Page 374 - IJB-10-2

International Journal of Bioprinting AM evaluation of medical device companies

Keywords: Custom implants; Ti6Al4V; Powder bed fusion; Implant quality; Defects; Quality control

1. Introduction The challenges involved in producing defect-free AM
implants motivated us to perform a preliminary evaluation
In recent years, additive manufacturing (AM) has become of the quality of manufacturing provided by the medical
a common method to create custom metallic implants with device industry, with a particular focus on companies
complex shapes and biomimetic features. Its increasing using Ti6Al4V to develop custom implants. Our study
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popularity has generated some regulatory concerns was carried out as a quality control step to select the
because traditional developing guidelines are not suitable best companies to co-produce custom implants with and
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for three-dimensional (3D) printing technology. This is guarantee high quality and safety to patients.
due to the layered microstructure of additive manufactured
parts that produces mechanical properties different than 2. Materials and methods
those of traditionally manufactured parts. The newly
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released Medical Device Regulation (MDR) based on We designed a pelvic bone reconstructing implant (see
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the EU regulation 2017/745 requires medical device Figure 1) to be manufactured by as many companies as
manufacturers to have a quality management system with possible. The objective was to simulate the collaborative
relevant requirements included in the ISO 13485, which process of co-producing a pelvic implant with several
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is a formal document that specifies requirements for good manufacturers to achieve the best possible performance
management practices. However, its compliance does and quality. Participation in this study was voluntary. The
not guarantee the production of high-quality implants resulting information is presented anonymously to respect
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because it does not give explicit requirements to which the confidentiality of the participating companies.
the medical device should conform. The lack of specific
technical requirements and regulatory pathways for 2.1. Selection of companies
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3D-printed implants can lead to manufacturing errors that The companies selected for this study adhered to the
criteria as follows: (i) a medical device manufacturer of
may possibly affect device performance. This is the case
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when developing bone reconstructing implants that are titanium custom orthopedic implants using AM; (ii) a
additively manufactured in Ti6Al4V by powder bed fusion medical device manufacturer that provides services to
(PBF) technology, including selective laser melting (SLM) Spain (being located in Spain was not required); (iii) a
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medical device manufacturer that is willing to collaborate
or electron beam melting (EBM). The inappropriate choice
of postprocesses and printing parameters such as laser for the co-development of custom orthopedic implants for
diameter and temperature, cooling cycle, or layer thickness clinical use; and (iv) a medical device manufacturer that is
(among others) can lead to invisible fabrication errors willing to collaborate for the purpose of this study.
compromising material properties, dimensional accuracy, A total of 13 companies based in several locations
and biological function. 9 around Europe were identified as potential participants.

Figure 1. 3D CAD design of the pelvic implant designed to evaluate several manufacturing features including four different surfaces of lattice structures (L),
three extracortical plates, some screw holes as well as a threaded hole marked in red.

Volume 10 Issue 2 (2024) 366 doi: 10.36922/ijb.0140