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team is mechanically alloying leftover FDM ABS material with other ingredients for various purposes. The concept of natural fi bers is also being employed and tested including wood particulates and bamboo fi bers and may be applicable to low-cost O&P devices.


Medical implants have been fabricated dominantly from metallic compounds such as stainless steel or titanium al- loys. However, polymer materials are being developed for implant purposes. Polyetherketoneketone (PEKK) is a semi- crystalline thermoplastic material. Its structure gives PEKK a high heat resistance, chemical resistance, and the ability to withstand high mechanical loads. Oxford Performance Materials (OPM; South Windsor, CT) developed two PEKK composites, OXPEKK-MG (medical grade) and OXPEKK-IG (implant grade). OPM materials come in the form of amor- phous and crystalline injection grade unfi lled pellets, com- posite pellets, crystalline extrusion rods, mono or multifi la- ment fi lms. Filler materials include metallic compounds and carbon. OPM was granted the fi rst patent for a 3D-printed polymer implant and has the ability to create a wide range of implants including cranial maxillofacial, upper extremity, and small bone implants for hands and feet. Selective Laser Sintering (SLS) process (labeled as OsteoFab by OPM) and the newly developed PEKK materials allow fabrication of these custom polymer implants for patients within short turnaround times. The benefi ts of customization and characteristics of the PEKK composites result in a rough structure with strong osteo-integration ability. SLS process is desirable for poly- mers because the part can be built without fully melting the substrate while the mechanical properties of the parent material are still maintained at the grain interfaces. Other than sterilization, no major operations, including fi nishing or polishing, are needed for postprocessing.


General characteristics of OXPEKK biomedical polymers


include: • Radiolucence • Osteoconductivity • Density and stiffness similar to bone • Excellent abrasion resistance • Minimization of detrimental stress shielding • Compatibility with common sterilization methods


• Twice the compressive strength of Polyetheretherk- etone (PEEK)


• Chemically inert and nonabsorbable OXPEKK-IG materials were designed to meet the FDA and the European Union requirements for use in Long Term


Top: Variable Impedance Prosthetic socket (VIPr) for transtibial amputees. Bottom: FEM Analysis graphing.


Human Implantable Medical Devices. OXPEKK-IG had been tested according to ISO 10993 (Biological Evaluation of Medical Devices) through a successful 52-week biocompat- ibility test. In 2013, OPM received its fi rst 510(k) clearance for the OsteoFab Patient Specifi c Cranial Device, a 3D-printed device made from the OXPEKK-IG. OPM’s South Windsor facility was also certifi ed to ISO 9001 and ISO 13485 quality systems and with 100% dimensional inspection certifi cation.


Future Work The role of 3D printing in the medical fi eld will grow


greatly and will include the O&P devices mentioned in this article and more. 3D printing is poised to change the medi- cal fi eld due to its quicker turnaround time compared to its competitors, fabrication ability of customized devices which closely replicate desired body characteristics, and the po- tential that encompasses bone implants, exoskeletons, den- tal prosthetics, and even biofi cial organs. Recent develop- ments of 3D-printed full jaw and hip replacements are signs of what is to come. Even the technology of the hobbyist 3D printing space will impact the medical applications and especially O&P with its low-cost processes and materials, allowing developers to experiment freely. After overcoming the cost barrier, the technology will require integration of imaging technologies with 3D printers.


71 — Medical Manufacturing 2015


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