6th IFAC Conference on Management and Control of Production

and Logistics
The International Federation of Automatic Control
September 11-13, 2013. Fortaleza, Brazil

New Opportunities and Challenges for Additive Manufacturing to Produce

Biomedical Devices
Joaquim Ciurana*


*Department of Mechanical Engineering and Industrial Construction, University of Girona, Girona, 17003
SPAIN (Tel: 34 972418265; e-mail: quim.ciurana@udg.edu).

Abstract: Additive Manufacturing (AM) technologies permit to build up products with high level of
geometrical complex shape and personalized as unique product by implying low cost and quick time
production compared with other manufacturing processes. However, AM needs to improve some
misalignments such as process parameters set up, materials consolidation, easy to work with technology
and reliability with product design to obtain optimal results. Biomedical devices needs are growing up so
fast in last years and it is good market where to invest and to create new developments mainly due to
personalized products demand. This paper shows some practical studies where AM were applied to fulfill
biomedical devices products requirements. Three case studies based on three medical products are
analyzed by using several AM technologies to produce the prototype. It can be concluded AM seems to be
the solution to reach required products in biomedical market and these technologies shows good
opportunities in the near future.

processes with metallic components. Those authors analysed
1. INTRODUCTION
material and process aspects of AM, including physical
Rapid prototyping (RP) developed around mid 1980 is known aspects of materials for AM and microstructural and
as technologies, which allows producing prototypes useful to mechanical properties of AM processed components. The
check fit, form and function when new products have to be work establishes a relationship between material, process,
launched to the market. First RP technology was developed and metallurgical mechanism for laser based energy AM of
by Hull (Hull, 1984) and latter on several other technologies metallic components.
using similar or different principle became popular as well.
AM technologies have increased its use and presence in the
Once all those technologies improved they evolved first to
market of final parts because their advantages. Some
Rapid Tooling (RT) (Levy et al., 2003) producing tools such
examples can be summarized as, other manufacturing
as moulds and inserts and second to Rapid Manufacturing
processes do not allow producing parts with some complex
(RM) producing functional parts and products. Nowadays,
geometry and one only part or personalized part due to high
RM has changed to be called Additive Manufacturing (AM)
inversion cost while AM can produce unique parts with
and it also referrers to Additive Freeform Fabrication (AFF),
difficult geometries to get. For that reasons, AM seems to be
Layered Manufacturing (LM) or 3D Printing (3DP).
ideal solution to manufacture biomedical devices, which
AM technologies can produce custom parts, replacement often they are required as customized and one person
parts and short series production runs to be used as a final dedicated part. However, further research should to be done,
product by the user starting as a three-dimensional (3D) to increase functional properties and use of AM technologies,
images or CAD file which is converted to STL format. There since materials and process combinations sometimes do not
are more than 30 AM techniques that can be used with direct reach mechanical or other user requirements and needs.
and indirect methods (Chua et al., 2010). Almost all AM Without any doubt, that is going to be the big challenge of
technologies have a similar process using the same layer by AM technologies in coming years. AM technologies are also
layer method, but when looked at the physical principles, applicable on tissue fabrication as Cohen (Cohen et al., 2010)
differences arises showing in the layer adhesion the demonstrates when tissue engineering seems to repair injury
difference due to material consolidation phenomena (Kruth et and it is also appropriate solutions for replacement of
al., 2005). It can be recognized two main principles in AM defective body parts. In their work they develop novel
technologies; laser based energy and fused deposition geometric feedback-based approaches and appropriate
material, there are other principles but not further analyzed. printing-material combinations to demonstrate the in situ
There are a big number of investigations going through to repair of both chondral and osteochondral defects that mimic
characterize and increase knowledge for AM processes and naturally occurring pathologies. They demonstrate in situ AM
research work on materials, such as metals, polymers, plastics suggests potential biomedical applications and also explores
and biomaterials. Research works focus mainly on material in situ-specific issues. Murr (Murr et al. 2010) prospected for
properties or process parameters (Tolochko et al. 2000). Gu the manufacture of patient-specific biomedical implants
(Gu et al., 2012) wrote a review on laser energy based replacing hard tissues using additive manufacturing (AM) by

978-3-902823-50-2/2013 © IFAC 283 10.3182/20130911-3-BR-3021.00119

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electron beam melting (EBM), which is rather new
technology. One interesting point is the fabrication of
complex functional mesh arrays. Different design elements
have been used to fabricate prototypes by AM using EBM of
Ti-6Al-4V powders.
This paper focuses on AM technologies applied to build and
manufacture biomedical devices as new opportunities for AM
in the market. Several samples where AM technologies have
been utilized to solve biomedical parts production are
analysed and studied by discussing advantages and
disadvantages. From that analysis it can be concluded that
AM technologies needs to improve some of their features,
namely the material and process combination when some
mechanical and geometrical requirements needs to be reached
(Delgado et al. 2012) and these technologies will increase
their presence in the biomedical devices industry during the
close future.
2. HEALTHCARE SECTOR OPPORTUNITIES
During the last five to ten years, the healthcare sector is
increasing its research activity, not only because final
terminal cases are looking for solutions, but also diagnosis,
treatment and life-long care are becoming ways to reduce
costs of health care. Even in non-life threatening medical
cases doctors and patients are constantly looking for better
technologies in products such as orthopedic prosthesis,
diagnostics, surgery instrumentation, drug dosing and
delivery systems. Besides each time it is more necessary to
dedicate and sum up the effort for the wellbeing of the whole
society, searching for medical solutions which improve the
quality of life and reduce the health care global costs. Shih
(2008) already demonstrates that investment in healthcare is
increasing surprisingly high nowadays and it is going to
increase more and more during coming years (Figure 1).
Fig. 1. GDP comparison between manufacture and healthcare
industries
In addition, because technologies are evolving constantly and
too fast, Physicians realized needing help to understand how
to use their tools when they are doing their job at surgery
shop or office and how it can be possible to develop new
products with improved features as well. For that reason it is
going to be important to enhance collaborations and
knowledge exchange between medical doctors, surgeons and
284
engineers in order to find better solutions in healthcare sector.
One big goal will be to reinforce synergies between applied
investigation fields of engineering and medicine in order to
help those people working on healthcare sector. European
commission fundraised IREBID proposal (International
research exchange for biomedical devices design and
prototyping (FP7-PEOPLE-2009-IRSES 247476), which
creates high level expertise and understanding on Design,
Prototyping and Manufacture for Medical Devices using
computing tools, biomaterials and other biocompatible
engineering materials in collaboration between medical
doctors and engineers.
Level of communication between physicians and engineers
should not be difficult since physicians could be considered
as customer with needs and engineer could follow traditional
design methodologies (Pahl et al., 1996). The first stage of
those methodologies used to establish a conversation with the
customer who provides the description and the needs to the
engineer. Engineers start the life cycle by defining and
designing a new product based on customer requirements,
manufacturing solutions developed and at the end
commercializing. The same schema could be applied to the
medical sector. In this case, Health Sciences will be the
customer -represented in light grey- in Figure 2, providing
realistic needs and requirements for the medical and surgical
tasks.
There are numerous needs in the field of biomedicine and
bioengineering and it is very difficult to range the complete
set of possibilities in only short research of work.
Nevertheless, it is known from some medical fields, in which
the intervention of the engineering helps in development and
innovation. That is why some examples of these joint studies
could be shown in this paper. Because AM permits on
developing novel and innovative parts like medical devices, it
seems to be the solution to carry on with better medical and
surgical devices, implants and prosthesis by which they can
help improve their work in providing better health care
services to larger populations at affordable costs.
Customer
Needs &
Market Trends
Production
Product
Concepts
Manufacturing
Process
Health Design
Sciences
Product
Engineering
Design
3. PRODUCT DEVELOPMENT
There are many design methodologies as useful tools for
developing new products or improving them. These
methodologies assist the engineer in the inventive process,
either as a resource for ordering ideas and requirements or to
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come up with creative solutions to recurrent problems. The
way design methodologies are used and arranged depend
solely on the engineer decision, but there are some general
recommendations found in the literature. There are many
design tools and techniques, however Quality function
deployment (QFD) (Otto, 2001) is on of the most popular
tools and it is used mainly in this work to reach geometrical
and shape solutions for biomedical devices. QFD has been a
good tool to offer solutions to medical requirements fulfilling
all needs from the physicians.
The QFD tool had its origins in Japan in the sixties and it was
not until the early eighties that gained attention all around the
world. QFD is a systematic process that helps planning the
development of new products or improving them, by fully
understand the necessities and requirements of the client,
which are medical doctors in this study. QFD helps to
visualize many attributes from the product and summarizes
them in a set of graphics kwon as “Quality tables”, where
information related with the client is collected. Once attribute
listing is applied, the specific attributes can be translated into
“WHAT’S”, which forms part of the QFD Matrix, and
establishes technical requirements, “HOW’S”, to each one of
them (Figure 3). A step by step description of how the QFD
must be filled is described below.
Fig. 3. QFD Matrix
The WHAT’S is the first portion of the QFD to be completed
and also the most relevant. It documents a structured list of
product customer requirements described in their own words.
This information is usually gathered through conversations
with the physicians in which they are encouraged to describe
their needs and problems. The technical requirements or
HOW’S is the section of the QFD referred as the engineering
characteristics. It describes the product in the terms of the
designer. This information is generated by the QFD team and
identifies all the measurable characteristics of the product
which are perceived as optimal to meet the specified
customer requirement or WHAT’S.
285
The relationship between the WHAT’S and HOW’S is the
main body of the QFD. Its purpose is to translate the
requirements as expressed by the customer into the technical
characteristics of the product. Its structure is based on a
standard two-dimensional matrix with cells linking individual
customer and technical requirements.
The level of interrelationship discerned is weighted usually
on a four point scale (high, medium, low, none) and a symbol
representing this level of interrelationship is entered into the
matrix cell. For each level of interrelationship weighting a
score is assigned. Engineers should understand and agree
with the scores before completing this matrix. The relative
values of these weightings should be chosen to suit the
individual QFD.
The target values are the final section of the QFD to be
completed and it summarizes the conclusions drawn from the
data contained in the entire matrix and the team’s
discussions. These are a set of engineering target values to be
met by the new product. The relative importance of each
technical requirement of the product in meeting the specified
need can be calculated from the weightings contained in the
planning and interrelationship section or known as
importance rating. Each interrelationship weighting is
multiplied by the overall weighting from the planning matrix.
These values are then summed down (columns) to give a
priority score for each technical requirement.
4. BIOMEDICAL DEVICES PROTOTYPE
Several biomedical devices are designed in collaboration
between physicians and engineers resulting on geometrical
shapes to be manufactured. Some prototypes are done to
check fit, form and function. This section shows some case
studies were biomedical devices are produced using AM
technologies giving clear idea about the potentially of AM to
built biomedical devices.
4.1 Tracheal Stent - FDM
Tracheal stent is endoprosthesis used to avoid tracheal
closure allowing normal respiration with enough flux of air.
Several pains and injuries could cause not normal section at
trachea, which should be repaired. Following methodology
explained in previous section new customized wavy D-shape
design is proposed having in mind all requirements from
physicians and afterwards manufactured with AM
technology.
Prototyping system manufactures tracheal stent with special
inner and outer surface to allow mucus flow and external
shape to increase efficacy to avoid migration compared with
commercial stents. For that reason, Fused Deposition
Modelling (FDM) was considered the manufacturing
technology most suitable for the creation of the stent. The
FDM is an additive manufacturing technology based on the
extrusion of a thermoplastic material layer by layer. For this
case study two different manufacturing possibilities were
envisaged: a) Additive manufacturing – building directly the
prototype using a FDM machine and b) Rapid tooling –
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building a mould using a FDM machine and filing it with the technology was used to build a mould and afterwards fill the
final chosen material. mould with a biocompatible material, AM technology was
used as RT instead of RM. Mould produced with FDM
Open source FDM machine was used to manufacture a first technology was filled with implantable grade liquid platinum
prototype of the new stent design. The machine, called cured silicone rubber (LSR). Figure 5 shows mould and stent
Fab@Home, is able to build 3D objects by carefully produced with new arrangements.
depositing material drop by drop, layer by layer. However, its
main limitation is the material. This machine can process
only materials extrudable at room temperature. For this
reason, the first prototype was build using a commercially
available common silicone (not biocompatible) with full
factorial experiments to know about optimal process
parameters to produce the tracheal stent.
First prototype was build using common silicone without
having good accuracy of the prototype and high surface
roughness. After a detailed assessment of the problem, it was
found that the path calculation method used by this machine
was not suitable to manufacture the stent, and therefore a new
printing method was proposed instead to change AM
technology which is not the problem. The method used by the
Fab@Home machine is a non-continuous method based on
the automatic creation of printing paths from the STL file.
Sometimes multiple passes are done over a single path,
creating excess of material and a poor finish quality surface.
In order to obtain better results, a new continuous approach Fig. 5. Mould produced in Fab@home and New stent made
was developed in Python to create the main points of the of biocompatible silicone
printing path with a single pass. This code creates the stent
printing path and saves all the points as a text file. As a result, FDM became suitable technology to produce tracheal stent as
the prototype obtained was more accurate and with better biomedical device customized. It was required to modify
surface finish (Figure 4). technology set up and found out about alternative methods to
utilize Fab@home for obtaining optimal results, although the
product was produced with all requirements that physicians
needs in that product.

4.2 Maxillofacial - SL

Mandible prosthesis is used to reconstruct face bone due to

several reasons such as tumours developed, no functional
movement when chewing and esthetical. Following
methodology explained in section 3 new personalized bone
shape design is drawn taking into account all requirements
from physicians and mandible function of chewing (Figure
6). Geometrical shape is manufactured with AM technology
able to produce parts with enough tensile mechanical
properties. Numerical simulations to check tensile strength
and deformation were carried out before manufacturing the
Fig. 4. New stent printed in the Fab@Home machine using a
prototype using Ansys workbench 12.
continuous method

Nevertheless, one of the main requirements concerning the

new stent is its biocompatibility. For this reason FDM
technology was used to build a mould and afterwards fill the
mould with a biocompatible material, AM technology was
used as RT instead of RM. Mould produced with FDM
technology was filled with implantable grade liquid platinum
cured silicone rubber (LSR). Figure 5 shows mould and stent
produced with new arrangements.
Nevertheless, one of the main requirements concerning the
new stent is its biocompatibility. For this reason FDM Fig. 6. New mandible product design

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Prototyping system manufactures mandible with special
material requirements to resist chewing and functional
movement. For that reason, Selective Laser process (SL) was
considered the manufacturing technology most suitable for
the creation of that product. SL is an additive manufacturing
technology based on laser energy to sinter or melt metallic or
polymeric powder on a bed-building platform. For this case
study DMLS M270 – EOS Gmbh machine with
biocompatible material was selected. This machine can
process only materials Titanium alloys (Ti6Al4V) (Figure 7).
First prototype was build using optimal process parameters
provided by machine manufacturer. However, first prototype
do not met mechanical properties and it is over-strengthen
causing too much pain on healthy bone part of mandible.
After a detailed analysis of the problem, it was found that
solution could be reached by changing shape design without
modifying AM manufacturing process.
Fig. 7. Mandible manufactured with SL technology
SL became suitable technology to produce mandible as
prosthesis device personalized. It was not required to modify
technology set up and only geometrical shape was found to
be modified to reach optimal results, thus the product was
produced with all requirements that physicians needs in that
product as well.
287
4.3 Scaffolds - FDM
Scaffolds are structural parts with high porosity to help cells
in-growth. Nowadays, scaffolds are proposed to be a good
solution to regenerative medicine instead of implants or
prosthesis. The development of scaffolds as accurate
constructs made of a matrix and living cells to repair and
regenerate damaged tissue is a great challenge in the tissue-
engineering field.
In terms of tissue engineering, additive manufacturing
technologies enable the fabrication of customized scaffolds
directly from the patient, by using a scanner to import the 3D
data needed, and employing a range of materials such as
polymers or ceramics. For this purpose, existing additive
manufacturing machines are currently being modified to
improve their accuracy and capabilities. The optimization of
process parameters is important to obtain adequate scaffold
morphology and biomechanical behavior, to improve cells
adhesion and proliferation, and therefore, tissue regeneration.
Indeed, appropriate porosity, pore size, pore shape, and
mechanical strength are required to achieve cell growth and
scaffold formation.
In this case study RepRap machine as open-source extruder is
utilized instead of Fab@home with same FDM technology
because it is able to control material and process temperature.
Scaffolds production needs to have temperature under control
due to polymeric and biocompatible materials utilized. In
addition all other process parameters are controlled because
have a direct influence on the morphology and biomechanical
performance of scaffolds built in RepRap machine.
This case study focuses on produce Poly-L-lactic Acid (PLA)
scaffolds with open-source and low-cost 3D extruder
machine, called RepRap Prusa 3D printer (MakerGear,
USA). Performance of porosity is the great goal to verify AM
technology. RepRap consists of a thermoplastic extruder
positioned within a computer-controlled Cartesian platform.
Once the material is supplied to the extruder, a certain
temperature and pressure, exerted by a gear, causes the
change of the filament diameter from 1.75 to 0.35 mm, which
is ejected through a nozzle and finally deposited onto a
heated platform which controls process and material
temperature.
Several prototypes with different process parameters
conditions and temperature were built to check mechanical
and geometrical properties. After a detailed analysis of
scaffolds, it was found that process parameters affect to final
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September 11-13, 2013. Fortaleza, Brazil
result and therefore process parameters optimization is
launched. As a result, final prototype obtained was
manufactured with better mechanical and geometrical
conditions (Figure 8).
FDM with temperature control became suitable technology to
produce Scaffolds as biomedical device for tissue
engineering. It was required to optimize technology process
parameters including temperature set up to obtain required
results.
5. FUTURE CHALLENGES
Recent research works on AM technologies demonstrate
great potential and opportunities to manufacture personalized
biomedical devices. A wide range of solutions applicable to
AM is still going on but there are future challenges to reach
because of new materials, technologies, principles or
demanded products. Nowadays, it seems that biomedical
devices will focus on regenerative solutions where scaffolds
will play an important role than other permanent implants
solutions did. For that reason, several techniques arise with
great potential to cover human needs but with uncertainty to
work with. That should be the way where all researchers on
additive manufacturing processes and medical doctors will
focus their efforts. Some relevant challenges to be addressed
in the future include the following list without missing other
important ideas not related with this paper:
 Additive technologies like Electro-spinning and electron
beam melting (EBM) which are real new technologies
still undergoing with their potential and applications;
 Increasing reliability of AM technologies based on
results obtained by comparison of product designed in
geometrical, dimensions and tolerances;
 Developing open and flexible solutions for users where
AM technologies and materials can be combined;
 Achieving understanding of AM processes and
convergence of techniques for application to health care
sector;
 Enhancing multidisciplinary collaboration between
engineers and physicians
6. CONCLUSIONS
This paper shows how AM technologies will play an
important role in the future for these products that needs high
level of personalization. Three case studies analyzed
demonstrated that AM can be modified to offer optimal
solutions for those products belonging to biomedical devices
sector where products required are always different. The
expected result of this work was successfully reached by
showing solutions for the sector of biomedical devices and
bioengineering. Collaboration between technology
developers, engineers and physician had been crucial to fulfill
product expectations. Finally there is a long way to do as
previous section exposes but AM technologies offer some
enthusiastic challenges for the future.
288
ACKNOWLEDGEMENTS
Author wishes to thank European Commission and Spanish
government for their valuable support. This work was
partially carried out with the grant supports from the
European Commission project IREBID (FP7-PEOPLE-2009-
IRSES-247476) and the Spanish Science and Innovation
Minister project TECNIPLAD (DPI2009- 09852).
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