Cytocompatibility of Polymers for Skin-Contact Applications Produced via Pellet Extrusion

Orthoses and prostheses (O&P) play crucial roles in assisting individuals with limb deformities or amputations. Proper material selection for these devices is imperative to ensure mechanical robustness and biocompatibility. While traditional manufacturing methods have limitations in terms of customization and reproducibility, additive manufacturing, particularly pellet extrusion (PEX), offers promising advancements. In applications involving direct contact with the skin, it is essential for materials to meet safety standards to prevent skin irritation. Hence, this study investigates the biocompatibility of different thermoplastic polymers intended for skin-contact applications manufactured through PEX. Surface morphology analysis revealed distinct characteristics among materials, with TPE-70ShA exhibiting notable irregularities. Cytotoxicity assessments using L929 fibroblasts indicated non-toxic responses for most materials, except for TPE-70ShA, highlighting the importance of material composition in biocompatibility. Our findings underscore the significance of adhering to safety standards in material selection and manufacturing processes for medical devices. While this study provides valuable insights, further research is warranted to investigate the specific effects of individual ingredients and explore additional parameters influencing material biocompatibility. Overall, healthcare practitioners must prioritize patient safety by meticulously selecting materials and adhering to regulatory standards in O&P manufacturing.