摘要：
Jakarta as a very populated urban city has various problems related to the traffics. Epidemiological data show that craniomaxillofacial fractures occur in 82% of motorcycle traffic accident victims in Indonesia. In terms of medical rehabilitation, the high number of cases of traffic accidents requires the handling of maxillofacial fractures. Miniplates and screw in general already consist of various types and dimension. Moreover, there are two main types of materials that existed, namely polymers and metals. In this case, a production system that has an agile production capability shall be needed to meet this requirement. The previous study showed that an implant industry must have a versatile skill in designing those various implant systems as well. Therefore, this study aims to realize a complete set of implant system that delivered the expectations of users in terms of quality as required. Not only the research-based product that must be realized but also followed by a a production system that complied to ISO 13485:2016 Medical Device-Quality Management System standards. Our experience also showed that there was unique validation method that need to be assured when a custom product was designed. Here, we reported a study case that realizing a degradable implant system for craniomaxillofacial fixation to be used specifically for pediatric patient. We introduced our teaching industry, TiBio, that focused on design, prototyping and validate the product to meet the predetermined specification. The validation covers the geometrical, physiochemical, mechanical characterization, and toxicity of the prototyped products. Briefly, TiBio served as a proof of design platform of a customized medical device before the upscaling phase. The TiBio resumed previous knowledge-based research in a systematic way to realize new product design in a faster, functional and safe as complied to ISO 13485:2016 Medical Device-Quality Management System.
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中文科技期刊
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