Hourd Paul, Medcalf Nicholas, Segal Joel, Williams David J
EPSRC Centre for Innovative Manufacturing in Regenerative Medicine, Centre for Biological Engineering, Loughborough University, Leicestershire, LE11 3TU, UK.
Manufacturing Research Division, Faculty of Engineering, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.
Regen Med. 2015;10(7):863-83. doi: 10.2217/rme.15.52. Epub 2015 Nov 13.
Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.
用于组织和器官功能修复的定制3D功能性活体构建体的工业生产的计算机辅助3D打印方法面临重大监管挑战。以制造定制的3D生物打印鼻植入物为例，这是一个信息充分但假设性的示例，我们研究这些产品可能如何受到监管。欧盟和美国现有的监管框架没有考虑到3D打印与传统制造方法之间的差异，也没有考虑到使用机械化而非手工方法制造个性化定制产品的能力。这些复杂的3D生物打印先进组合产品的制造商已经受到广泛的监管控制，与计算机辅助设计到制造过程以及相关软件系统链的控制相关的问题带来了额外的科学和监管挑战。
