers. SABIC materials are making an important contribution by enhancing design freedom, reducing weight and providing new colors and effects.
• The portable Neurovision 500P pocket Transcranial Doppler (TCD) device from Multigon Industries, Inc., provides a new way to detect unseen, yet traumatic, brain injuries in the field. To provide required shielding from radio and electromagnetic interference, the company chose SABIC’s LNP Faradex* compound, a PC-based material with stainless steel fibers, for the housing. The material minimizes weight for maximum portability.
• To create the Breastlight device for breast self-examinations at home, Scotland’s PWB Health Ltd. selected SABIC’s Cycoloy PC/ABS HC resin for the housing components. Cycoloy resin offers high flow for thin-wall molding that can cut the weight of hand-held devices. This grade is assessed for biocompatibility in accordance with the ISO 10993 standard.
• Indusbello selected SABIC’s Ultem resin for its sterilization trays for medical and dental instruments. Compared to metal, Ultem resin delivered design flexibility, transparency, superior aesthetics and enhanced productivity through injection molding. Its ability to be custom colored using LNP Colorcomp* compound further expanded design freedom.
• To enhance its new dental station, Gnatus replaced polyamide with Valox* polybutylene terephthalate (PBT) resin in the articulators. Valox resin provided outstanding chemical resistance to maintain appearance over time, as well as custom color for superior aesthetics.
Healthcare Product Policy Expedites Device Development
SABIC created a comprehensive Healthcare Product Policy including more than 50 high-tech healthcare materials designed with the intent of supporting OEMs in achieving regulatory compliance for their applications. The policy gives OEMs the confidence that SABIC materials meet global safety standards, are pre-assessed for biocompatibility and offer consistent formulation. It is contributing to faster market approval and successful commercialization of a range of medical devices.
For example, Biorep Technologies was able to bring a distinctive diabetes treatment to the market quickly and efficiently by selecting Ultem HU resin from the SABIC healthcare portfolio. The Ricordi Chamber isolates and purifies islets for transplantation in patients whose Type-1 diabetes cannot be controlled with insulin injections. It is used to break down the pancreas mechanically and chemically to isolate these islets. The Ricordi Chamber was originally custom-made from stainless steel, which was quite heavy to shake during the 30-45 minute isolation process and prevented doctors from visually assessing progress. Injection molded Ultem HU resin provides lighter weight, translucence and autoclave capability, while speeding up the manufacturing process.
Another illustration of the benefits of SABIC’s Healthcare Product Policy is the Braile Biomédica membrane oxygenator. The company wished to streamline production and reduce manufacturing breakage that resulted in costly waste. Using a healthcare grade of high-impact, transparent Lexan PC resin to replace acrylic, Braile Biomédica reduced breakage during processing and cut adhesive cure time from 12 hours to approximately one minute.
The SABIC Healthcare Product Policy provides:
• Easily identifiable product nomenclature (“H” or “PCG” series resins)
• Biocompatibility assessment according to ISO 10993 or USP Class VI
• Food contact compliance for most healthcare products
• FDA Drug Master File and/or Device Master File listing (letter of authorization provided as needed)
• A “formula lock” and stringent management of change process