Cham, CH, October 2022. New and promising manufacturing methods such as 3D printing of PEEK implants must be able to compare with conventional processes like injection molding and milling. Only if results can be achieved that stand up to direct comparison in a reproducible manner, emerging technology such as 3D printing of implantable filaments can be used as a validated, advantageous alternative in medical technology. That´s why the decision makers from Orion Medical GmbH together with the global players Solvay and Evonik, the most important international manufacturers and suppliers of polymers, including medical grade PEEK started a comparative test series of 3D printing versus injection molding.
The focus of interest was on the mechanical properties of 3D printed PEEK components in medical use, for example, as load-bearing implants compared to injection molded parts. To this end, the filaments supplied by the respective manufacturers, Solvay and Evonik, were printed in test form and compared with injection molding, as injection molding is seen today as the gold standard in the manufacturing of PEEK implants. In this comparative setting, the 3D printed, and injection molded specimens were tested for Tensile Strength (MPa), Elastic Modulus (GPa), and Elongation at break (%).
“By exploring boundaries of additive manufacturing, we are expanding the possibilities of individual treatment of patients for a better quality of life alongside common injection molding”
Orion’s Thermal Radiation Heating (TRH) – next-level technology for 3D printed PEEK in MedTech applications
The second series of tests with Evonik’s VESTAKEEP PEEK also confirmed the consistency and repeatability of the results previously published in September. The TRH technology used by Orion Medical in its 3D printers combined with Evonik’s materials outperformed the results of injection-molded PEEK.
Table 1: Evonik Evonik VESTAKEEP PEEK i4-3DF-T
“The mechanical data of the test specimen once again confirms the quality of our biomaterial”, explains Frank Claus, Senior Business Manager Medical Systems, High-Performance Polymers these outstanding test results.
TRH technology proves Injection Molded + Strength (IMS+)
As evident from the results of the study, the key advantage of Orion Medical’s additive manufacturing technology is its Thermal Radiation Heating (TRH) system, which enables 3D printing of medical devices with injection molded+ strength and virtually 100% density: “By exploring boundaries of additive manufacturing, we are expanding the possibilities of individual treatment of patients for a better quality of life alongside common injection molding”, adds Frank Claus.
Direct Print Process (DPP)
As is customary at Orion, all test specimens were produced using a direct-print process, which means no post-processing after printing such as annealing. Rather, Orion’s TRH process achieves high crystallinity in PEEK during the process without the need for additional annealing. The result of this is tensile strength and elastic modulus even greater than injection molding. “For us, this proves that Additive Manufacturing has its place for small series or customized production", says Christoph Koslowski, Managing Director of Orion Medical GmbH.
QM System according to MDR (EU) 2017/745, following ISO 13485:2016
To act as a qualified supplier for its customers according to ISO 13485:2016 and MDR, Orion Medical follows the requirements for a QM system as demanded by MDR 2017/745 in Art. 10. In addition, Orion Medical has started its ISO 13485:2016 certification process that is expected to be completed in Q4 2022.
About Orion Medical GmbH
Orion Medical is a privately held company focused on developing and producing additive manufacturing technologies to solve today's complex problems and create innovative solutions for tomorrow's medical device industry. Originally focused on developing highly regulated aerospace solutions, Orion AM developed the A150 Series printers using its proprietary Thermal Radiation Heating (TRH) technology. With its knowledge of highly regulated environments and very complex parts using high-performance polymers, Orion AM applied its knowledge to the development of the first medical printer for Orion Medical, the M-Series. The medical 3D printer is designed and structured to easily adapt to any clinical scenario. It can create 3D prints based on patient-specific anatomy. This allows surgeons to plan, visualize, simulate, and develop a better understanding of potential solutions for congenital or acquired pathologies.
Orion Medical offers its customers and all parties interested in 3D printing of medical devices additional services besides the Medical Printers of the M-Series. These include design support, design transfer of implant concepts for 3D printing, but also regulatory assistance such as compiling product files, advice in terms of ISO 13485:2016 and the MDR (EU) 2017/745, especially advice regarding Article 5a of the MDR (EU) 2017/745: Placing on the market and putting into use - manufacture AND use in healthcare facilities.
Orion Medical GmbH, Klostermatt 6, 6330 Cham, Switzerland
Email: firstname.lastname@example.org , Web: www.orion-am.com
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