title: A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.
abstract: 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.
authors.affiliation: EPSRC Centre for Innovative Manufacturing in Regenerative Medicine, Centre for Biological Engineering, Loughborough University, Leicestershire, LE11 3TU, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Hourd
authors.affiliation: EPSRC Centre for Innovative Manufacturing in Regenerative Medicine, Centre for Biological Engineering, Loughborough University, Leicestershire, LE11 3TU, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Medcalf
authors.affiliation: Manufacturing Research Division, Faculty of Engineering, University of Nottingham, University Park, Nottingham, NG7 2RD, UK.
authors.forename: Joel
authors.initials: J
authors.lastname: Segal
authors.affiliation: EPSRC Centre for Innovative Manufacturing in Regenerative Medicine, Centre for Biological Engineering, Loughborough University, Leicestershire, LE11 3TU, UK.
authors.forename: David J
authors.initials: DJ
authors.lastname: Williams
mesh_terms: D000818:Animals; D006801:Humans; D066330:Printing, Three-Dimensional; D019736:Prostheses and Implants / Q000592:standards*; D011474:Prosthesis Design / Q000592:standards*; D023822:Tissue Engineering / Q000331:legislation & jurisprudence* / Q000592:standards*; D054457:Tissue Scaffolds / Q000592:standards*
keywords: 3D bioprinting; ATMP; EMA; US FDA; additive manufacturing; autologous; combination; customization; personalized; regulation; validation