For the design and production of patient-specific medical devices, the company uses only EU certified biocompatible materials and the state-of-the art design and manufacturing technologies. The processes of implants and single-use surgical instrument production are certified by Det Norske Veritas and fully meets the requirements of the ISO 13485 standard. The company’s Centre of Implant Design and Development is the only one in the Baltic States, and also in the entire Central Europe.
For the manufacturing processes of the patient-specific medical devices we use the following technologies:
3D reconstructionVirtual anatomical 3D reconstruction, also called as 3D segmentation, is performed using certified Materialise Mimics® Medical software. The result is the patient-specific anatomic model of internal organ and / or tissue structure.
Implant designVirtual implant design is created using Geomagic® Freeform® Plus and other virtual design software. These software use stl, 3dm, wrml, obj, ply, pcl, sldprt, iges and other data input / output formats. The result is models of 3D patient-specific medical devices: implants and single-use surgical guides.
Non-destructive testingSimulation of the strength characteristics of patient-specific implants is performed applying finite element analysis (FEA) method, using ANSYS® software. The finite element analysis is used to ascertain that the designed patient-specific implant meets the mechanical characteristics that are set out in the applicable standards as well as predict how it will react to the actual environmental conditions.
ManufacturingThe following materials and manufacturing technologies are used to produce patient-specific implants:
- To manufacture patient-specific implants, we use the additive manufacturing technology DMLS (Direct Metal Laser Sintering) and medical Grade 5 titanium alloy Ti6Al4V powder, which is poured in 30-micron layers and sintered with an optical laser;
- Some components of patient-specific implants (for instance, the component of the fossa for the temporomandibular joint endoprosthesis) are manufactured from ultra-high molecular weight polyethylene (UHMWPE) using a 5+1 axis milling technology;
- Single-use patient-specific surgical guides are printed from biocompatible polymer (PA 2200, also known as Nylon-12) using additive manufacturing technology SLS (Selective Laser Sintering).