FAME-MED
Orthopedic science & precision for overcoming challenges
Medical Ltd.
www.famemed.com.tr
Innovation for Human Life
Medikal Sistemleri Ltd. Þti.
(Import - Export)
(R & D)
www.biosismedikal.com.tr
www.famemed.com.tr
(Production)
www.neologic.com.tr
Biologic
Medikal Ltd. Þti.
(Import - Export Construction)
www.ute.com.tr
(Casting)
www.implantdokum.com
(Bio-Agriculture &
Biomedical Products)
FAME-MED
Medical Ltd.
Vision and Mission
V
M
Improving quality of
life by productive
biomedical design,
research and
production.
We design, test and
produce medical
implants using
cutting-edge
technologies. Our
mission is to convert
innovative
biomedical concepts
into novel products
through translational
research.
Design, Research and
Production to Improve Quality
of Life.
Fame-Med Medical Trade Ltd. is a high-tech medical
and biomedical R&D company founded in 2002 with
the aim of improving design, innovation, research and
development of medical materials and implants. The
company is currently based at Hacettepe University
Techno-City (www.hacettepeteknokent.com.tr),
Ankara, Turkey. Fame-Med is in collaboration with
universities human sources and infrastructure as well as
companies at industrial zones around the country. The
company is specialized in medical materials, implants
and devices mostly used to surgically treat
musculoskeletal and maxillofacial diseases and
disorders. Devices for measurement, such as ligament
tensioners, volumeters, cartilage strength probes are
also created.
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Research Based Engineering
of Medical Materials,
Implants and Devices.
"Precision from
scratch of the design
to the final product."
FAME-MED meets the
merits of combining
research among
medicine,
engineering and
basic sciences.
Material characterization,
mechanical testing, in vitro,
in situ and in vivo testing of
medical devices can be
performed by the own and
by mobilizing nearby
sources of the company.
Other nearby sources
including high-techcoating of medical
implants by biocompatible
materials. Production of
tissue engineering scaffolds
such as bioceramics and
regenerative medicine
tools are also in the scope
of this company.
Our group consists of
medical doctors,
maxillofacial surgeons,
engineers and researchers
as well as industrial experts
of the biomedical field.
Medical doctors are critical
decision makers in the
name of their patients who
are the end-users of
biomedical implants and
devices. We rely that
medical doctors, veterinary
and dental surgeons should
be involved from the first to
the last stages of designing
and researching these
devices for successful
product development.
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As we talk the same
language, we are able to
follow new approaches to
common problems with
great elasticity because of
our built in self-reliance to
our individual talent with a
homogenous selfconciseness.
The mission of Fame-Med
is to improve current
medical implants and to
develop/design new
medical implant
technologies.
In a fast grooving and
rapidly aging society, the
demand on new trauma,
reconstructing and joint
replacing biomedical
material technology is
versatile and increasing.
Human Sources
Together with its sister companies, Fame-Med recruits
28 staff at its facilities. Experts of various fields including
material scientists, mechanical engineers, electrical
and electronical engineers, biomedical engineers,
chemists and microbiologists gather together at
international and international projects.
Distributers in Turkey are located in 7 districts and 47
cities establishing a sales network that reaches all parts
of the country. Operations in England, Germany and
other European countries are carried out through various
offices. Nearby countries including those of Eastern
Europe, Middle East, Mediterranean and North Africa
are reached through our office in Istanbul.
Material
Development and
Characterization,
Mechanical Testing,
In Situ, In Vitro and
In Vivo Testing.
Our research partners at universities collaborate with
us on material development and characterization,
virtual and mechanical testing of implants, in situ and
in vitro genotoxicity, carcinogenicity (ISO 10993-3) and
cytotoxicity (MTT, Natural Red Uptake, XTT) testing (ISO
10993-5).
Implantation (ISO 10993-6), Biodegradation
(ISO 10993-9), Intracutaneous Reactivity and
Sensitization (ISO 10993-10) and Systemic Toxicity (ISO
10993-11) tests are nearby accessible at sources.
We are able to design clinical trials through our network
at state and university hospitals.
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Biomechanics
We are all genius. The time
line from "having an idea"
to designing, virtual testing,
prototyping and
environmental testing is
shortened recently.
Following steps of smart
medical implant and/or
instrument designing,
development and
prototyping are
undertaken step by step by
the experts of the field.
Concept Development:
Understanding the rational
of the design that we call
the project and its
originality may take the
longest time. To develop a
sound statement (a) the
literature is searched, (b)
patents are investigated
and (c) experts assess
similar products on the
market. Stating the
problem and the new idea
that can solve that
problem are approached
scientifically. Technical staff
designs the medical
implant and/or instrument
as soon as the concept is
set.
Research Capacity
Designing of the Solid
Model: The environment is
virtually designed together
with the medical implant
and/or instrument from
computerized tomography
(CT) pictures.
In the case of the proximal
femur for instance several
normal bones were
scanned with a multidetector CT. Voxel sections
were reconstructed with
commercially available
software and a threedimensional solid model of
the femur is created. The
design of the new medical
implant and/or instrument
is now ready to be assessed
by the owner of the
project. Re-designing and
fine-tuning of the new
medical implant and/or
instrument is undertaken
according to the project
owner and the experts'
opinion.
Finite Element Analysis
(FEA): Commercially
available softwares are
used for FEA. The
environment that is usually
the musculoskeletal system
is simulated for
physiological or
pathological conditions.
The original implant and its
available comparatives
are designed and
analyzed. The duration of
FEA can vary according to
the number of research
questions and the number
of medical implants to be
tested.
Mechanical Features of the Implants
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MATERIAL
Elastic Modulus
(N/ mm²)
Poisson
Ratio
Yield Strength
(Mpa)
Stainless Steel
Titanium (Ti6A14V)
193.000
114.000
0.28
0.34
310
830
Loads to the implant and
joins are simulated
according to the literature.
The forces are applied
'load case' then the
analysis is run and the von
Mises stress values (MPa)
are calculated. These
values are acquired
numerically from each of
the nodes established on
the model. Forces are
applied to the simulation
and the mesh structure is
formed. Bones are
modeled as a
homogenous, isotropic and
elastic material. If essential,
a fracture line can be
created on the model.
Stress values at every point
across the entire implant,
fracture line or bone can
be analyzed in these
models.
Biomechanical Testing:
Cestamide, a synthetic
material with mechanical
properties similar to those
of bone. Cestamide is
shaped into the desired
bone. Load cells are
placed into spaces to
measure loading on the
medical device or bone.
The medical device
applied bone is than
placed in a material-testing
device. Load
displacement curves are
obtained from this device.
Bending, tension and
torsion test equipment are
available at nearby
sources. ISO, CE and ASTM
tests are carried out by
subcontractors. In general,
cylindrical or H shaped
moulds of are prepared for
the tests. Six to 10 samples
are usually required to be
tested at our universal
mechanical test machine.
Material
Characterization
Pore Size and Structure
Assessment: Surface
topography and pore size
of medical devices or
biomaterials is examined
with Scanning Electron
Microscope (SEM). Small
samples of the medical
device are stabilized on
supports and are filmcoated with gold
fragments to maintain a
higher conductivity on the
surface.
The surface area is assessed
at a Quantachrome
Autosorts 6 single ray BET
Surface Characterization
Device at nearby
infrastructure. Materials are
cleared off moisture and
dissolvent before tests.
Surface area analysis is
carried out with nitrogen
adsorption.
Density Measurements:
X-Ray Diffraction (XRD) of
the surface of the medical
device or biomaterial is
tested under the JSM 6400
SEM using the Rigaku XRD
unit and the Cu K-alpha ray
at 2 Theta.
Porosity: Inner pore volumes
of biomaterials and
medical device coatings
are measured at 50 psi
using a mercury
porosimeter at nearby
sources. Visible density is
assessed at the same
device.
Expertise of 25
years in research
and 27 years of
production.
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Release Tests: Implants are
recently enhanced to
deliver medicine and
active molecules. In such
instances release graphics
are prepared. Implants are
separately placed in 20 ml
deionized water for 6
weeks. The solutions are
evaluated on a Single
Beam Diode Spectrometer.
Sensitive assessment of
release is utilized using a
High Pressure Liquid
Chromatography (HPLC)
device. Implants are kept
in 20 ml human sera for 24
hours. On the following day
the sera is distilled and
incubated at 37°C. The
incubated serum is
assessed at the HPLC
device and Symmetry C8,
3 are used. The mobile
phase of the serum is
maintained using 0.01 mol
heptansuphonic and
acetonitrile (85/15, h/h).
Absorbance is observed at
1.4 ml/min flow speed and
280 nm.
Microbiological Tests:
Bactericidal effect of the
implants is analyzed using
BD BBL Sensi-Disc
Antimicrobial Sensitivity Test
Discs . Methicillin-Resistant
S. Aureus (MRSA) (strain:
ATCC 2592) is a bacteria
frequently causing implant
related infections. MRSA is
diluted in 1.0 ml distilled
water a0.1 ml of this elution
is spread on agar plates.
Test discs are placed on
one half of the plate and
controls on the other half.
The agar plates are
incubated at 37°C for 4
days. The diameter of zone
of clearance around the
implants is measured.
Diameters of 9 mm and less
are accepted as resistant.
Diameters of 10 - 11 mm
are accepted as average
and diameters larger than
12 mm are recorded as
MRSA sensitive. A
subcontractor assesses the
production of a
biomembrane at implant
related infections.
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In Vitro Test
According to the scope of
the study, a) adhesion, b)
proliferation,
c) differentiation (for bone
mineralization), and d)
extracellular matrix
production is examined.
Human bone marrow
derived Mesenchymal
Stem (MSC) and MC-3T3E1 Cell lines are used for in
vitro tests.
Adhesion: 462.000 cells are
used for the adhesion
experiments. Cells are
placed on 12 well plates
with the implant and left
for incubation. Live and
death cell counts on
implants are assessed after
trypan blue staining.
Proliferation: 27,000 cells are
used for cell proliferation
and toxicity tests with MTT.
Cells are placed on 96 well
plates with the implants and
left for incubation. On
assessment days, 20µl
(5mg/ml) MTT paint is
added to each well and
the cells are further
incubated at 37°C for 4
hours. Change of color in
the wells is measured with
an ELISA Reader at 540 nm.
Quantitative Live Time
Analysis of Proliferation:
Adhesion and proliferation
of cells on biomaterials is
assessed using a Real Time
Cell Analyzer. Cells are
planted on 96 well plates
containing micro
electrolytes with the
implants. The analyzer is
placed in an incubator
containing 5 % CO2 at
37°C. With the integrated
computer system, the
proliferation of the cells is
analyzed at every 40
minutes.
Mineralization: 375.000 cells
are placed on 12 wellplates with the implants.
When the cells reach 50 to
60% saturation, the
differentiation solution is
added. Alizamine Red
staining reveals
mineralization. The
Quantichrom Calcium
Assay Kit is used to identify
the calcium content.
qRT-PCR Studies: Osteogenic protein
analysis is conducted at cells derived
from implants. The RNA is isolated
from the cells that contacted with
the medical implants and
biomaterials. Alkaline phosphatase
(ALP), osteocalcin (OCN) and
osteopantin (OPN) gene expression
levels are analyzed.
Research Projects
(Completed)
-Ankle Rotation Stabilizer (Middle East Technical University Research Fund)
- Load distribution at the knee joint according to hip anteversion and varus/valgus (Osmangazi
University Research Fund)
- Double layered self-adhesive kollagen membrane production (for ArsArthro Co. Bilkent, Technocity)
(Patented)
- OnKap/TedKap: Antibiotic containing polymer coating of metallic implants to prevent/treat implant
related infections (for Orthopro Co.) (Patented)
- Production of a gait analysis system (for Tümer Electronic Ltd.)
- Production of a mini/micro plate system (Middle East Technical University Technology Development
Center)
- The designing and production of an Anterior Cruciate Ligament (ACL) fixation set (sold under the
brand name of Orthopro)
- Canine hip prosthesis (designed and prototyped for Hipokrat Ltd.)
- The Modified Anatomic Plate (Finite Element Analysis pilot study for Fuad Öken MD)
(Öken F. et.all. Performance of modified anatomic plates is comparable to proximal femoral nail, dynamic
hip screw and anatomic plates: Finite element and biomechanical testing. Injury. 2011; 42: 1077-83.)
- The Modified Axial Fixator for Hip Fx (Finite Element Analysis pilot study for Hakan Özdemir MD)
- The Modified Epiphysiodesis Set (designed and prototyped for Hipokrat Ltd.)
- Maxillofacial Mechanical Tester (produced for Ankara University Dentistry Faculty)
- Educational Simulator for Dentistry (DiHES) (supported by TUBITAK)
(Konukseven EI. et.all. Development of a visco-haptic integrated dental training simulator. J Dent Educ.
2010; 74: 880-91.)
- Mechanical testing of the proximal loads of a tibial Ilizarov fixator: Finite Element Analysis pilot study
(for Turgay Çavuþoðlu MD)
(Çavuþoðlu T. et.all. Biomechanical comparison of two different wire stretching methods in the treatment
of tibial plateau fractures with the Ilizarov technigue and the related clinical results. Joint Diseases & Related
Surgery 2009; 20: 2-10.)
- New concepts of Mini Maxiollofacial Distiractor (completed for Kýrýkkale University)
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International Research Collaborations
A monoblock acetabular cup
was developed to enhance
ceramic-bone integration.
([FP7/2007-2013]
[FP7/2007-2011] under grant
agreement
n° [286548].
http://match-euproject.com/
Intervertebral textured polymerceramic composite cages are
designed and prototyped using
the 3D printing technology.
TUBITAK_TEYDEP Project n° [9120071].
ORIGAMI
Development of new high-peed Additive Manufacturing
Industrialised complex processing for Osteointegrable ceramic
Implants.
HIPster
HIP manufacturing Solutions Towards Efficient
Revision-prostheses.
Development and application of innovative processes to transform
hierarchic structures existing in nature into innovative biomedical devices
with advanced biomechanical characteristics. M-ERA.NET Project n°
[evaluation process]
In Vitro and In Vivo Tests
BioBone
Development and implementation of a new hip revision prosthesis through the
combination of new processing methodologies applied to innovative ceramic
compositions, an improved structure design and an innovative deep coating
methodology with the goal to obtain a new cost-effective and long-lasting
device. MANUNET-ERA Project n° [27030]
Confocal Microscopy: Along with other types of
microscopy techniques, cells on medical implants and
biomaterials are evaluated by Confocal Microscopy
at nearby sources. Behavior of live cells colored with
fluorescent dyes of Typotitic Carbocianin is observed.
Same samples are further monitored by SEM and
Transmission Electron Microscopy for academic merits.
In Vivo Testing: Access to small and large animal testing
facilities after ethical committee approval is available.
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Medical Ltd.
Hacettepe University Beytepe Campus
University District. 1596. St.
Techno-city Building #4, No: 95
2. Floor Office No:52,
Çankaya, Ankara, 06800, Turkey
www.famemed.com.tr
[email protected]
Phone: +90 312 299 26 33
Fax: +90 312 236 17 47