Application of additive manufacturing technology for manufacturing medical implants a review

International Journal of Mechanical Engineering and Technology (IJMET), ISSN 0976 – 6340(Print),
ISSN 0976 – 6359(Online), Volume 6, Issue 4, April (2015), pp. 45-55© IAEME
45
APPLICATION OF ADDITIVE MANUFACTURING
TECHNOLOGY FOR MANUFACTURING MEDICAL
IMPLANTS: A REVIEW
Vipul V.Ruiwale
Mechanical Department, MIT College of Engineering, Kothrud, Pune, Maharashtra, India,
Dr. Rajesh U. Sambhe
Mechanical Department, Jawaharlal Darda Institute of Engineering & Technology,
Yawatmal, Maharashtra, India,
ABSTRACT
With the advancement of technology every field of work is becoming more and more inter-
related and inter-dependant. So the fields of CAD/CAM and healthcare are no exception to this. As it
is said that human body is a machine, with every passing day, its wear and tear takes place and also
due to some trauma/accidents it is necessary to have certain bones/limbs to be replaced, or there can
be birth defects. A large number and variety of medical implants, prostheses, and surgical
instruments are required to reconstruct or correct lost, damaged, deformed, and degenerated limbs,
tissues and teeth. So CAD/CAM can be effectively used for the above purpose in the field of
Orthopedics (medical field dealing with bones, limbs etc), dentistry. Orthodontic and maxillofacial
implants, as well as distraction osteogenesis devices are used for correcting facial and oral
deformities. The range of implants extends to auricular, ocular, cardiovascular, spinal, pelvic, and
various joints: shoulder, elbow, wrist, hip, knee, and ankle. In India, the number of knee and hip
replacements alone is estimated to be around 40,000 per year, most of them using imported implants.
The number is nearly doubling every year, owing to better awareness and increasing affordability.
Implants and instruments need to be developed considering the target population of patients and the
consulting surgeons. The implants may be standard (suitable for a large population), modular (to
provide intra-operative flexibility), or customized (patient-specific). Anatomical measurements of
the target group or individual are carried out establish the geometric requirements. Now with the
help of new CAD/CAM technology it is very easier to model and manufacture the implants to very
accurate shape, size & dimensions according to patient’s requirements. This paper explores the scope
of additive manufacturing technology for manufacturing implants, work progress going on in this
field, challenges, future scope.
INTERNATIONAL JOURNAL OF MECHANICAL ENGINEERING AND
TECHNOLOGY (IJMET)
ISSN 0976 – 6340 (Print)
ISSN 0976 – 6359 (Online)
Volume 6, Issue 4, April (2015), pp. 45-55
© IAEME: www.iaeme.com/IJMET.asp
Journal Impact Factor (2015): 8.8293 (Calculated by GISI)
www.jifactor.com
IJMET
© I A E M E

46
Keywords: Additive Manufacturing, Bones, CAD/CAM, Implants, Orthopedics
1. INTRODUCTION
As it is said that human body is a machine, with every passing day, its wear and tear takes
place and also due to some trauma/accidents it is necessary to have certain bones/limbs to be
replaced, or there can be birth defects. A large number and variety of medical implants, prostheses,
and surgical instruments are required to reconstruct or correct lost, damaged, deformed, and
degenerated limbs, tissues and teeth. The implants should be fair and strong enough to sustain for a
long time otherwise a failure could give patients some sleepless nights physically, emotionally and
financially as well. With the advancement of technology every field of work is becoming more and
more inter-related and inter-dependant. So the fields of CAD/CAM and healthcare are no exception
to this [1]. So CAD/CAM can be effectively used for the above purpose in the field of Orthopedics
(medical field dealing with bones, limbs etc). The range of implants extends to auricular, ocular,
cardiovascular, spinal, pelvic, and various joints: shoulder, elbow, wrist, hip, knee, and ankle.
Implants and instruments need to be developed considering the target population of patients and the
consulting surgeons. The implants may be standard (suitable for a large population), modular (to
provide intra-operative flexibility), or customized (patient-specific). Anatomical measurements of
the target group or individual are carried out establish the geometric requirements. The
manufacturing of implants can also be done using additive manufacturing technique in addition of
traditional manufacturing technologies like subtractive manufacturing.[2] Additive manufacturing or
AM finds its best application in producing products that are either highly complex highly customized
or where the quantity needed is small and other production techniques are not cost-effective. The
high level of customization available with AM makes this technology well suited for custom-fitting
products to individual patients, an important factor in clinical efficacy. There are various types of
AM techniques which are used for manufacturing of implants such as Electron Beam AM,
Stereolithography (SLA), Fused Deposition Modeling (FDM), 3D Printing (3DP), Laminated Object
Manufacturing (LOM), Selective Laser Sintering (SLS), Selective Laser Melting (SLM), Laser
Metal Deposition (LMD), etc.[2].The biofabrication process can be used to manufacture implants,
tissue structure, artificial structure for cell formation etc.[1-28-34]. The development of medical
imaging, especially imaging software and digital three-dimensional (3D) scanning has made it
possible to create various 3D models from medical images. These 3D models can be directly
manufactured into physical objects using additive manufacturing (AM) or the 3D models can be used
as a design template for personalized medical devices.[2-3-4]
2. ADDITIVE MANUFACTURING
Additive manufacturing is “a process of joining materials to make objects from 3D model
data, usually layer upon layer, as opposed to subtractive manufacturing methodologies.” (From the
International Committee F42 for Additive Manufacturing Technologies, ASTM)[5].
The term "3D printing" is increasingly used as a synonym for AM. However, the latter is
more accurate in that it describes a professional production technique which is clearly distinguished
from conventional methods of material removal. Instead of milling a work piece from solid block,
for example, AM builds up components layer by layer using materials which are available in fine
powder form. There are different types of AM Methods like EBM, laser sintering, laser melting,
blown powder process, wire extrusion process, extrusion process, 3D Printing, Stereo lithography,
Fused Deposition Modeling.[5-6].It is a well-known fact that additive manufacturing (AM)
technology, more commonly known as 3D printing, is not currently at a maturity level that makes it
suitable for mass manufacturing — it is an expensive and time-consuming process compared to

47
conventional technologies[7]. However, additive manufacturing does have one significant advantage
over more established approaches: the ability to make custom parts usually meant for short-run
production. As a result, it becomes an ideal technology for fabrication of parts in industries that
typically do not operate in economies of scale. Also the wastage production in AM process is
considerably very less than subtractive manufacturing processes.
Fig 1: traditional vs. additive manufacturing [8]
Additive Manufacturing refers to a process by which digital 3D design data is used to build
up a component in layers by depositing material [8]. The term "3D printing" is increasingly used as a
synonym for Additive Manufacturing. However, the latter is more accurate in that it describes a
professional production technique which is clearly distinguished from conventional methods of
material removal [9]. Instead of milling a work piece from solid block, for example, Additive
Manufacturing builds up components layer by layer using materials which are available in fine
powder form as shown in Fig.2. A range of different metals, plastics and composite materials may be
used.
Fig. 2: additive manufacturing process [9]
The technology has especially been applied in conjunction with Rapid Prototyping - the
construction of illustrative and functional prototypes. Additive Manufacturing is now being used
increasingly in Series Production. It gives Original Equipment Manufacturers (OEMs) in the most
varied sectors of industry the opportunity to create a distinctive profile for themselves based on new
customer benefits, cost-saving potential and the ability to meet sustainability goals.[10]. AM plays a
role in reducing cost in manufacturing. Another reason is a cultural development: there is a trend
toward more custom products. The “one size fits all” model does not work as well as it once did. AM

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is a tool that allows designers to create unique products that can be manufactured at low volumes in
an economical way. Another driver of AM technology is its environmental and ecological promise.
AM technologies have the potential to reduce the carbon footprint of manufacturing by using less
raw material, creating less waste material, eliminating hard tooling, producing lighter-weight
components with optimized designs, and fabricating parts on demand[11-12]. Also, it can reduce
transportation costs by placing the manufacture of the products much closer to the customer.AM
technology presents wealth of new developments and opportunities Among them are new types of
products that would be difficult or impractical to manufacture by traditional methods.[13].AM also
presents opportunities in innovative businesses, business models, and supply chains. It considers
exciting possibilities in high-value custom and limited edition products, replacement part
manufacturing, short-run production, and series production in aerospace, defense, medical,
transportation, and other industrial sectors. Along with that, the ability to do custom devices for a
one-off type manufacturer is something that you can’t do with any of the traditional methods. The
biggest part is the design itself—whatever happens to work best for the patients, rather than what is
manufacturable. [14]
3. NEED OF ADDITIVE MANUFACTURING FOR MANUFACTURING OF MEDICAL
IMPLANTS
Traditionally medical devices are designed according to “an average person” because
customized devices need to be especially handmade and are therefore costly. Currently, the majority
of patient specific implants are handmade during surgery and oral appliances are handmade by a
dental technician in a dental laboratory. The development of medical imaging, especially imaging
software and digital three-dimensional (3D) scanning has made it possible to create various 3D
models from medical images [15-16]. These 3D models can be directly manufactured into physical
objects using additive manufacturing (AM) or the 3D models can be used as a design template for
personalized medical and dental devices [17]. This obviates the handicraft and may result in more
accurate and economical devices. Combining known techniques and novel design and manufacturing
methods offers medical professionals new means to treat patients and to enhance their quality of life.
The increase of welfare in Western countries sets higher expectations for a better quality of life. But
on the contrary, the ageing of the population sets its own challenges. The lifestyle of our Western
society has dramatically reduced physical exercise and increased the amount of sedentary work. As a
consequence, the physical condition of people is deteriorating causing various health issues, such as
problems with back and joints, among many others. These challenges require new and improved
medical devices and advanced manufacturing technologies. It is estimated that in the European
Union the old-age dependency ratio will grow from 25 % in 2010 to 50% by 2050 (Eurostat
2013).Furthermore, in the US, China and India the old-age dependency is estimated to double during
the next 40 years (United Nations 2012). Based on these figures, there is great potential for new
technologies, such as AM [18-19].
In India, the number of knee and hip replacements alone is estimated to be around 40,000 per
year, most of them using imported implants. Various spinal, pelvic, and various joints: shoulder,
elbow, wrist, hip, knee, and ankle replacements are also increasing. The number is nearly doubling
every year, owing to better awareness and increasing affordability. Bone cancer is also one of the
fastest growing problems as in the many cases the entire bone which is suffering from cancer has to
be replaced. Also Maxillofacial and Auricular (Cosmetic) implants are necessary to cure certain birth
defects and defects due to some accidents. It is very necessary to manufacture a safe and strong
implant so that it can sustain for a quite a good amount of time and it should not fail and there should
be no side effects.AM can be used to a greater extent to answer above problems. AM has the unique
ability to provide “complexity for free,” and the application here is for unique, interesting porous

49
surfaces or volumes.[20] Imagine being able to design your own porous structure, integrating your
specific “look,” dialing in pore size, interconnectedness, porous/solid volume, etc. and coming up
with something unique. Great, now take that unique porous structure and apply it across your product
line, and without secondary machining or manufacturing processes to adhere it to your parts as with
some traditional techniques. Now you’ve got a uniform porous structure that can be applied at will to
your product line, and the best part is that it’s not a surface; the surface is integral to the part as it is
produced as a single, unified body during the construction of the implant via AM. These techniques
are used both in Europe and the U.S. today for construction of implants that have been through the
appropriate regulatory hurdles, including the FDA 510(k) clearance process The greatest benefit to
using AM lies in being able to create geometric designs that we’re unable to do with other existing
technologies. A good example of that are the hip cups that had the welded beads on them. If those
beads come off, there can be a big lawsuit as a result of that against the implant manufacturer. Being
able to integrate that feature into the build for in growth of bone makes a phenomenal difference, and
really can only be done adequately using this type of technology[21]. Accurate Patient specific
implants produced using 3D scan data can reduce the removal healthy bone, eliminate the need of
bone grafting, promote effective planning of implantation/surgery and shorten the time of anesthesia
in addition with increased implant life. [22]
4. WORK PROGRESS OF ADDITIVE MANUFACTURING TECHNOLOGY FOR
MEDICAL IMPLANTS MANUFACTURING
Many companies worldwide such as Efesto, Renishaw, EOS etc. are manufacturing patient
specific medical implants using various additive manufacturing technologies from the data obtained
from computational topography (CT) scan using BIO-CAD.[42].The FDA 510(k) recently gave
clearance for the manufacturing of cranial implants using 3D Printing Technology in US and UK
[40]. Researchers have also been working on the development of hard and soft tissue with new
materials manufactured by 3D printing for medical purposes. As it is possible to manufacture a
volumetric net structure, which also allows cells and tissues to grow through it to and from
surrounding tissues. The net is created from surface and its thickness and hole size are
adjustable.[22-23-24-25-26] In India research work is going on Additive Manufacturing and Bio-Cad
for manufacturing of Medical implants using AM techniques .European union has funded many AM
research projects for the development of this technique. In the US also, President Obama have taken
a huge step towards development of AM recently.
4. MEDICAL IMPLANTS – DEVELOPMENT CYCLE USING ADDITIVE
MANUFACTURING
Implants Development of medical implants is a multi-stage design and manufacturing process
primarily based on computer numerical simulations and in-vitro tests. First stage is definition of the
problem based upon needs and objectives of the working environment. At this point standardization
of resembling fractures is reasonable. In the following, second stage preliminary ideas for implant
are given and preliminary design is created on the basis of computer tomography (CT) or magnetic
resonance imaging(MRI) scans which are used to process the medical image with high resolution
and precision in the reconstructed contours (3D model). In the third stage of the process is this model
the basis for numerical analysis (Finite Element Analysis-FEM), further prototype improvements and
manufacturing of the prototype using various additive manufacturing technologies [27-28].
Performance and functionality of the developed prototype are verified with different mechanical,
chemical, histological and cadaver tests (in-vitro tests). In case of positive expected results prototype
is tested on patients (in-vivo tests). [29-30-31] Finally, clinical use of developed implant. Implants

50
and instruments need to be developed considering the target population of patients and the consulting
surgeons. The implants may be standard (suitable for a large population) or customized (patient-
specific). Anatomical measurements of the target group or individual are carried out establish the
geometric requirements. Different imaging modalities (x-ray, CT, MRI, Scanners etc.) may be used
for this purpose. Various conceptual designs for the implant are evolved the most suitable one is
developed in consultation with the surgeon. Appropriate biomaterials are selected considering the
requirements of the patient and economic viability. This may include metals (ex. titanium, cobalt-
chromium, and stainless steel), polymers ceramics or a combination of these. The detailed design is
validated through rapid prototyping for checking the function and through computer simulation for
checking failure (by loosening, deformation, fatigue and wear) [32-33-34-35]. Recent advancements
in the areas of Additive Manufacturing (AM), Reverse Engineering (RE) and Image Processing (IP),
lead to the emergence of the field of Medical Applications of Additive Manufacturing where the 3D
physical model is built directly from the CAD file without the intermediary action. Manufacturing of
medical implants now days is considered to be a process planning problem to machine an object of
indeterminate shape into the specified shape, & additive manufacturing process planning. The
process planning problem is considered to be similar to the reconstruction of scanned data on a CAD
system in reverse engineering [36-37]. The requirements in modern implant production are highest
quality at most possible efficiency. All operations in this chain can be programmed by a single
CAD/CAM system.
The steps of this process are as shown in Fig 3:
• CT data Acquisition
• Creating CAD Model
• FEA Analysis of CAD model for various boundary conditions
• Manufacturing the part using Additive Manufacturing Techniques
Fig 3: implant development cycle [36]
Specialized surface engineering methods, treatments and coatings are used to enhance
integration of implant with local tissue. Advanced implants incorporate tissue grafts, fillers,
scaffolds, growth factors and infection inhibitors.[38-39] The implant is tested (mechanical,
metallurgical, biological) and certified for clinical use. Finally, it is laser marked, sterilized and
packaged. Standard or customized armamentarium (surgical instruments) required for implantation
are developed using a similar process. Appropriate documents and training material are created to
facilitate the implantation protocol.

51
5. CHALLENGES AND FUTURE SCOPE
Medical device/implant development is an inter-disciplinary knowledge-intensive process.
Developing different implants within a short time, with high quality, with new materials compatible
to human body and affordable cost suitable for the majority of the population is a very challenging
task. There is a clear need to enable large scale development of implants, instruments and human
resources. There are several research issues that need our attention.
Biomechanics / Ergonomics: This includes studying the kinematics and forces related to limbs of
both normal and post-operative patients. Research issues include scientific evaluation of the gait of
patients and various forces on implants, and developing an indigenous database useful for
development of implants suitable to local patients.[40]
Bio-Materials and Tissue Engineering: This includes developing and characterizing different low
cost bio-compatible materials, and evolving novel solutions to use them in implants. This requires
evaluation and improvement of implant-tissue integration, and development of hybrid scaffold-
implants that support growth of natural tissues. Validation of mechanical and thermal properties of
existing materials and AM technologies including part characterization.[40-41-42-43]
Computer-Aided Design and Additive Manufacturing: This includes computer-aided design
(modeling methods), evaluation and additive manufacturing in close collaboration with surgeons to
rapidly develop novel concepts for customized medical implants. Research issues include better
visualization (using virtual reality tools) and faster evaluation (using standardized finite element
method software tools). Development of modeling tools to ensure functionality of parts and increase
the understanding of how it will perform after surgery and further improvements in eliminating steps
in the process chain. Development of automation assessment of design and process planning tools.
Selection of Additive Manufacturing Technique: This includes selection optimum additive
manufacturing technology from available techniques to achieve the desired dimensional fidelity,
surface finish and internal properties in an economical manner, so that the implants are affordable to
the majority of the population.
Testing and Certification: This includes mechanical, metallurgical and biocompatibility tests (the
last one requires animal facilities). Research issues involve development of standard test protocols
for custom implants using a combination of virtual and physical test methods. Also to develop AM
Quality and process stability for medical/dental applications.
6. CONCLUSION
In summary we can say that, bio-medical reconstruction provides immense opportunities for
immediate application with concomitant social benefit, but comes with considerable technical and
collaboration challenges. The advantages obtained with CAD/CAM are numerous e.g. concerning
productivity reduces the time required to execute certain key steps of the manufacturing process, in
particular when a scanner is used to take measurements or when 3D is used to design the device.The
ability to produce physical models directly from the scanned data, promises to be the way of the
future in medical surgery. It is the ability of such engineering techniques to produce complex
“designs” coupled with the advances in surgical procedures that will enable replacement of human
parts, reconstruction of others, and the performance of operations with great precision. The process
of custom designing implants for each patient based on CT-data has been promising. However,

52
further research is necessary to lower the cost as well as time frame of such a process. With the
ability to design and produce any type of implant at a low cost, no more mass production of implants
would be necessary. The success of these efforts should be measured by the innovative medical
solutions developed for the ‘common man’ by advanced technologies available today.
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