Orion Medical enables 3D printing in precision medicine
Orion Medical GmbH, founded in Cham, Switzerland in March 2022, is a manufacturing solutions provider for the medical device industry. The company is closely affiliated with Orion Additive Manufacturing GmbH (Orion AM), an established manufacturer of high-performance polymer 3D printing systems based in Berlin, Germany. The main advantage of Orion Medical’s additive manufacturing technology is its thermal radiation heating (TRH) system, which enables 3D printing of custom medical devices on demand with injection molded strength and 100% density. .
In preparation for the use of its technology in the medical field, the founding team of Orion Medical embarked on an 18-month preparation period for the MedTech qualification of Orion AM’s technology before founding the company. .
To make HRT technology available to the MedTech industry and enable medical industry players (hospitals, care centers, legal manufacturers and/or MedTech providers) to participate in the growing precision medicine market segment , Orion’s technology has been adapted for MedTech and regulatory requirements. This includes the conversion of the print chamber as well as the conversion of all support systems of the 3D printer in accordance with aspects and requirements of applicable regulations, standards and norms: As a manufacturer of 3D printing systems for medical industry, Orion Medical GmbH complies with the specifications of the ISO 13485 standard as well as the requirements stipulated in the MDR (EU) 2017/745 for the manufacture of medical devices.
Extrusion-based printing technologies such as fused filament fabrication (FFF) typically suffer from poor interlayer bonding, delamination, and warping as the material cools after deposition. Orion’s proprietary technology applies continuous thermal radiation heating to the part during 3D printing to effectively bond the printed layers together, resulting in injection molded strength and 100% density. This makes Orion Medical’s solution extremely competitive against injection molding and CNC machining to produce custom medical devices on demand. Orion Medical’s M-Series additive manufacturing systems use this technology to enhance the properties of medical-grade polymers such as PEEK and PPSU, delivering best-in-class results in in-use functional parts. ultimate in medical device applications, including bearing implants.
“With thermal radiation, heat penetrates the material so that the layers actually fuse together. The result is parts with more uniform strength, higher density and stability. Orion’s technology solves the anisotropic nature of FFF 3D printing, even for hard-to-print aerospace materials like PEEK and PEI. This results in fully isotropic properties,” explained Christoph Koslowski, Managing Partner at Orion Medical GmbH.
To act as a qualified supplier for its customers in accordance with ISO 13485:2016 and MDR, Orion Medical follows the requirements of a quality management system as required by MDR 2017/745 in Art. 10. The strength of Orion Medical’s solutions lies in its ability to cover the entire value chain, from medical grade materials and additive manufacturing systems to surface functionalization of implants and regulatory services.
Orion Medical offers its customers, and all parties interested in 3D printing medical devices, additional services in addition to the M-Series medical printers. These include design assistance, transfer design of implant concepts for 3D printing, regulatory assistance such as compiling product files and advice in terms of ISO 13485:2016 and MDR (EU) 2017/745, in particular regarding Article 5a of MDR (EU) 2017/745.