Page 373 - IJB-10-2

International

Journal of Bioprinting

RESEARCH ARTICLE
Manufacturing evaluation of seven medical

device companies during the production of a
3D-printed titanium pelvic implant

Alba González Álvarez *, Rubén Pérez Mañanes 2,3,4,5 , José Antonio Calvo
1,2
Haro 2,3,4,5 , Lydia Mediavilla Santos 2,3,5 , and Javier Pascau 1,2
1 Departamento de Bioingeniería, Universidad Carlos III de Madrid, Madrid, Spain
2 Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Hospital General Universitario
Gregorio Marañón, Madrid, Spain
3 Servicio de Cirugía Ortopédica y Traumatología, Hospital General Universitario Gregorio Marañón,
Madrid, Spain
4 Departamento de Cirugía, Universidad Complutense de Madrid, Madrid, Spain
5 Advanced Planning and 3D Manufacturing Unit (UPAM3D), Hospital Gregorio Marañón, Madrid, Spain

Abstract
Powder bed fusion (PBF) technology has become a popular manufacturing method
to fabricate custom metallic implants. This trend has generated some regulatory
concerns because traditional developing guidelines are not suitable for three-
dimensional (3D)-printed implants. This is due to the layered microstructure of
additive manufactured parts that produces mechanical properties different than
those of traditionally manufactured parts. The inappropriate choice of the process
*Corresponding author:
Alba González Álvarez parameters and postprocessing methods can lead to fabrication errors that could
(ms.alba.gonzalez@gmail.com) negatively affect mechanical properties and dimensional accuracy. The objective of
Citation: González Álvarez A, the study was to perform a preliminary evaluation of the quality of manufacturing
Pérez Mañanes R, Calvo Haro JA, provided by the medical device industry and identify the best 3D printing practices.
Mediavilla Santos L, Pascau J. We designed a pelvic bone reconstructing implant and asked seven companies to
Manufacturing evaluation of seven
medical device companies during manufacture it in Ti6Al4V with PBF technology. We inspected some important aspects
the production of a 3D-printed of the manufacturing quality of the prototypes received by evaluating geometrical
titanium pelvic implant. Int J Bioprint. precision and microstructural integrity in the surface and in the matrix, including a
2024;10(2):0140.
doi: 10.36922/ijb.0140 qualitative assessment of voids and grain morphology. Results demonstrated a great
difference among the implant prototypes. Two companies proved to be superior and
Received: April 27, 2023
Accepted: July 24, 2023 provided defect-free implants. The other five produced evidence of some defects
Published Online: January 31, 2024 including: geometrical deviations (maximum values of up to 5 mm); heterogeneous
acicular grain morphologies; broken sections of lattice structures; and internal and
Copyright: © 2024 Author(s).
This is an Open Access article superficial voids and cracks that could potentially compromise functional and clinical
distributed under the terms of the performance. To our knowledge, this is the first study analyzing the production
Creative Commons Attribution of several custom implant additive manufacturers based on a geometrical and
License, permitting distribution,
and reproduction in any medium, microstructural evaluation of the same pelvic implant fabrication. The imperfections
provided the original work is found in some prototypes produced by companies certified to commercialize
properly cited. personalized implants highlight the urgent need for technical standards that
Publisher’s Note: AccScience regulate the safe development of 3D-printed implants. Further analyses are required
Publishing remains neutral with to determine the actual clinical and mechanical consequences of such imperfections.
regard to jurisdictional claims in
published maps and institutional The results also show that when additive manufacturing is adequately managed, it
affiliations. can be a valid manufacturing method to fabricate defect-free implants.

Volume 10 Issue 2 (2024) 365 doi: 10.36922/ijb.0140