materials

Article
Development of 18 Quality Control Gates for
Additive Manufacturing of Error Free
Patient-Specific Implants
Daniel Martinez-Marquez 1 , Milda Jokymaityte 2 , Ali Mirnajafizadeh 3 ,
Christopher P. Carty 4,5 , David Lloyd 4 and Rodney A. Stewart 1, *
1 School of Engineering, Griffith University, Gold Coast, QLD 4222, Australia;
[email protected]
2 Ortho Baltic, Kaunas 51124, Lithuania; [email protected]
3 Molecular Cell Biomechanics Laboratory, University of California, Berkeley, CA 94720, USA;
[email protected]
4 School of Allied Health Sciences and Gold Coast Orthopaedic Research and Education Alliance, Menzies
Health Institute Queensland, Griffith University, Gold Coast, QLD 4222, Australia;
[email protected] (C.P.C.); [email protected] (D.L.)
5 Department of Orthopaedic Surgery, Queensland Children’s Hospital, Children’s Health Queensland
Hospital and Health Service, Brisbane, QLD 4101, Australia
* Correspondence: [email protected]




Received: 6 August 2019; Accepted: 20 September 2019; Published: 24 September 2019


Abstract: Unlike subtractive manufacturing technologies, additive manufacturing (AM) can fabricate
complex shapes from the macro to the micro scale, thereby allowing the design of patient-specific
implants following a biomimetic approach for the reconstruction of complex bone configurations.
Nevertheless, factors such as high design variability and changeable customer needs are re-shaping
current medical standards and quality control strategies in this sector. Such factors necessitate
the urgent formulation of comprehensive AM quality control procedures. To address this need,
this study explored and reported on a variety of aspects related to the production and the quality
control of additively manufactured patient-specific implants in three different AM companies. The
research goal was to develop an integrated quality control procedure based on the synthesis and the
adaptation of the best quality control practices with the three examined companies and/or reported
in literature. The study resulted in the development of an integrated quality control procedure
consisting of 18 distinct gates based on the best identified industry practices and reported literature
such as the Food and Drug Administration (FDA) guideline for AM medical devices and American
Society for Testing and Materials (ASTM) standards, to name a few. This integrated quality control
procedure for patient-specific implants seeks to prepare the AM industry for the inevitable future
tightening in related medical regulations. Moreover, this study revealed some critical success factors
for companies developing additively manufactured patient-specific implants, including ongoing
research and development (R&D) investment, investment in advanced technologies for controlling
quality, and fostering a quality improvement organizational culture.

Keywords: additive manufacturing; patient-specific implants; quality control; 3D printing; regulations

and standards

Materials 2019, 12, 3110; doi:10.3390/ma12193110 www.mdpi.com/journal/materials

Materials 2019, 12, 3110 2 of 31

1. Introduction

1.1. Impact of AM in the Medical Industry

Additive manufacturing (AM), generally known as 3D printing, uses technologies supported by
computer-aided design (CAD) software to progressively build 3D physical models from a series of
cross sections that are automatically joined together to create the final shape [1]. This 3D printing
technology was pioneered in the 1980s by Charles Hull, who used a system called stereolithography
(SLA) [2], and over subsequent years, a number of different systems emerged, all using the same basic
principle of fusing 2D layers to create a 3D model. The existing AM processes are classified into seven
main categories: binder jetting; directed energy deposition; material extrusion; material jetting; powder
bed fusion; sheet lamination; and vat photopolymerization [3]. Within these AM categories, the most
used AM systems in the biomedical industry are stereolithography, selective laser sintering, Inkjet 3D
printing, electron beam melting, polyjet photopolymer, and fused deposition modeling [4,5], especially
in orthopedics, dentistry, and maxillofacial surgery [6,7].
Appropriate materials for implantation require distinct biocompatible properties depending on
implant function and location within the human body [8,9]. There are a large variety of materials
used with AM to produce bone implants and scaffolds. For example, ceramic materials are used in
tissue engineering for bone substitution and regeneration due to their good biocompatibility and
mechanical properties [10]. Some of the most representative ceramic materials in AM for bone scaffolds
applications are hydroxyapatite (HAP) and β-tricalcium phosphate (β-TCP) [11]. Ceramic materials
are brittle and crack prone; however, their high wear resistance makes them the preferred choice
for surface coating in joint prostheses [12]. Different polymers and bioglasses, such as collagen,
chitosan, alginate, and 45S5 Bioglass® , have been intensely investigated for bone tissue engineering
applications due to their biodegradability, easy processability, and flexibility to tailor their properties
for bone regeneration [9,13–15]. Nevertheless, practical application of these materials for load bearing
applications is limited due to their low resistance to cyclic loading, brittleness, and processability
difficulties, to name a few [16,17]. Therefore, these types of materials are mainly used in industry
for cranial and facial reconstruction [18,19]. Therefore, to replace hard tissue for load bearing
applications, metals have been the best choice due to their mechanical properties, corrosion resistance,
and biocompatibility. Most of these materials are alloys, such as 316L stainless steel (316LSS), cobalt
chromium (Co-Cr), and titanium alloys [20]. Above all metallic materials, titanium alloys such as
Ti-6Al-4V are currently considered as the gold standard for orthopedic applications [21]. Consequently,
the majority of AM patient-specific implants currently produced in the orthopedic industry are made
of Ti-6Al-4V alloy.
Unlike subtractive manufacturing technologies, AM offers several advantages in terms of product
design and manufacturing environment due to its ability to build parts by joining the material layer
by layer [3]. Firstly, due to the manufacturing flexibility of AM, just-in-time production becomes
the natural manufacturing environment for these technologies, where a short-lead to market is
needed [22,23]. This AM capability allows companies to adapt to the immediate intermittent demand
of personalized products using minimal amounts of material resources to produce high-quality
goods with maximum variety [24]. Secondly, AM technologies are capable of fabricating complex
shapes that are not possible with the use of traditional manufacturing methods. This capability
permits fabrication of hierarchical structures at the micro-scale level, allowing the manipulation of
material properties to create meso-materials. In terms of implant design, this means that products
can be designed with a biomimetic approach according to patient anatomy and the bone tissue
mechanical properties [25]. This design freedom opens the way for AM to be used for difficult clinical
scenarios where bone diseases, deformities, and trauma usually require reconstruction of bone defects
with complex anatomical shapes, which is extremely difficult to perform, even for the most skilled
surgeon [26]. The complex reconstruction of bone defects is possible by combining the advantages of
AM with CAD and medical image technologies such as computed tomography and magnetic resonance
Materials 2019, 12, 3110 3 of 31

in order to fabricate implants according to the patient’s specific anatomy, thus achieving an exact
adaptation to the region of implantation. Nevertheless, factors such as high design variability and
changeable customer needs of patient-specific products increase complexity in all domains, requiring
shorter and more effective product development cycles with the integration of high performance
processes and technologies in order to achieve reliable production systems [27–29]. These factors are
also re-shaping manufacturing and medical standards, manufacturing management, quality control,
and product lifecycle management [7,27].

1.2. The Quest for Comprehensive Standards for the AM Medical Industry
Standards are voluntary documents that establish specifications, procedures, and guidelines to
maximize the reliability of products, services, and systems and ensure they are consistent and safe.
Standards help to make better products that are compatible and able to interact with other products.
Standards facilitate the implementation of technologies and speed up the product development cycle.
Generally, standards stimulate innovation by accumulating, codifying, and sharing technological
knowledge and experience [30] through the identification of best industry and research practices in
producing better products [31].
In the medical field, companies are subjected to strict regulations that require the implementation
of quality standards, such as ISO13485:2016, in order to demonstrate their ability to provide medical
devices and related services that consistently meet customer requirements [32]. These standards
and regulations are designed for mass production and off-the-shelf standard implants that have low
variability of product characteristics. As a result, the recommended quality control methods for medical
devices heavily rely on statistical techniques and regulations focused on compliance of customer
requirements instead of continuous product improvement and satisfaction of customer needs [33].
Imposed priority forces companies to deliberately design their products to fit within existing approved
thresholds in order to avoid seeking further time consuming approvals for minor variations [34].
The introduction of additive manufactured patient-specific products into the medical market
is presenting serious challenges to regulatory bodies tasked with managing and assuring product
quality and safety [35]. According to the Food and Drug Administration (FDA) [36], some of these
challenges include “determining optimal characterization and assessment methods for the final finished
device, as well as optimal process validation and acceptance methods for these devices”. Medical
device regulatory bodies around the world are slowly introducing regulatory changes to cope with
the significant technological and scientific progress in the medical area. For example, in 2017, the
European Union (EU) created the Medical Device Regulation (MDR) that will come into force in 2020
to replace the current Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical
Devices Directive (AIMDD 90/385/EEC) [37]. Furthermore, despite the drastic changes that MDR will
impose, currently, there is no published guidance on patient-specific medical devices [38,39].
On the other hand, in December 2017, in an effort to cope with the rapid growth of 3D-printed
medical devices in the market, the FDA released its first guidance document called Technical
Considerations for Additive Manufactured Medical Devices: Guidance for Industry and Food and
Drug Administration Staff [36]. The objective of this document is to provide a framework to evaluate
AM processes by identifying different aspects of AM technologies. Therefore, the guide does not
intend to establish a quality system for the manufacture of patient-specific devices produced with
AM; instead, the guide emphasizes the use of current International Organization for Standardization
(ISO)/American Society of Testing and Materials (ASTM) standards for additive manufacturing. ASTM
and ISO are two similar organizations focused on the development of standards for a great variety of
industries [40,41]. Establishing ISO/ASTM standards is a collaboration work between the two main
organizations with the purpose of developing the standards for AM.
Currently, there are a total of fifteen ISO/ASTM active standards for AM as well as approximately
119 related standards, which should be considered for the development and the manufacture of metallic
patient-specific implants and of polymeric surgical guides, as presented in Table 1. To date, ISO
Materials 2019, 12, 3110 4 of 31

and ASTM are actively working on fourteen new guides for designing, manufacturing, and testing
methods of AM parts, as presented in Table 2. Overall, it can be said that, despite the considerable
efforts to create standards for AM technologies, there is still a lack of medical regulations for medical
devices produced with AM technologies [25,42,43], which is also preventing manufacturers and
practitioners from adopting these technologies [44]. Therefore, as we showed in previous work, to
achieve a successful industry transformation in this domain, collaborative efforts are needed to share
best industry and research practices to promote the use of AM technology and to foster innovation in
the medical area [45].

Table 1. Existing ISO/ASTM active standards for additive manufacturing relevant to patient-specific
implants and surgical guides.

Standard Designation Code Standard Last Revision Date

Standard Terminology for Additive Manufacturing
ISO/ASTM 52900 2015
(AM)—General Principles—Terminology
Standard Guide for Additive Manufacturing—General
ISO/ASTM 52901 2016
Principles—Requirements for Purchased AM Parts
Additive Manufacturing—Design Requirements,
ISO/ASTM 52910 2018
Guidelines, and Recommendations
Standard Specification for Additive Manufacturing File
ISO/ASTM 52915 2016
Format (AMF) Version 1.2
Standard Terminology for Additive
ISO/ASTM 52921 Manufacturing—Coordinate Systems and Test 2013
Methodologies
Standard Specification for Additive Manufacturing
ASTM F2924 Titanium-6 Aluminum-4 Vanadium with Powder Bed 2014
Fusion
Standard Practice for Reporting Data for Test Specimens
ASTM F2971 2013
Prepared by Additive Manufacturing
Standard Guide for Characterizing Properties of Metal
ASTM F3049 2014
Powders Used for Additive Manufacturing Processes
Standard Specification for Additive Manufacturing
ASTM F3001 Titanium-6 Aluminum-4 Vanadium ELI (Extra Low 2014
Interstitial) with Powder Bed Fusion
Standard Specification for Powder Bed Fusion of Plastic
ASTM F3091 2014
Materials
Standard Guide for Evaluating Mechanical Properties of
ASTM F3122 Metal Materials Made via Additive Manufacturing 2014
Processes
Standard for Additive Manufacturing—Finished Part
ASTM F3213 Properties—Standard Specification for Cobalt-28 2017
Chromium-6 Molybdenum via Powder Bed Fusion
Standard for Additive Manufacturing–Post Processing
Methods–Standard Specification for Thermal
ASTM F3301 2018
Post-Processing Metal Parts Made Via Powder Bed
Fusion1,2
Standard for Additive Manufacturing—Finished Part
ASTM F3302 Properties—Standard Specification for Titanium Alloys 2018
via Powder Bed Fusion
Standard for Additive Manufacturing—Process
ASTM F3303 Characteristics and Performance: Practice for Metal 2018
Powder Bed Fusion Process to Meet Critical Applications
Materials 2019, 12, 3110 5 of 31

Table 2. Work in process of ISO/ASTM new guides for designing, manufacturing, and testing methods
of AM parts.

Draft Number Standard

WK64190 New Guide for Additive Manufacturing Design—Decision Guide
New Guide for Orientation and Location Dependence Mechanical Properties for Metal
WK49229
Additive Manufacturing
New Specification for Additive Manufacturing Feedstock Materials Technical
WK62190
Specifications on Metal Powder
New Test Methods for the Characterization of Powder Flow Properties for Additive
WK55610
Manufacturing Applications
New Guide for Additive Manufacturing—General Principles—Guide for Design for
WK62867
Material Extrusion Processes
New Guide for Additive Manufacturing—General Principles—Guide for Design for
WK62946
Directed Energy Deposition Processes
New Guide for Assessing the Removal of Additive Manufacturing Residues in Medical
WK60265
Devices Fabricated by Powder Bed Fusion
New Guide for Additive Manufacturing—Feedstock Materials-Creating Feedstock
WK58219
Specifications for Metal Powder Bed Fusion
New Specification for Additive Manufacturing Qualification Principles for
WK65420
Equipment—Standard Guidelines Laser Powder Bed Fusion (L-PBF) for Metal
New Test Method for Additive Manufacturing—General Principles—Effective Shear
WK60942
Properties for Ordered Cellular Additively Manufactured (AM) Materials
New Test Method for Additive Manufacturing—General Principles—Effective Tensile
WK60943
Properties for Ordered Cellular Additively Manufactured (AM) Materials
New Test Method for Additive Manufacturing—General Principles—Effective
WK60941
Compressive Properties for Ordered Cellular Additively Manufactured (AM) Materials
Revision of F3301—18 Standard for Additive Manufacturing—Post Processing
WK62417 Methods—Standard Specification for Thermal Post-Processing Metal Parts Made Via
Powder Bed Fusion
New Guide for Additive Manufacturing—Process Characteristics and Performance
WK58220 -Standard Guidance for Specifying Gases and Nitrogen Generators Used with Metal
Powder Bed Fusion Machines

2. Purpose and Objectives

According to Gausemeier et al. [46], quality control of AM processes will be one of the most
crucial technological requirements in 2020. Moreover, to overcome the worldwide need of AM
regulations and patient-specific standards, a proactive collaboration between regulatory authorities,
industry stakeholders, and research is required [47]. However, to create adequate standards for AM
patient-specific implants first, it is important to better understand quality control and quality assurance
methods currently used in this industry. As a result, there is a critical need for research that explores
the medical AM industry to facilitate the development of standards and the sharing of best quality
control practices. Nevertheless, to the authors’ knowledge, there is no empirical research on how
different companies in the sector of AM patient-specific implants deal with product quality.
Taking this into consideration, the purpose of this study was to explore and report on a variety of
aspects related to the production and the quality control of additively manufactured patient-specific
implants in three different companies. These aspects are: AM technologies, quality management
systems, manufacturing process performance, quality control methods, and technologies used for
this purpose. Furthermore, this study aimed to propose an innovative integrated quality control
flow diagram based on the best quality control practices of the studied companies. For this purpose,
Materials 2019, 12, 3110 6 of 31

the FDA “Technical Considerations for Additive Manufactured Medical Devices” were followed in
conjunction with current ASTM standards for AM and the results from our previous study [36].
Thus, the objectives of this study were:

1. Describe the different AM technologies used for fabrication of patient-specific implants from an
industry perspective;
2. Identify current quality issues and percentages of rework and scrap in the industry of AM
patient-specific implants;
3. Identify key quality control methods and technologies used during design and fabrication of AM
patient-specific implants from an industry perspective;
4. Develop an integrated quality control flow diagram with gates for the design and the fabrication
process of AM patient-specific implants taking into consideration best industry practices.

3. Material and Methods

To develop the clearest possible picture of a contemporary phenomenon within its real-life context,
it was vital to perform an in-depth examination in the form of a case study, which in this case required
gathering primary data from different organizations [48,49]. Moreover, where there was limited
information about the topic, a qualitative approach was more suitable to capture textual data from a few
selected cases [50]. Therefore, to achieve objectives 1, 2, and 3, a qualitative exploratory investigation
in the form of a case study was performed following the consolidated criteria for reporting qualitative
research (COREQ) [51]. Furthermore, to produce a validated managerial solution (objective 4) to this
practical problem, a constructive research approach was employed [52].

3.1. Data Collection

Conducting a case study in business and management research requires the gathering of primary
data through interviews and questionnaires from key individuals such as managers, workers, and
technical staff to extract expert knowledge about their experiences, beliefs, or opinions [48,53,54].
Semi-structured interviews are mainly used to gather qualitative data as well as when the researcher
wants to delve deeply into a topic to thoroughly understand the answers provided [55]. Face-to-face
interviews have the advantage of having the highest response rate in survey research [56]. Moreover,
face-to-face interviews capture the most detail of both verbal and nonverbal communication and
provide a space to establish rapport with participants, permitting the researcher to clarify ambiguous
answers during the interview [56]. Therefore, the team selected face-to-face interviews as the main
data collection method for this research. To ensure that each interview was performed under the same
standards, an interview guide and a protocol were developed following the consolidated criteria for
reporting qualitative research (COREQ) [51].

3.2. Study Selection

The criteria to select the companies for this study were based on their experience and expertise
in the design and the manufacturing of medical devices using AM technologies. These included
companies in the aerospace field due to their shared similarities in relation to materials used and strict
quality regulations. Hence, the companies selected for this study had to comply with at least one of the
following criteria: (1) companies that manufacture patient-specific implants and/or medical devices
using AM; (2) companies that design patient-specific implants and/or medical devices for AM; (3)
companies that manufacture aerospace parts with AM technologies; and (4) companies that design
aerospace parts with AM.
It is noteworthy to mention that, currently, the use of AM in biomedical and aerospace industries
is limited with a relatively small number of international companies operating in this new industry.
Many of these companies are not open to researchers and open sharing of knowledge due to intellectual
property concerns. This study sought to extract in-depth knowledge on AM processes and practices
Materials 2019, 12, 3110 7 of 31

from companies that were open to knowledge sharing. The niche size of the biomedical AM industry
and the limited number of companies willing to share in-depth information necessitated that the research
team focus on a sample of comprehensive case studies. Consequently, this study is characterized by a
small sample size but with in-depth and comprehensive data collection [57].

3.3. Data Extraction

For the data extraction of this study, the team developed a semi-structured guide and a PowerPoint
presentation to be conducted in the form of face-to-face interview in the premises of each company.
Moreover, a research information sheet and a consent form were developed and delivered at the
beginning of each interview. The purpose of the information sheet was to provide a detailed description
of this study and the type of information that would be requested from each company. The consent
form described that the identity of each participant would be considered confidential and that only a
de-identified summary of results would be used for presentations and publications. The interview
guide was composed by constructing a set of 28 open-ended questions to guide the direction of the
conversation. The interview questions were divided in six main groups. The first group was composed
of 7 questions aimed to acquire participants’ and companies’ backgrounds. The remaining five groups
of questions were designed to achieve objectives 1, 2, and 3.
The types of questions asked during each interview were descriptive and structural. Descriptive
questions are used to gather descriptions of things and processes in order to obtain insight or to
check validity or accuracy about them [54]. In contrast, structural questions help the researcher to
categorize groups of things and processes and to understand their relationships [54]. Furthermore,
semi-structured interviews allow for new questions to emerge through the interview process [58],
which may reveal new and different aspects of the topic [55]. Additionally, a protocol composed of
11 steps was developed to perform the semi-structured interviews. A more detailed description of
the data extraction method, the protocol, and an example of the questionnaire are provided in the
Supplementary Material S1.

3.4. Data Analysis

The data analysis was performed following within-case and cross-case analysis approaches [59].
In this study, the within-case analysis was concerned with the evaluation of the collected data as well
as the reporting of the findings of each individual case study. The information obtained from each
interview and visits to the manufacturing premises provided a clear understanding of the design, the
fabrication, and the quality control process of each company. Following this, the cross-case analysis
was performed between the technologies and the processes of the studied companies with the purpose
of making a comparative analysis of their advantages and disadvantages [48] in order to later produce
an integrated quality control flow diagram that contains the best practices of each company, thus
achieving objective 5. For a detailed description of the data analysis method, refer to the Supplementary
Material S1.

4. Results
A total of 10 invitations to participate in this study were sent to different companies in America,
Europe, and Australia to explore the design, the manufacturing, and the quality control processes of
AM medical devices produced by these companies. Three companies agreed to participate in this
study. To protect participant companies’ confidentiality and anonymity, they are referred as companies
A, B, and C.
A total of nine face-to-face interviews were performed between June and August 2018 with
pertinent experts in AM, quality control, and implant design on a one-to-one basis at the headquarters
of each company. The participants interviewed in Company A comprised the head of the additive
manufacturing group, the head of the product quality control group, the quality manager, and the
head of the clinical engineering research group. In the case of Company B, the director of research and
Materials 2019, 12, 3110 8 of 31

development (R&D), the head of additive manufacturing, and two clinical engineers were interviewed.
In Company C, the interviews were carried out with the chief technology officer and the head of R&D.
The duration of each interview ranged from 90 to 120 min and was followed by a detailed tour through
the manufacturing premises of each company. Moreover, at the beginning of each interview, a consent
form was signed by each company participant. Nevertheless, none of the participants agreed to be
voice recorded. Furthermore, a non-disclosure agreement was delivered by each company and signed
by the research team members of this study to protect the companies’ confidential information shared
during meetings and visits in their premises.
In the following section, a description of each company background is provided. This is followed
by a description of their design, manufacturing, and quality control processes. Finally, an integrated
quality control workflow diagram based on the best practices of each company is presented.

4.1. Companies’ Background

Company A is a medium size company that operates two business units, one in the field of design,
manufacturing, sales, and distribution of patient-specific orthopedic footwear, and the other for patient
specific prosthetic-orthotic devices using AM technologies. Currently, this company is producing,
through the use of AM technologies, a large variety of products such as patient-specific implants,
anatomical models, surgical guides, and patient-specific orthoses and prosthetic covers.
Company B is also a medium size company dedicated to product development, manufacturing,
sterilization, packaging, sales, and distribution of standard and patient-specific orthopedic implants.
The main headquarters of Company B are located in Europe from where its products are distributed to
more than 65 countries worldwide. The types of products produced by Company B are a variety of
standard and patient-specific implants, including surgical guides.
Company C is a recently incorporated American company founded to supply, manufacture, and
provide the design service needed for complex metallic parts. This company produces specialized
components for aerospace, medical, automobile, and oil and gas sectors solely fabricated using AM.
The medical products include different types of surgical instruments and medical devices. For more
details about these companies, refer to Table 3.

4.2. AM Systems Used in Each Company

This section discusses the different AM used by each of the companies studied. Moreover, the
reasons why each company chose a specific AM are highlighted. Each of the three firms studied in this
research selected a different AM system to manufacture their products. Their selection criteria were
mainly based on: specific needs; budget; machine acquisition cost; operation cost; maintenance cost
and downtime; technical support; fabrication accuracy and resolution; manufacturing speed.

4.2.1. Company A
Company A selected three different AM systems to fabricate their products based on their
advantages and disadvantages. For the fabrication of patient-specific implants made of cobalt
chromium and titanium alloy Ti-6Al-4V, Company A decided to acquire an EOSINT M 280 Direct
Metal Laser Sintering (DMLS) system. To fabricate surgical guides, anatomical models for surgical
planning, and prosthetic covers, this company uses an EOS P 396 Selective Laser Sintering (SLS) system
with polymer PA 2200 (also known as Nylon-12) as the main material. To fabricate patient-specific
anatomical models for training purposes and visual means, Company A chose a 3D SYSTEMS ProJet
CJP 660 Pro, which uses Binder Jetting (BJ) technology.
Materials 2019, 12, 3110 9 of 31

Table 3. Summary of companies’ profile.

Total Production of
Type of Products Produced
Company Number of Years in the Products Per Year with
Company Research Method Experts Interviewed Company Age with AM and Traditional
Location Employees AM Market AM and Traditional
Manufacturing
Manufacturing

• Head of Additive Manufactured with AM:

Manufacturing Group Prosthetics and orthotics
• Head of Product Orthopedic footwear.
Visit to the company’s Quality Control Group Standard implantable
A headquarters and face to • Quality Manager Europe 18 years 160 6 years 20,000 units per year
medical devices.
face interviews • Head of Clinical Patient-specific implants.
Engineering Not manufactured with AM:
Research group Prosthetics and orthotics.

• Director of Research Manufactured with AM:

and Development Standard implantable
Visit to the company’s (R&D) medical devices.
B headquarters and face to • Head of Europe 30 years 600 5 years Not manufactured with AM: 820,000 units per year
face interviews Additive Manufacturing Standard implantable
• Two Clinical Engineers medical devices.
Patient-specific implants.

• Chief Manufactured with AM:

Video conference and Technology Officer Standard implantable
C America 3 years 20 3 years 24,000 units per year
interviews • Head of R&D medical devices.
Patient-specific implants.
Materials 2019, 12, 3110 10 of 31

The DMLS and the SLS AM systems selected by Company A use a laser to scan and fuse cross
sections of compacted powder particles in a preheated bed inside a chamber filled with an atmosphere
of inert gas, such as argon and nitrogen [60]. The difference between these two machines is that the
EOSINT M 280 DMLS system requires a more powerful laser (400 watt) to partially melt metallic
materials [61], whereas the EOS P 396 machine uses a 70 W laser to sinter thermoplastics [62].
According to the head of the additive manufacturing group of Company A, they decided to
acquire a DMLS system to manufacture titanium implants firstly because the machine acquisition
costs are less than other AM systems such as electron beam melting (EBM). However, other factors
such as its easy maintenance, system assembly, and agreement conditions were are also heavily taken
into consideration. Additionally, they can also create almost fully dense (99.8%) objects with high
accuracy and resolution of small details with similar mechanical properties to common manufacturing
methods, such as cast or machined parts [2]. Moreover, in terms of operational cost, the DMLS system
uses less power and requires shorter downtimes compared to other AM machines. Furthermore, after
building an object, it is possible to recycle the unsintered material [1]. Nevertheless, there are several
disadvantages of this AM system.
First, DMLS requires long fabrication cycles that can take several hours to a couple of days
depending on the size and the number of parts [63]. Building metal parts also demands a large number
of support structures that are difficult to remove, usually leaving marks on the surface [64]. Furthermore,
the drastic temperature changes during the DMLS building process cause detrimental effects in the
material mechanical properties, such as internal stresses, changes in material microstructure, the
occurrence of pores, and anisotropic behavior along the building direction [65]. Nevertheless, these
effects are counteracted with different heat treatments, such as annealing to provide the required
mechanical properties for medical use [66].
In the case of the SLS system, its advantages are that it can build large and small parts for prototypes,
models, and final products [67] without the need of supports [68]. Moreover, for this system, there is a
wide range of semi-crystalline and amorphous polymers available [69]. Additionally, SLS builds plastic
objects with less anisotropy and best mechanical properties among AM systems [68]. Nevertheless, the
disadvantages of this system are that objects fabricated with SLS have a rough surface [68], and their
mechanical properties may vary depending on their orientation during fabrication [70]. Furthermore,
the unsintered powder has poor reusability because it suffers from thermal degradation, affecting its
molecular weight [70].
Inkjet 3D Printing (3DP), also known as binder jet printing, is a low temperature (room temperature)
AM technique that builds the 3D model by applying discrete droplets with the method drop on demand
(DoD) that releases drops of liquid adhesive one-by-one when needed to bind powder material on a
powder bed layer by layer [69]. This technology can create parts made of polymers, ceramic, metals, and
wax [71,72]. However, the machine acquired by Company A uses ColorJet Printing (CJP) technology to
bind a plaster-ceramic material with water-based binder. Full-color anatomical models with different
textures can be created to facilitate surgical planning [73–75]. Other advantages of inkjet 3D printers
are that they are cost effective machines that can rapidly build small and large parts without the need
of supports [5,76,77]. Nonetheless, the drawbacks of using Inkjet 3D printing are that the built parts are
fragile, it requires post-processing, it has large tolerances, and it produces rough surface finishes [74].

4.2.2. Company B
Currently, Company “B” is using four Arcam Q10 plus EBM machines. The EBM system is similar
to the SLS technology in the way that cross sections of metal powder are melted in a powder bed to
build the model. However, EBM uses a 60 kW beam of electrons to fuse the powder particles inside
a vacuum chamber at temperatures between 600–1000 ◦ C [78,79]. When the model is finished, the
chamber is filled with helium gas to speed up the cooling process [80].
According to the head of additive manufacturing and the director of R&D, the company decided to
acquire this system for several reasons. First, with the EBM system, it is possible to fully use its volume
Materials 2019, 12, 3110 11 of 31

capacity because it allows an easy stacking of parts in the Z-direction, which is not possible with other
AM systems. These advantages in combination with the numerous electron beams simultaneously
used in the EBM system makes this system suitable for high production rates [64]. Moreover, parts
fabricated with EBM require a lower number of supports, which can easily be removed. Furthermore,
due to the high temperatures inside the vacuum chamber and the controlled temperature cycles, the
produced parts have very low residual stresses and distortion, creating fully dense high purity metallic
parts with unique mechanical properties and microstructures that can meet and in fact exceed the
ASTM standards [81]. For example, Co-Cr-Mo alloy parts that are fabricated with EBM have a higher
percentage of elongation (up to 20%) compared to Co-Cr-Mo ASTM alloys when made using traditional
processes [80].
Further, EBM produces parts with higher surface roughness [82], which are known to promote
the early stages of bone healing and osseointegration of titanium implants [83,84]. However, high
surface roughness has detrimental effects in material mechanical properties that reduce its fatigue
resistance [85]. Other disadvantages of EBM are the costs associated with machine acquisition,
maintenance, and production. Apart from its high acquisition cost, its downtimes are 50% higher than
laser-based AM systems. Moreover, due to the high amount of energy required to operate the electron
beam, its consumption of electricity is much higher [82].
Additionally, EBM has a narrow range of available materials, which are metals with sufficient
electrical conductivity that can be melted. Therefore, only the cobalt chromium alloy Cr-Co ASTM F75,
three titanium alloys, Ti-6Al-4V, Ti-6Al-4V ELI, and Ti Grade 2, and nickel alloy 718 are commercially
available for this technology [86].

4.2.3. Company C
In the case of Company C, they are producing 24,000 stainless steel parts per year for aerospace,
medical, automobile, and oil and gas applications solely with AM. According to the company’s
chief technology officer, this ultra-fast production rate is only possible thanks to their own in-house
developed AM system. This system works in a similar way as an Inkjet 3D printer with a powder
bed. However, instead of precisely building the part’s geometry layer by layer, their system uses a
non-inkjet-based spray system combined with a micro CNC milling machine.
Their fabrication process starts with a spray head that locally sprays binder droplets onto the
powder bed, wetting and binding the entire layer of powder particles of the target area. This process is
repeated several times, layer by layer. Then, the process is followed by a 250 micron end-mill CNC,
which cuts, shapes, and contours several layers at once with high precision. When the fabrication
process is finished, the green specimen is extracted from the powder bed and sintered in an oven at
about 1000 ◦ C. As reported by the chief technology officer, the advantages of this AM system are that
the final cost is cut by up to 80% compared to other AM systems.
Moreover, the ultra-fast production rate allows them to mass produce and compete with traditional
manufacturing methods such as machining and metal injection molding. Additionally, the produced
parts have an approximate density of 99%+ with excellent mechanical properties and surface finish
that exceed the Metal Powder Industries Federation (MPIF) standards MPIF 35 for metal injection
molded parts.
According to the head of R&D, this is due to the powder material that this system uses, which is
a standard metal injection molding (MIM) powder. Nevertheless, the drawbacks of this technology
are that there is only one material available (i.e., stainless steel 17-4PH), and that the final parts can
experience deformation and shrinkage due to the sintering process. Unfortunately, more details
about this technology cannot be further described due to the company’s policies. Table 4 details the
production volumes and the AM machines used by each of the three studied companies. Table 5 details
advantages and disadvantages of the different AM systems used by these companies.
Materials 2019, 12, 3110 12 of 31

Table 4. Summary of AM production rates and the technologies used by Companies A, B, and C.

Company AM Technology Used Number of Machines Total AM Production Per Year

EOSINT M 280 Direct Metal Laser 50 Class IIb-III patient-specific
Sintering system implants and unspecified number
1
Material used: Cobalt chromium of other surgical and dental
A
and Ti-6Al-4V products
EOS P 396 Selective Laser
100 patient-specific surgical
Sintering system
1 guides and unspecified number of
Material used: polymer PA 2200
other products
(also known as Nylon-12)
3D SYSTEMS CJP ProJet 660 Pro Unspecified number of anatomical
1
Material used: VisiJet® PXL Core models and other products
Arcam Q10plus electron beam
500 Class IIb-III patient-specific
B melting (EBM) system 4
implants
Material used: Ti-6Al-4V
In-house developed AM system 24,000 parts for medical and
C for serial production: 4 dental applications, aerospace,
Material used: Stainless steel automobile, oil and gas

Table 5. Advantages and disadvantages of the AM machines for production of metallic parts used by
the studied companies.

AM System Advantages Disadvantages References

• Moderate production rate

• High accuracy and details (layer thickness
20–40 µm)
• Fully dense parts after heat treatments • High energy consumption
• Good static mechanical properties • Long building cycles
• Finer grain size • Need of building supports,
• Produces pars with medium surface which are difficult to remove
roughness that improves • Grainy surface
EOSINT M 280 Direct biological performance
Metal Laser Sintering • Difficult part cleaning [1,4,63,66,76,77,87,88]
• Requires heat treatments
(DMLS) • Parts require heat treatment
• Metals: AlSi10Mg, Cobalt-Chrome MP1,
to release internal stresses
Cobalt-Chrome SP2, Maraging-Steel MS1,
• Needs high quality powder
Nickel Alloy HX, Nickel Alloy IN625,
spec, only supplied by
Nickel Alloy IN718, Stainless Steel 17-4PH,
machine brand
Stainless Steel CX, Stainless Steel GP1,
Stainless Steel 316L, Ti-6Al-4V, Ti-6Al-4V
ELI, TiCP grade 2, and Tungsten W1
• Low maintenance time

• High production rates

• Good accuracy (layer thickness 50–70 µm)
• Easy nesting of parts
• Produces pars with a high surface
roughness that improves • High maintenance time
biological performance • Only conductive materials
• Fully dense parts • Rough surface
• Lower residual stresses than DMLS • Needs high quality
Arcam Q10plus EBM • Easy removal of support structures powder spec [77,80,87,89]
(manually) • Needs high quality powder
• No heat treatments required spec, only supplied by
• Metals: cobalt chromium alloy (CrCo ASTM machine brand
F75), Ti-6Al-4V, Ti-6Al-4V ELI, TiCP grade 2,
and nickel alloy 718
• Compliance with ASTMF136 standards
• High maintenance time
Materials 2019, 12, 3110 13 of 31

Table 5. Cont.

AM System Advantages Disadvantages References

• Ultra-fast production rate (mass production)

• Cuts up to 80% in production costs
compared to other AM systems
• Low energy consumption
• Machine cost is two orders of • Only one material
Company C in-house magnitude lower is available
developed AM system • Complies with metal injection • Parts require heat treatment
molding standards
• Metals: Stainless steel
• Use of standard metal injection molding
(MIM) powder material

4.3. Companies’ Quality Management System and Quality Control Processes

Almost every organization that produces products and services is supervised by some form of
quality management system. These systems are aimed at establishing product and process confidence
within given requirements and standards [90] through the use of policies, procedures, and guidelines
to prevent and mitigate risks of non-conformance. The most well-known quality management system
is ISO 9001, which is designed to suit most businesses to demonstrate an acceptable level of control
over their processes with the aim of ensuring customer satisfaction and continuous improvement [91].
However, aerospace, medical, and automobile industries require the implementation of more specialized
quality systems. For example, organizations that are involved in at least one of the stages of the
life cycle of medical devices must demonstrate their ability to consistently meet both regulatory and
customer requirements through ISO 13485 certification [32]. Moreover, an appropriate organizational
culture is required for the development of an organization’s quality management practices towards
continuous quality improvement. Organizational culture is composed of the belief and the values
shared among the people in an organization that shape its policies and philosophy of managing
business [92]. Therefore, organizations that aim to continuously improve the quality of their products
and services require an organizational culture that encourages employees to proactively be concerned
with quality, thus empowering quality in all activities [93].
During the visits to the premises of the studied companies, it was found the each of the three
companies have obtained ISO 13485 certification and a variety of different standards to complement
their quality management system, as presented in Table 6. For example, Companies A and B
have their medical devices certified with the Council Directive 93/42/EEC, which is compulsory
for standard medical devices in order to obtain the Conformité Européenne (CE) mark before they
can be marketed in any country of the EU [94]. Moreover, Company A has three additional ISO
certifications to cover different aspects of their business model. The first management system that
this company implemented was the ISO 9001 in conjunction with the ISO 14001:2015, which is a
voluntary environmental management standard aimed at reducing the environmental impact of a
firm’s activities [95]. According to Company A’s quality manager, this certification allows the company
to maintain a production that is sustainable and environmentally driven through the identification
and the understanding of toxicological and environmental hazards as well as safety issues of their
AM process and post processing activities. Additionally, this company has also implemented ISO/IEC
27001:2013 as its security management system to manage and preserve confidentiality, availability,
and integrity of their information assets [96]. These assets, which include sensible digital data such as
implants’ designs and patient information, are shared between the company and its clients. In the
case of Company C, it recently acquired ISO 9001 certification and AS9100 certification, which is the
quality system standard for the aerospace industry. The AS9100 is based on the ISO 9001, but it is
enhanced with additional aerospace industry requirements in order to satisfy Department of Defense
(DOD), National Aeronautics and Space Administration (NASA), and Federal Aviation Administration
(FAA) quality requirements [97]. Interestingly, we noticed that all the companies studied have a strong
Materials 2019, 12, 3110 14 of 31

organizational culture that encourages a proactive emphasis on quality and continuous improvement
similar to total quality management.

Table 6. Quality management systems, control gates, and technologies used by the three
studied companies.

Quality System and Number of Quality

Company Technologies Used for Quality Control
Certifications Control Gates

• Biomedical software package

• Finite element analysis software
• Powder handling and sieving AM equipment
• ISO 9001:2015
• Real time AM process monitoring system
• ISO 13485:2016
• Micro CNC 5 + 1 axis milling machine
• ISO 14001:2015
A 15 • Tactile and laser 3D coordinate
• ISO/IEC 27001:2013
measuring system
• Council Directive
• Micro-CT scanner
93/42/EEC
• Light optical microscope
• X-Ray fluorescence spectrometer
• Surface roughness tester

• Biomedical software package

• Finite element analysis software
• Powder handling and sieving AM equipment
• Real time AM process monitoring system
• ISO 13485:2016 • Tactile 3D coordinate measuring system
B • Council Directive 14 • Industrial X-ray machine
93/42/EEC • Light optical microscope
• X-Ray fluorescence spectrometer
• Surface roughness tester
• Fatigue testing machine
• Universal testing machine

• Finite element analysis software

• Powder handling and sieving AM equipment
• Real time AM process monitoring system
• ISO 9001 • Tactile 3D coordinate measuring system
• ISO 13485 • Optical measuring system
C • AS9100 12 • Light optical microscope
• MPIF Standard 35 • X-Ray fluorescence spectrometer
• Surface roughness tester
• Fatigue testing machine
• Universal testing machine

Some of the external advantages of ISO 9000 series are higher perceived quality,
competitive advantage, better documentation, quality awareness, and improvement in operating
performance [98,99]. On the other hand, ISO 13485 provides a strong foundation towards meeting
the minimum regulatory requirements of medical device regulatory bodies [91]. Many companies,
including the three in this study, perceived the implementation of ISO quality systems as a major
achievement [100,101]. However, quality improvement does not stop with ISO certification. ISO quality
management certifications do not guarantee the production of high-quality products and reduction in
the cost of poor-quality [102]. ISO 9001 only addresses the implementation of quality practices through
conformance of the required documentation [103]. Therefore, ISO quality management certification is
just the first step towards more advanced quality systems such as total quality management and Lean
Six Sigma [104–106].
To demonstrate each companies’ quality control processes being implemented, a thorough site
visit was undertaken through their premises. In these site visits, the team focused on the identification
of quality control gates and key quality control technologies used in each gate. Quality control gates are
go/no-go checkpoints designed to facilitate the detection of quality issues by measuring and monitoring
products quality. Thus, in quality control gates, it is decided whether a product can continue or not
Materials 2019, 12, 3110 15 of 31

thought the production chain. Moreover, it was found that the total number of quality control gates
differed between the three companies. The differences in the number of quality control gates and the
technologies used could be the result of their experience, competitive strategy, available budget to
invest in different technologies, and their interpretation of what is needed to fulfill current regulations.
A summary of quality control gates, technologies, and quality management systems is presented in
Table 6.

4.4. Production Process Performance

Process performance evaluation is vital for future financial success. It allows the evaluation
of the performance of manufacturing and organizational processes to achieve optimum business
performance benchmarks [107]. Six Sigma methodology uses the Sigma quality level to measure the
performance of a process. This is done by identifying the capability of the process to accomplish
defect-free products [108], thus allowing the comparison of the performance of different processes
irrespective of their nature [107].
The term Sigma (σ) refers to the number of standard deviations from the mean, where the products
of a process with a normal distribution curve fall within specification limits [109]. However, Six
Sigma assumes that, for long-term performance, the process mean has a 1.5 Sigma distribution shift in
either specification limit [110]. Taking this into consideration, a process with a Six Sigma level means
that 3.4 defects are produced per million opportunities (DPMO), giving a yield of 99.99966%. Most
companies have a Sigma quality level between 2σ and 3.3σ (yield of 93.319%) [101,110–113]. Whereas,
world-class companies usually operate between 4σ and 5σ levels [114,115], having between 6000 to
230 DPMO, respectively.
Some of the most commonly used Six Sigma metrics are percentage of defective products and
scrap [100,101]. During the interview with the quality managers of the three companies studied, we
obtained data in relation to the total number of defective additively manufactured products that each
company is producing per year. For patient-specific implants, quality characteristics such as geometry
and mechanical properties are targeted to nominal values with upper and lower specification limits
determined by the clinical engineer, the surgeon, and specific standards. In this industry, if the final
product has characteristics outside of the tolerance limits, the final product is considered scrap.
Using this defect information provided with Equations (1) and (2), the Sigma process performance
and the DPMO of each company was determined (Table 7). Equation (1) calculates the Sigma process
performance in an Excel spreadsheet using NORMSINV, which is the inverse of the standard normal
cumulative distribution [108]. The DPMO is determined by dividing the number of defective products
by the total opportunities (number of components in a batch) and multiplying the results by one
million [108].
Sigmaprocessper f ormance = NORMSINV (probability) (1)
  
Sigmaprocessper f ormance = NORMSINV 1 − De f ects/106 + 1.5

DPMO = [De f ects/Opportunities] × 106 (2)

Table 7. Comparison of Sigma process performance based on their internal production defect rate
solely of additive manufactured products.

Production Per Production Defect Defects Per

Company Six Sigma Rating
Year with AM Rate Million
A 50 ≈4% ≈40,000 ≈3.25
B 500 ≈0.4% ≈4000 ≈4.14
C 24,000 ≈40% ≈400,000 ≈1.75
Materials 2019, 12, 3110 16 of 31
Table 7. Comparison of Sigma process performance based on their internal production defect rate
solely of additive manufactured products.
According to Table 7, the company with the highest Sigma level was Company B with a 4.14σ,
Production Per Year with Production Defect Defects Per Six Sigma
followed
Companyby Companies A (3.25σ) and C (1.75σ). As shown in Figure 1, the Sigma process performance
AM Rate Million Rating
of the studied companies follows an increasing trend in relation to their size and years of experience in
the medical
A device industry.
50 The level of process performance
≈4% of these≈40,000
two companies may look low
≈3.25
compared with the 4σ and the 5σ levels of world-class companies. However, it must be considered
B 500 ≈0.4% ≈4000 ≈4.14
that these are young companies in the market of orthopedic implants with very short performance
trackCrecords [116]. 24,000 ≈40% ≈400,000 ≈1.75

5.
4.14

3.75 3.25
Sigma σ level

2.5
1.75

1.25

0.
20 employees 160 employees 600 employees

Figure
Figure 1.1.Comparative
Comparativeanalysis
analysis of Sigma
of the the Sigma production
production processprocess performance
performance of the
of the studied studied
companies
companies against years of experience and
against years of experience and firm size. firm size.

4.5. Integrated
Moreover,Quality
CompaniesControlA Flow
and BDiagram
have a very small production rate to provide statistical confidence
with these results. Furthermore, it should be noted that, for all companies studied, they have excellent
Multistage manufacturing systems such as those used to produce patient-specific implants are
systems in place for ensuring that no defective products are released to the market, meaning that none
composed by multiple production processes that require a delicate coordination to obtain the final
of these companies have had products recalls.
product. The overall performance of these types of systems depends on the accumulated performance
of
4.5.their stagesQuality
Integrated [117]. Control
Therefore,Flowerror
Diagrampropagation is the major contributor to suboptimal overall
system performance of multistage manufacturing systems [118]. According to Hrgarek [114], the cost
Multistage
of fixing an errormanufacturing systems such
increases exponentially when asitthose
moves used to produce
forward through patient-specific implants are
the product development
composed
cycle and theby multiple
production production
chain [114]. processes
This costthatisrequire a delicate
even higher in thecoordination to obtainbecause
medical industry, the finala
product. The overall performance of these types of systems depends on
defective product can represent a life threatening risk and lead to product recalls with serious the accumulated performance
of their stages
financial [117]. Therefore,
implications such as error propagation
liability costs andismarket
the major contributor to
capitalization suboptimal
loss overall system
due to negative brand
performance of
image [114,119–121]. multistage manufacturing systems [118]. According to Hrgarek [114], the cost of fixing
an error increases exponentially when it moves forward through the product
Quality control is composed of several processes designed to effectively monitor and prevent development cycle and
the production
quality issues chain
in order[114].
to This
helpcost is eventhe
achieve higher in the medical
necessary processindustry,
performancebecauseanda defective
product product
quality
can represent a life threatening risk and lead to product recalls with serious
standards [122]. More recently, we identified 85 main causes that lead to non-conformance quality financial implications such
as liability costs and market capitalization loss due to negative brand image
through design and manufacturing processes of patient-specific implants [123]. These potential risks [114,119–121].
Quality control
of non-quality is composed
conformance are of severalcaused
mainly processes by designed
the novelty to effectively monitor and product
of AM technologies, prevent
geometrical complexity, material properties, and the great variability of customers’ needs. quality
quality issues in order to help achieve the necessary process performance and product
standards [122]. the
Controlling More recently,
quality wetype
of this identified 85 main
of product is a causes
difficultthat lead
task. to is
This non-conformance quality
due to fact that patient-
throughimplants
specific design and aremanufacturing
one-off designprocesses
products of patient-specific
that require higher implants
quality [123]. These
standards potential
than risks
traditional
of non-quality conformance are mainly caused by the novelty of AM technologies,
implants, leaving no space for uncertainty. Moreover, the large variation of product characteristics product geometrical
complexity,
in the design material properties, and
of patient-specific the great
implants variability
increases theofprobability
customers’ needs.
of human errors due to the
decreasing learning from repetitive operations [118]. Therefore, the quality This
Controlling the quality of this type of product is a difficult task. is due
control to fact
activities forthat
the
patient-specific implants are one-off design products that require
design and the fabrication of patient-specific implants should take place in the most sensible higher quality standards than
traditionalThis
activities. implants,
is notleaving
a rare no space for
practice uncertainty.
in many discreteMoreover,
manufacturingthe large variationwhere
processes, of product
total
characteristics in the design of patient-specific implants
inspections at each intermediate operation are commonly performed [117]. increases the probability of human errors due
to theTodecreasing learning from repetitive operations [118]. Therefore,
overcome some of these challenges, this study explored the quality control methods the quality control activities
for the design
employed andthree
within the fabrication of patient-specific
different companies to selectimplants
the best should
quality take place
control in the most
practices sensible
and propose
Materials 2019, 12, 3110 17 of 31

activities. This is not a rare practice in many discrete manufacturing processes, where total inspections
at each intermediate operation are commonly performed [117].
To overcome some of these challenges, this study explored the quality control methods employed
within three different companies to select the best quality control practices and propose an integrated
quality control flow diagram for patient-specific implants. The selection of best practices was based on
the quality performance of each company, including their internal quality management culture, and
technologies used. The integrated quality control flow diagram was also developed taking into account
the FDA guideline, “Technical Considerations for Additive Manufactured Medical Devices” [36] and
ASTM standards, including the following assumptions:

• Mass production with AM is performed;

• The biocompatibility assessment was previously performed following the ISO 10993 standard;
• The aim is to achieve the highest production performance and customer quality ratings, pursuing
the 6σ rating;
• Defective products are unacceptable due to the potential high risks that they represent to the
company, the customer, and the patient;
• Missed flaws in the final product have serious consequences to the patient ranging from injury
to fatality;
• Product external failure costs and penalty costs are much higher than a quality inspection cost.
Therefore, they should be avoided in any instance;
• The scrap and rework costs and penalty risks should stay at a minimum level;
• The company employees should embrace a proactive quality culture similar to the one promoted
in total quality management;
• Inspections are only performed by highly qualified personnel;
• If defects are not detected in a quality control gate, they should be detected in the following gate;
• The minimum quality management system in place should be ISO 13485;
• A detailed risk identification and a failure mode analysis should be previously performed.

The proposed quality control workflow diagram presented in Figure 2 considers the entire design
and production cycle of patient-specific implants. It focuses on preventive quality control activities
from a conservative approach. This integrated quality control flow diagram is composed of 18 go/no-go
quality control gates that take place before, during, or after the most sensible processes and activities
depending on their criticality and availability of quality control technologies. Go/no-go gates mean
that the corresponding product quality attributes at each stage must be satisfied in order to continue
to the next process [122]. Each quality control gate must have its corresponding product validation
documentation containing checklists and control diagrams to track/trace product quality variations at
each stage.
Materials 2019, 12, 3110 18 of 31

Figure
Figure2.2. Integrated qualitycontrol
Integrated quality controlworkflow
workflowchart
chart with
with thethe
18 18 gates
gates forfor
thethe design
design andand fabrication
fabrication of of
patient-specific implants
patient-specific implants by AM. The meanings of the operators in the chart are as follows: black solidsolid
AM. The meanings of the operators in the chart are as follows: black
outlined boxes =
outlined boxes processes;black
= processes; blackdash
dashoutlined
outlinedboxes
boxes = overarching
= overarching processes;
processes; green
green solid
solid outlined
outlined
boxes == quality
boxes control gates;
quality control gates;green
greendash
dashoutlined
outlinedboxes
boxes = overarching
= overarching quality
quality control
control gates;
gates; red red
pentagonal boxes =
pentagonal boxes = decision
decisiongate;
gate;blue boxes= =
blueboxes experts/staff;
experts/staff;solid arrows
solid arrows = on-line
= on-line processes; dashed
processes; dashed
arrow== off-line processes.
arrow processes.
Materials 2019, 12, 3110 19 of 31

According to the Pareto principle, decisions made during product planning and design phases are
responsible for approximately 80% of the product final costs [124,125]. Therefore, 28% of the proposed
quality control gates of this study were strategically allocated in the product design phase, which could
be divided into four different sub-phases: (1) information design phase; (2) conceptual design phase; (3)
preliminary design phase; (4) detailed design phase [126]. From all of the 18 proposed quality control
gates, 56% were on-line inspections. These inspections are part of the flow process of the design and
the production line [127]. They are performed during production to catch quality variations caused by
careless workers, maladjusted and uncalibrated machines, and environmental conditions [128]. This
type of inspection is also aimed to control and ensure that the quality requirements of incoming materials
and semi-finished/finished products are met before a value-adding operation is undertaken [128].
The remaining 44% of the quality control gates corresponded to off-line inspections performed by
specialized quality inspectors. These are more detailed and time-consuming inspections that interrupt
the process flow. However, they are more effective than on-line inspections [127]. Table 8 presents a
brief description of all the 18 quality control gates (i.e., G-1 to G-18) of the herein developed integrated
quality control workflow diagram shown in Figure 2 with their required technologies and tools.

Table 8. Description and characteristics of the proposed integrated quality control flow diagram.

Technology and Tools

Quality Control Gate (G) Inspection Type Description
Required
G-1 is to validate all software used throughout the
G-1: Software validation Off-line whole product design workflow and fabrication
processes
G-2 is to control communication issues between the
surgeon and the clinical engineer. This quality
control gate uses an online communication
interphase. Through this interphase, the most
suitable medical image protocol is decided, and the Integrated
G-2: Implant specifications On-line necessary surgical requirements, patient’s communication
information, and implant specifications are collected interphase
and corroborated in a systematic way before
proceeding to the next steps of the workflow.
Moreover, this interphase allows to perform
concurrent surgery planning to identify issues.
In G-3, the 3D volumetric reconstruction is compared
G-3: Volumetric Segmentation software,
On-line to the original medical images from the patient in
reconstruction validation CT images
order to find segmentation mistakes.
In G-4, a 4D implant design approach is used to
validate patient-specific implants with
patient-specific computational neuromusculoskeletal
(NMS) predictions and multiscale finite element Multiscale finite element
analysis (MFEA). Therefore, non-destructive static analysis software
G-4: Computer simulation and dynamic simulations are performed to test the package, and
On-line
validation implant design performance. Moreover, a biomechanical modeling,
thermo-mechanical simulation is required to identify simulation and analysis
thermic deformations during the fabrication process. software package
The simulations are carried out two times during the
overall design process, one after the primary design
process and the other after the final design approval.
G-5 takes place as a final design approval. Here, the
surgeon is asked to fill out and sign the presurgical
planning protocol to approve that the surgical
procedure plan, the patient-specific implant design, Integrated
G-5: Final design approval On-line and its corresponding surgical guides are suitable for communication
the patient. The result of this procedure is a detailed interphase
planning report of the preoperative situation, which
includes the characteristics of the implant and the
expected postoperative situation to be achieved.
G-6 is used with the purpose of controlling the
quality of the powder material that comes from the
material supplier. According to each AM equipment
supplier, to achieve the highest performance of their
G-6: Material supplier specific AM system, it is necessary to use validated
On-line
validation powder material, which is strictly supplied by them.
However, regardless of who the supplier of the
powder material is, the supplier must have a
recognized quality management program such as
ISO 9001, AS9100, or ISO 13485.
Materials 2019, 12, 3110 20 of 31

Table 8. Cont.

Technology and Tools

Quality Control Gate (G) Inspection Type Description
Required
G-7 is performed in order to guarantee the physical
and the chemical characteristics of virgin and
blended powder. For this purpose, first it is needed
to characterize the metal powder to control its
G-7: Blended material characteristics such as particle size distribution, flow
On-line
validation rate, particle shape, tap density, oxygen content, and
hydrogen content [16]. Moreover, metal powder
should have a chemical composition within the
established limits required by the ASTM and medical
standards and be free from inclusions and impurities.
G-8 is a validation of the AM process that links
machine-process and nesting parameters with part
mechanical properties and more general dimensional
and shape-related metrological parameters. Here,
coupons and representative components are also
tested using destructive and non-destructive
standard methods to verify that dimensional
G-8: AM process accuracy, mechanical properties, porosity, chemical
Off-line
validation composition, and material microstructure are within
the required quality standards and specifications.
This allows one to verify the correct functioning of
the AM machine through the identification of links
between material properties of coupons and final
products, including worst case scenarios and process
limitations in relation to machine conditions, part
placement, and geometry.
Real-time process monitoring is essential for
self-regulating process control. Therefore, the
objective of G-9 is to monitor, in real time, the most
important process parameter of the AM system used.
G-9: Real time AM process Real-time AM
On-line Some of the machine parameters that need to be
validation monitoring system
monitored are: laser or electron beam power and
diameter; scanning speed; layer thickness; hatch
spacing; bed temperature; melt pool; cooling cycle;
chamber temperature, atmosphere, and pressure.
G-10 is a visual inspection of the implant surface
quality and dimensional deviations. This is required
because, during the processes of fabrication,
G-10: Visual inspection On-line
detachment from the build platform, and removal of
support structures, dimensional variations and
visible surface marks could be introduced.
G-11 is a rapid but detailed dimensional validation
of the semi-finish components. The dimensional
validation of components is performed by an expert
that compares each component with the original
design and its specified tolerances using basic
measurement tools such as caliper and micrometer.
However, if the implant’s geometrical complexity
does not allow the undertaking of accurate
metrological measurements using traditional tools, a
G-11: Semi-finished
more detailed dimensional inspection is required. In CMM and 3D laser
product dimensional Off-line
this detailed dimensional inspection, a scanner
validation
high-resolution point cloud data obtained from a
coordinate measuring machine (CMM) and a 3D
laser scanner are combined to improve measurement
resolution and speed. The result is a deviation map
that quantifies critical component sections such as
holes for future threads, spherical surfaces, bearing
surfaces, and surface roughness. A report is then
generated to determine whether the component is
rejected or accepted based on the deviation map.
Materials 2019, 12, 3110 21 of 31

Table 8. Cont.

Technology and Tools

Quality Control Gate (G) Inspection Type Description
Required
G-12 is a periodic inspection that takes place to
certify that each manufactured batch complies with
the required chemical composition and
microstructure standards for its specific use. For this
Light stereo microscope,
purpose, representative test coupons are used. The
etching solutions,
G-12: Periodic results of the metallographic examinations should be
grinder/polishing
metallography and reported in the device master record with
On-line machine, microhardness
chemical composition microphotographs of the material microstructure
tester, and X-ray
inspection along with a paragraph containing an interpretation
fluorescence (XRF)
of the results. The results of the metallographic
spectrometer
examinations should be reported in the device
master record with microphotographs of the material
microstructure along with a paragraph containing an
interpretation of the results.
G-13’s objective is to perform an evaluation of shape
deviations, defectoscopy, and dimensional analysis
of semi-finished components in one single test. For
this purpose, a micro-CT scanner is used to obtain a
G-13: Defectoscopy and 3D representation of the real implant. The
Off-line Micro-CT scanner
dimensional validation dimensional validation is performed with a color
deviation map similarly as in G-11. The defectoscopy
test looks through the entire part to identify internal
pores and powder particles trapped within the
trabecular and lattice structures.
To guarantee consistent mechanical properties, the
objective of the 14th quality control gate is to
perform periodic tests of each manufactured batch.
For this, the Food and Drug Administration (FDA)
G-14: Periodic inspection recommends the use of test coupons for tensile and Universal testing
On-line
of mechanical properties micro-hardness tests [26]. The test coupons should machine
be built within each batch, and their location and
orientation in the building chamber shall correspond
to the worst-case scenarios previously identified in
G-8.
G-15 is a non-destructive quality control gate for
implant surface characterization. For modified and
non-modified surfaces of metallic implants, there are Non-contact
G-15: Surface and coating several surface characteristics at the microscale and profilometers such as low
On-line
characterization the nanoscale that need to be controlled. For this coherence interferometer,
purpose, a noncontact topography characterization is confocal microscope
preferred. However, micrometric and nanometric
features should be characterized separately.
The objective of G-16 is to perform periodic random
destructive tests of standard and bespoke
components. In the case of bespoke components,
they can only be randomly tested if a strong data
base is present. This data base should contain
enough information about all the different variations
of an implant family to be able to predict the
mechanical behavior of its different variations. If this
is not the case, bespoke components should be
Fatigue testing machine
manufactured with a twin coupon to be subjected to
and universal testing
G-16: Detailed periodic the same destructive tests of AM standard
machine, indentation
random inspection of Off-line components. Moreover, surface properties of coated
hardness tester, scanning
finished product and non-coated implants also need to be tested.
electron microscope, and
Some of these properties are roughness, hardness,
coating thickness gauges
layer thickness, shear fatigue strength, static shear
strength, plastic deformation, and abrasion.All of
these tests should be performed not just to control
quality but also to create a strong data base for
continuous improvement of the whole
manufacturing process chain. The tests are static and
dynamic mechanical tests that should be performed
following the corresponding ASTM standards of
each component type.
Materials 2019, 12, 3110 22 of 31

Table 8. Cont.

Technology and Tools

Quality Control Gate (G) Inspection Type Description
Required
G-17 is a comprehensive visual inspection of the final
product. The aim is to detect residual errors that
could not be detected in previous stages. Here, an
inspector checks the overall quality of each implant
and assembly, including all the product
Caliper, micrometer,
G-17: Visual inspection of documentation from the previous quality control
On-line magnifying goggles, and
finished products gates. In this quality control gate, the inspector
schematics
visually compares each component and assembly
with the original design and its specified tolerances.
Some of the critical areas to be measured are thread
holes, assembly tolerances and movement, and
height and width of each component.
The objective of G-18 is to perform a validation and
routine inspections of cleaning, disinfection,
sterilization, marking, labeling, and packaging
processes. G-18 also includes biocompatibility tests
to certify batches. The sterility validation of medical
devices at the industrial scale can be performed using
a small number of product samples to determine the
sterility assurance level (SAL). After validation, the
efficiency of disinfection, cleaning, and sterilization
processes most be routinely monitored on each cycle.
Therefore, during routine production, quality Product master record,
G-18: Sterilization and
Off-line engineers must check sterilization certificates and sterilization certificates,
Packaging validation
sterilization indicators.Regarding marking, labeling, and magnifying goggles
and packaging of patient-specific implants, a visual
inspection is required. In this visual inspection, it is
necessary to verify that each component is
adequately marked based on patient information
and intended used. Moreover, external package
labeling should correspond to it content and follow
the corresponding standards. Regarding the main
implant package, it is important to inspect it in an
exhaustive way to identify potential issues such as
punctures, damage, or defective sealing.

Additionally, a detailed description of each quality control gate is provided in a comprehensive

practitioner companion guide to this paper provided in Supplementary Material S2.

5. Discussion
The different AM technologies for metal 3D printing presented in this study have proven to
be ideal for the fabrication of patient-specific implants. The advantages and the disadvantages of
each system heavily rely on the needs, the budget, and the market strategies of each company. For
example, DMLS systems have lower acquisition cost and can fabricate higher resolution parts than
EBM systems. On the other hand, EBM systems have a better monitoring system and much higher
production rate than DMLS. Furthermore, the patented AM system of Company C is the only AM
system that can truly mass produce metallic components, making this system the best competitor for
mass production of medical devices. Regarding quality control technologies for the design and the
fabrication of patient-specific implants, it can be said that there are several key technologies that are
currently applied by some companies to further improve the production quality of these products.
Firstly, a concurrent engineering online communication interphase is vital not only to facilitate the
communication between the clinical engineer and the surgeon but also to support real time information
exchange that reduces the risks of miscommunication, helping to easily identify potential issues during
the implant design process.
The second key technology is a real time monitoring system for AM that can accurately monitor
and control the AM production process. These real time monitoring systems are the first steps in quality
control of AM machines. The last vital technology for quality control of patient specific implants is the
combination of contact coordinate measurement machine, 3D laser scanner, and micro CT scanner for
an accurate dimensional analysis and defectoscopy of metallic components. Nevertheless, to mass
produce complex and high-performance metallic components with reliable characteristics with AM,
Materials 2019, 12, 3110 23 of 31

more advanced AM machines are needed. These types of AM need to be completely integrated with
micro-CT scanners—infrared cameras with smarter in-line monitoring systems—to fully control the
manufacturing process in real time and achieve zero defects rates.
ISO quality management system certifications such as ISO 9001 and ISO 13485 as well as medical
device registrations have proven to be great competitive advantages for many companies [129]. They
can also be considered as the starting point towards more specialized quality management systems
such Six Sigma, Lean Six Sigma, and total quality management [101,113]. Aspiring to world-class
quality standards and process performance requires great organizational efforts and investment in
training and advanced technologies [101,113]. For AM practices to achieve similar process performance
levels as traditional manufacturing, comprehensive standards and well-tailored quality management
systems are needed [118]. In the current environment, companies may perceive that the journey to
world-class quality is long and undefined; nonetheless, there are a number of companies who are
venturing into this unexplored territory with promising results.
With the explosion of AM technologies, companies such as the ones studied in this research
are rapidly adapting and learning to take the great opportunities that AM is offering to the medical
device industry. For this purpose, these companies are employing a variety of different strategies and
approaches that are providing insight towards high quality AM products. There are several lessons
learned in this research regarding process performance of AM of patient-specific implants. The first
lesson is that R&D oriented companies are more prepared to apply innovative technical advances and
can react more rapidly against the innovations of competitors. In this way, corporate emphasis on
R&D leads towards higher levels of performance [130]. This can be clearly reflected by Companies A
and B, who were able to develop and apply their own technology to extract powder particles from
lattice structures, achieving results well surpassing the regulatory allowance.
Secondly, a company’s knowledge and expertise are some of the main factors for competitive
advantage [131]. When a company ventures into a new market that is closely related to their core
business, the new success factors that it faces are similar to the original challenges [132]. However,
this situation can only positively impact corporate performance if the firm is able to rely on its
previous strengths and adapt to overcome the new challenges [130,132]. For example, Company B has
successfully integrated their 30 years of experience, human resources, and quality control technologies
to control the production of patient-specific implants.
Finally, in emerging markets, companies have the opportunity to obtain competitive advantage by
aligning their efforts and strategies towards new external opportunities [133]. In these circumstances,
a competitive advantage can be created by adding exclusive, valuable resources that rivals are
unable to replicate [134]. New venture companies are key players in the development of high-tech
industry [135], which can give to them significant competitive advantage [136]. In the case of Company
C, their in-house developed AM system provides this company a significant technological competitive
advantage in terms of production capacity. The production capacity of the AM system used by
Company C allows them to mass produce additively manufactured components at a rate rarely seen
in the AM industry. This strong manufacturing capability also allows Company C to aggressively
compete in the market with a much lower price (up to 80% less). Another strategy to compete in the
AM industry is the manufacture of components for different markets to increase profitability without
affecting production costs [136]. This strategy can be seen in Company C, which manufactures products
for a variety of sectors such as aerospace, automobile, oil and gas, medical, and dental. Early entry in a
new market can lead to high levels of long-term performance [130]. Nevertheless, one of the main
important challenges for new ventures is to build long-term performance, which requires acquisition of
knowledge, experience, manufacturing assets, and tangible and intangible resources [136]. Therefore,
production performance improvements within Company C can be obtained by gaining further AM
production experience and capital to invest in R&D and high-tech quality control technologies.
Meeting current regulations and standards is not enough to register and market high quality
patient-specific medical devices. Knowing that the future changes in the medical device regulations
Materials 2019, 12, 3110 24 of 31

will make more stringent the requirements to register and commercialize patient-specific implants, it is
vital that companies in this sector are better prepared. It is already known that regulatory changes will
force manufacturers and designers of patient-specific medical devices to provide sufficient clinical data
and clinical evaluation before the registration of a device in order demonstrate its clinical performance
and benefits. However, following traditional design approaches and trial-and-error studies, it is not
feasible to clinically test every patient-specific implant that is produced due to the large number of
clinical trials and costs involved during this process. Moreover, it is not possible to fully demonstrate
the benefits of patient-specific implants if current design approaches do not account for patient specific
joint contact forces produced during real-life activities.
To adequately address these challenges, we propose the combination of the Quality by Design
(QbD) system with a 4D implant design approach, presented in our previous work [123], in conjunction
with the 18 integrated quality control gates formulated in this study. The QbD system allows
practitioners to systematically design, test, and produce reliable products with minimal clinical trials
and costs. This is possible because using the QbD system can result in a 90% reduction in required
experimental runs while providing a deep understanding of a product, as already proven in the
pharmaceutical sector [123]. On the other hand, the 4D implant design approach can help to validate
patient-specific implants with patient-specific computational neuromusculoskeletal (NMS) predictions
and multiscale finite element analysis (MFEA), reducing the number of mechanical and in vivo tests.
This 4D implant design approach can accelerate the development process of patient specific
implants and simultaneously improve their reliability before clinical testing. Finally, the 18 integrated
quality control gates proposed in this study can be used as a starting point to further improve
quality control strategies in the sector of additively manufactured patient-specific implants. These 18
integrated quality control gates combine the best proven quality control practices from three companies
manufacturing patient-specific implants as well as best-practice guidance outlined in the literature,
making the proposed 18 quality control gates of great value to this industry, new ventures, and research
groups. Readers are referred to the practitioner companion guide provided in the Supplementary
Material S2 for a complete description of the developed procedure.
For mass production of AM standard components and bespoke components, the proposed
quality control gates can help to reduce the potential costs related to defective products. Obviously,
these savings must be higher than the inspection costs, because unnecessary inspections and longer
inspection times can force the inspection capacity to an increment of inspection errors and excessive
costs [137]. However, to reduce inspection time without decreasing the performance of the process, a
more detailed study is required. Hence, future studies should focus on time and cost-efficient AM
inspection processes in combination with in-line quality control technologies.
The limitation of this study was the small sample size of studied companies. However, this is
common in qualitative research, which is characterized by small samples but detailed and extensive
work [57]. Moreover, the openness and the knowledge sharing of the studied companies gave us an
accurate snapshot of the technologies, the manufacturing processes, and the quality control methods
used by them. This allowed us to acquire valuable detailed information to perform a comprehensive
analysis and to develop an integrated quality control workflow. Therefore, the results of this study are
the starting point to further improve quality control strategies in the sector of patient-specific implants
and to help this industry be properly prepared for future changes in medical regulations. Overall, this
study can be used as the foundation for future studies in engineering quality management of additive
manufactured patient-specific implants.
Consequently, in future research, the authors will work on a dedicated paper that will be focused
on complementing the developed quality control workflow by identifying the most critical quality
risks and their corresponding corrective and preventive actions in the form of a Failure Mode Effects,
and Critical Analysis (FMECA). Moreover, future work in the field of engineering management should
focus more on AM industry case studies in order to share best industry practices, which are necessary
to fully leverage the great advantages of AM. Furthermore, another important area to consider is
Materials 2019, 12, 3110 25 of 31

bioprinting, which is a rapidly growing field of research and development [138]. Bioprinting is a
promising research field aimed towards the fabrication of complex biological constructs of living
tissues, such as muscles and organs [139].
Despite the fact that bioprinting is not yet widespread at a commercial scale [140], several efforts
have been made for its standardization [141,142]. Nevertheless, there is a significant need for future
research to focus on the development of quality control technologies and strategies as well as process
validation methods for bioprinting [143] in order to facilitate its clinical testing and foster its adoption
and standardization.

6. Conclusions
This study explored a variety of aspects related to the production and the quality control of
additively manufactured patient-specific implants in three different companies. Companies operating
in this market sector should adhere to several critical success factors identified in this study, including
continuous investment in R&D, investment in advanced technologies for quality control, and fostering
a quality improvement organizational culture. Furthermore, in time, companies should embrace more
advanced quality management systems such as Six Sigma and TQM.
This study developed an innovative quality control workflow composed of 18 gates. This quality
control workflow comprises the best practices adopted by the studied companies, the FDA guideline
for AM medical devices, and ASTM standards. This integrated quality control workflow represents a
starting point to further improve quality control strategies in the sector of patient-specific implants
and to help this industry for future changes in medical device regulations. Implementation of the
developed quality control procedure outlined herein should reduce the propagation of quality issues
through the product development cycle and production chain, thus minimizing the risk of product
recalls and ultimately leading to heightened levels of confidence with AM patient-specific implants.
Nevertheless, having a comprehensive quality workflow does not help to improve the yield or reduce
the defect rates in production.
Manufacturing processes must be able to produce products within specification limits, otherwise,
there will be defective products that would eventually increase costs, prices, and customer
dissatisfaction. However, due to the infancy of the AM industry for patient-specific medical products,
there is presently a low level of maturity with respect to quality control technologies, comprehensive
standards, and a tailored quality management system. From the results of this study, it can be said that
much more has to be done to improve AM machines in order to achieve Six Sigma production levels.
For this purpose, further developments are necessary to produce faster and more accurate AM
machines coupled with smarter and more advanced real time quality control technologies. Therefore,
the journey for AM to achieve a Six Sigma level process has not yet been well defined and may take
some time to be realized. It is important to remember that the success of world-class companies relies
not only on their products but also on the use of advanced quality management systems, decades of
experience, and a strong collaboration with other industries towards standardization.
In order to accelerate the maturity of the AM industry and derive greater quality outcomes for
its products, there is a need to review and share industry best-practices, as has been conducted in
this study.

Supplementary Materials: The following are available online at http://www.mdpi.com/1996-1944/12/19/3110/s1,

S1 File: Interviews and questionnaire data collection and analysis details, S2 File: Practitioner companion guide.
Author Contributions: Conceptualization: D.M.-M., M.J., A.M., C.P.C., D.L., R.A.S.; Formal analysis: D.M.-M.;
Funding acquisition: D.M.-M., C.P.C.; Investigation: D.M.-M.; Methodology: D.M.-M., R.A.S.; Project
administration: C.P.C., R.A.S.; Resources: D.M.-M.; Supervision: A.M., C.P.C., R.A.S.; Visualization: D.M.-M.;
Writing—original draft: D.M.-M.; Writing—review & editing: D.M.-M., M.J., C.P.; Carty, D.L., R.A.S.
Funding: This is a project funded by a Griffith University International Postgraduate Award (GUIPA). This is
a scholarship stipend covering living costs and tuition. Chris Carty was funded by an Advance Queensland
Mid-Career Fellowship.
Materials 2019, 12, 3110 26 of 31

Acknowledgments: The authors would like to acknowledge the Company A, B, and C participants for their
valuable assistance and knowledge sharing; without you, this research could not be possible. No industry funding
has been received to conduct this research.
Conflicts of Interest: The authors declare no conflict of interest.

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