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MPMD

TM

Materials and Processes

for Medical Devices

www.asminternational.org/amp
JANUARY 2009

TECHNICAL
AND
BUSINESS
NEWS
FOR THE
MEDICAL
DEVICE
INDUSTRY

Medical Device
Materials
Industry
News

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JANUARY 2009
TM

Editorial Staff

A publication of ASM International

9639 Kinsman Road
Materials Park, OH 44073
Tel: 440/338-5151; Fax: 440/338-4634
www.asminternational.org/amp

Margaret W. Hunt
Editor
peg.hunt@asminternational.org

Eileen De Guire
Managing Editor
Eileen.deguire@
asminternational.org

FEATURES

Trisha McKay
Contributing Editor

Barbara L. Brody

SPECIAL REPORT ON
MEDICAL DEVICE
MATERIALS
FROM THE FOLLOWING
SUPPLIERS:

Art Director

Joanne Miller
Production Manager
joanne.miller@
asminternational.org

Joseph M. Zion
Publisher
joe.zion@asminternational.org
Please send news releases to
magazines@
asminternational.org

Editorial Committee
Roger Narayan
North Carolina State University
and the University of North
Carolina, Chair

Ishaq Haider
BD Techologies

Harold Pillsbury
University of North Carolina

Ray Harshbarger
Walter Reed Army Medical Center

Sebastien Henry
Porex
The MPMD Editorial Committee is
strictly an advisory group,
and membership on the
committee in no way implies
endorsement of any of the
publications content.

Sales Staff
Kelly Thomas, CEM.CEP
National Account Manager
Materials Park, Ohio
tel: 440/338-1733
e-mail: kelly.thomas@
asminternational.org

On the Cover
This image from Buehler Ltd. is a
photomicrograph of a section of an
acetabular cup. It shows the Ti-6Al4V substrate and a coating that consists of commercially pure titanium
powder and tantalum beads.
The Ta beads are made by taking
polyurethane foam and volatilizing it
to break down the hydrocarbons and
form a reticulated vitreous carbon
(RVC) foam. This pure carbon foam
is crushed to powder and then
coated with tantalum by chemical
vapor deposition to form the beads.
To make the coating, titanium
powder and a polymer binder are
mixed together and combined with
the tantalum beads on the titanium
alloy substrate. The coating is then
sintered, evaporating the binder. The
titanium mechanically locks the tantalum beads in place, and forms a
metallurgical bond between the
coating and the substrate.
www.buehler.com

ATI Medical
Buehler Ltd.
Carpenter
Technology Corp.
CoorsTek Inc.
Sandvik Bioline
Ulbrich Stainless
Steels and Special
Metals Inc.

DEPARTMENTS
Industry News
Products and Services

ADVANCED MATERIALS & PROCESSES/JANUARY 2009

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11
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INDUSTRY NEWS
Cobalt-chromium stent carries drugs in hundreds of reservoirs
A cobalt-chromium reservoir-based stent design that incorporates
hundreds of small reservoirs, each acting as a depot into which drugpolymer compositions are loaded, has been announced by Cordis
Corp., Warren, N.J. The Nevo Sirolimus-eluting Coronary Stent allows drug delivery from an implant surface that is 75% polymer-free
bare metal upon insertion. It becomes fully bare metal following drug
delivery and polymer bioresorption in approximately three months.
The technology also greatly enhances control of the rate and direction of drug delivery, enabling a
wider range of drug therapies to
be delivered, and potentially increases the range of clinical applications of drug-eluting stents and
other drug-device combinations.
For more information: Christopher Allman , Cordis Corp., 7 Powderhorn Drive, Warren, NJ 07059;
tel: 908/412-3223; www.cordis.com.

Nanoporous alumina membrane

coated with diamondlike carbon
Nanoporous alumina membranes coated with diamondlike
carbon thin films could build an
interface between human tissues
and medical devices that is free of
protein buildup, say researchers
at North Carolina State University, Raleigh. The membranes
were examined via scanning
probe microscopy, nanoindentation, and MTT viability assay. The
new research, published in a special issue of Biomedical Materials,
is the first in-depth study of the
biological and physical properties
of the membranes. The study suggests that the human body does
not reject the nano-porous ceramic
membrane.
Dr. Roger Narayan adds that this
could be a major advance for the
development of kidney dialysis
membranes and other medical devices whose development has been
stalled by poor compatibility with
human tissues. Dr. Narayan was
also the lead researcher on the
team that first developed these
new materials.
For more information: Roger
Narayan, North Carolina State
University, Raleigh, NC 27695; tel:
919/696-8488; roger_narayan@msn.
com; www.ncsu.edu.
46

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INDUSTRY NEWS
Nitinol now available in continuous sheet form
Continuous Nitinol sheet is now available from
Nitinol Devices & Components, Fremont, Calif.
Sheets of thickness from 0.003 to 0.020 inches, in
widths up to 3.0 inches, are supplied on spools or
cut to length. This sheet has the tightest gauge tolerances in the industry (typically 0.0003 in. or
better). Continuous sheet is ideal for laser cutting,
etching, stamping, and EDM machining. A smooth,
light oxide surface allows for efficient processing
and surface finishing.
Tensile properties for superelastic material (Af<
15C): UTS: 155 ksi min; UP: 55 ksi min; elong: 10%
min; perm. set: 0.5% max , after 6% strain. Material
is in stock in various gauge sizes.
For more information: Nitinol Devices & Components, 47621 Westinghouse Drive, Fremont, CA
94539; tel: 510/623-5996; www.ndc.info.

Zirconia-toughened alumina
reinforced with platelets
A zirconia-toughened, platelet-reinforced alumina ceramic designed to incorporate the wear
properties and stability of alumina with vastly improved material strength and toughness has report-

edly been developed by Ceramtec North America,

Laurens, S.C. Biolox Delta contains approximately
74% alumina and 25% zirconia. Small additions of
chromium dioxide and strontium oxide enhance
performance.
In zirconia-toughened alumina (ZTA) materials,
some of the original hardness of the alumina material is lost. The addition of chromium oxide restores
hardness to the matrix. Strontium oxide (SrO) additions form strontium aluminate (SrAl12O19)
platelets during the sintering process. These
platelets dissipate crack energy, preventing microcracks in the material from advancing. The result
is a further increase in material strength and
strength distribution, as well as an increase in fracture toughness. The final product is a high-strength
material with high hardness and high toughness.
For more information: Ceramtec North America,
One Technology Place, Laurens, SC 29360; tel: 800/
845-9761; information@ceramtec.com; http://
www2.ceramtec.com.

Titanium powder for implants

made by lower cost method
A cheaper and better way to make a titanium

Powders
you can trust.

MIM
HIP
PTA
Braze
Laser
Rapid Prototyping
Thermal Spray
PM Millforms

www.cartech.com

For more information email jhunter@cartech.com

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INDUSTRY NEWS
alloy powder for artificial joints is under development at the DOE Ames
Laboratory, Ames, Iowa. Led by Iver Andersen, the research team has already developed and patented a special pouring tube that can stand up
to molten titanium, and has developed the atomization technology for
converting molten metal into titanium powder. That could mean titanium joints, which can resist corrosion for the lifetime of a patient, could
be affordable enough to replace stainless steel joints, which are commonly
used today but can corrode after five years.
A grant from the U.S. Department of Energy and
the Iowa State University Research Foundation will
help build a prototype atomizer to produce the titanium alloy powder. The alloys and processing
technology could lead to establishment of a new
company, Iowa Powder Atomization Technologies,
which might serve as the basis for a biomedical
manufacturing industry in Iowa.
For more information: Iver Anderson, Ames
Laboratory, Ames, IA 50011; tel: 515/294-9791;
andersoni@ameslab.gov; www.ameslab.gov.

Orthopaedic salvage system provides joint reconstruction

The Orthopaedic Salvage System (OSS) from Biomet Inc. is said to offer
the most comprehensive joint reconstruction prostheses designed specifically for orthopaedic surgeons and oncologists. The centerpiece of this
system, the Finn Rotating Hinged Knee, promotes the restoration of
normal knee function and is designed for distribution of weight-bearing
forces through the entire knee mechanism. It
features six separate
resurfacing and segmental distal femoral
ISO / ASTM / FDA Testing
replacement options.
Implants / Surgical Instruments
For more information:
Barbara
Goslee, Biox Mechanical
x Screws
met
Inc.,
Warsaw, IN
x Metallurgical
x Knees
46581;
tel:
574/372-1514;
x Fatigue
x Hips
www.biomet.com.
x Failure Analysis
x Spines
x Dilatometry
x Bone Plates

Fatigue Equipment:

Dynamic Tension / Compression / Torsion / Shear

A/P Draw, M/L Shear
Rotating Beam, Taber Abrasion, Friction, Static Torsion,
MTS Bionix Spine Wear Simulator

Material ID & Metallography

Grain Size / Direction / Coatings / Stereological Evaluations

ISO/IEC 17025:2005(E)
Certified

Certificate # 2422.01
ISO/IEC 17025

testing@accutektesting.com
Ph: 513-984-4112 Fax: 513-984-8258
www.accutektesting.com
48

Norman Noble Inc. announces

the completion of a $1.9 million
expansion of its metal finishing
operations. The expansion,
which was conducted in strict
adherence with ASTM
standards, centered on
increasing the level of
automation in Norman Nobles
production finishing
capabilities. The changes
include automating the
companys processes for
chemical descaling of laser-cut
materials as well as automating
its passivation and finishing
lines and various polishing
processes. www.nnoble.com
Medtronic Inc. announces the
U.S. market launch of the
Endeavor Sprint drug-eluting
stent (DES) on a rapid
exchange (RX) delivery system.
The Endeavor Sprint system
incorporates a new tip design
for a low profile, a new balloon
material, and an enhanced
shaft design, which together
greatly improve the devices
deliverability.
www.medtronic.com
Tronics Microsystems SA, a
global leader in custom MEMS
components and microsystems
for demanding applications,
has acquired all the assets of
MedTech Development LLC,
a full-service design and
development company
exclusively focused on medical
devices. www.tronics.eu

Nanocrystalline hydroxyapatite
granules fill scaffold with bone
Nanocrystalline hydroxyapatite granules in collagen
biopolymer encourage bone ingrowth, reports Pioneer
Surgical Technology Inc., Marquette, Mich. FortrOss bone
void filler for orthopaedic applications is a scaffold for
the in-growth of new bone when superior bone regeneration is required.
The FortrOss bone void filler combines the nanotechnology of NanOss hydroxyapatite with the bone growth
promotion of E-Matrix scaffold, a sterile, injectable collagen biopolymer designed to repair or regenerate diseased or damaged tissue. The FortrOss osteoconductive
matrix utilizes Pioneers NanOss technology and is designed to mimic the nanostructures in bone tissue.
For more information: Pioneer Surgical Technology, 375
River Park Circle, Marquette, MI 49855; tel: 906/226-9909;
www.pionersurgical.com.
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INDUSTRY NEWS
Nitinol/stainless steel tubing welded for delivery shafts
Creganna Medical Devices introduces Fusion Technology for Nitinol
to Stainless Steel tube joining. A patented breakthrough welding solution enables combining the unique attributes of Nitinol with the
trackability of stainless steel for a cost-effective product design. Nitinol
offers a unique range of characteristics when designing medical device delivery shafts including superelastic and shape memory behavior, superb crush resistance, and flexibility.
When designers choose Nitinol
tubing for catheter design, it is typically in the distal section of the
shaft that the unique attributes of
the metal are important. By using
Nitinol in the distal section only,
and an economical metal tube for
the proximal section, designers can
optimize both the performance
and cost of the overall design. Cregannas unique technology
demonstrates a strong weld zone
not achieved by standard welding
technologies or other joining
methods such as bonding, heat
shrinks, or mechanical joining.
For more information: Maura
Leahy, Creganna Medical Devices,
Galway, Ireland; tel: 353 91 757801;
maura.leahy@creganna.com;
www.creganna.com.

C.R. Bard Inc. has received

approval from the United States
Food and Drug Administration to
market the Flair Endovascular
Stent Graft with an optimized
delivery system. The device is
comprised of a self-expanding
Nitinol stent encapsulated within
Bards proprietary ePTFE graft
material. www.crbard.com

Cobalt-chromium rod
designed for spinal implant
Cobalt-chromium rods for the
treatment of complex spinal
pathologies and procedures have
been announced by K2M Inc.,
Leesburg, Va. The Range Rigid
Rod features flexural rigidity properties comparable to 5.5 mm diameter stainless steel and 6.35 mm titanium alloy. Since cobalt
chromium is compatible with titanium, surgeons may have more
intra-operative flexibility with various rod offerings in one system.
Also, the cobalt-chromium material is more MRI compatible than
stainless steel. The rod provides
increased construct rigidity while
maintaining the low profile of the
taper-lock implant design.
For more information: K2M Inc.,
751 Miller Drive SE, Leesburg,
VA 20175; tel: 866/526-4171;
www.k2m.com.
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Medical Device Materials

In this special section, suppliers of medical device materials and analysis
instruments describe the capabilities and services they provide.

Implant materials at ATI Medical

Marty Pike
ATI Allvac
Monroe, South Carolina

ATI

Medical is an industry-focused team of professionals dedicated to supplying one of

the worlds largest suites of implantable metallic alloys to manufacturers of medical and surgical devices.
The team is drawn from three of the
companies that make up Allegheny
Technologies Inc.
ATI Allegheny Ludlum traces its
roots to 1854, and is one of the world
leaders in stainless and specialty steel
technology and manufacturing.
ATI Allvac is over 50 years old, and is a global leader
in nickel-, cobalt-, and titanium-base alloys, particularly
in the aerospace, energy, and medical market sectors.
ATI Wah Chang, also more than 50 years old, is a premier manufacturing and technology company that makes
titanium-, niobium-, and zirconium-base alloys, primarily for chemical processing, biomedical, and nuclear applications. Wah Chang also manufactures Nitinol, probably the most important shape-memory nickel-titanium
alloy.
Metallic biomaterials
The table lists twenty-four implantable metallic alloys
designed for the manufacture of temporary or permanent
biomaterial implants in humans.
Biomaterial Name
ATI 316 LVM
ATI XM-19
ATI TJA-1537
ATI TJA-1537
ATI L-605
ATI 35N
ATI 35N LoTiTM
ATI Ti CP-1
ATI CP-2
ATI CP-4
ATI Ti-3Al-2.5V
ATI Ti-6Al-4V
ATI Ti-6Al-4V ELI
ATI Ti-6Al-7Nb
ATI Ti-15Mo
ATI Ti-12Mo-6Zr-2Fe
ATI Beta 22
ATI Ti-13Nb-13Zr
ATI Ti-45Nb
ATI Ti-35Zr-10Nb
ATI TiOsteum
ATI Unalloyed Tantalum
ATI Zircadyne 705
ATI Nitinol

50

Composition
Fe-18Cr-14Ni-2.5Mo
Fe-22Cr-12.5Ni-5Mn-2.5Mo
Co-28Cr-6Mo, Lo-Carb
Co-28Cr-6Mo, Hi-Carb
Co-20Cr-15W-10Ni-1.5Mn
Co-35Ni-20Cr-10Mo
Co-35Ni-20Cr-10Mo, LoTiTM
Ti CP-1
Ti CP-2
Ti CP-4
Ti-3Al-2.5V
Ti-6Al-4V
Ti-6Al-4V ELI
Ti-6Al-7Nb
Ti-15Mo
Ti-12Mo-6Zr-2Fe
Ti-12Mo-6Zr-4Sn
Ti-13Nb-13Zr
Ti-45Nb
Ti-35Zr-10Nb
Ti-35Nb-7Zr-5Ta
Ta CP
Zr-2.5Nb
Ni-45Ti

The list includes:

Stainless and specialty steels
Cobalt-base alloys
Titanium-base alloys
Zirconium-base alloys
Nitinol shape memory alloys
Commercially pure titanium, zirconium, and
tantalum
These alloys and their various associated product forms
are among the broadest available for implantable metallic
biomaterials in the world. Several (including ATI Ti CP2, ATI Ti-6Al-4V ELI, and ATI TJA-1537) have been manufactured and supplied for medical devices by ATI companies for more than 35 years. They can be produced
entirely within the ATI company manufacturing sites.
This in-house manufacturing capability for titanium
alloys is probably the broadest in the specialty metals industry. ATI produces the entire range of products, from
raw materials such as titanium sponge, to product forms
such as ingot, billet, bar, and sheet. Advanced melt capabilities include plasma-arc melt and vacuum-arc remelt.
Product forms
Implantable metallic biomaterials in different product
forms can vary based on the complexity of the alloy system
and processing properties. Variations also depend on the
semi-finished mill product specifications, customer requirements and applications, and the broad-based production patterns and schedules for alloys and alloy groups.
ATI Medical has the ability to supply new and specialty
biomedical grade metallics in quantities, production lots,
and sizes to meet mill-production scale. Many of the
widely used implantable metallic biomaterials may be
available as ingot, slab, forging billet, extrusion billet, and

UNS
S31673
S20910
R31537
R31538
R30605
R30035
R30035
R50250
R50400
R50700
R56320
R56400
R56401
R56700
R58150
R58120
R58030
R58130
R58450
Unassigned
R58350
R05200
R60705
N01555

ASTM/AMS Standard
ASTM F 138
ASTM F 1314
ASTM F 1537, Alloy #1
ASTM F 1537, Alloy #2
ASTM F 90
ASTM F 562
ASTM F 562
ASTM F 67, Grade 1
ASTM F 67, Grade 2
ASTM F 67, Grade 4
ASTM F 2146
ASTM F 1472
ASTM F 136
ASTM F 1295
ASTM F 2066
ASTM F 1813
AMS-T-9046
ASTM F 1713
AMS 4982D

ASTM F 560
ASTM B 550
ASTM F 2063

ISO standard
ISO 5832-1

ISO 5832-12
ISO 5832-12
ISO 5832-5
ISO 5832-6
ISO 5832-6
ISO 5832-2
ISO 5832-2
ISO 5832-2

ISO 5832-3
ISO 5832-3
ISO 5832-11

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machining billet. Other forms include round forging bar,

round machining bar, rectangular bar, custom rolled
shapes, and cold drawn bar and rod. Flat rolled sheet and
plate, as well as rod, bar, and rod coil are also available.
ATI Medical is committed to providing implantable
metallic alloy choices to manufacturers of medical and surgical devices, and will continue its leadership efforts in
product breadth, technical depth, and access to unsurpassed
manufacturing capabilities. Product breadth, including
both alloys and product forms, is evident from the materials choices shown in the table, and the many product
forms manufactured at ATI facilities around the world.
Expansion projects
ATI announced capital improvement and expansion
projects totaling $1 billion for the production of titanium,
nickel, and cobalt-base alloys. Much of this new equipment is now operational, with the remaining projects
scheduled to begin production in 2009.
Further, in September 2008, a billion-dollar ATI project
was announced for a new state-of-the-art flat-rolled products facility in Brackenridge, Pa. When completed, this
advanced specialty metals hot-rolling and processing plant
will provide unsurpassed manufacturing capability and
versatility in the production of a wide range of flat-rolled
specialty metals. These include stainless and specialty
steels; alloys based on titanium, nickel, cobalt, and zirconium; ATI Precision Rolled Strip products; and stainless
sheet and coiled plate products.
For more information: Marty Pike, ATI Allvac, 2020
Ashcraft Avenue, Monroe, SC 28110; tel: 704/517-0422;
marty.pike@allvac.com; www.allvac.com.

Medical device analysis

Gabe Lucas
Buehler Ltd.
Lake Bluff, Illinois

Buehler

offers a comprehensive set of materials analysis products and services

that improve device manufacturing and quality, whether
the device is a hip/knee implant or a delicate drug-eluting
cardiac stent. Experts at Buehler laboratories throughout
the world are ready to help develop methods to reveal the
true structure of medical specimens.
The main challenge is to minimize surface deformation
and surface damage during the cross-sectioning process.
Larger devices, such as hip or knee implants, require abrasive cutters as the first step of metallographic preparation. However, these materials may be coated with porous
metal or ceramic coatings, and these must be protected to
view the true microstructure of the entire device.
When preparing a stent implantation sample, the metal
and tissue interface must be prepared without distortion
of the interface. Drug-eluting stents (gold sputter-coated
for drug protection) must be sectioned without damaging
the drug layer. Standard practice is to mount the stent in
an epoxy for ease of handling before sectioning.
All of Buehlers abrasive and precision saws have a variety of vises and fixtures that accommodate most of the
medical industrys requirements. The largest abrasive
saws can handle specimens up to 7 inches (178 mm) in diameter. Proprietary cutting blades have been developed
for accurate sectioning.

After specimens are sectioned to a workable size, they

normally are mounted for grinding and polishing. Three
mounting alternatives are available, depending on the
type of specimen.
In compression mounting, specimens are placed in
the press chamber and a suitable resin is poured over the
specimen. These mounts are quick and easy to use, offer
short heating and cooling times, and provide excellent
edge retention. However, this method is not suitable for
heat-or pressure-sensitive samples.
Castable mounting compounds are for specimens
that are sensitive to high pressures and temperatures. Several epoxies are available depending
on requirements such as cure time,
peak temperature during the curing
cycle, hardness, and edge retention.
A vacuum-assisted, castable mount
was chosen for the acetabular cup
shown on the cover.
Specialty castable glass slide
mounting of tissue or bone adjacent
to implanted biomaterial is best
when the true architecture must be
maintained for histological examination. Buehler can assist the pathologist with proper cutting, grinding, Drug-coated Nitinol stent. The
and polishing methods of glass slide layers consist of a gold sputter
coating to protect the drug during
mounted specimens.
cross sectioning, drug, polymer, and
Nitinol substrate. Dark field image,
Grinding and polishing
Buehlers EcoMet grinder-pol- original magnification 500X.

isher product line offers medical implant manufacturers

options for preparing samples in single or central force
modes when combined with an AutoMet Power Head.
Three platen sizes are available to accommodate varying
specimen sizes and volumes. The EcoMet family of instruments includes a large variety of specimen holders
for central and single force operations.
Specialty holders are available for histological specimen preparation. Handheld glass slide holders are suitable for hand polishing, or they can be mounted in a
grinder-polisher machine. These holders provide controlled material removal rates while retaining sample flatness because they grind only to the stop ring.
Histological specimens can be precision thinned with
the PetroThin Thin-Sectioning System, which is designed
to cut and grind a specimen already mounted on a glass
slide. Medical specimens should be cut first with an IsoMet
precision saw before grinding on the PetroThin. The IsoMet
saws offer thinner blades (less kerf loss) that minimize tissue
damage and conserve the specimen. The specimen can be
thinned further in the histolic glass slide holders.
Image analysis
Image analysis software ranges from a simple image
archiving and database management tool, to a fully functional suite of applications. The OmniMet Capture Advanced System incorporates database management tools,
basic image processing, and measurement functions (including feature classification and counting), as well as full
reporting capabilities to help support Part 11 of Title 21
Code of Federal Regulations (21CFR Part 11).
Educational programs
Buehler offers several educational programs to support

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the medical industry: Metallographic Techniques for

Medical Devices, Metallographic Interpretation, Advanced Metallographic Techniques, and more. Visit the
Buehler biomedical website at www.buehler.com/
biomedical for additional information. Access to Buehlers
database of technical publications and solutions on
a variety of material applications, including medical,
is available by subscribing to the e-club at http://
www.mybuehler.com/publiclogin/login.aspx.
For more information: Gabe Lucas, Buehler Ltd., 41
Waukegan Road, Lake Bluff, IL 60044; tel: 847/295-4680;
gabe.lucas@buehler.com; www.buehler.com.

Metallic Orthopaedic Materials

Anthony Guiterrez
Carpenter Technology Corp.
Wyomissing, Pennsylvania

Carpenter

Technology Corp. develops

and produces metallic orthopaedic materials specifically, cobalt alloys, stainless steels, and titanium alloys. These materials are ideal
for applications requiring higher strength, improved fatigue resistance, and enhanced wear resistance.
These alloys are found in a variety of medical devices,
including artificial joints, medical instruments, plates,
screws, rods, hooks, spacers, and cages. They are also in
motion preservation devices such as artificial discs and
dynamic stabilization devices.
CarTechs powder metallurgy alloys, designated MicroMelt, offer more uniform grain structure, higher mechanical properties, improved fatigue life, and improved workability.
For example, BioDur CCM Plus alloy,
manufactured by a proprietary powder metallurgy

process, offers improved wear resistance, finer grain, enhanced forgeability, and superior fatigue strength.
BioDur 108 alloy is a high-nitrogen, essentially nickelfree stainless implant alloy that is capable of developing
mechanical properties well in excess of 200 ksi. This alloy
also demonstrates improved galling resistance when
compared to BioDur 316LS and 22Cr-13Ni-5Mn stainless. Higher strength alloys like BioDur 108 are increasingly specified for more demanding applications.
In addition, Carpenters titanium subsidiary, Dynamet,
has developed titanium Ultrabar products to ultra-tight
dimensional tolerances and exceptional diameter uniformity required for some titanium MIS implants. Ultrabar
is produced in diameters ranging from 3 to 12mm and
lengths up to 14 feet in a variety of implantable titanium
alloys. Diameter tolerance control is down to 0.00015 inch,
depending on size.
SLIC titanium, produced by Dynamet from prestraightened coil, has been used for formed fasteners; and
Ti-15Mo is capable of achieving higher properties, depending on the application.
Currently in development is Ti6Al-4V ELI, CP 4, and
6Al-7Nb precision-rolled flat bar. It provides closer-tofinish tolerances, improved surface finishes, and better
shape consistency. It has the added benefits of enhanced
mechanical properties and improved grain structure compared with parts typically cut from plate.
In addition, customized ultra-high strength conditions
of current stainless alloys are also available, as shown in
the table. Whether the designer needs titanium, cobalt or
stainless as their material solution, options are available
that can provide that customized feel that some surgeons
require.
For more information: L. Anthony Guitterez, Market
Manager Medical Products, at 610/208-3603; aguitterez@
cartech.com. Tom Zuccarini, Market Manager Medical, Dynamet Inc.; tel: 714/229-4153; tzuccarini@cartech.com.

Ceramics and polymers

for medical devices
Kalani Fogleman
Coorstek Inc.
Golden, Colorado

Carpenter Technology Corp. manufactures a variety of innovative alloys that have been used in the global medical devices
market.

Coors

Tek manufactures medical device components in both advanced ceramics and

engineered plastics. Technical ceramics offer longer lasting
wear than other materials, and higher flexural and compressive strength properties. They provide superior chem-

Carpenter Technology alloys for orthopaedic devices

Typical properties
Alloy/Condition
Ti-6Al-4V ELI annealed
Ti-6Al-4V ELI cold worked
BioDur 316LS annealed
BioDur 316LS CW - B
BioDur 316LS CW - C
BioDur 108 annealed
BioDur 108 CW - B
BioDur 108 CW - C
Micro-Melt CCM

52

0.2% Yield
strength, ksi
125
140
45
110
140
85
140
190
160

Ultimate tensile
strength, ksi
135
160
90
140
180
145
180
230
200

Elongation, %
15
16
50
30
20
52
25
18
28

Reduction in
area, %
45
45
80
70
60
75
70
60
24

Elastic
modulus, ksi
16,500

28,000

30,000

33,000

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ical resistance and excellent electrical resistance, especially in high temperature environments all properties
designed to work well in medical device applications.
CeraPure advanced ceramics are available in alumina and
zirconia, both approved for USP Class VI for medical applications. Grades include Alumina FG and CeraPure
Alumina Plus.
CeraPure alumina (aluminum oxide) can be pressed,
extruded, molded, or cast. Resistant to high temperatures,
products are ideal for applications needing medical
sterilization. It is an excellent insulator against electric
currents, provides strong resistance to thermal shock,
and causes little or no reaction in environments with
biomaterials.
CeraPure zirconia-toughened alumina (ZTA) resists
extreme impacts and provides high flexural strength for
components that must bend or pry.
CoorsTek Dura-Z is zirconia partially stabilized with
magnesium, and it offers an even higher level of flexural
strength. Dura-Z zirconia represents a huge performance
gain over competitive materials such as iron and steel,
and is the most fatigue-resistant standard zirconia
available.
CeraPure YTZP (yttria-stabilized tetragonal zirconia
polycrystals) is available in hot isostatically pressed or
sintered forms. Stabilized with yttria, the YTZP provides
excellent chemical resistance in chemically corrosive environments. Its flexural strength is nearly double that
of traditional zirconia-toughened alumina, necessary for
high wear environments.
In addition to advanced ceramics, CoorsTek offers a
line of high-performance plastics for a proprietary line of
energized seals, polymer bearings, and custom precision
parts. These polymers are suitable for applications requiring wear resistance, chemical compatibility, extreme
thermal stability, and low friction.
High-temperature polymers include polyetheretherketone (PEEK), polyetherimide (PEI), and polyethersulfone (PES). Fluoropolymers, including polytetrafluoroethylene (PTFE, also known by DuPonts tradename, Teflon),
exhibit the lowest coefficient of friction available. With
excellent dielectric strength and chemical resistance, PTFE
functions well at extreme temperatures. Tetralon, CoorsTek
trademarked PTFE, is virgin material, with the ability to
wear longer than traditional Teflon. Plastics can be enhanced by adding fillers that include graphite, bronze,
glass, or molybdenum disulfide.
CoorsTek provides individually tailored technical assistance through our sales and engineering staff, assisting
in the right selection of materials. Our worldwide manufacturing capabilities support quick-turn prototype development to high-volume production for both our technical ceramic and high-performance plastic components.
For more information: Kalani Fogleman, CoorsTek Inc.,
17750 West 32nd Avenue, Golden, CO 80401; tel: 303/2774654; kfogleman@coostek.com; www.coorstek.com.

Medical and dental alloys

Tim D. Jones
Sandvik Bioline
England

Sandvik

Materials Technologies is a global

industrial group and worldleading partner to medical device companies. Operating

CoorsTek manufactures medical device components in both

advanced ceramics and engineered plastics.

Sandvik manufactures a range of orthopaedic alloys.

in 130 countries, Sandvik offers cutting-edge manufacturing expertise combined with a unique understanding
of materials and metallurgy. Sandvik has the capability
to provide a complete product and service portfolio to
customers, from materials development and supply,
through to contract manufacturing of finished implants
and instruments.
For more information: Tim Jones, Sandvik Bioline, West
Midlands, England; tel: 44 114 263-3122; tim.d.jones@sandvik.
com; www.smt.sandvik.com/medical.

Ulbrich alloys for medical devices

Todd Hall
Ulbrich Stainless Steels and Special Metals Inc.
North Haven, Connecticut

Ulbrich

metals for medical devices include

titanium and its alloys, Nitinol,
stainless steels 304V, 301, 302, 316L, 17-7 PH, and 455, and
many superalloys. They are applied in components such
as fine braid wire and pacemaker and defibrillator cans,
as well as orthopaedic implants, surgical instruments, and
hypodermic needles. Our technical services department
often works with medical suppliers on prototyping new
tools and products as soon as they are conceived.
Our new Medical Wire Focus Factory is staffed with
dedicated management and engineers who use state of

ADVANCED MATERIALS & PROCESSES/JANUARY 2009

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the art equipment to produce the industrys top quality

products. Our production equipment features the latest
in on-line gauging and data acquisition technology,
which generates full statistical summaries of each
production run. Precision spooling of fine wires onto a
variety of spools or bobbins by CNC winders enables
trouble-free performance in the most demanding
applications.
Ulbrich works closely with customers to develop
custom inventory management programs (KANBAN,
VMI, etc.) upon request. Maintaining lead times that are
typically much shorter than the rest of the industry, turning
around sample requests quickly,
and working closely with our
customers to customize products are just a few examples that
make our service second to
none. Our Focus Factories in
South Carolina, Connecticut,
and Galway, Ireland, are all ISO
certified and ready to meet your
demanding quality requirements.
Ulbrich Shaped Wire products are found in a variety of
medical applications, ranging
from spacers for surgical devices
With the addition of the new UltraLite to archwire for braces in the orFoil line, Ulbrich can produce alloy foil thodontic industry. In addition
under 0.0005 inch thick and up to 14 to all of the stainless steel
grades, we work with and stock
inches wide.

10

a wide range of other medical quality alloys, including titanium, titanium alloys, nickel alloys, cobalt alloys, and
nitinol.
The versatility of our shaped wire process allows us to
produce net or near-net custom cross-sectional shapes
with compositions and mechanical properties tailored to
meet your specification requirements. Flat rolling and
shape rolling or drawing, with intermediate anneals to
restore properties and control finished properties, allow
us to achieve your custom shape.
With the recent addition of Delta Ulbrich, we can now
offer plated materials such as silver-plated copper mandrels for catheter manufacturing, gold-plated tungsten
fine wire for radiopacity applications, and drawing capabilities for fine wire nitinol and other materials down to
under 0.001-inch round and flat configurations.
Precision strip products are found in a variety of medical applications. Our controlled atmosphere annealing
lines work in tandem with the rolling process to produce
exacting mechanical properties as well as maintain the required finishes. With the addition of our new UltraLite
Foil line, we can produce materials under 0.0005 inch thick
and up to 14 inches wide.
Our engineering staff can assist in selecting alloys and
formulating a specification, and we can custom produce
small coils or spools for R&D work, or we can produce
full production quantities.
For more information: Todd Hall, Ulbrich Stainless Steel
and Special Metals, 57 Dodge Avenue, North haven, CT 06473;
tel: 502/644-4722; fax: 502/228-4722; thall@ulbrich.com;
www.ulbrich.com.

MPMD 2009 CALL FOR PAPERS AND FIRST ANNOUNCEMENT

VE AT
SA D
E

TH

Materials & Processes

for Medical Devices
Conference & Exposition

Conference: August 10-12, 2009 Exposition: August 11-12, 2009

Hilton Minneapolis Minneapolis, MN USA

2009 Call for Papers and First Announcement

Abstract submission deadline: January 12, 2009
Present your research to the only medical devices conference and exposition that
brings together materials scientists and engineers, metallurgists, product designers,
researchers, and clinicians.

Questions?
Contact us:
ASM International
Event Planner, MPMD 2009
9639 Kinsman Road
Materials Park, Ohio USA 44073-0002
Telephone: 440-338-5151
Fax: 440-338-4634

54

For more information and to submit your

abstract, visit the web at
www.asminternational.org/meddevices.
To exhibit or for more information
on sponsoring this event, contact
Kelly Thomas, National Account Manager,
at 440.338.1733 or e-mail
kelly.thomas@asminternational.org.

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PRODUCTS & SERVICES

Device testing
Accutek Testing Laboratory,
Cincinnati, Ohio, has increased
its Cincinnati office and laboratory space by 50%. This expansion will allow Accutek to continue to grow and meet the
demands of current and future
clients. All testing is done on site
and is on a first come, first served basis.
www.accutek.com
Tubing shapes
Admedes Schuessler, Germany, offers complex
shapes and patterns in any length cut from tubing in the
range of 0.4 to 12 mm diameter as well as in sheet material. Strut widths down to 60 m and slot widths of 15
m can be achieved. Finishing procedures result in very
low surface roughness. www.admedes.com
Metal powders
Advanced Specialty Metals, Nashua, N.H., offers ultraclean, high-performance metal powders with consistent particle morphology, highly spherical shapes,
and narrow particle size distribution. Other services include heat treatment, sintering, plasma technology,
and metallurgical bonding of dissimilar metals.
www.asmpowders.com
Sectioning equipment
Allied High Tech, Rancho Dominguez, Calif., designs,
manufactures, distributes, services, and supports a
wide range of high-quality sectioning, mounting, polishing, grinding, cleaning, imaging and analysis equipment, and consumables, for technicians and scientists
involved in sample preparation for research and development, failure analysis, and quality assurance.
www.alliedhightech.com
Antimicrobial plastic
BASF Corp., Florham Park, N.J., offers a styrene acrylonitrile copolymer that has the property of killing microbes. Called Luran S BX 13042, it contains silver compounds that kill microorganisms such as bacteria and
mold that attempt to grow on the surface, making the
surface germicidal. www.luran-s.com
High-performance coatings
Boyd Coatings Research Co. Inc., Hudson, Mass.,
offers development and application of high performance coatings, from a simple protective paint on equipment to the most sophisticated coating systems for
medical device applications. www.boydcoatings.com
Test instruments
Bose Corp. ElectroForce Systems
Group, Eden Prairie, Minn., offers
ElectroForce BioDynamic test instruments, which provide precise
characterization of biomaterials and
biological specimens within a
closed saline or cell culture media
environment.
www.bose-electroforce.com
Specimen analysis
Buehler Ltd., Lake Bluff, Ill., provides the prepara-

11

tion equipment, image analysis system, consumables,

and methodology to analyze medical device specimens.
Equipment enables preparation of a biomaterial containing an implant 100 microns or less. Additionally, degeneration or regeneration of bone, penetration of tumors and the like, or ingrowths of tissue into porous
implants may be studied. www.buehler.com
Medical device adhesives
Dymax Corp., Torrington, Conn., offers MD 1000 series medical device adhesives that make possible highspeed, high-volume bonding of medical device housings, tube sets, catheters, enclosures, and housings.
These solvent-free adhesives replace ultrasonic welding
applications and costly two-part products.
www.dymax.com
Materials information
Granta Design, Cambridge, England, offers Granta
MI, the industry-standard solution for materials information management. The latest version, Granta MI 2.0,
is more robust and faster than ever, with an enhanced
user experience and new features that will prove indispensable to any organization that needs to manage, analyze, and apply materials data. www.grantadesign.com
Metalworking fluids
Houghton International, Valley Forge, Pa., offers a
broad range of metalworking fluids for the medical device and medical implant industries. Metalworking fluids
have been designed for machining, forging, heat
treating, cleaning, or vibratory finishing orthopedic implants made of metals such as plain carbon steel, stainless steel, titanium, aluminum, or hastelloy.
www.houghtonintl.com
Medical device testing
Instron, Norwood, Mass., offers the
3300 single column medical device
testing system. Engineered as a solution for a variety of applications such
as needles, sutures, tubing, medical
packaging, and gloves, the system is
easily configured with grips or fixtures
for tension, compression, flex, and peel
testing. www.instron.com
Precious metals
Johnson Matthey
Medical, West Chester,
Pa., offers NiTi Brite
oxide-free Nitinol wire
at competitive prices.
NitiBrite features an exclusive one-step oxide removal
process that completely eliminates the toxic Hf acid solutions that cause embrittlement. Unlike other methods,
the NitiBrite process does not involve acid etch or costly
mechanical polishing. www.jmmedical.com
Freeform implants
Medical Modeling LLC, Golden, Colo., announces implementation of Electron Beam Melting (EBM), a rapid
manufacturing process that creates fully dense, freeform
shaped metal parts directly from digitally designed CAD
files. Medical Modeling is now running the first Arcam
EBM machine in the Americas focused on medical
product manufacturing. www.medicalmodeling.com

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PRODUCTS & SERVICES

Testing solutions
MTS Systems Corp., Eden Prairie, Minn., announces
the addition of several new components to its Bionix
accessories line. Comprising a variety of affordable
grips, fixtures, and compression platens, these new accessories provide a complete set of tools for conducting
full spectrum monotonic testing of biomaterials, medical device components, and medical packaging and
consumables. www.mts.com
Diagnostic materials
Porex Technologies, Fairburn, Ga., offers a comprehensive range of diagnostic materials and filters such
as sample and absorbent pads, lateral-flow and conjugate release materials, sample wicks, spin and
column filters, and sample preparation systems.
www.porex.com
NiTi products
SAES Smart Materials, New Hartford, N.Y., is a primary melter and manufacturer of nickel-titanium alloy
mill products with 40 years of experience formulating,
melting, and processing NiTi and NiTi-base alloys for
shape memory and superelastic applications.
www.shape-memory-alloys.com
Castings and forgings
Sandvik Medical Solutions, Milford, Conn., is a leading
supplier of cast and forged orthopaedic implants serving
the medical market worldwide. Materials include stain-

less steel, cobalt chromium, and titanium alloys. The

company works to internationally recognized standards
and applies a wide range of technologies to ensure outstanding quality products. www.smt.sandvik
Vacuum nitriding
Solar Atmospheres, Souderton, Pa., offers surface
hardening of stainless steel, including nitriding, carburizing, and nitrocarburizing processes. The R&D Technology Group has successfully completed high-temperature solution nitriding of grade 422 martensitic
stainless steel at sub-atmospheric pressures (vacuum
partial pressure nitrogen). www.solaratm.com
Surface treatment
Spire Biomedical, Bedford, Mass., has developed
Ion-Join, a low cost, reliable surface treatment that significantly enhances the bond strength of PMMA bone
cement to UHMWPE and Ti/Co-Cr orthopedic alloys.
This patented process strengthens fixation interfaces,
potentially leading to increased prosthetic joint life and
stability. www.spirecorp.com
Stainless steel wire
Ulbrich Stainless Steels and Special Metals Inc.,
North Haven, Conn., offers stainless steel wire in the
microscopic cross sections required for catheterrelated diagnostic devices in widths as narrow as
.0025 inch and thicknesses starting at .0003 inch.
www.ulbrich.com

The Materials for

Medical Devices
Database
One Source for Materials and
Bio-response Information on:
Nearly 9,000 manufacturers
specific implantable devices
215 material types /
634 manufacturers
specific grades

At Your
Fingertips
Comprehensive
materials and design
specifications
For complete details
for implanted
and a demonstration, contact
Cardiovascular
raymond.sirochman@asminternational.org
and Orthopaedic
800.336.5152, ext 5576
440.338.5418
devices.

56

Material, costing,
and drug
combinations
Fully linked to full
text FDA references
www.asminternational.org/meddev/

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Finally, a supplier with

materials and production.
A victory for all hips, knees
and shoulders!

ith increasing demand for

orthopedic implants in markets
around the world, the pressures for
differentiation and high quality
combined with production efficiency
continue to rise. Responding to the
market as quickly as possible is
essential. Cooperation with the right
partner all along the value chain
can help to ensure an advantage.

clinical designs into a product that

can be manufactured efficiently.
We work with you to identify full
production routes as well as tailor
programs with an extensive range of
processes including casting in
air or vacuum, forging,
powder technology
and machining
expertise.

JOINT COLLABORATION

SPEED TO MARKET

A partnership with Sandvik gives

you our full commitment to meet
your key business objectives in the
production of implants and instruments. Based on our unique expertise
in materials and contract
manufacturing, there
are many ways that we
can support your product design efforts.
We can, for
example, advise on the suitability of
materials as it pertains to achieving
your desired implant and instrument
characteristics. Through prototyping,
we can help you translate your

Cross-functional teams are ready to

advise and assist you on factors that
can make all the difference in getting
the product to market rapidly and
efficiently. With international resources
and a local field presence, we can
respond to urgent needs of a quick
turnaround as well as handle the
demands of a global launch.

The Sandvik R&D team employs

over 2,000 people, with a unique
knowledge base in metallurgy and
coatings. We have a proven track
record in materials development,
casting, machining and forging
technologies.
Sandvik is a global business
with a solid history of success
and growth, so you have the
security of dealing with a stable
company that has the
capability to invest
for the future. At
the same time, we
work locally in small teams, drawing
on our broad resources to ensure you
meet your timelines and commercial
objectives.
For all those hips, knees and
shoulders, Sandvik can be a winning
partner.

STRATEGIC PARTNERSHIP
Combining scientific research with
practical manufacturing experience,
well give you our total support in
developing the optimal products.

www.smt.sandvik.com/medical

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Contract manufacturing as sophisticated as

your implants.
CAPABILITY, MEET CAPACITY.
When it comes to spinal and extremity
implants, no one matches Norman Nobles
technology, experience and reputation for
quality. Now, with an expansion that includes
eight, 7-axis contour milling machines, no
one takes you from prototype to full-scale
production faster. No one.

 Orthopedic implants manufactured

and finished complete

 Single operation milling and turning

of complex geometries

 Tolerances of +/-.0001"

U
U
U
U
U
U
U
U

7-Axis Contour Milling

Laser Micromachining
Laser R&D
Laser Welding
Laser Marking
Electropolishing
CNC Turning
NiTinol Shape Setting

U Prototype Machining
U
U
U
U
U

Services
Electrochemical Grinding
Swiss Micromachining
Wire & Conventional EDM
Microhole EDM
Cleanroom Assembly,
Welding & Packaging

Corporate Headquarters
5507 Avion Park Drive
Highland Heights, OH 44143