Controversies in point-of-care 3D printing for oncological and reconstructive surgery with free software in oral and maxillofacial surgery: European regulations, costs, and timeframe
The aim of this paper is to discuss the controversies surrounding the most recent European regulations, as well as the cost, for a 3D printing workflow using free-source software in the context of a tertiary level university hospital in the Spanish public health system. Computer-aided design and man...
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| Published in | International journal of oral and maxillofacial surgery Vol. 53; no. 8; pp. 650 - 660 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Denmark
Elsevier Inc
01.08.2024
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0901-5027 1399-0020 1399-0020 |
| DOI | 10.1016/j.ijom.2024.01.005 |
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| Abstract | The aim of this paper is to discuss the controversies surrounding the most recent European regulations, as well as the cost, for a 3D printing workflow using free-source software in the context of a tertiary level university hospital in the Spanish public health system. Computer-aided design and manufacturing (CAD/CAM) for head and neck oncological surgery with the printing of biomodels, cutting guides, and patient-specific implants has made it possible to simplify and make this type of highly complex surgery more predictable. This technology is not without drawbacks, such as increased costs and the lead times when planning with the biomedical industry. A review of the current European legislation and the literature on this subject was performed, and comparisons made with the authors’ in-house 3D printing setup using free software and different 3D printers. The cost analysis revealed that for the cheapest setup with free software, it would be possible to amortize the investment from case 2, and in all cases the initial investment would be amortized before case 9. The timeframe ranged from 2 weeks with the biomedical industry to 72 h with point-of-care 3D printing. It is now possible to develop point-of-care 3D printing in any hospital with almost any budget. |
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| AbstractList | The aim of this paper is to discuss the controversies surrounding the most recent European regulations, as well as the cost, for a 3D printing workflow using free-source software in the context of a tertiary level university hospital in the Spanish public health system. Computer-aided design and manufacturing (CAD/CAM) for head and neck oncological surgery with the printing of biomodels, cutting guides, and patient-specific implants has made it possible to simplify and make this type of highly complex surgery more predictable. This technology is not without drawbacks, such as increased costs and the lead times when planning with the biomedical industry. A review of the current European legislation and the literature on this subject was performed, and comparisons made with the authors' in-house 3D printing setup using free software and different 3D printers. The cost analysis revealed that for the cheapest setup with free software, it would be possible to amortize the investment from case 2, and in all cases the initial investment would be amortized before case 9. The timeframe ranged from 2 weeks with the biomedical industry to 72 h with point-of-care 3D printing. It is now possible to develop point-of-care 3D printing in any hospital with almost any budget.The aim of this paper is to discuss the controversies surrounding the most recent European regulations, as well as the cost, for a 3D printing workflow using free-source software in the context of a tertiary level university hospital in the Spanish public health system. Computer-aided design and manufacturing (CAD/CAM) for head and neck oncological surgery with the printing of biomodels, cutting guides, and patient-specific implants has made it possible to simplify and make this type of highly complex surgery more predictable. This technology is not without drawbacks, such as increased costs and the lead times when planning with the biomedical industry. A review of the current European legislation and the literature on this subject was performed, and comparisons made with the authors' in-house 3D printing setup using free software and different 3D printers. The cost analysis revealed that for the cheapest setup with free software, it would be possible to amortize the investment from case 2, and in all cases the initial investment would be amortized before case 9. The timeframe ranged from 2 weeks with the biomedical industry to 72 h with point-of-care 3D printing. It is now possible to develop point-of-care 3D printing in any hospital with almost any budget. The aim of this paper is to discuss the controversies surrounding the most recent European regulations, as well as the cost, for a 3D printing workflow using free-source software in the context of a tertiary level university hospital in the Spanish public health system. Computer-aided design and manufacturing (CAD/CAM) for head and neck oncological surgery with the printing of biomodels, cutting guides, and patient-specific implants has made it possible to simplify and make this type of highly complex surgery more predictable. This technology is not without drawbacks, such as increased costs and the lead times when planning with the biomedical industry. A review of the current European legislation and the literature on this subject was performed, and comparisons made with the authors’ in-house 3D printing setup using free software and different 3D printers. The cost analysis revealed that for the cheapest setup with free software, it would be possible to amortize the investment from case 2, and in all cases the initial investment would be amortized before case 9. The timeframe ranged from 2 weeks with the biomedical industry to 72 h with point-of-care 3D printing. It is now possible to develop point-of-care 3D printing in any hospital with almost any budget. AbstractThe aim of this paper is to discuss the controversies surrounding the most recent European regulations, as well as the cost, for a 3D printing workflow using free-source software in the context of a tertiary level university hospital in the Spanish public health system. Computer-aided design and manufacturing (CAD/CAM) for head and neck oncological surgery with the printing of biomodels, cutting guides, and patient-specific implants has made it possible to simplify and make this type of highly complex surgery more predictable. This technology is not without drawbacks, such as increased costs and the lead times when planning with the biomedical industry. A review of the current European legislation and the literature on this subject was performed, and comparisons made with the authors’ in-house 3D printing setup using free software and different 3D printers. The cost analysis revealed that for the cheapest setup with free software, it would be possible to amortize the investment from case 2, and in all cases the initial investment would be amortized before case 9. The timeframe ranged from 2 weeks with the biomedical industry to 72 h with point-of-care 3D printing. It is now possible to develop point-of-care 3D printing in any hospital with almost any budget. |
| Author | Gómez, V.J. Fernández-García, A. Martín-González, A. Sánchez-Aniceto, G. Zubillaga-Rodríguez, I. Zafra-Vallejo, V. |
| Author_xml | – sequence: 1 givenname: V.J. surname: Gómez fullname: Gómez, V.J. email: vicencjg@gmail.com organization: Oral and Maxillofacial Surgery Department, 12 de Octubre University Hospital, Madrid, Spain – sequence: 2 givenname: A. surname: Martín-González fullname: Martín-González, A. organization: Engineering Department, 3D Printing Point-of-Care Unit, 12 de Octubre University Hospital, Madrid, Spain – sequence: 3 givenname: V. surname: Zafra-Vallejo fullname: Zafra-Vallejo, V. organization: Oral and Maxillofacial Surgery Department, 12 de Octubre University Hospital, Madrid, Spain – sequence: 4 givenname: I. orcidid: 0009-0007-7183-1644 surname: Zubillaga-Rodríguez fullname: Zubillaga-Rodríguez, I. organization: Oral and Maxillofacial Surgery Department, 12 de Octubre University Hospital, Madrid, Spain – sequence: 5 givenname: A. surname: Fernández-García fullname: Fernández-García, A. organization: Oral and Maxillofacial Surgery Department, 12 de Octubre University Hospital, Madrid, Spain – sequence: 6 givenname: G. orcidid: 0000-0002-9667-336X surname: Sánchez-Aniceto fullname: Sánchez-Aniceto, G. organization: Oral and Maxillofacial Surgery Department, 12 de Octubre University Hospital, Madrid, Spain |
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| Cites_doi | 10.3389/fcvm.2022.1029816 10.1055/s-0037-1621735 10.1016/j.acra.2019.08.011 10.1097/SCS.0000000000001443 10.1097/PRS.0000000000006261 10.1016/j.anorl.2020.02.002 10.3389/fcvm.2021.642011 10.1016/j.suronc.2018.03.007 10.1097/PRS.0000000000007161 10.1016/j.joms.2019.11.013 10.21037/gs-21-263 10.1016/j.mri.2012.05.001 10.1016/j.jot.2022.09.015 10.1016/j.joms.2014.07.038 10.1186/s40463-018-0320-9 10.1016/j.ijom.2019.05.005 10.1016/j.eng.2020.02.019 10.1016/j.oraloncology.2020.104914 10.1016/j.ijom.2016.10.004 10.1097/PRS.0000000000008085 10.1245/s10434-020-08732-y 10.1007/s42242-022-00187-2 10.1016/j.jcms.2016.04.003 |
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| Copyright | 2024 International Association of Oral and Maxillofacial Surgeons International Association of Oral and Maxillofacial Surgeons Copyright © 2024 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved. |
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| Keywords | Medical legislation Cost analysis Point-of-care 3D printing Computer-assisted surgery Maxillofacial surgery |
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| SubjectTerms | 3D printing Computer-assisted surgery Cost analysis Maxillofacial surgery Medical legislation Point-of-care Surgery |
| Title | Controversies in point-of-care 3D printing for oncological and reconstructive surgery with free software in oral and maxillofacial surgery: European regulations, costs, and timeframe |
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