TY - GEN
T1 - TiBio Teaching Industry
T2 - 1st International Conference on Advanced Technology and Multidiscipline: Advanced Technology and Multidisciplinary Prospective Towards Bright Future, ICATAM 2021
AU - Supriadi, Sugeng
AU - Whulanza, Yudan
N1 - Funding Information:
This research was funded by the LPDP Republic of Indonesia under Grant RISPRO Invitasi 2019 no. SK KEP-52/LPDP/2019.
Publisher Copyright:
© 2023 American Institute of Physics Inc.. All rights reserved.
PY - 2023/5/19
Y1 - 2023/5/19
N2 - 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.
AB - 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.
KW - agile concept design
KW - customized medical device
KW - degradable implant design
KW - ISO 13485:2016 Medical Device-Quality Management System
KW - Maxillofacial bone implants
KW - Teaching Industry
UR - http://www.scopus.com/inward/record.url?scp=85161415423&partnerID=8YFLogxK
U2 - 10.1063/5.0119127
DO - 10.1063/5.0119127
M3 - Conference contribution
AN - SCOPUS:85161415423
T3 - AIP Conference Proceedings
BT - Proceedings of the International Conference on Advanced Technology and Multidiscipline, ICATAM 2021
A2 - Widiyanti, Prihartini
A2 - Jiwanti, Prastika Krisma
A2 - Prihandana, Gunawan Setia
A2 - Ningrum, Ratih Ardiati
A2 - Prastio, Rizki Putra
A2 - Setiadi, Herlambang
A2 - Rizki, Intan Nurul
PB - American Institute of Physics Inc.
Y2 - 13 October 2021 through 14 October 2021
ER -
