在过去几年里，3D打印或增材制造技术彻底改变了医疗器械行业。该技术为提供患者特异性的医疗解决方案提供了机会。目前的产品范围涵盖广泛的医疗应用范畴，例如手术器械、假肢或植入物。皮肤、骨骼、组织、药物、生物制品甚至人体器官的3D打印技术也在开发中，但这些应用距离成熟落地还有很长的路要走。各式各样的市场分析报告于近期发布。他们提及目前3D打印医疗器械的全球市场价值约为20亿美元，并预测未来五到十年的复合年增长率 (CAGR)约为15-25%。3D打印或增材制造一词涵盖了各种工艺和技术，它们为生产不同材料的零部件和器械提供了全方位的能力：聚合物、陶瓷和金属。从本质上讲，所有这些工艺和技术的共同点是生产方式：在增材工艺中逐层进行，这与传统的减材生产方法或模塑工艺形成了鲜明的对比。由于这种类型的制造不依赖模具或多种专用设备，因而可以快速修改设计。3D打印也可用于在患者的照护机构或床旁现场制造，依据患者解剖结构生产出与患者相匹配的产品。
从监管的角度来看，伴随着3D打印技术而来的，是现有监管框架给监管机构和制造商带来的许多问题和挑战。现有框架还没有具体到能够回答这些问题和帮助应对这些挑战。除其他内容外，以下方面就需要更为具体的指导：
想想，例如在床旁生产的3D打印产品。当使用3D打印技术在床旁生产医疗器械时，谁负责监管，监管机构吗？目前尚不清楚监管机构将如何调整法规要求以确保这些3D打印产品相对其预期用途是安全有效的。医疗器械监管部门不直接监管医疗实践，而主要由医疗委员会或理事会监管，那么他们是否有责任监管？
FDA器械和放射健康中心正在开发一个基于风险的框架，其中包括3D打印可用于医疗器械床旁制造的五个潜在场景。
Table 1. Conceptual framework for 3D printing at the point of care
一些医疗专业组织正在发布在床旁使用3D打印的指南，其中包括关于如何一贯且安全地生产源于医学成像的3D打印解剖模型的建议，以及使用3D打印解剖模型用于临床的适宜性标准。
渐渐地，越来越多的法规指南正在发布。我们想提请注意以下内容（这并非详尽的清单）。这些指南文件涉及与3D打印技术相关的各方面法规内容。其中一些是随着SARS-CoV-2疫情和对相关医疗器械的大量需求一起出现的。此外，一些ISO和ASTM标准也为3D打印技术的多个技术方面提供了支持性信息。
- IMDRF (2018): „IMDRF/PMD WG/N49: Definitions for Personalized Medical Devices“.[1]
- IMDRF (2020): “IMDRF/PMD WG/N58: Personalized Medical Devices - Regulatory Pathways“.[2]
- MDCG (2021): “MDCG 2021-3: Questions and Answers on Custom-Made Devices”.[3]
- MDCG (2020): “Q&As: Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19“.[4]
- MHRA (2020): „Guidance: 3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic“.[5]
- US FDA (2021): “3D Printing Medical Devices at the Point of Care: Discussion Paper“.[6]
- US FDA (2017): “Guidance Document: Technical Considerations for Additive Manufactured Medical Devices”.[7]
- US FDA (2021): “Q&As: 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic“.[8]
- Health Canada (2019): “Guidance Document - Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing”.[9]
- TGA (2021): “Personalised medical devices (including 3D-printed devices)“.[10]
- HSA (2021): “Regulatory Guideline For 3D-Printed Medical Devices”.[11]
- BSI white paper (2019): “The impact and potential for 3D printing and bioprinting in the medical devices industry“.[12]
- TÜV Süd white paper (2021): “Validating additive manufacturing processes to meet medical regulations”.[13]
- Carl AK and Hochmann D (2021): “Regulatory framework for 3D printed custom-made devices in Europe”.[14]
- Adamo et al. (2018): “Regulatory interfaces surrounding the growing field of additive manufacturing of medical devices and biologic products”.[15]
- Beitler BG, Abraham PF, Glennon AR et al (2022): “Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care.“ 3D Print Med 8,7 (2022).[16]
还可等待更多的指南，现有法规需要随着3D打印技术对医疗相关性的不断提高而发展。[17] 在这种情况下，进一步的全球协调是令人期待的。
自从十多年前首次提出使用3D打印技术定制医疗器械以来，Qserve已对此类器械的设计和开发、产品和制造技术的验证和确认提供了咨询，包括由欧盟资助的大型项目。
医疗器械行业是3D打印技术的早期采用者之一，但由于其技术的定制化能力和3D可打印材料的改进，它还是一个具有巨大增长潜力的行业。Qserve有能力并乐于支持我们的客户应对与3D打印技术相关的法规挑战。
参考文献链接：- [1] https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-181018-pmd-definitions-n49.pdf
- [2] https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-pmd-rp-n58.pdf
- [3] https://ec.europa.eu/health/system/files/2021-03/mdcg_2021-3_en_0.pdf
- [4] https://ec.europa.eu/docsroom/documents/40562
- [5] https://www.gov.uk/guidance/3d-printing-additive-manufacturing-of-medical-devices-or-component-parts-during-the-coronavirus-covid-19-pandemic
- [6] https://www.fda.gov/medical-devices/3d-printing-medical-devices/3d-printing-medical-devices-point-care-discussion-paper?utm_medium=email&utm_source=govdelivery
- [7] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-additive-manufactured-medical-devices
- [8] https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic
- [9] https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/3d-licensing-requirements/document.html
- [10] https://www.tga.gov.au/sites/default/files/personalised-medical-devices-including-3d-printed-devices.pdf
- [11] https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/regulatory-guideline-for-3d-printed-medical-devices.pdf
- [12] https://www.bsigroup.com/globalassets/localfiles/en-gb/medical-devices/whitepapers/wp_3d_web_pdf.pdf
- [13] https://www.tuvsud.com/en/resource-centre/white-papers/additive-manufacturing-validating-processes-to-meet-medical-regulations
- [14] https://journals.infinite-science.de/index.php/ammm/article/view/542/253
- [15] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6390384/pdf/S205986611800331Xa.pdf
- [16] https://threedmedprint.biomedcentral.com/track/pdf/10.1186/s41205-022-00134-y.pdf
- [17] https://www.sme.org/technologies/articles/2021/september/regulations-need-to-evolve-with-additive-manufacturing-in-healthcare/