Orthotec20110910 DL

Providing expert insight on orthopaedic technology, development, and manufacturing
O
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o
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e
c
.
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COMPRESSED
FOR TIME
Molding Joint
Replacement
Parts
page 20
USE PROTECTION
Patent Reform
Strategies for
Your IP Portfolio
page 24
SEPTEMBER/OCTOBER 2011
VOL. 2 NO. 4
SURFACE MANUFACTURING
Implant Tech
Trends
page 8
A SUPPLEMENT TO
and
ORT1109 001 1 9/27/11 3:39:44 PM
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ORT1109 002 2 9/27/11 3:39:57 PM
Contents
ORTHOTEC | SEPTEMBER/OCTOBER 2011 3 orthotec.com
September/October 2011 Volume 2 Issue 4
Features Columns
Departments
20 16
On the Cover
Surface
Manufacturing
Plasma spray coatings and additive manufacturing technology
offer orthopaedic device manufacturers big benefts.
BY LEO GLASS AND PIERFRANCESCO ROBOTTI
16 Materials Characterization
3-D Optical Microscopy Solves Material
Selection Challenges
This method of precision surface metrology provides improved
characterization of implant materials.
BY ROGER POSUSTA AND MATT NOVAK, PHD
20 Compression Molding
Joint Replacements Fit The Mold
Compression molding offers cost benefts over other methods of
molding joint replacement parts.
BY ROBERT BOLAND
24 Intellectual Property
How to Weather the Patent Reform Storm
Orthopaedic device companies are entering a brave new world of IP
and patent reform.
BY DAVID J. DYKEMAN AND DANIELLE T. ABRAMSON, PHD
30 Testing
Testing Protocols Keep Customers Happy
Find out how to create effcient test protocols throughout the product
life cycle.
BY DANIEL SANTOS
The backside of a femoral condylus has been
coated with hydroxyapatite. Image courtesy of
Eurocoating s.p.a. (Cir-Pergine, Italy).
42 Ortho Scope
Wright Medical restructures
following the departure of several
executives.
6 From the Editor
14 Blog Teasers
34 Products & Services
39 Supplier Beat
41 Contributors
41 Advertisers Index
IMPLANT MANUFACTURING
Cover Story
14
8
ORT1109 003 3 9/27/11 3:42:15 PM
www.orthotec.com
Online Contents
4 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
ACCOUNT MANAGERS
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CULTURE
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ORT/OrthoTec (ISSN 2153-9782, print; ISSN 2153-9790, online) is published quarterly by UBM Canon, 11444
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reserved. Reproduction in whole or part without written permission is prohibited.
Monkeys Walk with Spinal
Implant; Humans Next
The once-paralyzed CEO of InVivo
Therapeutics designed his own
physical therapy program and
regained the ability to walk. Not all
patients with spinal cord injuries
(SCIs) are so lucky. Frank Reynolds
wants to save as many of them as
possible from life in a wheelchair
with an implant that protects the spinal cord from
infammation, further bleeding, and cell death
following SCI.
Check out the top OrthoTecs news story of the summer at
orthotec.com/article/invivo-implant
Get the
OrthoTec
Weekly
Subscribe to OrthoTecs
weekly e-newsletter for the
latest news and technology
trends in orthopaedics.
Also featured are business
developments and
Q&As with experts who
provide industry insider
perspectives.
New Implants,
Components,
and More
Recently given FDA
510(k) clearance, DePuys
Trumatch Personalized
Solutions system (right)
uses technology that customizes the ft of a knee
replacement. CT scans and software create femoral and
tibial cutting blocks that match the bone surfaces of a
specifc patient. These scans are quicker, cheaper, and
provide better imaging than MRIs. Get more product
and company updates at
orthotec.com/news
Follow Us on Twitter
For instant updates from OrthoTec,
follow @orthoteconline on Twitter.
EDITORIAL STAFF
DIRECTOR OF CONTENT,
MEDICAL DEVICE BRANDS
Rich Nass
EDITOR-IN-CHIEF
Heather Thompson
EDITOR, ORT
Maria Fontanazza
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ASSOCIATE EDITOR
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REGIONAL SALES DIRECTOR
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INTERNATIONAL
INTERNATIONAL SALES DIRECTOR
Andrew Porter
Tel: +44 2075 604029
Benelux, Ireland, Israel, Scandinavia, UK
ORT1109 004 4 9/30/11 1:51:57 PM
7
U
X
H
Copyright 2011 Tegra Medical. All rights reserved.
At Tegra Medical precision is our passion, which is why leading orthopaedic companies turn to us for help
with medical devices that enable successful outcomes. Looking for quick response times? With 200,000 sq. ft.
of manufacturing space, we have the capacity to respond quickly. Need awless manufacturing? We offer
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dedicated resources accelerate product development and improve design for manufacturing and assembly.
Engineered solutions. Precise products. True passion about the work we do. Thats Tegra Medical.
BOSTON MEMPHI S COSTA RI CA
Your customers require a passion for precision
www.tegramedical.com I 508.541.4200
ORT1109 005 5 9/27/11 3:44:05 PM
From the Editor
T
he business of manufacturing anything
isnt easy. Within the orthopaedics
segment, I often wonder how a company
can not just survive but also thrive in this
hostile economic environment. Is it luck
or smart business practices and strategic
thinking? In most circumstances Id say
that its a little bit of both. But times
are diffcult now; people who have lost
their jobs arent going to pay for elective
hip or knee surgeries. Implant manufac-
turers are being hit especially hard. In
2011 alone, Stryker, Biomet, Zimmer, and
Wright Medical have cut or announced
plans to cut jobs.
Manufacturers and suppliers must
think and operate strategically at all
times. Were seeing a lot more partner-
ships and acquisitions that are generating
new business. First, lets look at a young
company. OrthoSensor Inc. (Sunrise, FL)
was founded four years ago, and CEO
Jay Pierce is directing the company right
where he sees orthopaedics headedinto
an era of smart technology that integrates
electronics and sensors into implants. He
thinks his companys technology will be
a disruptive force in orthopaedics, and
so far, this strategy is leading to success.
Following a partnership announced with
Stryker in August, Pierce told the South
Florida Business Journal that OrthoSen-
sor is planning to hire up to 40 people
during the next year. Most of these jobs
will be in sales because the company out-
sources its manufacturing, which leads
me to another part of the equationthe
supplier.
Seasoned supplier Oberg Industries
(Freeport, PA) has been around for more
than 60 years. Its U.S. medical device
business has recently exploded. During
the past three years, the company has
experienced a compound annual growth
rate of more than 20%, according to Da-
vid Bonvenuto, executive vice president
and general manager at Oberg. Contrary
to the unemployment rates and the focus
on jobs [in] a stalling economy over the
last several years, weve seen the oppo-
site, he says. Oberg wants to add more
than 50 positions to its U.S. workforce,
and the company recently held its frst job
fair to fnd candidates.
Oberg, too, is looking at where the in-
dustry is headed but is doing so from the
standpoint of what OEMs want. [OEMs]
are looking to consolidate their supply
chains, says Bonvenuto. OEMs have
maintained supplier bases that are un-
manageable because theyre so large and
diverse. As we talk to OEMs about what
type of suppliers they want, they seek
to improve quality, delivery, and pricing
[while working] with fewer top tiertype
suppliers. Operating in harmony with
what OEMs need has been the key to
Obergs recent growth. Looking ahead to
2012 and 2013, the company is planning
to continue its upward trajectory.
Sometimes its easier to get caught up in
the negative news, but right now, I think
we need to talk about the positive things
happening in our industry. That being
said, how are you turning challenges into
success stories? Let me know whats going
on at your company.
MARIA FONTANAZZA
maria.fontanazza@ubm.com
Focusing on the future and listening to what customers want will help manufacturers
keep a strategic eye on the prize.
Whats Your Success Story?
ORT1109 006 6 9/27/11 3:45:40 PM
CORPORATE PROFILE
ADVERTISEMENT
Pro-Dex, Inc
Pro-Dex, Inc. designs, develops, and manufactures custom electric, air
and battery-powered surgical devices for leading Medical Device OEMs.
Headquartered in California, with facilities in Oregon and Nevada, Pro-Dex is
focused on getting customers to market faster, at a lower total cost, with a safe
and reliable product.
Pro-Dex headquarters, based in Southern California, is an ISO 13485-certified
manufacturer of cutting-edge powered surgical devices to leading OEMs. Prior to
its move in 2008, Pro-Dex took two years to design and architect a 30,000 sq. foot,
state-of-the-art, manufacturing facility with a focus on concurrent engineering,
prototyping, in-process inspection and lean manufacturing cells in order to deliver
highly reliable and safe products while compressing their customers time to
market. Pro-Dex also operates an ISO 2001 facility in Nevada that manufactures
custom motors for the aerospace and medical markets and a facility in Oregon
that produces multi-axis motion control products for leading research labs,
semiconductor, and medical diagnostics applications.
At the start of every project, Pro-Dex implements a process that incorporates
a proven, proprietary six-phase product development cycle consisting of the
following phases: Product Feasibility, Proof of Concept , Product Design and
Process Development , Design Verification and Validation, Product Transfer and
Release, Post-Production Evaluation. This thorough approach guarantees that the
end product will be safe, reliable and delivered on time, every time.
Pro-Dex understands how important it is to keep up with the ever-changing
regulatory guidelines. Safe and effective products are paramount to our clients
success. This is why Pro-Dex, Inc. has introduced its new 13485-certified contract
manufacturing division, focused on providing responsive, reliable contract
manufacturing capabilities to leading Medical Device Manufacturers. Coupled
with our full Quality Management System compliance, 13485-Certified Contract
Manufacturing offers an unmatched level of competency and excellence to
controlling manufacturing processes, document controls and CAPA systems.
Whether your are starting with a napkin concept, or a fully-designed product, O
Pro-Dex delivers a powerful solution for your surgical products including:
Detailed Design O
Product Feasibility O
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Prototyping and Production O
Program Management O
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Post-Market Surveillance O
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Pro-Dex Inc.
2361 McGaw Ave.,
Irvine Ca 92614
Phone: (800) 562-6204
e-mail: info@pro-dex.com
Website: www.pro-dex.com
Marketing contact: Tricia Rodewald O
Sales Contact: Jim McKenney O
ORT1109 007 7 9/27/11 3:45:45 PM
Plasma spray coatings and additive
manufacturing technologies offer signifcant
value to orthopaedic device manufacturers.
LEO GLASS AND PIERFRANCESCO ROBOTTI
T
he practical application of a
technology that differentiates a
product from its competition isnt
always the most novel approach. In
todays world, OEMs must consider us-
ing technologies to make products that
prove their relevance based on both in-
creased regulatory scrutiny and a cost-
beneft ratio. Plasma spray and additive
manufacturing technologies, which
are used to manufacture macroporous
surfaces for orthopaedic implants, can
accomplish this mission.
Part 1: Plasma Spray Coatings
The use of plasma spray coatings in
the manufacture of medical devices
began in the early 1980s with Bi-
omets introduction of the titanium
porous plasma spray coating. Another
breakthrough came later that decade
with the introduction of hydroxy-
apatite (HA) coatings for dental im-
plants. HA is a naturally occurring
mineral form of calcium apatite with
the formula Ca
10
(PO4)
6
(OH)
2
. The
material is synthetically derived into
a powder form and applied using an
air plasma system (see Figure 1). Un-
like many technologies in use during
the 1980s, plasma spray was a special
process technology that was not easily
verifable without destructive testing.
However, within the past fve years,
the technology has proven itself reli-
able, safe, and effective, with new
engineered process controls and auto-
mated equipment that is all validated
as a complete system.
When applied to a substrate, the
plasma spray process depends on
thermal conditions (the temperature
must be at the melting point) and
kinetic energy. The material melted
in the plasma is simultaneously ac-
celerated by high-velocity plasma-gas
stream. The molten or semimolten
droplets attach to the roughened
substrate and splats of particles. In-
ert gases (argon-nitrogen) fow over
a cylindrical copper anode and a
tungsten cathode. A dc arc is
maintained, which creates
gas plasma with a core tem-
perature that can reach up
to 30,000C. Powder met-
al or ceramics are injected
into the plasma stream in-
ternally or externally and
are then melted
and accelerated
at the substrate.
The entire pro-
cess is carefully
automated and controlled to prevent
the application or transfer of exces-
sive energyspecifcally heatto the
substrate.
The air plasma spray is used to
process an HA coating but is not typ-
ically used for processing titanium
metal powder. Controlled atmospher-
ic plasma spray (CAPS) or vacuum
plasma spray (VPS) is used to pro-
cess metallic powders that exhibit
oxygen-sensitive properties. In the
orthopaedics market, plasma-sprayed
titanium coatings are commonly
used to make titanium alloy hip im-
Macromanagement:
Surface Manufacturing
for Implants
Implant Technology
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ORT1109 008 8 9/27/11 3:58:19 PM
plants. Titanium coatings are being
applied to knee, shoulder, elbow,
and ankle implants, along with oth-
er products made from titanium and
cobalt-chromium-molybdenum alloys.
Titanium is extremely sensitive to
oxygen pick-up in high-temperature
environments. CAPS and VPS meth-
ods process titanium powder using
plasma spray technology but perform
the same process in a different manner
with different equipment. The CAPS
unit processes the coating and the
implant in a positive-pressure inert at-
mosphere, while the VPS unit processes
at a controlled low-vacuum pressure.
Both processes can successfully pro-
duce porous coatings that are benefcial
for bone up-growth and in-growth.
A porous coating is defned as one
that exhibits bone in-growth into the
coating. Bone will not grow into pores
that are less than 100 m.
1,2
Today,
plasma-sprayed titanium coatings
exhibit the minimum pore size char-
acteristics needed to be defned as a
porous coating. The porosity profle
is not an ordered structure like po-
rous beads but instead is a completely
random structure that is rough and
porous. The thickness of the coating
determines the predictable amount of
pore size, volume, and overall poros-
ity that can be achieved.
Tight Process Control
What are the distinct advantages to
plasma-sprayed titanium porous coat-
ings, and how do we understand how
to best use the technology? The an-
swer is multifaceted and depends on
the device market.
Advances in process control have
enabled the application of thick coat-
ings (up to 1000 m), which allows for
high porosity and interconnecting po-
rosity that is suitable for joint replace-
ment components. Ti-Growth is a VPS
coating that eliminates the pore-size
advantage of sintered beads. However,
the VPS coating process introduces
considerable heat. This process nor-
mally requires the use of metallic hard
masking to protect parts and can raise
the overall cost of production.
The CAPS coating process main-
tains a low-temperature coating
substrate interface that avoids metal-
lurgical bonding or elemental migra-
tion. It offers mechanical performance
benefits and allows for parts to be
moved in and out of the chamber. The
ease of manufacturing allows for great-
er overall output, which in turn gives
a service manufacturer more fexibility
on delivery times and overall cost.
Figure 2 shows the results that can
be obtained with tight process con-
trol over the application of a porous
titanium coating onto PEEK implants.
PEEK is used in fusion devices that are
designed to be inert, high strength, and
radiolucent. The spinal device market
will continue to use PEEK in a range
of applications, though the material
does have one limitation. Although
noted for its bioinert properties, PEEK
has little direct bone attachment. This
means that bone treats the polymer as
inert but does not want to attach to it
mechanically or chemically. The search
for a process that improves the uses of
this material has led OEMs to work with
a variety of surface-modifcation tech-
nologies. The basic concept is simple.
Apply a bioactive coating to a bioinert
material to enhance bone up-growth
or osseointegration. This application
fts into many of the uses for PEEK,
especially when applied to fusion-type
devices.
Process Capability of CP-Ti on Peek Tensile (PSI)
LSL
3500 4000 4500 5000 5500 6000 6500
LSL 3190
Target *
USL *
Sample Mean 5290.68
Sample N 34
StdDev(Within) 370.218
StdDev(Overall) 388.65
Process Data
PPM < LSL 0.03
PPM > USL *
PPM Total 0.03
Exp. Overall Capability
PPM < LSL 0.01
PPM > USL *
PPM Total 0.01
Exp. Within Performance
PPM < LSL 0.00
PPM > USL *
PPM Total 0.00
Observed Performance
Cp *
CPL 1.89
CPU *
Cpk 1.89
Potential
(Within) Capability
Pp *
PPL 1.80
PPU *
Ppk 1.80
Cpm *
Overall Capability
Within
Overall
Figure 2. This chart shows the resulting data from the tight process control of a porous
titanium coating onto PEEK implants.
- + +
Plasma Spray Process
Powder
Arc
Substrate
Anode
Cathode
Molten Particle Splat
Powder Spray Film
Water Ar, H
2
Water
Plasma Jet
Figure 1. The plasma spray process must be controlled to avoid excessive heat transfer to a
surface.
ORT1109 009 9 9/27/11 3:58:35 PM
Implant Technology
However, manuf act ures f ace
challenges when applying thermal-
ly sprayed materials to PEEK. The
physical and thermal properties of
polymeric materials are very differ-
ent from those of metallic or ceramic
materials. The chemical structure of
PEEK exhibits outstanding chemical
and radiation resistance. It can also
withstand structural degradation at
high temperatures. Nevertheless, the
material must be kept at a temperature
that does not exceed the glass transi-
tion temperature of 143C. To address
the challenges related to these char-
acteristics, the titanium coating can
be applied using specially developed
air or vacuum plasma spray processes
that provide low-temperature stabil-
ity during processing. CAPS has also
shown superior capability in enabling a
porous titanium coating on PEEK with-
out chemical or mechanical deteriora-
tion during the plasma-spray process.
The plasma spray process has
evolved from a misunderstood tech-
nology method to a mainstream
technology for manufacturing po-
rous coatings. These coatings can be
applied to almost any material and
geometry. Thus, the plasma spray pro-
cess is used extensively in the device
market. In addition, rapid or addi-
tive manufacturing (AM) technolo-
gies, although not new to the world,
are showing they can compete with
traditional coating technologies in
manufacturing porous titanium sur-
faces and offer the added beneft of
a complete near-net part construct.
Improved software and process con-
trols enable these technologies to pro-
duce devices with porous structures
that compete directly with those pro-
duced by alternative machining and
porous coating methods of manufac-
turing. By eliminating several manu-
facturing steps and inventory costs,
AM has created a loyal following
among suppliers.
Part 2: Additive Manufacturing
For at least two decades, there has
been technology that can build up solid
parts from 3-D computer-aided design
models. Starting materials are in liquid
or powder form and are subjected to
consolidation upon local energy sup-
ply, stimulating a specifc chemical or
Human mesenchemal stem cells proliferate onto a titanium additive-manufactured
macroporous surface.
ELEMENT WEIGHT (%) ISO 5832-3
Ti Balance Balance
Al 5.97 5.56.75
V 4.01 3.54.5
O 0.16 Max 0.2
N 0.01 Max 0.05
C 0.013 Max 0.08
H 0.0025 Max 0.015
Fe 0.056 Max 0.3
This image and table are an example of
atomized Ti-6Al-4V powder and its chemical
composition.
By eliminating
several
manufacturing
steps and inventory
costs, AM has
created a loyal
following among
suppliers.
ORT1109 010 10 9/27/11 3:59:09 PM
CORPORATE PROFILE
ADVERTISEMENT
Orchid Orthopedic
Solutions
Corporate Description
Orchid Orthopedic Solutions is a worldwide leader in contract design and
manufacturing solutions for the orthopedic, dental and cardiovascular markets.
Orchids key mission is to be the leader in contract medical design and
manufacturing by compressing time to market, providing new technology and
being the best total supply-chain value. The company meets the ISO 13485:2003
international standard for medical devices and related services that consistently
meet customer requirements and regulatory requirements. Orchids purpose is
to provide an opportunity for people to live a better life. The company offers an
array of implants and instruments within five core capabilities: design, forging,
machining, plastics and coatings.
Products/Services
Orchid Orthopedic Solutions specializes in implants, instruments and innovative
technologies for the following markets: reconstruction, trauma, spine, sports
medicine, orthobiologics, extremities, dental and medical devices. Orchid
Orthopedic Solutions contract design and manufacturing divisions offer the
following products and services: contract design and development (e.g., implant
and instrument systems, design troubleshooting; customs and specials; and
gage design and fabrication); near-net forging (e.g., joint and bone replacement
components, plates and extremity parts); advanced machining (e.g., implants,
surgical instruments, screws, nails, plates and joint replacement parts); medical-
grade precision-machined and molded plastic products (e.g., medical devices,
implants, components and delivery systems); and HP, TPS and RBM, porous
and bead coatings and surface treatments (e.g., implants). New technologies,
products,and design innovations are constantly being developed for Orchid
customers.
Facilities & Capabilities
Headquartered in Holt, Michigan, Orchid Orthopedic Solutions has more than 900
skilled employees at locations throughout the United States. The company provides
unparalleled customer service through innovative design and development, implant
manufacture, advanced machining, plastic technology, quality and regulatory,
instrument manufacture, implant coatings and surface treatments and packaging
for the medical device industry.
Major Markets Served
Orchid Orthopedic Solutions specializes in implants, instruments and innovative
technologies for the following markets: reconstruction, trauma, spine, sports
medicine, orthobiologics, extremities, dental and medical devices.
Orchid Orthopedic
Solutions
1489 Cedar Street
Holt, MI 48842
Phone: (517) 694-2300
Fax: (517) 694-2340
Sales@orchid-orthopedics.com
www.orchid-orthopedics.com
02_55565598 OT1004 re
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ORT1109 011 11 9/30/11 1:53:10 PM
Implant Technology
physical reaction. Technologies that
produce components according to this
strategy are categorized under AM.
3,4

The second part of this article fo-
cuses on two specifc AM technologies
electron beam melting (EBM) and
direct metal laser sintering (DMLS).
These technologies can produce parts
made of implantable metals such as
titanium alloy (Ti6Al4V).
The common feature of these AM
technologies is that they melt and
rapidly solidify portions of a metal
powder layer according to the specifc
drawing being replicated. Under spe-
cifc process conditions, solidifcation
results in a fully dense solid body.
In an EBM machine, an electron
beam gun preheats the powder layer
using a relatively low beam current
and a relatively high scan speed. This
process has two effects: frst, the par-
tial sintering of the powder, which
holds it in place during the subsequent
melting; and second, the high tem-
perature (about 600C) maintained
during the process reduces the ther-
mal gradient between the just-melted
layer and the already built-up body of
the part. This approach substantially
reduces residual stresses. A typical
layer thickness is 70100 m.
5
A DMLS machine for titanium al-
loys uses a laser beam with a higher fo-
cus capacity than EBM. Each layer can
be as thin as 30 m. The process leads
to improved resolution and accuracy
in the pieces manufactured compared
with those made via EBM. However,
tolerances against nominal design are
about 0.1 mm and are a long way
from typical values obtained by ma-
chining. Productivity for the DMLS
process as defned (melted material per
hour) is lower when compared with
the high-energy EBM process.
6
Designing and Manufacturing
Macroporous Surfaces
When a contract manufacturer uses
both EBM and DMLS technologies in
serial production, it can establish a pro-
cess surveillance strategy. One critical
concern is that titanium is chemically
prone to oxidation. If the oxide con-
tent in the manufactured parts exceeds
standard requirements (i.e., < 0.2%,
per ISO 5832-3), it may decrease mate-
rial ductility. The production cycle of
Ti-6Al-4V alloy-based parts presents
challenges. Part of the powder loaded
into the equipment that is not melted to
form the solid parts will eventually be
reused in the next manufacturing
cycle. The powder feeder tanks
are also routinely reflled with
new powder so that a blend
between reused and new pow-
der is permanently in place. Nu-
merous analyses were performed
to obtain a statistical picture of
the oxygen and carbon rate variation
against powder reuse, both for the
powder in the tanks and for the fnal
parts. Results revealed a high capabil-
ity to maintain the material within
specifcation when the processes are
performed correctly.
7
If porous structures are manufac-
tured on the pieces, a critical post-
process step such as titanium debris
cleaning may be required. The porous
structures, as manufactured, contain
a number of loosely adhered surface
beads, and it is necessary to remove
these particles. The most practiced
particle-removal methods are thermal
treatments, sandblasting, and chemi-
cal etching, or a combination of these
methods.
8
Once components with their po-
rous coating surface are additive
manufactured, they may be subjected
to further critical postprocess steps,
such as thermal treatments, hipping,
or machining, when high dimensional
accuracy is required for coupling com-
ponents. When additional mechanical
work is applied, it is crucial to avoid
or remove contaminants such as emul-
sions and lubricant residuals from
porous structures.
Both technologies release the Ti-
6Al-4V alloy with a specifc acicular
microstructure that cannot be modi-
fed by heat treatment and can be con-
sidered a building process fngerprint.
It does not fnd a correspondence in
the international standard dealing
with titanium alloy microstructures
for biomedical applications (ISO
20160). Nevertheless, a number of
studies have demonstrated how the
mechanical properties of the titanium
alloy obtained by AM may fully sat-
isfy the applicable standards and fa-
tigue resistance requirements.
5,6

When using AM technologies,
a number of different topographic
structures can be achieved with ex-
cellent performances. The ultimate
goal of porous titanium structures is
to host living bone tissue in a man-
ner that guarantees device fxation by
osseointegration. Such data has been
proven successful through in vitro and
animal testing. Properly engineered
and EBM-manufactured surface struc-
tures allow human mesenchemal stem
cells to attach to the structures and
spread.
9
Studies also showed that Ti
alloy macroporous structures that
were EBM-manufactured and surgi-
HA and titanium coatings were applied to
this PEEK Motis implant.
An HA coating is applied via the plasma
spray process onto a femoral hip stem.
ORT1109 012 12 9/27/11 3:59:17 PM
cally placed in immediate stable con-
ditions promoted a bone in-growth
of about 1.5 mm after six weeks of
implantation time in goats.
10
These
results show favorable conditions to
enable device fxation.
Applying Additive
Manufacturing
AM has a host of possibilities. The
main advantage is design freedom. The
method enables complex surface com-
ponents to be manufactured in a cost-
effective and timely manner. It enables
the delivery of intricate geometrical
components completed with designed
lattice surface topography in one
manufacturing step. Using the process
with titanium produces orthopaedic
components with a surface trabecular
(porous) structure that promotes bone
colonization and in growth, which
improves device fxation strength. The
method can also be used in the rapid
manufacture of complex-shaped cus-
tom implants and thousands of acetab-
ular components for hip arthroplasty.
Implant makers are examining ways
to meet inventory volume needs while
adhering to regulatory requirements.
AM technologies are proving to be the
way of the future.
References
1. CA Engh et al., Porous-Coated Hip Replace-
ment, The Factors Governing Bone In-Growth,
Stress Shielding, and Clinical Results, Brit-
ish Bone and Joint Surgery 69-B, no.1 (January
1987).
2. JD Bobyn et al., The Optimum Pore Size for
the Fixation of Porous-Surfaced Metal Implants
by the Ingrowth of Bone, Clinical Orthopaedics
150, (1980):26370.
3. T Wirtz et al., New Possibilities for the Design
and Manufacturing of Bone Implants with Ex-
ternal and Internal Functional Architecture,
Proceedings of the Second International WLT-
Conference on Lasers in Manufacturing (Munich,
June, 2003).
4. C Over et al., Rapid Manufacturing of Metal Parts
and Tools Using Laser Melting, Proceedings of the
Second International WLT-Conference on Lasers in
Manufacturing (Munich, June, 2003).
5. L. Facchini et al., Microstructure and Mechani-
cal Properties of Ti64 Produced by EBM of Pre-
Alloyed Powders, Rapid Prototyping Journal 15,
no. 3 (2009): 171178.
6. Facchini et al., Effect of the Microstructure on
the Ductility of a Ti-6Al-4V Alloy Produced by
SLM of Prealloyed Powders, Rapid Prototyping
Journal 16, no. (2010): 450459.
7. E Magalini et al., Industrialization and Valida-
tion of RM Process, Proceedings RAPID 2010
and 3D Imaging Conferences (Anaheim, CA, May
1820, 2010).
8. E Magalini et al., Porous Titanium Foams with
Additive Manufacturing Technologies, Proceed-
ings RAPID 2010 and 3D Imaging Conferences
(Minneapolis, May 2426, 2011).
9. JE Biemond et al., The Effect of E-Beam Engi-
neered Surface Structures on Proliferation and
Differentiation of hMSCs, Proceedings at ORS
2010: Orthopaedic Research Society (Louisiana
March 69, 2010).
10. JE Biemond et al., Frictional and Bone In-
growth Properties of Engineered Surface To-
pographies Produced by E-Beam Technology,
Archives Orthopaedic and Trauma Surgery131,
no. 5 (2011):711718.
Leo Glass is president of Surface
Dynamics (Cincinnati). Pierfrancesco
Robotti is responsible for scientifc
marketing in Eurocoating s.p.a (Cir-
Pergine, Italy).
Artifcial joints get pretty
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fnishes. So who do you trust to
provide the exact fnishes your OEM
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ORT1109 013 13 9/27/11 3:59:37 PM
Blog Teasers
OrthoTecs blog covers the latest development in the orthopaedics industry. Visit orthotec.com
Advanced electronics technology is
boosting the power of a lower-limb
prosthetic, enabling simultaneous knee
and ankle joint use. Developed at Van-
derbilt Universitys Center for Intelli-
gent Mechatronics (Nashville), the de-
vice is an improvement over traditional
prosthetics, which tend to drag or have
a lag in motion. It is designed to sim-
plify the daily movement (walking,
sitting, standing, etc.) that many take
for granted. According to studies, us-
ers who were equipped with the device
walked 25% faster on level surfaces
then they did when they used passive
lower-limb prosthetics.
Sensors monitor the prosthetics mo-
tion. Microprocessors take the data to
predict the users desired movement
and act accordingly. The development
of the device came after seven years of
research and was funded by the Na-
tional Science Foundation and the Na-
tional Institutes of Health. Vanderbilt
University patented parts of the design
and has given prosthetic manufacturer
Freedom Innovations (Irvine, CA) ex-
clusive rights to make the device.
With our latest model, we have
validated our hypothesis that the right
technology was available to make a
lower-limb prosthetic with powered
knee and ankle joints, said Michael
Goldfarb, H. Fort Flowers professor of
mechanical engineering at Vanderbilt,
who directed the research. Our device
illustrates the progress we are making
at integrating man and machine..
So whats next? The Center for In-
telligent Mechatronics is working on
an anthropomorphic prosthetic arm
project and an exoskeleton for use in
physical therapy.
Maria Fontanazza
Bionic Leg Integrates Man and Machine
Professor Michael Goldfarb (right) stands with
amputee Craig Hutto, who is wearing the new
bionic leg developed at Vanderbilt University.
P
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Y
Since April, the following executives have left Wright Medical:
Gary Henley, CEO.
Frank Bono, senior vice president and chief technology offcer.
Raymond Kolls, senior vice president, general counsel, and secretary.
Cary Hagen, senior vice president, EMEA commercial operations.
Alicia Napoli, vice president, clinical and regulatory affairs.
Lisa Michaels, vice president and chief compliance offcer.

Fast facts about
Vanderbilts bionic leg:
Weight: 9 lb.
Operation time on a single

charge: Three days of normal
activity/1314 km of continuous
walking.
Antistumble routine: If the leg

senses that the user is about
to stumble, it lifts the leg to get
away from the obstruction and
plants the foot on the ground.
Better hardware design: The

hardware has endured seven
designs, and the electronics
board has been revised 15 times.
Will Wright
Medical Straighten
Out Compliance
Issues?
The compliance scandal at Wright
Medical continued during the sum-
mer with the resignation of Lisa
Michaels, vice president and chief
compliance offcer. The companys
board of directors plans to hire a
recruiting frm to fnd Michaels re-
placement. John Knighton, compli-
ance director at the company, will
fll in for now. However, Wright Medi-
cal is trying to get back on track. It
has named Robert J. Palmisano CEO
and announced a signfcant restructur-
ing plan, which includes layoffs. The
company also voluntarily extended its
deferred prosecution agreement until
September 29, 2012. Read more about
this news on p. 42.
MF
ORT1109 014 14 9/27/11 3:47:04 PM
Smart Idea:
Stryker Embeds
Microelectronics
from OrthoSensor
At the start of 2011, OrthoSensor Inc.
(Sunrise, FL) was positioning itself to
be a disruptive force in orthopaedics
through its strategy of integrating elec-
tronics and sensors into implants. The
company is beginning to put this plan
into action, forming a partnership with
Stryker Orthopaedics. As part of this
agreement, the company is providing its
OrthoSensor KneeTrial system for use
with Strykers Triathlon Knee System.
The single-radius design philoso-
phy of Stryker knees is a perfect com-
plement to OrthoSensors innovative
technology, said Doug Leach, vice
president of global R&D, knee recon-
struction, at Stryker Orthopaedics, in
a statement.
The OrthoSensor Knee Trial has
embedded sensors and microelectron-
ics that give surgeons real-time feed-
back about ligament balance and joint
kinematics during knee arthroplasty
procedures. The data is wirelessly
transmissed onto a graphic display.
Surgeons use this information to alter
the position of an implant, change leg
alignment, and optimize soft tissue
balance.
MF
Glory Days of
Orthopaedics Are
Over
Although analysts are positive about
the gradual improvement of business
in orthopaedics, they say the industry
will never be the same.
The days of lavish spending on
surgeons and consulting agreements
are a thing of the past, while strug-
gling procedure volume growth com-
bined with steady price degradation
is the sign of the times, analysts with
investment research frm Canaccord
Genuity wrote in its assessment of
the market. They noted that business
should get better with the economy
but the question is when. We expect
medtech investors to play the waiting
game for many of these stocks until
consistent growth and subsequent
leverage opportunity returns.
The latest confusion surrounds joint
reconstruction volumes. Biomet saw
its sales fall in Q4 2011, right on the
heels of the previous quarters fat U.S.
sales. And the fallout from the metal-
on-metal hip controversy has yet to be
fully realized.
However, its not all bad news. Ro-
botics manufacturer Mako Surgical and
China-based KangHui Medical could
experience better-than-expected results
this year, according to the analysts.
KangHuis growth will be driven by
the eight trauma and spine products
that it released in 2009 and 2010. The
company, which enjoyed a strong
second quarter, launched a kypho-
plasty system earlier this year and
could be entering the joint implant
segment next year. Kanghui also has
an advantage in competing against
multinational companies in China,
because the medical insurance com-
panies prefer to reimburse domestic
implants, which tend to cost less than
imported implants.
Mako Surgical reported second
quarter revenues of $18.6 million, an
81% increase over Q2 2010. The com-
pany sold 12 of its RIO systems during
the quarter, which accounted for $9.5
million in revenue. Last year, the com-
pany began an orthopaedic surgeon
preference evaluation following the
clearance of its Makoplasty system for
the hips, which it says is progressing
according to plan.
MF
Zimmer Fights Back
Against Plaintiffs
Attorneys by Suing
Them
As is true of most product liability
litigation, the legal wrangling over Zim-
mers NexGen knee implants has been
contentious, to say the least. An article
in Bloomberg provides a snapshot of
just how contentious this fght has been,
detailing how Zimmer has begun suing
plaintiffs attorneys.
Zimmer is accusing the attorneys of
being dishonest about the safety records
of the knee implants in their zeal to
recruit potential plaintiffs. According to
the article, several frms have launched
campaigns to attract clients, campaigns
the company says have unfairly ma-
ligned its reputation.
There is generally a rough-and-
tumble favor to most product liability
litigation. Neither the aggressive cam-
paigns from plaintiffs attorneys nor
the aggressive response from Zimmer
are particularly surprising. However,
the article makes it clear that Zimmers
move is innovative. Roger Williams
University law professor David Logan
stated that it opens up a new front in
the product-liability wars.
Do you think hes right? Is this tac-
tic something other orthopaedic and
medical device companies can use in
future product liability defense efforts?
Or is it going to backfre? Is it time to
pull out all the stops when it comes
to fghting back against plaintiffs at-
torneys, or is this an overreaction on
Zimmers part?
Thomas Blair
OrthoSensors knee trial integrates
microelectronics and sensors.
ORT1109 015 15 9/27/11 3:47:10 PM
Materials Characterization
3-D optical microscopy provides improved wear characterization,
especially when assessing scar depth and volume removal.
ROGER POSUSTA AND MATT NOVAK, PHD
M
aterial selection can be a chal-
lenge for hip implant manufac-
turers. A major factor in long-
term success for implant procedures is
limiting the gradual and progressive
shedding of material from the implant
surfaces. This wear and the resulting
presence of particulates in the body
can lead to bone resorption, granuloma
formation, loosening of the joint, and,
ultimately, implant failure.
This failure mechanism is driving im-
provements in biometric materials that
provide several options for hip replace-
ment surgery. Todays top-performing 3-D
optical microscopes provide quantitative
evaluation of materials prior to implanta-
tion to determine the wear characteristics
of surfaces in a variety of preparations
(uncoated, coated, polished, etc.). This
evaluation enables the manufacturer to
make implants with improved wear and
that are more comfortable, have increased
fexibility, and last longer.
Technology-Driven Solution
Three-dimensional microscopy uses
white light interferometry (WLI) and
is one of the most accurate, repeatable,
and versatile methods of precision sur-
face metrology. Systems based on this
technology successfully measure ma-
terials in research and production line
environments in subnanometer vertical
resolution for a wide range of indus-
tries, including medical, automotive,
aerospace, electronics, solar, MEMS,
data storage, and general manufactur-
ing and precision machining inspection.
A 3-D microscope offers a noncontact
advantage over contact stylus systems
that have mechanical fltering due to tip
radius, which can also damage a surface
during measurement.
In WLI microscopy, light from a
source is focused on a sample and simul-
taneously refected from a reference mir-
ror in the instrument (see Figure 1). The
light refected from the sample is pre-
cisely compared with the light refected
from the reference mirror. Local height
Determining Material
Characteristics of Hip
Implants: 3-D Microscopy
is the Answer
Laser
Light Source
Beamsplitter
Reference Mirror
Mirror on the Scanner
Mirau
Interferometer
Objective
Sample
CCD
Reference signal
detector(s)
Mirror
Reference Signal Module
Figure 1. Basic design of a 3-D microscope with a self-calibrating helium-neon laser.
ORT1109 016 16 9/27/11 4:00:38 PM
information is obtained as a function
of lateral position on the sample. By us-
ing proper fltering and high-brightness
LEDs as source illumination, the mea-
surement conditions can be tailored
to match the application requirements
for a vast array of sample surfaces.
The presence of the helium-neon laser
delivers a self-calibrating reference for
the movement of the scanner in order to
account for changes in the position due
to environmental variations.
Applications for this technology are
being developed outside the traditional
surface measurement realm, specifcally
for areas such as flm thickness metrol-
ogy, environmental response (corro-
sion) studies, and actuated response
studies. Most recently, the technology is
enabling users to examine the behavior
of materials over a range of timescales
as they are worn via cutting or grinding
operations, or where material wear is
produced due to constant contact with
other components. This particular wear
mechanism is prominent in implants
specifcally hip implantswhere there
is necessary contact by device design
and function.
Plastic-on-metal, ceramic, and metal-
on-metal implants have drawn negative
attention for their tendency to produce
friction-created debris, which in turn
causes infammation of the tissues sur-
rounding the implants. This debris can
lead to increased residual presence of
polyethylene or metal components in the
body. The wear and resulting infamma-
tion can lead to osteolysis (bone destruc-
tion), pseudotumors, or in limited cases,
loud frictional squeaking due to ceramic-
on-ceramic stripe-wear patterns. Careful
characterization of the wear and wear
rate for the materials involved is critical
to improving the long-term performance
and stability of these products. This in-
formation is readily attained using 3-D
optical microscopy.
Wear Study Example
The following example is an alternative
method of performing wear studies based
on 3-D microscopic metrology that pro-
vides critical parameters to characterize
the wear scar, in addition to providing
the volume of material removed. This
information can be useful during process
development, material property analysis,
and material selection. It is invaluable to
process development engineers, materials
science engineers, and product develop-
ment engineers because the fnal perfor-
mance of a material in an application
can be correlated to the wear measured
in such a manner. A virgin PEEK sphere
with a diameter measuring 1 in. was used
to simulate a hip joint, and the top of the
surface was mapped using a 3-D micro-
scope. Several felds of view were mea-
sured at 5x magnifcation and combined
to produce an accurate and wide-angle
view of the top portion of the surface. A
photograph of the PEEK sphere and the
corresponding 3-D microscopic image of
the portion to be inspected are shown in
images 1 and 2.
After initial characterization of the
PEEK sphere, a wear mark was made
to simulate wear and volume removal.
After this small volume of material was
removed, the surface was remapped.
Images of the worn surface and the lev-
eled representation of the wear mark are
shown in image 3. By subtracting the
original pristine surface from the second,
worn surface, the material mass displaced
and the volume loss can be precisely cal-
culated. The high vertical resolution and
high lateral resolution achieved by WLI-
based 3-D optical microscopy ensures the
accuracy of this methodology.
The data presented in image 4 are
used to compute the volume displace-
Image 1. This image shows a PEEK sphere
with a diameter that measures 1 in.
Image 2. A 3-D surface map of the PEEK
sphere is made before wear.
Image 3. The worn PEEK sphere surface is
remapped.
Image 4. The wear data is used to compute
volume displacement.
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.55.0 5.56.2
Volume Calculations
Volume Options
Natural Volume
Normal Volume
Negative Volume
Positive Volume
Net Missing Volume
Total Displaced Volume
Normal
1.26e+009 m
3
24.22 m
3
652147136.00 m
3
664661888.00 m
3
12514752.00 m
3
1.32e+009 m
3
Thresh: 27.32 m 16.86% of P-V
Pts Below: 99.94% of Total
Vol: 7.88e+008 m
3
62.33% of Total
6.1
5.5
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.0
Figure 2. The chart shows 1 mg of
material removed, which correlates to
~7.5x108 m
3
/mg volume of material and
matches the nominal mass density of PEEK.
ORT1109 017 17 9/27/11 4:00:42 PM
Materials Characterization
ment. The depth and area over which the
material was removed is used to make
a computation of the material density,
which is highly correlated with gravi-
metric machines. The repeatability of
the surface metrology technique is more
than an order of magnitude higher than
the gravimetric method of measurement,
due to the higher uncertainty in measure-
ment of such small mass. The analysis
and volume computation for the initial
wear mark and computation are in Figure
2 on p. 18.
To verify the repeatability of the tech-
nique, a repeated wear mark was intro-
duced, removing approximately 4 mg of
additional material. This material was
removed from the same surface scar
location. and the surface was remapped.
The final volume removed was then
computed based on analysis of the fnal
depth and width of the resulting wear
scar (see Figure 3).
For this second stage of the material
wear and volume removal experiment,
slightly less than 5 mg of total mate-
rial was eventually removed. This mass
removal corresponds to approximately
~3.5x10
9
m
3
/mg of volume lost due to
wear on the PEEK sphere surface. Be-
cause some of the fnal volume of mate-
rial removed was taken from the sphere
slightly outside the measurement feld of
view, the fnal measurement of volume
lost was slightly less than the theoreti-
cal loss calculation (resulting in a slight
mismatch to nominal mass density). For
an even more accurate representation of
this removal, a large initial map could be
made to accommodate the additional re-
moval volume. Even with this mismatch,
the associated error in mass determina-
tion is on the order of 10 times smaller
than gravimetric means.
Noncontact 3-D Microscope
Metrology
The speed and versatility of 3-D micros-
copy brings accuracy and data-quality
advantages to the user. The filtering
that takes place with a mechanical sty-
lus measurement does not occur with
noncontact imaging. This is because
the sampling of the image is set by a
combination of the magnifcation of the
observing lenses and the charge-coupled
device camera spacing. Lateral resolu-
Label Value Units
Sa
Sku
Sp
Sq
Ssk
Sv
34.796
3.138
111.986
43.379
1.023
118.347
m
m
m
m
X Prole (2861.533 m)
m
m
50
0
50
100
150
0 1000 2000 3000 4000 5000 6000
M
R
Y Prole (3734.228 m)
m
m
50
0
50
100
150
0 1000 2000 3000 4000 5000 6000
M
R
6
0
0
0
.
0
5
0
0
0
.
0
4
0
0
0
.
0
3
0
0
0
.
0
2
0
0
0
.
0
1
0
0
0
.
0
0
.
0
0.0 1000.0 2000.0 3000.0 4000.0 5000.0 6000.0
m
m
m
85
50
0
124
100
50
Volume Calculations
Volume Options
Natural Volume
Normal Volume
Negative Volume
Positive Volume
Net Missing Volume
Total Displaced Volume
Normal
4.95e+009 m
3
92.53 m
3
1.16e+009 m
3
1.18e+009 m
3
15869696.00 m
3
2.34e+009 m
3
Thresh: 48.12 m 14.12% of P-V
Pts Below: 99.85% of Total
Vol: 3.35e+009 m
3
67.72% of Total
6.1
5.5
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.0
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.55.0 5.56.2
Figure 3. The 3-D profile (image) reveals a new wear mark, with 4 mg of material removed.
The chart shows the new volume loss calculation.
Figure 4. The data show a listing of various 3-D areal surface parameters measured via 3-D microscopy.
ORT1109 018 18 9/27/11 4:00:53 PM
tions at the diffraction limit are achiev-
able in this manner, enabling higher
sampling than is possible with a stylus
of 2, 5, or 10 m (some typical stylus
tip dimensions). Important 3-D surface
parameters, such as roughness (Sa),
peak/valley (St), and radius of curvature
(RoC), can easily be obtained from the
same data used for the volume calcu-
lations mentioned previously. These
parameters are computed automatically
for the entire field of view (FOV) of
the optical inspection area. The data, if
desired, can also be examined in 2-D,
thus offering the operator hundreds of
equivalent stylus traces for a single FOV.
The speed with which this information
can be collected is an advantage in pro-
duction settings.
Additionally, 3-D parameters of in-
terest (especially when computed in
accordance with ISO 21578 standards,
which are currently scheduled for adop-
tion across a wide range of industries)
provide an accurate and consistent
quantification of important surface
texture characteristics in a well-known,
industry-accepted manner. A few of
these parameters, representing average
3-D roughness, slope, skewness, kurto-
sis, height, and peak-valley information,
are depicted in Figure 4.
Such 3-D parameters allow materi-
als researchers to correlate properties
that are highly quantifable to product
performance in a fast, accurate, and re-
peatable manner. These measurements
exhibit high reproducibility, a hallmark
of good metrology for process and
quality control.
Conclusion
Three-dimensional microscopes provide
versatile and rapid noncontact means
of performing surface finish and tri-
bology measurements in several areas,
including the engineering lab and the
production floor. Fast, accurate, and
repeatable measurements based on the
capabilities of this technology are ideal
for the medical industry. The versatility
of 3-D microscopy enables end users
to measure materials in a range of ap-
plications. The study presented in this
article demonstrates the ability of 3-D
microscopy to deliver highly accurate
wear metrology to the medical implant
industry. The results showed an accurate
computation of wear volume on a hip
implant (a PEEK simulated hip ball) ob-
tained using 3-D microscopy while also
giving form and surface fnish param-
eters as value-added information. These
accurate results and the additional 3-D
surface texture parameters offer implant
materials development and production
teams a signifcant value over traditional
gravimetric approaches to materials
characterization.
Roger Posusta is senior marketing ap-
plications engineer at Bruker Corp.s
nano surfaces division (Tucson, AZ).
Matt Novak, PhD, is marketing appli-
cations manager at the company.
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ORT1109 019 19 9/30/11 1:53:53 PM
Compression Molding
This cost-effective process has advantages over other methods of
molding orthopaedic parts.
ROBERT BOLAND
C
ompression molding has been
used to make plastic parts since
Leo Baekeland introduced pheno-
lic resins in 1910. It is the oldest process
used to mold plastic parts.
1
A phenolic is
a thermoset resinwhen introduced to
heat and pressure, it cures to become a
plastic part. Thermoset parts have an ir-
reversible chemical crosslinking and can-
not be remelted. Thermoplastic materials
are compression molded and commonly
used in the orthopaedics industry. A
thermoplastic material becomes a liquid
when heated and freezes to a hardened
state when suffciently cooled.
Compression molding requires a ver-
tical press that is usually a hydraulically
actuated and an integrated temperature-
controlled mold. The mold usually con-
sists of two halvesan upper force half
and a lower cavity half, or vice versa.
It is precisely machined from tool steel
to form the desired geometry of the
molded part. The press can be up-acting
or down-acting. With an up-acting press,
the hydraulic cylinder is attached to the
lower press platen and moves upward,
guided by four identically machined tie
bars to close the press in a parallel con-
dition (See Image 1). In a down-acting
press, the hydraulic cylinder is attached
to the upper press platen that moves
downward to close the press. In many
cases, a press with two daylights is used
to double the production.
During operation, a preweighed
amount of molding material is placed
directly into the lower cavity of the
temperature-controlled mold. The ma-
terial can be in the form of powder,
granules, pellets, putty-like mass, or pre-
formed blanks. In the case of thermoset
materials, the mold is heated from ap-
proximately 300 to 350F. The heat
from the mold softens the material to a
viscosity low enough so that the material
can fow when pressure is introduced.
The press closes at a high speed until
just before the point at which both mold
halves make contact with the charge of
material to be molded. The fnal clos-
ing speed is slower to prevent damage
to the mold and to profle the velocity
of the close as the charge of material
deforms and flls the cavity to achieve
the optimum material fow. Once the
press is fully closed, the molding mate-
rial takes the shape of the cavity (see
Image 2). With the heat of the mold
and the pressure of the press (typically
12 tn/sq in. of molded surface area at
the parting line of the mold), there is an
irreversible chemical crosslinking. The
material hardens and in effect becomes a
plastic part. With thermoplastic materi-
als, the mold is cooled to allow the part
to harden. Cycle times can range from
60 seconds to several hours depending
on the material used and the thickest
wall section of the molded part. Upon
cycle completion, the press is opened. In
many cases, ejector pins in the mold are
actuated either mechanically or hydrau-
lically to lift the molded part away from
the cavity, so an operator or a robot can
easily remove it from the mold.
How to Use Compression
Molding to Make Joint
Replacement Parts
Image 1. The compression press is shown
with a preform of the molding material prior
to press closing.
ORT1109 020 20 9/27/11 3:48:10 PM
Some typical compression-molded
plastic parts include circuit breakers,
insulators, closures, cookware handles
and knobs, fuel cell plates, appliance
parts, dinnerware, automotive hoods,
fenders and valve covers, and interior
aircraft parts. Materials used for com-
pression molding include epoxies, urea,
melamine, phenolic, polyester, poly-
imide, polyamide-imide, PEEK, and
various fber reinforced thermoplastics.
Many rubber parts are also compression
molded. In the orthopaedics industry,
various knee, hip, and shoulder replace-
ment joint parts are compression mold-
ed out of medical grade ultrahigh mo-
lecular weight polyethylene (UHMWPE).
UHMWPE is a thermoplastic polyeth-
ylene that was frst introduced as an
orthopaedic implant material in 1962.
2

The odorless and nontoxic material has
high impact strength and many desir-
able features that make it the choice
for molding replacement joint parts.
It has low moisture absorption, a low
coeffcient of friction (comparable with
that of Tefon), is self-lubricating, and
is resistant to abrasion. It exhibits good
wear, an important factor in determining
the life span of orthopaedic implants.
2

As one of the lowest-cost methods of
molding, compression molding wastes
little material and has good surface
finish. With joint replacement parts,
a typical part surface fnish might be
equivalent to an SPI B-1 fnish. Fewer
knit lines are produced, and the process
can yield better impact and flexural
strength in the molded part than can
be achieved with injection molding.
Normally, any high-volume part would
be a candidate for injection molding.
However, the high molecular weight of
UHMWPE affects the melt viscosity to
the point that conventional thermoplas-
tic material processing equipment such
as injection molding cannot be used.
A disadvantage of compression
molding is that some material can seep
through the parting line of the mold
(called fash). This fash can affx to the
molded part and must be trimmed from
the part after molding. Another disad-
vantage is that cycle times are longer
than for injection molding.
In many cases, blocks or sheets of
UHMWPE are compression molded
or consolidated, and the desired part is
machined out of the block or sheet of
molded material. This process prevents
excessive tooling costs because replace-
ment joint parts are made in many dif-
ferent sizes. So instead of having 1000
different molds to make various joint
sizes, a machining center can be pro-
grammed with 1000 different programs
to machine the different joint sizes.
In other instances, orthopaedic im-
plants are compression molded to their
net shape. Called direct compression
molding, this process can result in a
fnished or almost-fnished part with a
highly polished part surface directly out
of the mold. In either case, the proper-
ties of the fnal part can be infuenced
by the technology available in todays
compression molding presses.
Compression Press Construction
A number of factors must be considered
when selecting the correct type of press
construction for an application. With a
heated press, the frst consideration is
thermal growth of the moving and fxed
platen relative to cylinder platen. Be-
cause the cylinder platen stays at room
temperature as the fxed platen rises in
temperature, the press tie bars are no
longer parallel.
Another consideration is the prob-
lem of clearance required between the
guiding and the tie bars, which allows
the moving platen to shift freely out of
parallelism. The next issue to consider
is the possibility of an offset load (the
mold or material is not centered in the
platen) putting a side load into and de-
fecting the tie bars, allowing the moving
platen to go out of parallelism. The last,
but not least, problem is the rigidity of
the frame itself. When the offset load is
transmitted into the tie bars, the cylin-
der platen wants to shift due to the side
loading, making the connection between
the tie rods and platens crucial.
There are two methods for con-
structing presses used for molding joint
replacement parts. The first method
uses round tie rods. Bronze bushings
are inserted into the moving platen and
ride up and down on the tie rods as the
press is opened and closed. The main
problem with this type of guiding is
that it is not adjustable. Clearances for
bushings must consider thermal expan-
sion conducted from the heat platen
into the press platen, as well as manu-
facturing variance of all of the piece
parts and running clearance. To replace
a round bushing, the press frame usu-
ally needs to be taken apart. Initially,
because the bushing diameter is larger
than the tie rod, the bearing area is very
small, which results in much higher
wear until the tie bar wears into the
Image 2. The compression press is closed
and is molding a part.
Image 3. When trying to reduce deflection,
use multiple clamp cylinders to spread the
load out over the press platen area.
ORT1109 021 21 9/27/11 3:48:15 PM
Compression Molding
bushing, creating an undesirable result
of more clearance.
The second method uses rectangular
tie rods or slab sides machined with
45 gib guides. This type of guiding is
more costly but has several advantages.
Contact area is higher and predictable.
When used properly, the 45 angle can
help offset most of the thermal growth
of the fxed and moving platen. The
press can be designed so that when
the moving platen grows from front to
back it increases the guiding clearance
relative to the cylinder platen, which is
offset by the left-to-right platen growth
to maintain good guiding. This type
of guiding is simple to replace and is
adjustable, so that clearances can be
run tight with easy adjustment for
wear. Regardless of the type of con-
struction used, it is important that the
press closes in a parallel condition to
mold high-quality parts. Parallelism
across the platen within 0.002 in. is
desired when molding joint replace-
ment parts.
The construction of the press must
also be robust enough to keep defec-
tion caused by the clamp to a minimum,
which is usually no more than 0.0015
in./ft of platen area. In addition to the
thickness of the press platen, another
way to reduce defection is to use mul-
tiple clamp cylinders to spread the load
out over the press platen area as shown
in Images 13 (p. 2021).
The Compression Molding
Process
The basic theory of compression mold-
ing thermoplastics is that the materials
are heated above their melting points,
formed, and then cooled. When using
medical-grade UHMWPE to make joint
replacement parts, the material comes in
powder form and must be consolidated.
The proper consolidation of the material
is a direct result of the heat, pressure, and
time combination used by the processor.
3

The equipment is commonly located in
a clean and controlled environment to
prevent any extraneous debris from get-
ting molded into the part.
In many cases, because of the long
cycle times, double-daylight presses are
used. A double-daylight press allows
for two molds in the press and doubles
the output of the press. In other cases,
vacuum presses, which can also have
two daylights, are required.
During operation, virgin UHMWPE
powder is loaded into the mold. This can
be done outside the press with the mold
placed onto heating and cooling platens
in the press after material loading. The
press is closed. Pressure and heat are
applied at a controlled rate. After sev-
eral hours, the press is opened and the
molded part or parts are removed from
the mold. The form and structure of the
molded UHMWPE joint replacement
part is greatly infuenced by the rate and
accuracy of the pressure and temperature
applied to the mold during the molding
cycle. This is where the technology in the
modern compression press can be the key
factor in producing high quality parts.
The long molding times are neces-
sary to maintain slow, uniform heating
and cooling rates and pressure ramping
throughout the cycle. The most effective
results are achieved when the ramping
accuracy of the pressure throughout the
entire tonnage range is within 450 lbs. on
a 75-ton press (accuracy within 0.3%).
Until now, such tight pressure accuracy
was unheard of in a hydraulic press. The
hydraulic system must have a number of
features to achieve this accuracy. Among
these features are the following:
Servo valves and a servo controller.
Proprietary programming of the coun-

terbalance valves.
Use of a pressure transducer in the

hydraulic line instead of a load cell
to determine force. Load cells are ex-
tremely sensitive to temperature and
off-center loading of the press.
Frictionless seals in the hydraulic

cylinders.
The pressure accuracy of the hydrau-
lic clamp is calibrated with portable
load cells at ambient temperature. The
pressure works in conjunction with the
temperature to achieve the optimum
molded part. Because UHMWPE is a
thermoplastic material, it must be heated
and then cooled. With orthopaedic parts,
the mold is not normally equipped with
direct heating and cooling. The heating
and cooling is done with heating and
cooling platens in the press. Each day-
light has top and bottom heating/cooling
platens that conduct the temperature
into the mold. The press is equipped
with a separate, dedicated controller
that specializes in heating and cooling.
This dedicated controller communicates
with the programmable logic controller
and human interface of the press, so
the heating and cooling values can be
input on the color touch screen and
are a part of the recipe set up for a
particular mold. Heating in the platens
is done with electric Calrod heaters
that are ftted tightly into holes drilled
in the platen. The dedicated temperature
controller senses the platen temperature
Four double-daylight presses operate from a common hydraulic power pack and control
system.
ORT1109 022 22 9/27/11 3:48:21 PM
with thermocouples in the platen and
sends the proper amount of current to
the heaters to achieve the desired heat.
The heat platen is typically heated to
450F. The wattage and arrangement
of the Calrod heaters in the platen must
be calculated to achieve heating that is
within 10F across the surface of the
platen. The platens are heated from ambi-
ent temperature to 450F at a controlled
rate. The platens are also gun-drilled with
passages for cooling air and water. To
start the cooling cycle, the electric heat-
ers are turned off. Cooling begins with
the dedicated heating/cooling controller,
sending a signal to the compressed air
and water solenoid valves to send the
proper amount of air into the cooling
passages. Then based on the desired rate
of cooling, it is followed by an air/water
mix, and then water. With the accuracy
of the controller, the rate of cool down
can be controlled to the optimum rate
that is most beneficial to the molded
UHMWPE part.
Vacuum Molding
During the past several years, vitamin E
has been blended with UHMWPE pow-
der for molding orthopaedic insert parts.
Vitamin E is an excellent biocompat-
ible stabilizer for UHMWPE as it goes
through the molding process.
4
However,
exposure to oxygen during the molding
process can break down vitamin E. To
eliminate this problem, the material is
molded in vacuum presses. A vacuum
press can have all of the features of a con-
ventional press except that is constructed
with solid-steel side plates (slab sides).
These take the place of the tie rods. The
moving platen rides up and down the slab
sides on 45 gib guides. Front and back
sealed doors are attached to the slab sides
to create an air-tight chamber (see Figure
1). A vacuum pump draws down the
press/platen chamber to a programmed
Torr value that is best for the molded
part. The vacuum can be maintained for
the entire length of the cycle.
Press Controls
In addition to controlling press move-
ment, pressure, and temperature, there
are other valuable tools on modern press
control systems, such as real-time graph-
ing, data collection, and Ethernet ca-
pability. Real-time graphing (RTG) is
a Windows application that displays a
graph of process data in real time and
collects and archives process data for
every machine cycle. When the machine
cycle begins, a real-time graph collects
each data point (i.e., position, pressure,
and temperature) 20 times per second
and saves the information when the cycle
ends. A new data fle is created for each
machine cycle. RTG allows the operator
to see exactly how the press is performing
at any time during the cycle. The user can
go back and observe the data collected if
there is ever a perceived problem with a
molded part.
Conclusion
Compression molding joint replacement
parts is a time-consuming and technically
demanding process. To mold high-quality
orthopaedic parts, it is essential that the
selected compression-molding press has
all of the necessary features to meet pro-
cess challenges. Those features include
very fne pressure control, accurate tem-
perature control, tight parallelism, and
low defection. Other helpful features that
will enable the user to keep track of the
manufacturing process include real-time
graphing, Ethernet capability, and data
collection. There may be other features
required of your press. It is a good idea to
work closely with the press manufacturer
to discuss the properties you will require
in the fnished molded parts. Choosing
a press manufacturer with experience
building presses for joint replacement
parts can help. Their knowledge can assist
in designing and building a press that will
produce high quality joint replacement
parts for many years.
References
1. B Davis et al., Compression Molding (Cincinnati:
Hanser Gardner Publications 2003), 118.
2. M Allen, Perplas Medical UHMWPE Processing
Techniques and Problems, (paper presented at
UHMWPE meeting, University of Torino, Italy,
September 19, 2003).
3. MB Turell et al., New Processes to Improve the
Mechanical Performance of UHMWPE, (Harvard
Medical School, March 18, 2005, presented at
UHMWPE meeting, University of Torino).
4. P Bracco, Stabilisation of UHMWPE with Vita-
min E Chemical Mechanisms, (paper presented at
Fourth UHMWPE International Meeting, 2009).
Robert Boland is sales director at Law-
ton Machinery Group (De Pere, WI).
Hot Plate Heater
Vacuum Seal
Bronze Gib
Figure 1. By using a double-daylight vacuum press, manufacturers can press two molds and
double their output.
ORT1109 023 23 9/27/11 3:48:27 PM
Intellectual Property
To weather the patent storm, orthopaedic device companies must
carefully navigate a new world of patent reform and build a strategic
patent portfolio.
DAVID J. DYKEMAN AND DANIELLE T. ABRAMSON, PHD
T
he orthopaedic device industry
has flourished in recent years
with the orthopaedics market
slated to produce more than $4.6 bil-
lion in revenue by 2015.
1
Orthopaedic
devices are typically categorized into
diagnostic, prosthetic, and surgical cat-
egories. This industry boom is largely a
response to the increase in healthcare
issues facing Americas aging popula-
tion. Currently, 40.3 million Ameri-
cans are over the age of 65, and this
number will nearly double by 2030.
2

Seniors are the primary patients in
need of reconstructive products such as
hip and knee replacements. Given the
shifting population dynamics and the
ensuing health problems, the orthopae-
dics industry is pressured to advance
technology that can diagnose and treat
age-related orthopaedic conditions.
In addition, the need for minimally
invasive surgical devices has recently
skyrocketed, leading to the develop-
ment of innovative devices and new
surgical methods.
Patents are the currency of the
orthopaedics industry. In order to sur-
vive, orthopaedic device companies
must distinguish themselves from their
competitors through their intellectual
property (IP) portfolios. These patent
portfolios are the key to success. They
should embody a well-reasoned busi-
ness strategy in which each patent is a
single building block in a larger portfo-
lio that refects present and future busi-
ness objectives. A strong patent port-
folio is also important in the current
orthopaedic device investment climate.
Venture capital funding often depends
on whether a company has secured its
IP assets, which validates a companys
technology and demonstrates its com-
mercial potential. Although building
and maintaining a strong patent port-
folio is important for all orthopaedic
device companies, it is most critical
for start-up frms. Patent portfolios are
often the driving force for major events
in the life cycle of an orthopaedic de-
vice company, including mergers and
acquisitions, public offerings, venture
capital investment, strategic collabora-
tions, joint ventures, and litigation.
There have been recent measures
taken by Congress, the U.S. Patent and
Trademark Office (USPTO), and the
Supreme Court to reform the current
Patent Reform: Navigating
the Changing Patent
Landscape
B
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c
k
g
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o
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n
d
:

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i
n
t

S
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/
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:

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i
c
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S
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.
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ORT1109 024 24 9/27/11 3:49:38 PM
www.MDEAwards.com
VISIT OUR WEB SITE FOR COMPLETE INFORMATION.
Transforming Healthcare
One Innovation at a Time
PRESENTED BY:
ENDORSED BY:
2
0
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1
2
Early-bird Deadline
:
November 14, 2011 (Discounted Fee)
Standard Deadline
:
December 9, 2011
ORT1109 025 25 9/27/11 3:49:46 PM
patent system. Orthopaedic device
companies must respond with strong
patent strategies that take these new
reforms into account while establish-
ing a competitive edge in the market.
Such comprehensive technology strate-
gies must maximize patent coverage of
a companys current core technology
and future improvements, monitor the
patent landscape, and explore ways
to patent white space, while also con-
sidering crosslicensing opportunities
with competitors. Companies will then
be able to withstand patent reform
and ensure their success in todays
competitive and rapidly changing IP
environment.
Congress Passes
Major Patent Reform
Major changes to the U.S. patent sys-
tem are brewing, with Congresss patent
reform legislation, the USPTOs pro-
posed changes in patent examination
processes, and the Supreme Courts is-
suance of far-reaching opinions. These
changes will affect how orthopaedic
device companies develop and manage
their patent portfolios.
After years of anticipation, President
Obama signed the America Invents Act
into law on September 16, 2011. This is
the frst major legislative change to the
U.S. patent system since 1952.
The most signifcant changes include
switching the U.S. patent system from a
frst-to-invent to a frst-inventor-to-fle
system and introducing postgrant op-
position review. These changes, slated
to become effective 18 months and 12
months after enactment, respectively,
will dramatically affect current pat-
ent fling strategies in the orthopaedic
device industry. For example, the frst-
inventor-to-fle rule will cause inven-
tors to err on the side of fling strong
provisional applications as quickly as
possible. As a result, inventors may end
up prematurely fling patent applica-
tions, before they understand the full
capabilities of an innovative technol-
ogy. Inventors will also need to write
more detailed patent applications, to
minimize opportunities for third parties
to block improvement patents. Further-
more, eliminating the much reliedupon
one-year grace period under the current
frst-to-invent system may hamper the
natural scientifc review process, where
ideas are shared and discussed by col-
leagues, particularly in university and
research settings.
Meanwhile, the postgrant patent
opposition review will increase the
number of challenges to patents based
on both novelty and obviousness
grounds. Orthopaedic device compa-
nies should monitor the issued patents
of key competitors to determine if they
want to challenge their competitors
patents. This change favors major
medical technology players that have
resources to challenge patents in an
increasingly complex and time-con-
suming process. Orthopaedic device
companies must carefully adjust to
these congressional reforms to main-
tain a strong patent portfolio that
protects their core technology.

U.S. Patent Office Proposes
New Rules
According to data from the USPTO, the
current backlog of unexamined patent
applications is at nearly 700,000.
3
As
a result, the average processing time,
from fling an application to receiv-
ing a frst USPTO action, is at least
two years. Further, it takes more than
three years, on average, for a patent to
be issued. In an effort to reduce this
logjam, the USPTO is advancing its
own patent reform by proposing new
programs that could lead to faster pat-
ent allowances.
First, the USPTO has implemented
an accelerated examination program
to address the lengthy turnaround pro-
cess regarding the allowance or denial
of patent applications. Accelerated ex-
amination promises that final deci-
sions on patentability will be rendered
within 12 months of fling. A quicker
turnaround time not only allows in-
ventors to protect their products from
infringement, but also attracts inves-
tors who want the certainty of an is-
sued patent.
Another USPTO program designed
to facilitate the patent process is the
Full First Action Interview Pilot Pro-
gram. An expansion of earlier success-
ful examiner interview programs, the
program includes all technology areas,
including classes that cover diagnostic,
prosthetic, and surgical devices. Under
this program, applicants have the right
to an interview with the patent exam-
iner before the frst offce action on the
merits in a utility patent application.
This interview resolves patentability
issues at the beginning of the process,
thereby advancing prosecution of a
patent application. The program is
scheduled to run through May 16,
2012 and may be extended.
Finally, the USPTO has joined the
Patent Prosecution Highway (PPH), an
international program that speeds up
examination by relying on prosecution
in a corresponding foreign applica-
tion filed in one of 15 participating
countries, including Canada, Austra-
lia, those represented by the Euro-
pean Patent Office, and Japan. The
PPH reduces time spent on examina-
tion because patent examiners reuse
the search strategies of their foreign
counterparts. The PPH also shortens
the wait time prior to examination.
A granted PPH request will result in
patent applications being examined
within two to three months, accord-
ing to the USPTO. Once examined,
PPH patent applications enjoy a sur-
prisingly high allowance ratemore
than 90% of PPH cases are allowed,
compared to only 50% of standard,
non-PPH cases.
4
In an industry where a well-developed
IP portfolio is indicative of success,
In order to survive, orthopaedics
companies must distinguish
themselves from their competitors
through their IP portfolios.
Dykeman
ORT1109 026 26 9/27/11 3:49:50 PM
orthopaedic device companies should
take advantage of the USPTOs pro-
grams to expedite patent prosecution.
Doing so allows a company to estab-
lish a strong patent portfolio that re-
fects current innovation and industry
developments.
The Supreme Court Weighs In
The U.S. Supreme Court recently issued
far-reaching opinions that affect pat-
ent prosecution and licensing strategy.
In 2007, it ruled on one of the most
challenging questions in patent law:
what makes an invention obvious
and thus unworthy of a patent? In
KSR International Co. v. Telefex, the
Supreme Court affrmed the invalidity
of Telefexs U.S. patent no. 6,237,565.
5

The Court found that the patent claim
merely combined obvious elements in
the prior art and rejected a narrow
application of the teaching, sugges-
tion, or motivation test for assessing
obviousness. KSR particularly affects
orthopaedic device companies whose
products tend to comprise incremental
improvements and combine established
devices and techniques. It may bar their
patentability and characterize them
as predictable variations of already
existing art and devices. To survive
obviousness challenges post-KSR, pat-
ents should clearly state the products
new features, discuss the challenges of
altering the design of the product, and
identify how its combining features are
not predictable in light of prior art.
The Supreme Court addressed the
patent eligibility of a process in Bilski
v. Kappos, one of the most anticipated
U.S. Supreme Court decisions of 2010.
6

Although the claims of the Bilski U.S.
patent application relate to fnancial
services, the Supreme Courts inter-
pretation in Bilski of the machine or
transformation test is applicable to
the patentability of medical diagnostic
and personalized medicine methods.
The Bilski decision states that the ma-
chine or transformation test is not the
sole test for determining the patent
eligibility of a process, but rather a
useful and important clue or tool for
investigation.
After the Bilski decision, the Su-
preme Court granted judicial review,
vacated the decisions of the U.S. Court
of Appeals for the Federal Circuit, and
remanded to the federal circuit for re-
consideration two cases related to med-
ical diagnostics: Prometheus Laborato-
ries Inc. v. Mayo Collaborative Services
and Classen Immunotherapies Inc. v.
Biogen Idec. In Prometheus, the patent
claims were again found patentable
under the machine or transformation
test. In Classen, an opposite decision
was issued in which two of the three
Classen patents were patent-eligible,
while one patent was not. Previously,
all three patents at issue in Classen
were held invalid. Thus, medical device
companies must work closely with
their patent counsel to draft patent
claims that conform to the decision in
Bilski and its aftermath.
These Supreme Court rulings in-
dicate a trend in recent years of the
Courts willingness to address perceived
problems in the U.S. patent system. To
build and maintain a strong patent
portfolio, orthopaedic device compa-
nies will need to implement patent
strategies that account for these major
Supreme Court decisions.
Protecting Core Technology
Developing a strategic patent portfolio
that addresses Congresss reforms and
the frst-inventor-to-fle rule means es-
tablishing patent protection for a com-
panys core technology. One or more
patent applications should be filed
providing the broadest possible patent
protection covering the core technol-
ogy. When drafting patent applications,
an orthopaedic device company should
teach current and future technology
innovations, as well as alternative em-
bodiments that competitors may at-
tempt to design around the companys
core technology. Where applicable,
patent claims should be directed at
diagnostic, surgical, prosthetic, and
combination devices; kits; methods of
manufacturing, treatment, or use; and
any other aspects of the invention. As
the core technology evolves, incremen-
tal improvements should be patented to
form a picket fence of protection.
Another key to broad patent protec-
tion is an offensive strategy that pre-
vents competitors from infringing on
(making, using, or selling) a companys
invention. Companies need to patent
aggressivelythey need to fle quickly
and frequently. Filing aggressively en-
sures that a company will claim own-
ership of the technology frst and can
block competitors by fling patent ap-
plications that cover improvements to
a competitors product to effectively
limit product enhancement options.
Meanwhile, companies should monitor
their competitors portfolios to identify
potential patent infringement.
Filing international patent appli-
cations further strengthens a patent
portfolio by expanding a companys
presence in the global marketplace. A
company should consider fling in spe-
cifc countries with a large target mar-
ket for the productcountries where
competitors manufacturing facilities
are located and countries that export
products to other countries through
channels of distribution. Having pat-
ents in these countries will protect the
company against potential infringers
around the world.
Finally, a company should conduct
frequent audits of its patent portfolio
to ensure its patent strategy adapts to
Building a Patent
Portfolio to Endure
Change
Devel opi ng and mai ntai ni ng a
strong patent portfolio is critical to
an orthopaedic device companys
growth and survival. Given the re-
cent furry of patent reform mea-
sures initiated by Congress, the
USPTO, and the Supreme Court, or-
thopaedic device companies must
effectively address reform through
a three-pronged approach:
Filing strong patent applications
to protect a companys current
core technology and future
improvements.
Monitoring the patent landscape
and exploring ways to patent
white space.
Considering crosslicensing
opportunities.
ORT1109 027 27 9/27/11 3:49:54 PM
changes in the legal landscape and the
marketplace. A patent audit allows a
company to assess strengths, weak-
nesses, and gaps in its patent portfolio
and identify opportunities to enforce
patents against competitors. Conduct-
ing periodic patent audits ensures that
a companys patent portfolio achieves
broad and cost-effective coverage of its
discoveries.

Finding Freedom to Operate to
Patent White Space
Exploring white space is another
method for obtaining a strong patent
portfolio. The amount of white space
measures the crowding of a particular
technology area with patents and pat-
ent applications. If the patent landscape
is relatively clear, there is room to stake
meaningful new patent claims. Given
the USPTOs recent programs to ad-
dress the patent application backlog
and provide accelerated examination
procedures, companies pursue patent
applications in clear patent landscapes
before they become crowded with com-
petitor patents.
Before patenting white space, a com-
pany should undertake a freedom-to-
operate analysis to avoid infringing on
patents owned by third parties. After
conducting a thorough search of patent
and scientifc literature databases and
identifying third-party patents, a com-
pany should maximize its patent pres-
ence within that particular commercial
area. It can accomplish this by identi-
fying potential patent design-around
opportunities that a competitor might
use and blocking these opportunities
by seeking new patents or modifying
current patent applications.
Combination products and therapies
provide another means of exploring
white space and anticipating industry
developments. A combination prod-
uct pairs biologics, drugs, and medi-
cal devices to provide a targeted and
specialized treatment that minimizes
side effects. Examples of combination
products in orthopaedics include bone
fracture fxation devices combined with
an antiinfection coating and implants
combined with bone growth factors.
To avoid issues regarding ownership
of combination products (one company
may claim ownership of a device and
another company may claim ownership
of a drug or biologic), patent rights can
be assigned either entirely to one party
or jointly between the parties. Or, an
exclusive or nonexclusive license may
be established among the companies.

Crosslicenses and Competition
Crosslicensing with competitors is an-
other way to bolster a patent portfolio
and address challenges to the patent-
ing system.
7
A crosslicense is a mutual
sharing of patents between compa-
nies without exchanging a license fee.
Companies enter into crosslicenses
when they have overlapping patents,
and practicing one patent would mean
infringing on another. The companies
pool the relevant patents together
and divide the patent rights amongst
themselves so that each party takes
exclusive or nonexclusive rights to a
particular area of use covered by the
combined patents. A crosslicense is also
accompanied by a promise not to sue.
Therefore, each party in the agreement
can practice its patent rights without
infringing on anothers, thereby avoid-
ing expensive and time-consuming pat-
ent litigation.
Crosslicensing agreements are in-
creasingly important given a recent
rise in patent infringement cases in the
orthopaedic device industry, especially
among key industry players. To counter
this trend in court filings and avoid
costly litigation, companies should
consider crosslicensing strategies with
competitors to further bolster and pro-
tect their patent portfolios.

Conclusion
Orthopaedic device companies must
build and maintain high-value patent
portfolios to be successful in todays
competitive and rapidly changing pat-
ent environment. These patent portfo-
lios face numerous challenges in the
patent reform storm from Congress,
the USPTO, and the Supreme Court.
By aggressively protecting core tech-
nology, optimizing the patenting of
white space, and seeking crosslicensing
opportunities with competitors, ortho-
paedic device companies can achieve a
strong patent portfolio. This will secure
a companys competitive advantage in
the marketplace by maximizing patent
protection, securing funding, enhanc-
ing revenue, and increasing marketing
value. It will also be broad and fexible
enough to withstand the changing pat-
ent landscape.

References
1. US Orthopaedics Extremity Market to Grow to
$4.6 Billion by 2015, Millenium Research Group
Inc., January 17, 2011.
2. The Demographics of Aging Transgenera-
tional Design Matters (2009); available from
Internet: http://transgenerational.org/aging/
demographics.htm.
3. B Stoll, First Office Action Backlog Dips Be-
low 700,000, USPTO Directors Forum: David
Kappos Public Blog (July 12, 2011); available
from Internet: www.uspto.gov/blog/director/entry/
frst_offce_action_backlog_dips.
4. USPTO, PPH-Fast Track Examination of Ap-
plications, PPH Brochure; available from In-
ternet: www.uspto.gov/patents/init_events/pph/
pphbrochure.pdf.
5. KSR International Co. v. Teleflex, 550 U.S. 398,
127 S.Ct. 1727 (2007).
6. Bilski v. Kappos, 130 S. Ct. 3218, 561 U.S. __
(2010).
7. S Qualters, Cross-Licenses Grow; Legal Work
Follows, The National Law Journal 29, No. 36
(May 14, 2007).
David J. Dykeman is a patent attor-
ney and cochair of the IP department
at Greenberg Traurig LLP (Boston).
Danielle T. Abramson, PhD is a patent
agent at the frms offce in Florham
Park, NJ.
Abramson
Conducting periodic patent audits
ensures that a companys patent
portfolio achieves broad and cost-
effective coverage of its discoveries.
ORT1109 028 28 9/27/11 3:49:57 PM
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Testing
Effcient test protocols remove excess cost and complexity from the
product design equation.
DANIEL SANTOS
Test Protocols: Accelerate
the Process and Keep
Customers Happy
C
reating effective test protocols
can pose many challenges for
medical device design engineers.
Its critical to establish test protocols
that verify a device will operate safely
and reliably from its frst through its
1000th use. However, in the competi-
tive world of medical devices, speed
to market is important. Test protocols
must consider a devices entire life
cycle in the shortest amount of time
possible.
Determi ni ng whi ch tests wi l l
accelerate design evaluation, analy-
sis, and verifcation can make a design
engineers head spin. Overthinking
the parameters can delay product
release and result in added cost for
the customer. Taking short cuts with
certain tests can lead to failures late
in the process, requiring the team to
start overor worse, it can lead to
failures in the feld.
However, creating test protocols
that verify and validate that a device
meets a customers specifcations and
performance requirements doesnt
have to be as complex and costly
as it might seem. This article dis-
cusses tips and insights that can help
design teams avoid unnecessary test-
ing, shorten the development process,
prevent nonessential spending, and,
most importantly, increase customers
satisfaction by meeting their needs.
Customer and Crossfunctional
Collaboration
How a medical device company applies
its process to designing, developing, and
manufacturing an orthopaedic device
greatly affects the accuracy and effec-
tiveness of test protocols.
Firms will often assemble key
peopleespecially those involved in
testingin the same room at a kick-
off meeting with the customer. At this
stage, variables that affect the design
should be explained.
For example, after its clear where
the product will be released (i.e., the
United States or Europe), the regu-
latory affairs and quality assurance
(RA-QA) team can offer insight on
relevant sterilization parameters. The
procurement group might have unique
knowledge about what materials are
available, and the manufacturing team
can give input as to whether the compo-
nents, dimensions, and materials being
considered will withstand high produc-
tion levels. Without the early collabora-
tion between all involved departments,
it is diffcult for a design engineer to
create expeditious and comprehensive
test protocols that account for these
diverse variables.
Siloed processes whereby phases of
the project are handed off from one
department to another (i.e., business
development to design engineering to
RA-QA) tend to limit the scope and
Solving a Rubiks cube is
a good example of design
of experiment. To align
all the colors, you must
factor in how multiple
variables interact and
affect one another.
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ORT1109 030 30 9/27/11 4:04:21 PM
effectiveness of test protocols. For ex-
ample, if design engineers dont know
the orthopaedic device will be released
in Europe, they arent likely to take
higher pH levels into account during
the design or testing of that parameter.
As a result, the device could fail in the
feld or during clinical trials, requiring
design engineers to start from the begin-
ning of the process. In such case, time-
lines are pushed back, costs increase,
and customers are left unhappy.
Had the RA-QA group been present
during the design and testing process, it
could have given the engineers impor-
tant insight about the types of steriliza-
tions required or performed in Europe.
More upfront testing could have been
done, resulting in nominal design issues
later in the project. Early communica-
tion, comprehension, and collaboration
about what the customer wants among
all departments can signifcantly reduce
cost, time delays, redundancies, and
failures in testing, and minimize cus-
tomer frustrations.
Understand Application and
Environment
In addition to bringing crossfunctional
team members together at the begin-
ning of a project, it is important to
understand how an orthopaedic device
will be used in all aspects of a surgical
procedure. This greatly infuences which
test protocols are established.
If how a device will be operated and
handled is unclear to a design engineer,
many important parameters will be
overlooked in the testing process. For
instance, if limited knowledge leads a
designer to mistakenly think that a de-
vice will be turned on and off and then
placed directly into an autoclave for ster-
ilization, test protocols are more likely to
refect only those limited parameters
especially if timelines are tight.
However, if that design engineer
had continuously communicated with
the customerfrom the beginning of
the project onwardthey would have
learned the full extent of the intended
sterilization process, which in this case
is much harsher. Rather than simply be-
ing sterilized after the device is turned
off, it is frst handed to a nurse or surgi-
cal technician who rinses it with water,
Siloed processes whereby phases of the
project are handed off from one department
to another tend to limit the scope and
effectiveness of test protocols.
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ORT1109 031 31 9/30/11 1:54:39 PM
Testing
scrubs it with a brush, dips it into a
cleaning chemical, and then puts it into
the autoclave. Having full knowledge
of how the device will be used early on
enables design engineers to create rigor-
ous test protocols that accurately verify
and validate safety factors. Customers
should divulge how an orthopaedic de-
vice will be handled, along with any po-
tential misuses that can result in failure,
because engineers cant always decipher
such factors on their own.

Align Customer Wants and
Needs
More often than not, customers come
to medical device manufacturers with
a vague idea of what they want and
need from their orthopaedic device.
They may need their device to contain a
motor with 60 in.-oz of torque, but they
want it to be the size of a highlighter.
Because test protocols are only as good
as the customer specifcations, the de-
sign team and the customer must be on
the same page as to what the customer
wants and what they actually need.
Without clear and detailed specifca-
tions, protocols can miss the mark for
performance, safety, functionality, and
reliability testing.
An effective strategy to ensure cus-
tomer needs are established before the
design and test protocols are developed
is to create a functional prototypea
bare bones, primitive model of what
the customer is requestingwhile still
in the feasibility stage. If the manufac-
turer has the capability, it can create this
mock-up in-house. If not, leveraging the
resources of the production foor or an
outside prototype house is worth the
effort because this preliminary model
ultimately saves time and money.
Returning to the motor example, the
design engineer may intrinsically know
it isnt feasible for a highlighter-sized
orthopaedic device to generate 60 in.-oz
of torque and may be overkill, consid-
ering what the customer really needs.
However, providing the customer with a
rudimentary sample that demonstrates
why alternatives must be considered is
often more effective than just dismissing
the request out of hand. If the customer
can see and feel that the device must be
the circumference of a baseball to meet
their power requirement, theyre more
likely to compromise between what
they want and what they need.
The sooner the customer and manu-
facturer can nail down feasible product
parameters, the faster the engineer can
design the device and focus on testing
variables.
Understand Variables
Associated with Design of
Experiment
Design of experiment (DOE) is a sta-
tistical tool for creating effective and
efficient test protocols. It takes into
account multiple variables simultane-
ously before test protocols are actually
written and carried out. It is important
to use DOE during process validation.
In DOE all the factors of interest can be
investigated in a single trial, minimizing
the size of the experimental schedule re-
quired and providing information on key
process interactions...This latter aspect is
of importance since optimal conditions
may occur when one factor is high and
another low. This type of information on
interactions between factors cannot be
easily obtained by investigating the effect
of each factor separately.
A DOE approach permits efficient use of
resources (personnel time, machine time,
materials, etc.), provides detailed analysis,
gives information on reproducibility and
errors, and provides a predictive capabil-
ity...Applying DOE reduces the size and
hence the cost of process validation trials.
It is a regulatory requirement to run suf-
ficient trials to demonstrate the statistical
significance of results, and DOE can assist
in this procedural aspect.
1
Device and process specifications

must be established before a piece of
equipment can be validated because
this information is used to write the
protocol.
2
Table I illustrates an example of
DOE process limits for how a sealant in
an orthopaedic bone drill might hold up
in an autoclave. This DOE process gives
a design engineer a holistic understand-
ing of how multiple variables interact
with each another in an autoclave envi-
ronment. Evaluating multiple variables
at the same time (rather than evaluating
one variable at a time while all others
are held constant) reduces the number
of iterations required, which accelerates
the design and development process.
Balance Functional Testing and
Sterilization Testing
It is both an art and a science to en-
sure youve adequately tested a devices
functionality and its ability to withstand
harsh sterilization environments. Con-
ducting sterilization tests between every
functional test takes time, and thats
something many medical device makers
cant afford. To accelerate the process,
many testers separate functional and
sterilization testing methods, which,
unfortunately, causes many important
variables to be disregarded.
For example, some testers might
verify that an orthopaedic handpiece
meets autoclave testing standards, but
they wont run its duty cycle. Sterilizing
the device hundreds of times without
running it doesnt test the functionality
of the handpiece. The seals are essen-
tially being tested over and over again
without being subjected to the rigors
of regular use, which is an unlikely
scenario in the feld.
On the other hand, some may test
device functionality by running it 500
times to ensure that the motor, seals,
and internal components are work-
ing properly without testing its abil-
ity to withstand sterilization. If they
arent running the device through an
autoclave, its not being exposed to
moisture as it would in a real-world
application.
In fairness, there is no single easy
answer that balances these two im-
portant testing needs. It helps to have
experience conducting other tests and
FACTOR
LOW
LEVEL
HIGH
LEVEL
Temperature
(C)
115 135
Time (min) 5 20
Pressure (psi) 20 60
Table I. The high and low limits for
temperature, time, and pressure of the
autoclave are hypothetical examples for
these ranges. The levels of each factor
selected are based on knowledge of the
system being tested.
ORT1109 032 32 9/27/11 4:04:24 PM
verifying past failures because there
are some similarities in how certain
variables in each handpiece interact.
However, if historic data or previous
experience is lacking, it is important to
at least do the following:
Clearly understand how the device

will be used in the feld.
Conduct component level testing and

subsystem testing early.
As noted previously, understand-
ing the operation and handling of an
orthopaedic device makes it easier to
set up test protocols that replicate the
conditions of actual feld usage. You
can run a motor all day, not stopping
until it burns up (fails), but if thats not
how it will be used in the feld, youre
wasting valuable testing time and caus-
ing unrealistic failures. However, if
you conduct a test that closely mimics
feld usage, verifes that the device lasts
through all testing cycles, and verifes
that the device will cause no unintend-
ed consequences, youve determined a
good testing protocol framework.
It is crucial to conduct component
and subsystem-level testing. These
tests should be started early in the
development phaseslong before a
product is completed. Component-
level testing analyzes individual as-
pects of the device. For example, it
can involve testing a shaft to verify
that it meets strength requirements,
testing gear teeth to ensure they can
withstand torque load, or analyzing
material properties to assess how they
withstand high pH levels.
After verifying that individual com-
ponents will survive real-world use,
subsystem testing can begin. Subsystem
tests bring different components togeth-
er to evaluate how they interact. Take
the example of a motor. You would test
the motor separately before putting it
into a system to determine its limits
and ensure that it functions properly.
Testing the motor frst reduces unin-
tended consequences that could make
the entire handpiece fail in later testing
phases. Once the motor is tested using
realistic testing parameters, add another
variable, such as the cable, to see how
the two interact. If these two variables
interact successfully, the next step is to
add other handpiece components or
subsystems to the test. This process can
make it easy to pinpoint failures. After
youve determined that the motor and
cable tested well together, you know
any issue or a failure must be caused
by an interaction between other com-
ponents or subsystems.
Subsystem testing is a key part of
product design. Verifying that each
subsystem can handle the rigors of the
feld eliminates much of the variable
testing later on, further accelerating the
speed of reliability testing.
Recreate Realistic Usage
Environments In-House
Another way to accelerate reliability
testing is to create a real-world, real-
time testing environment in-house. This
method provides more control over
how a device is tested. Testers have the
ability to see how the orthopaedic de-
vice is tested, hear how it sounds, and
experience how different variables are
interacting.
This in-house environment might
include dishwashers for pH testing,
machines for autoclaving, a simulated
cadaver lab to test bone density, and a
prototype shop to quickly create func-
tional prototypes. If a design engineer
doesnt have adequate in-house capa-
bilities to test components and subsys-
tems, its diffcult to recreate realistic
applications. They must rely on the
material specificationshoping they
are corrector farm out tests to verify
failures, gaining little understanding of
why the failures occurred.
In addition to keeping the whole
testing process under one roof, devel-
oping proprietary testing equipment
specific to the orthopaedic medical
device helps create an authentic test-
ing environment. Equipment that isnt
specifc to the device often wont pro-
vide an accurate prediction as to how
the device will hold up in the feld. For
example, using an oven to replicate the
autoclave temperature thermal cycling,
which reduces testing time, may seem
adequate. In actuality, the lack of steam
and pressure cycling eliminates crucial
variables that the device will likely
encounter in the feld.
Proprietary testing equipment can
also save a lot of time compared with
manual testing. For example, creat-
ing an automated panel system to test
multiple orthopaedic surgical drills
eliminates the need for an operator
and increases a manufacturers ability
to test more than one unit at a time. De-
veloping proprietary testing equipment
to mimic operative handling enables
the manufacturers to meet the strictest
customer specifcations.
Conclusion
Theres no one-size-fits-all approach
to creating effective, proprietary test
protocols, especially when it comes to
accelerating reliability testing. How-
ever, overlooking key fundamentals will
delay processes. The most important
starting point is to ensure all individu-
als involved in testing or testing-related
activities are on the same page and
understand the customers parameters
and the devices intended feld use. This
makes developing accurate, legitimate
test protocols an intriguing process of
discovery, rather than one of uncer-
tainty and adversity.
References
1. D Dixon et al., Application of Design of Experi-
ment (DOE) Techniques to Process Validation in
Medical Device Manufacture, Journal of Valida-
tion Technology 12, no 2 (2006).
2. GHTF/SG3/N99-10:2004 Edition 2, (PDF)
Quality Management SystemsProcess Vali-
dation Guidance.
Daniel Santos is engineering manager
at Pro-Dex Inc. (Irvine, CA).
The design team and the customer must be
on the same page as to what the customer
wants and what they actually need.
ORT1109 033 33 9/27/11 4:04:28 PM
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Another performance attribute is its processability.
Solvay Specialty Polymers
Houston, TX, 713/525-6000
www.solvayplastics.com
Swiss Clamp System
A Swiss clamp system is used with machine tools in the
manufacture of orthopaedic instruments and
components, including bone screws and implants. The
EZR Swiss Clamp System ensures increased torque
by achieving proper settings and enables fast, positive
ER collet clamping. It
eliminates wrench slippage
and prevents the loss
of clamping nuts in the
machine sump-chin bin.
Operators hands are
kept clear of the sharp
tools in the tooling zone.
The system also prevents
accidental breakage
of ID microtooling. The
Swiss clamp nuts can be
tightened using standard
box wrenches or a
3
8-in.
drive ratchet wrench with the EZR wrench adaptor or the
EZR torque adaptor. Both adaptors engage and lock to the
clamping nut with a specialized cam system on the face,
delivering positive torque to the nut.
Genevieve Swiss Industries, Inc.
Westeld, MA, 413/562-4800
www.genswiss.com
Machining Vise
A company is replacing a currently avail-
able model of machining vise with an
upgraded version of an older model. The D688
features an 8.8-in. jaw opening and repeatability to
within 0.001 in. It is replacing the D675. The new
model produces up to 7968 lb of clamping force with
80 ftlbf input torque. The D688 has a jaw capacity
that is 25% greater than that of the D675 model, and
its clamping torque is greater by 36%. The distance
from the keyway to the stationary jaw is identical in the
two models, so they can be easily aligned on a vise
table. The vise is designed with an alloy steel screw
mechanism and high-precision roller bearings. The
vise has a porosity-free ductile iron body, which is
designed to provide overall vise rigidity while absorbing
machining vibration.
Kurt Manufacturing Co.
Minneapolis, MN, 877/226-7823
www.kurtworkholding.com
Laser Ablation Machine
A five-axis laser ablation machine is designed for 3-D machining.
LaserSmart is suited for extra-fine 3-D laser machining of super-hard
materials, such as PCD and CBN. Surfaces do not have to be flat; the
machine can handle surfaces with an arbitrary geometry. It can be used to
apply logos and tool numbers to PCD, CBN, or CVD silicon carbide inserts.
Rollomatic Inc.
Mundelein, IL, 847/281-8550
www.rollomaticusa.com
ORT1109 034 34 9/27/11 3:51:27 PM
Grinder
A specialty grinder can be used to grind
multifaceted cannulae, trocars, and
other specialized surgical tools. Fanuc
CNC servo-programmable controls
enable the grinding of multiple axes.
They control profle and angle, as well
as the length and depth of cut and the
number of facets. The controller can
store individual programs for grinding
different products. Machine technicians
who know the g-code language used
by Fanuc machine controls can use the
grinder immediately. Operators are able
to quickly change the parameters of a
given program. Canned programs are
also provided.
Concep Machine Co.
Northbrook, IL, 847/498-9740
www.concepmachine.com
Blast Machine
A blast machine can clean substances
such as hydroxyapatite and titanium-
coating overspray from equipment
such as cup-and-stem implant fxture
masks, which can become encrusted
with coating when medical implants are
vacuum plasma sprayed. The Multiblast
RSB machine is ftted with a 14-station
planetary component drive and two
vertically traversing pressure-fed blast
nozzles. The objects to be cleaned are
manually loaded into component hold-
ers on the turntable, in the center of
the rubber-lined blast chamber. The
door is closed and the turntable begins
rotating clockwise, while the 14 com-
ponent holders rotate on their own
axes. The objects rotate at a controlled,
adjustable speed and are blasted from
the two blast nozzles, which vertically
traverse the component, aiming at a
prepositioned angle and from a prepo-
sitioned distance. After the blast cycle
is fnished, an integral air knife blows
the residual dust from the components.
The system is ftted with a PCL-HMI,
enabling full operational control over
all machine variables. A simple menu
system enables recipes to be entered and
recalled as needed.
Guyson International Ltd.
Skipton, North Yorkshire, UK
+44 1756 799911
www.guyson.co.uk
Online Bone Database
An online information resource covers
the properties of human bone. The Hu-
man Biological Materials data module
is part of an expanded materials infor-
mation system for orthopaedic device
designers and manufacturers. It can
help them make informed decisions
regarding the selection, substitution,
qualifcation, regulation, and biocom-
patibility of materials. The module is
an authoritative collation of data on the
mechanical properties of primary load-
bearing bones gathered from various
publications. It can serve as a reference
for a designer working on an implant-
able device that must complement or
mimic human body performance. In
its frst release, the searchable resource
presents the tensile, compressive, fexur-
al, and general properties of the femur,
tibia, vertebrae, and acetabulum.
Granta Design
Mason, OH, 800/241-1546
www.grantadesign.com
Optical Inspection System
Relying on the white-light axial chro-
matism technique, an automated op-
tical inspection system is capable of
stand-alone operation or in-line in-
tegration. Featuring a stage that can
move as fast as 1 m/sec, the HS100
provides both speed and resolution. At
maximum speed, the unit can measure
one point every 32 m. Scan rates range
from 31,000 points per second with
nanometer accuracy up to 324,000
points per second when a line sensor is
employed. The x-y measurement area is
IMPLANT COMPONENTS
Implantable Biomedical Fabrics
Custom implantable biomedical fabric structures made of Zeniva PEEK fber
are for OEM use in therapeutic devices that have applications in orthopae-
dics and general surgery. The PEEK material, manufactured in conditions
compliant with ISO 13485 and GMPs and tested in an accredited laboratory
compliant with ISO 17025, has a modulus similar to that of bone and exhib-
its good biocompatibility, toughness, and fatigue resistance. The fabrics for
implantable devices are woven, knitted, or braided from the fbers for use in
high-strength sutures; bone-anchoring devices; rotator cuff and arthroscopic
joint repair; spinal stabilization and disk repair and replacement; textile-based
heart valves and vascular grafts; and mesh structures for tissue reinforcement
and wound support in surgery. The PEEK is supplied by Solvay Advanced
Polymers through a partnership.
Secant Medical LLC
Perkasie, PA, 877/774-2835
www.secantmedical.com
ORT1109 035 35 9/27/11 3:51:46 PM
Products & Services
400 600 mm. The system features a
range of automated options for measur-
ing such surface characteristics as pro-
fle, dimension, roughness, shape and
form, flatness and planarity, volume
area, step-height depth, and thickness
values.
Nanovea Automated Optical Inspection
Irvine, CA, 866/333-4674
www.nanovea.com
Carbon-Fiber Composites
Exhibiting mechanical strength and
heat-distortion properties, thermoplas-
tic carbon-fber composites consist of
a thermoplastic matrix and a woven
fabric made of carbon-fber bundles. Ac-
cording to the manufacturer, the Tecatec-
series provides higher tensile and fexural
strength than fiber-reinforced extru-
dates. Supplied in standard plate thick-
nesses of 340 mm and in other dimen-
sions upon request, the lightweight,
chemical-resistant materials are also
radiolucent, making them suitable for
external fxation devices and surgical
instruments. One of the compositesa
PEEK-matrix polymer compressed with
laminated woven-carbon fabric mats
constituting 50% of the composite
provides torsional stiffness and resists
warping even after multiple sterilization
cycles. The other composite is a PEEK
matrix laminated with a 60%-carbon-
fiber fabric. Capable of undergoing
steam sterilization, this carbon-fiber
component ensures dimensional stabil-
ity and stiffness.
Ensinger Inc.
Washington, PA, 724/746-6050
www.ensinger.co.uk
Laser Processing and
Cable Assembly
A company partners with medical de-
vice OEMs to provide diverse laser
processing services, including laser
welding of stainless steel and titanium
components for bone screws. The ISO
13485:2003certified company of-
fers precision laser machining, cutting,
drilling, and welding of surgical imple-
ments and implantable devices from
many materials, including stainless
steel, titanium, platinum, borosilicate,
quartz, ceramic, and silicone. Lasers
incorporating the latest technology,
along with high-output production
equipment, enable the service provider
to concentrate on medical device ap-
plications involving small component
features and requiring high precision.
Laserage Technology Corp.
Waukegan, IL, 847/249-5900
www.laserage.com
Turning Center Software
A supplier of precision machine tools has
developed software for its line of turning
centers. CAMplete TruePath Turn-Mill
software is an integrated suite of g-code
editing, optimization, analysis, and veri-
fcation tools for use with Nakamura-
Tome multitasking turning centers. The
software can enable a range of turn and
mill functions. It was designed to com-
bine g-code from CAM systems and
hand-coded g-code into a set of programs
that could be simulated, fne-tuned, and
optimized using 3-D machine models.
Methods Machine Tools Inc.
Sudbury, MA, 978/443-5388
www.methodsmachine.com
Miniature Medical Parts
A contract medical device manufacturer
has acquired a Tornos 7 Swiss turn-
ing center to facilitate the machining
of miniature medical parts. Suited for
the high-precision machining of very
small surgical instrument and medical
implant components, the machine can
produce parts as small as 0.030 in. in
IMPLANT COMPONENTS
ePTFE Materials
Used to manufacture orthopaedic implant coverings, an ePTFE material is
chemically inert, hydrophobic, and gas permeable. Available in a range of
tubular diameters, lengths, and
wall thicknesses, the material is
suitable for a variety of implant-
able medical device applications.
In addition to displaying con-
formability, temperature stabil-
ity, and gas permeability, the
ePTFE material can be made
thin and strong using the com-
panys high-density microwall
technology. This process can
produce fat sheets with thick-
nesses as low as 0.1 mm.
Bard Peripheral Vascular OEM
Products
Tempe, AZ, 800/655-8722
www.bardpvoem.com
ORT1109 036 36 9/27/11 3:51:57 PM
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Comprehensive Project Acceleration
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ORT1109 037 37 9/27/11 3:52:16 PM
Products & Services
diameter and length, with tolerances
of 0.0002 in. As a Swiss machining
center, the system minimizes defection
and supports attainment of very close
dimensional tolerances by machining
the area of the part immediately adja-
cent to the collet. The Swiss machin-
ing center, according to the company,
enables the more precise and effcient
production of smaller parts than is pos-
sible with computer-aided machining.
This advantage can, in turn, translate
into higher-quality parts at a reduced
cost, according to the company.
MicroGroup Inc.
Medway, MA, 800/255-8823
www.microgroup.com
Modular Workholding
System
A modular workholding system uses
compact clamp, power clamp, and
microclamp technology to hold small
and midsize parts. The system, which
enables parts to be changed easily, is
designed for machining medical prod-
ucts. The clamping designs minimize
interference, ensuring machine spindles
have full access to the workpieces. Ep-
oxy mineral tombstones have the char-
acteristics of cast iron with the weight
of aluminum.
Triag
Allenwinden, Switzerland,
+41 41727 2727
www.triag.ch
Laser Welding Workstation
Capable of joystick-controlled deposit
welding and high-precision CNC-
controlled welding processes, a system
is equipped with functions to support
process validation for medical device
manufacturing. The Select laser weld-
ing workstation enables the observation
of crucial welding parameters, includ-
ing yielding gas monitoring, to ensure
process reliability.
Ron-Baasel Lasertech
Starnberg, Germany, +49 8151 7760
www.ron.com
Biomedical Materials
A company provides a range of biomed-
ical materials for minimally invasive de-
vices, orthopaedic implants, and surgi-
cal instruments. The frm also maintains
a cleanroom facility for developing
and manufacturing custom formula-
tions. These include PEEK compounds
for long-term implants and bioresorb-
able polymer compounds with such
additives as tricalcium phosphate and
hydroxyapatite.
Foster Corp.
Putnam, CT, 860/928-4102
www.putnamplastics.com
Precision Machining
A manufacturer is repositioning its
precision medical machining services
to include device design assistance,
prototype development, component
device validation, and volume precision
machining. The company specializes
in the process design and manufac-
ture of high-precision Swiss-machined
components. End-use products include
surgical tools and spine implants.
Marshall Manufacturing
Minneapolis, MN, 800/321-6727
www.marshallmfg.com
Lubricious Coating
Lubricious coatings can prevent medi-
cal devices from shedding wear parti-
cles inside patients bodies. Baymedix
CL 100 is a polymer coating that is
grown directly from a material sur-
face, enabling it to bond to a substrate
through strong covalent linkages. This
bond enhances the coatings durability
and its ability to resist particle genera-
tion. The company says the technology
gives its coating an advantage over
other lubricious coatings, like hydro-
philic coatings, which are weakened by
the water they absorb.
Bayer MaterialScience LLC
Pittsburgh, PA, 412/777-2000
www.baymedix.bayermaterialscience.com
Microabrasive Blasting
Platform
A microabrasive blasting platform
can fulfill the surface modification
and cleaning needs of medical device
manufacturers. ProCenter Plus is a
freestanding workstation and dust col-
lection unit in one platform. The con-
sole swiftly evacuates spent abrasive
from the blasters chamber, keeping the
work area clean. Unlike conventional
dust collectors that require frequent
cleanings, this HEPA flterequipped
unit can handle a large amount of
spent abrasive in its oversized stor-
age hopper without any infuence on
blasting performance. The system has
built-in silencers and features quiet
operation. Other design highlights in-
clude advanced downdraft technology
and a large, well-lit work chamber
to maximize operator comfort. ESD
control features and a magnifer are
also available.
Comco Inc.
Burbank, CA, 818/841-5500
www.comcoinc.com
ORT1109 038 38 9/27/11 3:52:20 PM
Supplier Beat
Recent news about suppliers to the orthopaedics industry.
OrthoWorx (Warsaw, IN),
an industry, community, and
education initiative promot-
ing the orthopaedic device
sector in the Warsaw region,
has hired David K. Floyd as
its CEO.
Formerly the president of
DePuy Orthopaedics (War-
saw), Floyd is also a founding
member of the OrthoWorx board of
directors, where he served until this past
April, and chaired the organizations
transportation and logistics initiative.
We are delighted that Da-
vid has agreed to join our or-
ganization as chief executive
offcer, Cheryl R. Blanchard,
chair of the OrthoWorx
board of directors, said in
a statement. Davids indus-
try experience as the global
head of a multi-billion dollar
orthopaedic enterprise, his
leadership in the creation and launch of
OrthoWorx, and his deep connections
to the Warsaw community make him
ideally suited for this position.
In addition to his tenure at DePuy
Orthopaedics, Floyd served as presi-
dent of Abbott Spine (Austin, TX),
president of Centerpulse Orthope-
dics (Austin), and president and CEO
of AxioMed Spine Corp. (Garfield
Heights, OH).
I am delighted to join OrthoWorx
and to be able to draw on my experi-
ences in leadership and in the ortho-
paedic industry in a different wayto
help the Warsaw region continue to
thrive as the orthopaedic capital of the
world, Floyd said in a statement.
OrthoWorx Taps Former DePuy
Executive for CEO Position
UL Expands
Capabilities with
Acquisitions
Product safety testing company UL (Camas, WA)
has acquired test laboratory MDT Medical Device
Testing (MDT; Ochsenhausen, Germany) and MD
Registration Support (MDRS; Ochsenhausen), an
advisory frm that helps medical device manufac-
turers achieve CE marking for their devices.
The acquisition is designed to enable UL to
reach more medical device manufacturers, in-
cluding makers of orthopaedic, ophthalmic, and
cardiovascular implantable devices.
The deepening of our service offerings will
put the UL brand in front of a wider variety of
customersincluding some of the biggest com-
panies in the medical and health feld, Anil Patel,
general manager of UL Health Sciences, said in a
statement. From sterile gauze and bandages to
more complex devices such as bone screws, contact
lenses, orthopaedic, dental, and other implantable
devices, ULs testing capabilities will help manu-
facturers develop products that will keep patients
healthy and mobile.
MDT and MDRS are joining ULs life and
health business unit and will expand its services,
including testing, to help medical device manufac-
turers improve the safety of their products.
Floyd
Marshall Manufacturing
Increases Services
Medical components manufacturer Marshall Manufacturing (Min-
neapolis) has broadened its service offerings to better serve OEMs
that have downsized their in-house engineering departments.
The company now offers in-
creased medical device design as-
sistance, prototype development,
component device validation,
and volume component preci-
sion machining.
Simply being a precision parts
manufacturer in todays medical
device industry is not enough,
Michael Burchill, president of
Marshall Manufacturing, said in
a statement. We will be mak-
ing more of our experience and
resources available to assist cus-
tomers with the development and
manufacturing of their products.
As the engineering outsourcing trend has grown, it has been a challenge
and opportunity for our talented staff to step up and play a greater role
in our medical customers innovation.
Marshall Manufacturing specializes in the design and manu-
facture of high-precision, Swiss-machined components; machined
needles; 2-D and 3-D contouring; and bending machined wire and
tubes. Its components are used in products including trocars, surgical
tools, and spine implants.
ORT1109 039 39 9/27/11 3:54:27 PM
Supplier Beat
University Purchases EOS Laser-Sintering System
eCustoms
Launches Service
for Export Law
Compliance
International trade services provider
eCustoms (Buffalo, NY) has added a
service to help orthopaedic device com-
panies comply with export laws gov-
erning restricted or denied parties. The
companys Easy List-Check service helps
clients achieve continuous compliance
without the use of IT resources or ad-
ditional employee training.
Few companies have people who
are trained in the complete ins and outs
of country-specifc trade regulations or
customs compliance, Jackson Wood,
eCustoms corporate business manager,
said in a statement. We wanted to make
it easy. Thats why weve created the
Easy List-Check service. It provides a
simple way for orthopaedic companies
to address their compliance needs.
Easy List-Check takes less than one
working day to implement, according
to the company. It provides eCustoms
with a list of names or companies to be
checked and creates a compliance report
summarizing the results of the review.
The process is protected by encryption
and security technology, and users are
charged per record. Easy List-Check can
be used on a regular basis to help compa-
nies maintain long-term compliance.
EOS (Krailing, Germany) has an-
nounced that the Centre for Additive
Layer Manufacturing (CALM) at the
University of Exeter in the United King-
dom has purchased one of its EOSINT
P800 laser-sintering systems.
With its ability to process tempera-
tures up to 385C, the EOSINT P800
can process high-performance poly-
mers, such as polyether ether ketone
(PEEK), a material used in medical im-
plants. The system, which is the frst of
its kind in the United Kingdom, will be
used to research applications across
industry and to provide services for
universities and companies, according
to a spokesman for the company.
Partnering with the University of
Exeter to provide additive manufactur-
ing facilities for the southwest of the UK
will further help to raise awareness for
a technology that is currently shifting
paradigms in design and manufactur-
ing, Hans J. Langer, founder and CEO
of EOS said in a statement. We are also
looking forward to expanding the use
of the PEEK material, which is being
processed on the P800, in the aerospace,
medical, and motorsports arena.
Millstone Medical Outsourcing
Hires VP of Operations
Precision Medical Technologies
to Expand Instrument Business
Precision Medical Technologies (War-
saw, IN), a contract manufacturer
specializing in spine, trauma, and
sport medicine devices, plans to open
a second facility in 2012.
The site will be an extension of the
companys instrument manufacturing
division. It will be located in Rome
City, IN, which the company owners
believe is a highly desirable location
from which to attract skilled machin-
ists and CNC programmers, accord-
ing to a press release.
The facility will feature at least $1
million in new equipment and is ex-
pected to create at least 10 new jobs.
Millstone Medical Outsourc-
ing (Fall River, MA), an out-
sourcing company serving or-
thopaedic OEMs, has named
Karl Neuberger vice president
of operations at its Memphis
facility.
Neuberger, who has served
in executive positions for vari-
ous companies, including a durable
medical equipment supplier, will be re-
sponsible for managing the facility, run-
ning programs, and ensuring effcient
loaner kit processing and distribution.
Karl is a veteran operations pro-
fessional, Chris Ramsden, Millstone
CEO, said in a statement. We are
excited to have his experience and
expertise in place as we grow to meet
the needs and expectations
of our customers. At Mill-
stone, we are committed to
continuous improvement,
and I am confdent that Karl
will help us maintain and
then exceed the high level of
quality with which we oper-
ate in Memphis.
Neubergers expertise includes devel-
oping and implementing programs, im-
proving sales and marketing, strength-
ening infrastructure, and streamlining
operations. He is charged with scaling
operations to meet the demands of
Millstones customers. Millstone pro-
vides inspection, cleanroom packaging,
loaner kit processing, and distribution
services for medical device OEMs.
Neuberger
ORT1109 040 40 9/27/11 3:54:34 PM
Contributors
Ad Index
Roger Posusta is senior marketing ap-
plications engineer in the stylus and op-
tical metrology business unit at Bruker
Nano Surfaces. Posusta has experience
in engineering, R&D, electronics, and
optical metrology. He has provided ex-
pert applications support for 3-D opti-
cal microscopy. Send him an e-mail at
roger.posusta@bruker-nano.com.
Pierfrancesco Robotti is responsible for scientifc market-
ing at Eurocoating (Italy), an international service vendor
that manufactures porous structures for bone integration.
Robotti has 15 years of experience working with orthopae-
dic companies. He received his MSc in biomedical engineer-
ing at Milan Polytechnic University, in Italy. Reach him at
francescorobotti@eurocoating.it.

Daniel Santos is the engineering man-
ager at Pro-Dex Inc. (Irvine, CA), which
designs, develops, and manufactures
surgical devices, components, and sub-
assemblies for leading medical device
OEMs. He has a masters degree in engi-
neering from UCLA, with specialization
in design and manufacturing. His previ-
ous experience includes design and development of various
types of orthopaedic and surgical devices. Contact him at
daniel.santos@pro-dex.com.
Danielle Abramson, PhD, is a registered
patent agent in the New Jersey offce
of Greenberg Traurig LLP. Abramsons
practice focuses primarily on patent
prosecution in the area of biomedical
sciences, with particular expertise in
orthopaedic devices, medical devices,
and pharmaceuticals. She received her
PhD in medical sciences from Brown University. E-mail her
at abramsond@gtlaw.com.
Robert Boland is the sales director for
Trinks Inc. (De Pere, WI), with respon-
sibility for both domestic and foreign
equipment sales. Boland has worked as a
consultative representative involved with
the sale of compression, transfer, and
injection molding machines to various
industries, including the medical indus-
try. He graduated from Temple University with a bachelors
degree in business administration. Reach him at rboland@
lmgpresses.com.
David Dykeman is cochair of the intellec-
tual property department in the Boston
offce of the law frm Greenberg Traurig
LLP. Dykemans practice focuses on se-
curing strategic worldwide intellectual
property protection for high-tech clients,
with particular expertise in orthopaedic
devices, medical devices, biotechnology,
and healthcare IT. He can be reached at dykemand@gtlaw.
com.
Leo Glass founded Surface Dynamics
(Chelsea, MI) after 23 years at APS Ma-
terials Inc., where he served as executive
vice president and vice president of sales
and marketing. During his time there, he
held various positions in sales, engineer-
ing, and regulatory management. Glass
has a bachelors degree in chemical en-
gineering from the University of Cincinnati. Get in touch
with him at lglass@sdbiocoatings.com.
Matt Novak is the marketing applica-
tions manager in the stylus and opti-
cal metrology business unit of Bruker
Nano Surfaces (Tucson, AZ). Novak
has 15 years of experience developing
metrology products and systems across
a range of applications, including opti-
cal inspection, surface characterization,
and thin flm flter characterization. He can be reached at
matt.novak@bruker-nano.com.
Lowell Inc...........................................................31
www.lowellinc.com
763/425-3355
Master Bond Inc. ................................................19
www.masterbond.com
201/343-8983
Orchid Orthopedic Solutions ... Inside Front Cover, 11
www.orchid-orthopedics.com
517/694-2300
Pro-Dex Inc. ......................................7, Back Cover
www.pro-dex.com
800/562-6204
Rsler ................................................................13
www.rosler.us
269/441-3000
Rush Machinery .................................................19
www.rushmachinery.com
800/929-3070
Tegra Medical ......................................................5
www.tegramedical.com
508/541-4200
ORT1109 041 41 9/30/11 1:55:06 PM
Ortho Scope
The pie chart shows the breakdown of net
sales for 2010, which reached $519 million.
During the second quarter, net sales
increased 4% over last years Q2.
A full profle of Wright Medical is at
orthotec.com/article/wright-medical-
profile
Online
Extremities
and Biologics
(International) 7%
Other
2%
Orthopaedic Reconstruction
(United States) 27%
Orthopaedic Reconstruction
(International) 32%
Extremities and
Biologics
(United States) 32%
N
e
t

S
a
l
e
s

(
$

m
i
l
l
i
o
n
s
)
133
132
131
130
129
128
127
Q2 2010 Q2 2011
126
Wright Medical Group Inc.
Leadership

Robert J. Palmisano, president and
CEO
Lance A. Berry, senior vice president

and CFO
Timothy E. Davis, Jr., senior vice

president, corporate development
William L. Griffin, senior vice presi-

dent, global operations
Karen L. Harris-Coleman, senior vice

president, sales and marketing, Ja-
pan, Latin America, and Pacifc Rim
Edward A. Steiger, senior vice presi-

dent, human resources
Eric A. Stookey, senior vice presi-

dent and chief commercial offcer
John T. Treace, senior vice president,

global marketing and U.S. sales
Highlights
September 2011: Names Robert J.

Palmisano president and CEO.
September 2011: Reaches agree-

ments with U.S. Attorneys Offce of
New Jersey and the OIG.
July 2011: Announces exclusive deal

with ArthoCare for foot and ankle
products.
April 2011: Appoints chairman David

D. Stevens as interim CEO following
the resignation of Gary Henley.
January 2011: Expands relation-

ship with Kinetic Concepts to sup-
ply Graftjacket regenerative tissue
matrix through December 2018 for
orthopaedics markets.
Focus Going Forward
Implement first phase of cost re-

structuring plan over the next nine
months.
Continue to strengthen compliance

program.
Transition from interim to permanent

senior management while operating
under the terms of the DPA and the
surveillance of the federal monitor.
With a solid portfolio and strong pipeline
of new products, the company is well
positioned for success.
ROBERT J. PALMISANO, president and CEO
I
n the span of just a few days, Wright Medical Group Inc. (Arlington, TN)
announced a cost-restructuring plan, extended its deferred prosecution agree-
ment (DPA), and named a new president and CEO. Its a lot to swallow for
a company that has seen one executive after another leave this year following a
scandal involving its compliance program.
The problems began in April with the abrupt resignation of then-CEO Gary
Henley, which came prior to a board meeting that planned to discuss managements
handling of the companys ongoing compliance program. The company also received
a letter from the U.S. Attorneys Offce for the District of New Jersey, stating that it
had knowingly violated provisions of the DPA. The scandal snowballed and led to
several executive resignations.
In September, the company announced a cost-restructuring plan in the hopes of
improving cash fow and shareholder value. The plan will cost between $25 million
and $30 million, with the frst phase occurring over the next nine months. As part
of the initiative, the company will lay off 80 employees, or 6% of its workforce.
Wright Medical also hopes that the steps it takes to improve operating effcien-
cies will boost the company to an adjusted earnings per share of about $0.05 to
$0.06 next year and about $0.08 thereafter. The company also agreed to extend
the terms of its DPA for 12 months.
The fnal twist came a day later with the appointment of Robert J. Palmisano
as the new company president and CEO. In recent months, we have taken many
positive steps to better position the company for success, including strengthening
our compliance program and implementing a plan to reduce operational costs,
said interim president and CEO David Stevens in a company statement. We be-
lieve Bob is the right person to continue building on this progress. The company
has temporarily suspended its sales and earnings outlook to allow Palmisano to
transition into his position. Maria Fontanazza
Trying to Right the Ship
ORT1109 042 42 9/27/11 3:55:56 PM
For information on exhibiting or attending, please visit
CanonMed.com
The Worlds Leading Project Acceleration
Resources for Medical Device Design
and Development
North and South America
Europe and Asia
MD&M Minneapolis
November 23, 2011
Minneapolis, MN
MD&M Online
When Face-to-Face
is Not an Option
East Edition:
December 1415, 2011
MD&M West
February 1416, 2012
Anaheim, CA

MD&M Texas
March 1415, 2012
Fort Worth, TX
MD&M East
May 2224, 2012
Philadelphia, PA
MD&M Chicago
June 1921, 2012
Chicago, IL
MD&M Brazil
June 2627, 2012
So Paulo, Brazil
MD&M Florida
March 67, 2013
Orlando, FL
MEDTEC Ireland
October 56, 2011
Cork, Ireland
MEDTEC India
October 1920, 2011
Mumbai, India
MEDTEC Southeast Asia
November 30
December 1, 2011
Penang, Malaysia
MEDTEC Europe
March 1315, 2012
Stuttgart, Germany
MEDTEC France
April 45, 2012
Lyon, France
MEDTEC Japan
April 1819, 2012
Yokohama, Japan
MEDTEC UK
May 2324, 2012
Birmingham, UK
MEDTEC China
September 2627, 2012
Shanghai, China
BIOMEDevice
December 67, 2011
San Jose, CA
BIOMEDevice
April 2526, 2012
Boston, MA
BIOMEDevice
February 1516, 2012
Paris, France
OrthoTec
June 67, 2012
Winona Lake (Warsaw), IN
OrthoTec Europe
Fall 2012
Zrich, Switzerland
Pharmapack
May 2223, 2012
Philadelphia, PA
Diagnostica North America
May 2224, 2012
Philadelphia, PA
MEDevice Spain
October 56, 2011
Barcelona, Spain
Pharmapack
February 1516, 2012
Paris, France
MEDevice San Diego
Fall 2012
San Diego, CA
ORT1109 043 43 9/27/11 3:56:04 PM
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ORT1109 044 44 9/27/11 3:56:08 PM

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Providing expert insight on orthopaedic technology, development, and manufacturing

Gary Henley, CEO.

Frank Bono, senior vice president and chief technology offcer.

Raymond Kolls, senior vice president, general counsel, and secretary.

Cary Hagen, senior vice president, EMEA commercial operations.

Alicia Napoli, vice president, clinical and regulatory affairs.

Lisa Michaels, vice president and chief compliance offcer.

Operation time on a single

Antistumble routine: If the leg

Better hardware design: The

Servo valves and a servo controller.

Proprietary programming of the coun-

Use of a pressure transducer in the

Frictionless seals in the hydraulic

Device and process specifications

Clearly understand how the device

Conduct component level testing and

Lance A. Berry, senior vice president

Timothy E. Davis, Jr., senior vice

William L. Griffin, senior vice presi-

Karen L. Harris-Coleman, senior vice

Edward A. Steiger, senior vice presi-

Eric A. Stookey, senior vice presi-

John T. Treace, senior vice president,

September 2011: Names Robert J.

September 2011: Reaches agree-

July 2011: Announces exclusive deal

April 2011: Appoints chairman David

January 2011: Expands relation-

Implement first phase of cost re-

Continue to strengthen compliance

Transition from interim to permanent

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