Global medical plastics market is projected to exceed 10 billion lbs by the year 2015, as per Global Industry Analysts, Inc. Biocompatibility, autoclavability, chemical resistance, transparency and the ability to produce complex shapes make plastics an ideal choice for medical applications. Besides, the demand for plastics in medical devices is also propelled by its ability to produce low-weight medical devices. Plastics currently form one of the most important components of the medical industry. Medical device designers and engineers increasingly prefer plastics to conventional packaging materials such as metals owing to superior flexibility offered by plastics in fabrication process. Advancements in sterilization techniques, shift towards disposable devices, development of enhanced plastic materials, and technological innovations are factors driving the overall market growth and expansion. The development of novel materials such as biocompatible polymers for use in medical implants will furthermore provide the required impetus for the global medical plastics market.
The United States represents the single largest market for medical plastics worldwide, as stated by a new report on Medical Plastics. The medical plastics market is projected to grow rapidly in the near future, particularly in developing countries such as Asia-Pacific and Latin America, driven by a gradual increase in demand for sophisticated medical devices, and enhanced medical care. Asia-Pacific constitutes the fastest growing market for medical plastics in the world. In terms of end-use segments, medical product components represent the largest and the fastest growing end-use segment as compared to medical packaging.
Some of the new technology and material developments include:
Bionate® Thermoplastic Polycarbonate Urethane (TPU) is a thermoplastic elastomer with oxidative stability. These polymers are attractive in applications where oxidation is a potential mode of degradation, such as in electrostimulation leads, ventricular assist devices, and catheters. They are also extensively used in orthopedic applications for their tough, load bearing qualities. Its benefits include
• Combines flexibility with strength
• In vivo biostability, biocompatibility and oxidative stability
• Tough, load bearing qualities and resistant to abrasion
• Available with customizable hardness and/or Surface Modifying End Groups®
• FDA Master File
DSM’s agreement with Interventional Spine Inc. grants use of Bionate® PCU, a proprietary DSM polymer, in its PDS System™. The Percutaneous Dynamic Stabilization system is the first and only percutaneous bilateral facet-augmentation system for treating degenerative disc disease and Lumbar Spinal Stenosis. The Interventional Spine PDS System™ implant is delivered percutaneously through the skin, making the over-the-wire procedure minimally invasive for the patient. The tough, load bearing qualities help secure the implant in place as it flexes with the natural movement of the spine. Another agreement grants FH Group the use of Bionate® PCU, in its LP-ESP® (lumbar) and CP-ESP (cervical) disc replacement products. This was chosen as the material for the disc replacement elastomer core based on its biocompatibility and elastomeric quality, enabling the implant to mimic motion of the human disc.
Invibio® Biomaterial Solutions’s PEEK-OPTIMA polymers feature a long history of implantation (since 1999) and successful use in regulatory approved devices. They are an industry standard in spinal fusion, and rapidly growing in other applications. PEEK-OPTIMA offers exceptional product purity, quality testing and control. It provides a "no change" supply assurance agreement, guaranteeing its long term specification and production methods. Their proven biocompatibility and biostability is supported by US FDA Drug & Device Master files and use in thousands of regulatory approved implantable devices. In fact, no other implantable PEEK is as extensively used in US FDA, CE-marked and other regulatory body approved devices. PEEK-OPTIMA polymer and compounds come in a range of grades and forms that offer nearly unlimited medical design and manufacturing flexibility across highly diverse applications requiring implantation or blood, bone and tissue contact greater than 30 days such as Spinal fusion, dynamic stabilization and motion preservation, Suture anchors, Fixation and trauma screws, Femoral implants, Dental implants, Total and partial joint replacement, Cranio maxillofacial patient-specific implants. Options for non-metal implantable biomaterials are broader than ever with ENDOLIGN composite. This versatile implantable polymer delivers proven strength and performance in high-load applications - allowing it even to replace traditional metals such as cobalt chromium alloys, titanium alloys and stainless steel in many applications. It features exceptional fatigue behavior, excellent biocompatibility and biostability, and is supported by US FDA Drug & Device Master files.
Kelyniam Global, Inc. (KLYG) will have commercially available Custom Skull Implants (CSI), manufactured using this polymer. THe company recently received its FDA 510(k) clearance to market cranial implants. Designed and manufactured on a patient-by-patient basis, Kelyniam CSI rely on the exceptional strength, bone-like modulus, radiolucency, purity, versatility and guaranteed supply of high quality PEEK-OPTIMA polymer. The CSI is intended to correct or replace bony voids in the cranial skeleton caused by trauma or birth defects while promoting a better anatomic fit versus conventional reconstruction methods and materials. Streamlined CAD/CAM design and PEEK-OPTIMA processing techniques enables to deliver patient-specific implants in as little as 24 hours from the receipt of CT scans, thus significantly shortening the time between trauma and implantation. Less waiting time means healing can begin more quickly, promoting greater patient satisfaction, shorter hospital stays and minimizing the potential need for subsequent hospital admissions.
Invibio™ has introduced a carbon fiber-reinforced grade of its highly successful PEEK-OPTIMA™ polymer- composed of short carbon fibers dispersed in a PEEK-OPTIMA polymer matrix. The resulting material has enhanced mechanical and physical properties for more demanding, load bearing applications requiring blood, bone or tissue contact of more than 30 days. The compound offers all of the benefits of unfilled PEEK-OPTIMA polymer with the added advantages of tailored mechanical strength and creep performance. Additionally, it is a true structural polymer that offers improved wear performance over UHMWPE in articulating joints against polymer, metal and ceramic counterfaces. It demonstrates significantly lower wear than that observed for UHMWPE/CoCrMo wear couples under identical conditions. It also provides an exceptional matrix-to-fiber interfacial bond strength which is at least an order of magnitude stronger than that between carbon fibers and UHMWPE. Especially important for orthopaedic applications, the flexural stiffness is more similar to human bone than other biomaterials, thus implants developed allow for better load sharing, reducing the impact of stress shielding. It also offers proven biocompatibility to ensure safe, long-term implantation and has FDA Drug and Device Master Files. Invibio also manufacturers ENDOLIGN™ composite and PEEK-CLASSIX™ polymer. ENDOLIGN is a PEEK-OPTIMA-based continuous carbon fiber-reinforced composite for structural uses and metal replacement in sustained or cyclic load applications requiring blood, bone or tissue contact of greater than 30 days. PEEK-CLASSIX polymer is a thermoplastic designed and manufactured for non-implantable medical device applications requiring blood or tissue contact of less than 30 days.
Evonik Degussa Corporation has further expanded its technological lead in the high-performance polymers sector with VESTAKEEP® PEEK (polyether ether ketone) polymers. VESTAKEEP®1 PEEK polymers are suitable for applications with extremely high mechanical, thermal, and chemical requirements. VESTAKEEP® PEEK polymers are particularly characterized by the following material properties: •  very high heat resistance •  high rigidity •  low water absorption and therefore •  high dimensional stability •  high hardness •  good strength •  excellent sliding friction behavior, minimal abrasion •  good electrical characteristics •  excellent chemical resistance •  excellent hydrolytic stability •  good processability •  low tendency to form stress cracks.
Solvay Advanced Polymers’ Zeniva PEEK offers numerous advantages over metals such as titanium for these intervertebral implantable devices. The material offers many important benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is closer to that of bone than traditionally used metals. Based on biocompatibility testing, it demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and has radiolucent properties which permit x-ray procedures. Zeniva PEEK and the entire line of Solviva® Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant. DiFUSION Technologies Inc. has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Xiphos™ line of posterior interbody devices made of Zeniva® that has a modulus very close to that of bone plus excellent toughness and fatigue resistance. The interbody implants, made from Zeniva PEEK rod, are for intervertebral body fusion of the thoracolumbar spine and are intended for use with supplemental internal fixation. These implants are hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae. The Xiphos posterior interbody platform includes a range of implant shapes and sizes for varying patient anatomy and surgical preference and allows for posterior, posterior oblique, and transforaminal approaches. These best-in-class implants are expected to serve as a platform for future development.
US demand for implantable medical devices will increase 8.3% pa to US$48 bln in 2014, as per Freedonia. Although weakened in the past few years by product recalls and safety controversies, especially in the cardiac implant segment, growth will remain strong. The development of next generation devices based on new technologies and improved materials will rectify recent performance problems experienced by implantable cardiac rhythm devices and lessen the thrombosis risk of drug-eluting coronary stents. Shortcomings in existing drug therapies will promote the increasing use of implantable devices in the treatment and management of cardiovascular, orthopaedic, neurological, ophthalmic and various other chronic disorders. US demand for orthopedic implants will increase 8.8% pa to nearly US$26 bln in 2014, with the four major product segments - reconstructive joint replacements, spinal implants, orthobiologics and trauma implants - all providing strong growth opportunities. The market for reconstructive joint replacements, which is forecast to reach US$10.5 bln in 2014, will gain upward momentum from an aging population and the widespread prevalence of physically active lifestyles. These trends will expand the number of persons suffering from degenerative and injured joints, especially deteriorated knees and hips. Demand for cardiac implants in the US is projected to increase 7.3% pa to US$16.7 bln in 2014. Based on breadth of indications served, pacing devices will remain the top-selling group of cardiac implants. Cardiac resynchronization therapy (CRT) devices will post the fastest growth among pacing devices as they greatly improve therapeutic outcomes in patients afflicted with congestive heart failure. Advantages over anti-arrhythmia drugs will keep implantable cardioverter defibrillators (ICDs) the preferred treatment for tachycardia. Improvements in safety and performance properties will enable ICDs to recapture growth opportunities lost over the past year to product recalls. The lack of effective pharmaceuticals for bradycardia will continue to create a sizeable market for implantable cardiac pacemakers. Other implantable medical devices are forecast to post demand of US$5.7 bln in 2014, up 9% pa from 2009. Growth will be led by implantable stimulators for neurological conditions, brachytherapy for prostate cancer indications, cochlear devices for restoring hearing loss, and gastric bands for obesity intervention. These products offer significant performance and outcome advantages over alternative treatments. Among other implantable medical devices, silicone gel-filled breast implants and dermal and tissue implants for cosmetic surgery will fare the best in the marketplace, reflecting widening popularity among the appearance-conscious population.