Samaplast uses the advantages and synergies of additive manufacturing to minimize the risk during design definition and to shorten the "time-to-market" in the manufacture of medical devices. The aim is to reduce lead times and project costs.
Due to the increase in chronic and degenerative diseases, innovative products and implants are becoming increasingly important. Research is particularly focused on the topics of miniaturization, biocompatibility and long-term stability. The industry is increasingly relying on additive processes in the manufacture of its products.
Taking this trend into account, Samaplast AG in St. Margrethen has set a milestone with the acquisition of an Arburg 2K Freeformer and its qualification as well as the possible process validation according to ISO 13485 or 21 CFR Part 820.
The Swiss plastics processor and the injection moulding machine manufacturer Arburg GmbH + Co KG from Lossburg worked together on a current user project: They tested the processability of PCU in different degrees of hardness using a permanent implant for the spinal column. Samaplast was satisfied with the results in terms of processability and appearance - i.e. surface quality.
In supplementary tests, the company tested the joining possibilities of PCU materials with various Shore hardnesses in the 2K process. In a further series of tests, parts with absorbable implant materials from Essen-based manufacturer Evonik such as LR 704 S and LR 706 S were constructed with the freeformer and the reduction of the inherent viscosity (IV value) was compared with injection-molded parts and the additive parts.
The results show that the degradation of the IV value in both processes is of a similar magnitude. Further trials are planned with existing customers and suppliers such as Evonik to confirm the initial results and successes.
(Source: medizin&technik 02/2018)