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Polymers in medical devices expected to grow rapidly over next decade and spur material innovations

Polymers in medical devices expected to grow rapidly over next decade and spur material innovations

Device innovations, demographics and hospital austerity will drive the global medical device market. Kalorama Information's analysts presage a US$312 bln medical device market in 2011. Few of the drivers for medical device market globally include growing demand for healthcare services in emerging nations, the need for reducing hospital stays and the ageing world population. This market includes products as different as complex MRI machines, laparoscopic surgical equipment, wheelchairs and medical gloves. Kalorama sees roughly 4-6% growth for the next few years in the global device market, which was valued at US$290 bln in 2009. Growth has been slow the past few years, given the world recession. But as the economy recovers and new middle class customers in emerging markets demand better healthcare services, the pace of revenue growth is predicted to increase. Patient monitoring, oxygen systems, home dialyses anything that can reduce hospital stays and keep patients at home with their family are seeing faster revenue growth. The global top 10 medical devices market is estimated to reach US$228 billion by 2015, growing at a CAGR of 6.8% from 2010 to 2015. The cardiovascular devices, orthopedic devices, and diagnostic imaging devices markets are the major revenue generators for the medical devices industry as per Markets and Markets. The use of polymers in medical devices is expected to grow rapidly in the next decade. The possibilities for new product development using medical polymers are endless and start with essentials like lenses, catheters, stents, joint replacements. The past few years have seen robust growth of innovative application of polymers in medical devices, driven mainly by design and technology developments, enabling their use in ever more complex medical devices and replacing conventional materials. The use of polymers in medical devices is expected to grow rapidly over the next decade and beyond. Leading polymer manufacturers are developing diverse and innovative products and technology for the hygiene and medical market. Some of the developments include:

Dow Chemical's ASPUN Fiber Grade Resins and INFUSE Olefin Block Copolymers. ASPUN Fiber Grade Resins are being used for over two decades to address the trends in hygiene nonwovens like infant diapers, feminine hygiene articles, and adult incontinence products, offering:
• Excellent nonwoven softness and drape
• Excellent spin ability, giving nonwoven manufacturers an opportunity to run their lines significantly longer between die changes
• Increased elongation properties for good comfort fit in the final application
• Low dust for a clean processing resin
Due to their low melting point, they are also suitable for lamination and thermal bonding applications such as monocomponent or bi-component fibres. They are used in soft nonwovens, spun in bi-component spunbond with Polyethylene Terephthalate (PET) cores for softness and combined with both polypropylene (PP) and PET for bi-component staple fibres for absorbent core strength. With the addition of polyethylene-based AMPLIFY MAH-Grafted Functional Polymers, it improves adhesion between polymeric and cellulose fibres, resulting in improved wet-ability. High molecular weight grades of INFUSE Olefin Block Copolymers (OBCs) now help enable blown film converters to create elastic products with advantaged processibility, elastic performance, and sustainability for the hygiene market. The combination of appropriate viscosity, fast crystallization kinetics and a unique multi-block structure may result in:
• Suitability for conventional monolayer and coex blown film technologies
• Excellent bubble stability
• Outstanding elastic performance (low hysteresis and permanent set)
• High elongation to break and tensile strength
• Sustainability of olefins (low energy consumption, low carbon footprint)
• Economy (ability to achieve very low basis weight films)
As a result of this advantaged combination of processibility, performance, sustainability, and economy, INFUSE OBCs present an attractive alternative to formulated styrenic block copolymer compounds (SEBS/SEPS, SIS, SBS, etc.), and random propylene and ethylene copolymers for blown film suppliers who are interested in developing innovative elastic products for the hygiene market.

Borealis has expanded its Borsoft grades for extruded film applications such as medical pouches and monoblister packaging as an alternative to PVC, glass and other polymers. The grades are said to offer low migration into medical products and liquids and provide high security and integrity during transport and handling. Compared to block copolymers, these grades offer superior optical film and welding properties. Bormed™ LE6601-PH has since proven itself in the market for eye, ear and nose drop treatment ampoules as well as dip-tubes in pharmaceutical sprays. Packaging converters benefit from trouble-free conversion on standard blow moulding and blow, fill and seal (BFS) machinery. Wall thickness and ampoule weight are easy to control due to it's optimised molecular weight distribution that produces material with low swell. This allows difficult shapes to be formed, while ensuring straightforward dosing to simplify production of consistent, high quality ampoules. The easy processing creates less waste and a low energy requirement during extrusion. High flow Bormed™ HE9601-PH developed for high speed injection moulding with decreased energy use. This HDPE grade creates productivity improvements for manufacturers of, for example, two-part syringe plungers, caps and closures, etc. With a melt flow rate (MFR) of 31, this grade delivers a flow rate improvement of up to 2.5 times that of comparable alternatives. The injection moulding process, particularly components with complex design parameters or long flow lengths, is simplified. Converters see faster production and increased throughput at decreased pressure and temperature. Energy and mould maintenance requirements are both lowered providing a cost advantage. These benefits are gained without compromising the performance of medical devices and pharmaceutical and diagnostic packaging. Another Bormed development leading the way in creating new opportunities for improved performance and efficiency in the healthcare market is Bormed™ SC820CF for primary and secondary medical pouches. This random heterophasic polypropylene (PP) copolymer for cast- and blown film applications combines softness with toughness and is steam sterilisable. It also maintains good optical and mechanical properties after retorting. This grade is iintended as a blending component or co-extrusion layer for primary pouches with contents such as intravenous (IV) solutions, nutrition and dialysis fluids. Furthermore it is used as part of the solution for secondary wrap films for dust and vapour barrier and protection. This new material contributes to all PP pouch solutions, which serve as a viable alternative to commonly used glass bottles or polyvinyl chloride (PVC) pouches.

Heat-stabilised polypropylene (PP) from Quadrant Engineering Plastic Products withstands repeated steam and autoclave sterilisation cycles thanks to its deflection temperature (HDT) >149°C under 0.455 MPa (66 psi) load. Resistant to cleaning agents, disinfectants and various solvents, the material is suitable for the fabrication of surgical trays, caddies and components routinely used in life science applications. Such parts are often difficult to produce by injection moulding, owing to their complexity and the need to use high viscosity resin. The Proteus LSG HS PP material is supplied in plate form. The production process includes a proprietary heat-treatment phase, which increases HDT, improves machinability and optimises dimensional stability. The material is described as a cost-effective alternative to polyphenylsulphone (PPSU) in cases where temperature resistance is less critical, but resistance to repeated sterilisation cycles is still needed. Quadrant LSG stock shapes are tested and evaluated for biocompatibility according to ISO 10993. The plates are available in white and black, and in thicknesses of 25.4, 38.1, and 50.8 mm. Standard size is 600 x 1200 mm.
Bayer MaterialScience has added a new grade of polycarbonate to its Makrolon series. The Makralon 2258 polycarbonate is designed for moulding devices with thin walls and long flow lengths. It is a high-flow grade with an internal mould release additive that allows it to be more easily released from the mould. These properties mean that designers can use less material, offering greater processing efficiency. The material allows for ethylene oxide and steam sterilisation at 121°C. It is especially suitable for applications such as needle safety guards and other medical devices requiring thin walls and complex components. It can be used for devices with walls as thin as 0.355 mm and flow lengths as long as 150 mm.
Clariant Masterbatches and TOPAS Advanced Polymers are working together to bring bright, clear colors to medical devices and packaging made of TOPAS cyclic olefin copolymer (COC). The new color concentrates and pre-color compounds are part of the MEVOPUR family of products developed and manufactured for customers whose applications call for risk control, consistency of product and regulatory compliance. TOPAS COC offers high shine even in thick sections and, unlike resins such as polycarbonate and polyester, has a non-reactive surface for pharmaceutical packaging and medical devices. It is also free of bisphenol-A and estrogen-active components. The colors being presented represent both a standard palette and custom formulations. They use only raw materials that have been biologically evaluated against USP parts 87 and 88 (Class VI devices) and/or the international standard ISO10993. Segregated manufacturing lines to reduce the risk of cross contamination, and segregated storage and change-control processes ensure consistency.

 
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