Biomet Spine • Biomet Trauma
After several turbulent years,
Biomet Spine • Biomet Trauma is
on the rise. Under the direction of
company president Glen Kashuba,
Biomet Spine • Biomet Trauma has
enjoyed a renaissance as a result of
their remarkable rebuilding process.
During fiscal year 2007 (fiscal
year ended May 31, 2007), Biomet
Spine • Biomet Trauma hit the
bottom of their decline, closing
the year with -14.6% annual
revenue growth. Upon Mr.
Kashuba’s arrival in April of 2007,
Biomet Spine • Biomet Trauma
began its “Pathway To Growth”
first by rebuilding its foundation.
This included hiring proven senior leadership; retaining Biomet
talent; and addressing the fundamentals such as supply chain
management, sales recruitment, and product launch processes.
By the end of fiscal year 2008, the company showed a considerable
turnaround by closing the year with -4.7% annual revenue versus a -
14.6% performance in the prior fiscal year. The employees of Biomet
Spine • Biomet Trauma had stabilized the organization, rebuilt its
core capabilities, and were in a position to move to the next step on
the “Pathway To Growth”, by re-launching the company.
Fiscal 2009 year end results were encouraging. Annual revenue
growth was +3.7% for fiscal year 2009. In the second half of fiscal
year 2009 Biomet Trauma stabilized and Biomet Spine grew strongly
with a 16.3% increase over prior year. Biomet Spine • Biomet
Trauma launched 35 new products and/or new line extensions
during fiscal year 2009 (12 spine product launches, 9 trauma product
launches and 16 bracing product launches). The employees and
sales representatives of Biomet Spine • Biomet Trauma are proud of
their achievements, yet intensely focused on the future.
NOTE: Financial results exclude royalty.
Biomet Spine • Biomet Trauma
100 Interpace Parkway, Parsippany, NJ 07054
Hip & Knee Surgery
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Published in the U.S. by: ORTHOWORLD Inc.
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Copyright © 2009 Pelican Magazines Ltd and ORTHOWORLD Inc.
FROM THE EDITOR
Healthcare Reform: An Orthopaedic Surgeon’s Perspective
SURGEON AS ENTREPRENEUR
Rejection: Learn to Deal with It
SURGEON AS ENTREPRENEUR
A Roadmap to Success for Surgeon Inventors, Part 3: Technologies for
Development of Your Ideas
PRACTICE MANAGEMENT SOLUTIONS
Let’s Get Together: Reasons why Orthopaedic Practice Mergers Can
Make Dollars and Sense
Glen Kashuba, Senior Vice President of Biomet, Inc., President of
Biomet Spine - Biomet Trauma
PRODUCT NEWS AND LAUNCHES
Physician Dispensing: A Cost Savings, Patient Benefit, and a Revenue
PRACTICE MANAGEMENT SOLUTIONS
The Best Asset Protection Is Not Asset Protection… Is Yours?
Controlling Device Costs: Sustainable Innovation or Commoditization?
ORTHOWORLD Position Paper On Healthcare Reform
Emerging Orthopaedic Technologies & Treatments
Including Ticker Track & Company Financials
OrthoMind Buzz: Surgeons Speak
A Solution for Undercoding or Miscoding Spine Procedures
Use of Spinal Vessel Protection to Facilitate Anterior Revision Surgery
Posterior Lumbar Arthroplasty
VIEWS ON THE NEWS
Spinal Surgery & Cement Systems
CALENDAR OF EVENTS
A Comprehensive Guide To Meetings and Events
THE TOP LINE
Employment Agreements: The New “Inducement”?
FISCAL FITNESS UPDATE
Teaching Fracture Repair in Tanzania
New Film Helps Spine Surgery Patients Get Back On Their Feet
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 3
FROM THE EDITOR
The past two months may prove to be pivotal in ensuring the place
orthopaedic treatment receives in the minds of our lawmakers.
Industry, the societies, surgeons and patients are speaking out loudly
in defense of the specialty.
In August, ORTHOWORLD published its position paper on
Orthopaedics and Healthcare Reform, on behalf of its global membership.
Its purpose is to avoid the noise of political rhetoric, and stick to
proven facts concerning the value of orthopaedic and spine treatment
to society. We have included the statement in this issue, and encourage
readers to use any portions or all of it as they see fit.
In the same month Biomet’s CEO, Jeff Binder, published via the net a statement containing similarly powerful
data on the economics of orthopaedic treatment. It can be accessed at www.biomet.com/corporate/ceoblog/.
The AAOS, the American College of Surgeons and others issued official statements expressing profound
disappointment at the inaccuracy of recent comments made by the President of the United States regarding
compensation of surgeons performing amputations. The gist of the AAOS statement was a call to using clear
vetted facts and data as the optimal way to identify areas of concern and value in the healthcare equation.
A production-quality video produced by a disc replacement patient and featuring a group of spine patients has
recently been released. It is emblematic of a new, more empowered and technologically savvy patient who may
have a more influential voice in the healthcare debates of the future. An article herein describes the video.
“It is our firm belief
surgeons and their
patients must remain
the most powerful
voice in the dialogue.”
The significance of the above developments is that those involved in
the specialty all along the “supply chain” realize the compelling
nature of the facts of orthopaedic care, and have begun with a heightened
sense of urgency to make themselves heard. It has become
obvious that the participation of all of us is required to assure the
continued evolution of the specialty.
This issue’s guest editorial is by U.S. Congressman Tom Price,
himself a former orthopaedic surgeon. He argues for a reform
solution that embraces patients and their physicians as the deciders
of appropriate care.
It is our firm belief that orthopaedic surgeons and their patients must remain the most powerful voice in the
dialogue. You have hopefully experienced this in the content that this publication contains. It is meant to provide
you with power through knowledge gleaned from the experts in the given areas of value to you, whether that is
practice management, wealth preservation and maintenance, business development, entrepreneurship or
emerging clinical technologies and therapies and government regulation.
You have told us that you don’t have time to read anything just to pass the time. You read to gain knowledge, to
become more powerful. At no time in recent history has the exercise of that power been more critical to moving
As I review the status of the healthcare reform debate, I am convinced that we have provided in this single issue
of this single publication more value to you as surgeons than many of our elected officials whose charge is
We are responding to your needs aggressively through a campaign to continually re-engineer this publication to
best provide the tools you need to thrive in the years ahead. We appreciate your support, and look forward to
John A. Engelhardt
Editor in Chief
4 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
Healthcare Reform: An
Author: Congressman Tom Price
Today in Washington and across the country, Americans are tackling
the monumental challenge of reforming our health care system.
Citizens are engaging in passionate debate because they
understand the imperative of reform, and even more, they recognize
the significance of the manner in which it is carried out.
As those who have worked in the medical industry know, we
have the greatest care in the world, offering patients more options
and innovative procedures than any nation. Americans have long
been dynamic innovators, creating the most cutting-edge ideas in
the world. It's no different when it comes to medicine. Our creativity
has constantly put us at the front when it comes to fighting
the most dangerous of diseases and complex injuries.
Yet to know the system also means understanding that there is
much that can be done to improve American health care. Patients,
doctors, medical professionals all recognize
that the status quo is unacceptable.
Counterproductive mandates, endless
regulations and third party decisionmaking
are increasingly distancing
patients from the care they need.
The challenge lies in reforming the system
in a way that expands coverage and
lowers costs without destroying quality,
innovation and choices in care. The fundamental question we must
answer to achieve a positive 21st century system is, whom will we
empower? Patients or the government? Should we create a system
that puts priority on the people who actually receive the care, or the
bureaucrats who administer it? We cannot accept just any reform,
but rather must demand the right reform: patient-centered reform.
As a practicing orthopaedic surgeon for more than two
decades, I know first-hand how incapable Washington is when it
comes to processing the complex and highly personal decisions
that patients and medical professionals are faced with on a daily
basis. No two patients are completely alike. The same diagnosis
may be reached for both, but the appropriate treatments may
vastly differ based on countless factors that only patients and
their doctors truly understand. Ensuring that patients and their
physicians maintain the proper medical options, decision making
power and flexibility is essential for quality care.
Sadly, the plan being pushed by the President and many in
Congress is a 1,000-page expression that Washington knows best
about American health care. Their solution puts decision-making
power in the hands of paper-pushing government officials who
“Empowered patients, not
government or insurance
companies, are best
equipped to tackle the
serious challenges we face.”
are thousands of miles away from the exam or operating room.
Rather than those intimately involved, the government will
decide what defines quality, what is included in every single
health plan and who will have access to treatments. The legislation
includes a bureaucratic behemoth government-run plan that
will do away with private insurers and make certain that the government
is the only game in town. What’s more, the bill relies on
the same onerous mandates, regulations and reimbursement
rules that are already driving medical professionals out of the
We know that the current system needs improvements, but
we ought not throw out the good with the bad. We can’t risk
losing the dynamism of American health care that has healed
so many and led to worldwide innovation, which is precisely
what would happen if we hand control
to a static Washington. All this is
at stake if we see a government
takeover of American health care.
While our goal should be to empower
patients in the process, the plan of the
Democrats in charge will instead
make the government a permanent
middle man between patients and the
care and treatments they seek.
Thankfully, there is a better way to reform our system. The
President talks endlessly about his way or the status quo. This
is a false choice. We can enact fundamental reforms that will
provide the accessibility, affordability, responsiveness, innovation,
choices and the quality we should expect in American
medicine. This solution lies in empowering patients.
Recently, I joined with a number of my colleagues in the
Republican Study Committee to introduce H.R. 3400, the
Empowering Patients First Act, a plan that puts patients back
at the center of the debate.
Our solution starts with ensuring that all people can afford
personal, private health care coverage. By providing a series of
tax credits and deductions and allowing the use of pretax dollars
for the purchase of care, we can make it so there is no
financial reason to go without coverage. By giving all
Americans purchasing power, we can avoid destructive mandates
while allowing patients to choose the plan that best fits
continued on page 7
6 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 6
Secondly, H.R. 3400 leads us to an American system in
which patients truly own their coverage, giving people control
and helping ease the fear that losing your job means losing
your health care. When people choose and own their own coverage
it creates greater competition and makes insurers directly
accountable and responsive to patients. No matter who is
paying the bill, insurers will have to live up to the standards of
the patients, not their employers or the government.
These fundamental reforms will pave the way to more positive
changes that will address the issues so many patients face. By creating
large pooling mechanisms, we can overcome the obstacle of
pre-existing conditions by allowing patients to come together with
the purchasing power of millions to create a more affordable market
with increased accountability. By breaking down counterproductive
federal regulations, patients will be able to cross state lines
to purchase coverage anywhere in the nation that fits their needs.
Lastly, we know that the skyrocketing costs patients experience
cannot be fully controlled without addressing the runaway
medical liability crisis in America. Doctors are forced to use too
many resources that drive up costs and only serve to defend
against frivolous lawsuit abuse. Our solution eases these burdensome
costs by creating special health courts, relying on the guidance
of medical specialty societies to give their expert opinion on
what qualifies as appropriate care. This will take away the burden
of forcing doctors to practice defensive medicine and allow
them to do what they do best: give patients the best quality care
and reasonable costs.
At its core, the Empowering Patients First Act states that what is
good for people is good for American health care. It recognizes that
empowered patients, not government or insurance companies, are
best equipped to tackle the serious challenges we face. Our solution
recognizes that when proper incentives are in place and people
are free to make the decisions that fit their needs and those of
their families, the system will move in the direction that is best for
those whom we sometimes forget health care is all about: patients!
Representing the Sixth District of Georgia, Congressman Tom Price
was first elected in 2004. Price received a Doctor of Medicine degree
from the University of Michigan, completed his residency at Emory
University and practiced orthopaedic surgery for more than 20 years
in metro Atlanta. This year, Price was chosen by his colleagues to
serve as chairman of the Republican Study Committee, the largest caucus
in Congress. He has been a vocal supporter of conservative principles
including fundamental tax reform, limiting government spending
and ensuring patient-centered health care. To find out more, visit
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 7
SURGEON AS ENTREPRENEUR
Rejection: Learn to Deal with It
Author: Perry E. Van Over, Esquire
In an earlier article published in ORTHOPAEDIC PRODUCT
NEWS (OPN, May/June 2008), entitled “Patent Prosecution:
Understanding the Process,” I sought to acquaint the reader with
a general understanding of the steps a patent applicant typically
follows in the patent prosecution process through the U.S. Patent
and Trademark Office (USPTO). The reader is encouraged to read
that earlier article so as to better understand the reasons why the
patent prosecution process follows the course that it does.
Looking a little deeper into the prosecution process, this article is
directed to the two types of claim rejections based on prior art
that virtually every patent application will suffer as the patent
examiner goes about his duty of deciding if a Letters Patent
should be issued for the claimed invention.
Rejection is a fact of life. Whether it is rejection in affairs of the
heart, a rejected sales proposal, the rejection of a writer’s manuscript
of the great American novel or the rejection of an inventor’s
application for a U.S. Patent, it is always a hard pill to swallow.
The disappointment of rejection is something we all must learn to
deal with sooner or later. Rejection is almost universally viewed
(at least initially) as a failure. However, often, when viewed retrospectively,
the momentary disappointment of being rejected is
overshadowed by things somehow working out for the better in
the long term. That is very often true when a patent application
is the subject of a patent examiner’s rejection of the claims. Not
every patent application will be issued as a U.S. Letters Patent;
however, through the rejection and argument or the rejection and
amendment process that is carried out between the examiner and
applicant, a better, stronger patent is ultimately granted.
Having an early understanding of the basic rejections that will
be leveled against the patent claims and how to deal with those
rejections is valuable knowledge for the patent applicant that can
serve him in two ways. First, knowing of the likelihood of patent
claim rejections during the patent prosecution process will motivate
the applicant to more openly work with his patent attorney
in the development of a strong patent application with the depth
of disclosure information that will allow argument and amendment
as necessary to overcome most, if not all, rejections of the
claims. Second, having a foreknowledge of the rejections and disappointments
inherent in the patent prosecution process will provide
the inventor with the determination and resiliency necessary
to see the process through to the end.
While a patent application can be rejected for a variety of reasons
that are principally based upon application or claim form,
subject matter or other technical reasons, “The primary object of
the examination of the application is to determine whether or not
the claims are patentable over the prior art.” (Manual of Patent
Examination Procedure (MPEP), para. 706.03.) For an application
claim to be patentable over the prior art requires that the process,
machine, manufacture, or composition of matter (35 U.S.C. §101)
be novel and unobvious over the relevant prior art. It is the examiner’s
rejections under 35 U.S.C. §102 (novelty) and 35 U.S.C. §103
(obviousness) that we will discuss in this present article. For
some readers, the focus of this article may already be well understood,
and for others, completely novel. For all readers, however,
I hope that the article will impart an understanding of the importance
of anticipating the likelihood of receiving one or more rejections
during the course of a patent prosecution effort and, further,
to receive an understanding of the value added to the patent as a
result of those rejections.
An invention defined in a claim of a U.S. patent application is
“novel” if it meets the specific requirements defined in 35 U.S.C.
§102. That section of the patent code includes subsections (a)
through (g), and for any reader who would like to know the
detailed requirements of those subsections, they are invited to
study the same at their leisure through the USPTO website
(www.uspto.gov). However, for any reader so inclined, it is a fair
warning to say that each of the seven subsections of 35 U.S.C.
§102 has, through innumerable patent litigation cases, been the
subject of intense litigation and, thanks to the courts’ interpretations
of the meaning of virtually every word in the statute, a casual
reading will fall far short of providing a good understanding of
the controlling law. For that reason in this article we will discuss
35 U.S.C. §102 (novelty) in general terms and how it differs from
the other prior art based rejection under 35 U.S.C. §103 (obviousness).
A rejection of the claims based upon prior art that is cited by
the patent examiner will be submitted to the patent applicant in
a communication of an Office Action from the USPTO in one of
two basic forms that either challenge the novelty of the invention
or indicate that the claimed invention would be an obvious result
continued on page 10
8 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
SURGEON AS ENTREPRENEUR
continued from page 8
of modifying a cited reference, the modification being obvious to
one of ordinary skill in the art at the time the invention was
made. Such a modification is generally explained by the patent
examiner as a combination of two or more cited references, which
when combined include each element of the claimed invention.
If the rejection is based upon a single piece of prior art, such as
a U.S. patent, a published patent application or any other citation
that the examiner contends discloses each and every element of
the invention as defined by the rejected claim, the examiner will
reject the claim(s) under one of the seven subsections (a-g) of 35
U.S.C. §102. The language of the received rejection will be very
similar to the following: “Claims 1-9 are rejected under 35 U.S.C.
§102(b) as being anticipated by Smith et al. (U.S. Patent
The use of the term “anticipated” or “clearly anticipated” is
used by the patent examiner exclusively when the rejection is
based upon a single citation of prior art that the examiner contends
teaches or discloses each element of the invention defined
in the claims. Hypothetically, assume an
invention that is defined in Claim 1 of a
patent application as being “a device comprising
(including) element “A” connected to
element “B,” element “B” being connected to
element “C.” The patent examiner can reject
that claim as being anticipated (not novel)
only if the examiner provides a citation to a
solitary prior art reference that includes “A”
connected to “B” and “B” connected to “C.”
If the patent examiner can only find a prior
art reference that discloses a device that
includes “A” connected to “B,” the claimed
invention of A-B-C will not be anticipated by
the prior art and thus will be novel. However,
if the Examiner also finds a second reference in the relevant technical
field of art that teaches or discloses that when “B” is present in
a device, it can be connected to the element “C,” the rejection of the
claims can be based upon 35 U.S.C. §103 if it would have been
obvious to one of ordinary skill in the art to modify the first reference
A-B on the basis of the teaching of B-C in the second reference.
Thus, in this two-tier prior art examination conducted by the
patent examiner, when the claim is novel over the prior art, that
is the invention defined in the claim is not anticipated by a single
reference that discloses each and every element of the claim, it
can still be rejected based upon a cited prior art reference that is
modified by one or more additional cited references in a rejection
under 35 U.S.C. §103. The language of the patent examiner’s
rejection as communicated in the Office Action will be very similar
to the following: “Claim 1 is rejected under 35 U.S.C. §103(a)
as being unpatentable over Smith et al. (U.S. Patent X,XXX,XXX)
in view of Jones (U.S. Patent Y,YYY,YYY).”
As discussed above, this two-tiered novelty and unobvious
determination process, which is employed by the patent examiner
when comparing the claimed invention to the prior art of
record, seems relatively simple. As with all things of importance
or value, the seemingly simple determination of novelty and
unobviousness over the prior art is subjected to close examination
and argument over the details of the rejection. Frequently, an
examiner’s rejection of a claim as being anticipated by a single
piece of prior art can be overcome by argument in a written
response submitted to the examiner showing that his interpretation
of a structure in the reference as element “A” was unintentionally
mischaracterized; that is, incorrectly identified and thus
no element “A” is shown to be present in the cited reference. It
may also be shown by argument in the response to the rejection
that there actually is no real connection of element “A” to element
“B” and thus, again, there is novelty over the prior art of record.
These simple examples are only provided to show that such arguments
as well as more complicated exchanges can be employed to
overcome what on the face of it seems to be an iron-clad rejection
and an insurmountable obstacle to patentability of the invention.
Similarly, in the case of an examiner’s rejection of a claim
based upon 35 U.S.C. §103, obviousness, the applicant with his
patent attorney may be able to overcome the rejection simply
through close analysis of the modification of the cited references
proposed in the examiner’s rejection. It is often the case that the
structure of the first cited reference is such that if any attempt
were made to modify it based upon the teaching of the second
cited reference, the resulting device would be inoperable and
thus any such combination would not
“A rejection of one
or more of the claims
of (your) patent
application does not
represent the defeat
of (your) effort to
obtain an issued
teach one of ordinary skill in the art to construct
an operable modified device having
any utility. Many other such arguments
can be submitted by the applicant in
response to an examiner’s obviousness
type rejection; but most important is that
the reader understand that a rejection of
one or more of the claims of his patent
application does not represent the defeat of
his effort to obtain an issued Letters Patent.
It in fact represents an opportunity for the
applicant and his patent attorney to
include important, substantive information
in the record or prosecution history of
the patent application. Such information is historical evidence of
the examiner’s diligent effort to keep a non-deserving claimed
invention from being the subject of an issued U.S. Patent.
Whether the rejection is based upon 35 U.S.C §102 or 35 U.S.C.
§103, if arguments are insufficient to overcome the examiner’s cited
prior art rejections, the applicant may still overcome the rejections
by amendment of his claims to include one or more elements (i.e.,
“D,” “E,” etc.) that are not disclosed in the prior art of record. It is
very important to understand that additional elements of the invention
such as “D” and “E” in our hypothetical example cannot be
added as an amendment to the rejected claims if those elements
were not described in the specification of the application before it
was filed with the Patent Office. This amending of the claims can be
done in such a way as to cause insignificant narrowing of the
breadth of patent protection provided. In drafting the specification,
it is imperative that every possible detail of the invention that can
be anticipated be included. Many of these structural details can be
directed to aspects of the device that would almost inevitably be
included in any commercial embodiment of the invention yet need
not be included in the broadest of the claims as originally filed in
the application. If it does become necessary to further limit the
claimed invention by adding additional elements to overcome a
prior art rejection, the more depth provided in the specification the
continued on page 11
10 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
SURGEON AS ENTREPRENEUR
continued from page 10
more options will be open to the applicant and his patent attorney.
Understanding the basic premise of the examiner’s rejections under
35 U.S.C. §102 and 35 US.C. §103 serves to motivate the patent
applicant to expand his vision of the claimed invention to include
each and every additional element of limitation, which might reasonably
be included in his original concept. It is not unlike a soldier
preparing for battle who fills his bandolier with ammunition in
anticipation of the possibility that he will need every last bullet, in
contrast to the soldier who is less prepared and finds himself out of
ammunition in the midst of the battle. The patent applicant who
understands the rejections that await him in the patent prosecution
process will wisely prepare for a long and exhausting battle if he
expects success in his efforts to obtain an issued patent.
Another benefit of knowing what rejections may lie ahead in the
prosecution of a patent application may not be fully realized until
some time after the patent application has issued as a Letters Patent.
Once the battle of obtaining the patent has been won, it may still not
be a time of peace and profitability for the patent holder. It has been
said that if a patent is truly worth anything, sooner or later someone
will try to steal it—that is, someone will infringe one or more of
the claims of the patent. As discussed in an earlier submitted article
on patent litigation, the effort and costs of holding a patent infringer
accountable for his actions can be enormous. Worse than the merely
enduring the high costs of a patent infringement litigation is for
the patent holder to go through the time and expense of such an
action, only to find that the court has determined his patent to be
invalid. This determination of invalidity by the court would be
made in response to the accused infringer’s defense that the patent
should have never been issued by the U.S. Patent Office due to prior
art that anticipated or rendered obvious the claimed invention. It
has been said that what doesn’t kill us makes us stronger. At least
in the process of prosecuting a patent through the USPTO, that is a
true statement. In an infringement suit, the issued patent being
challenged by the accused infringer’s defense that the patent is
invalid is given the benefit of a presumption of validity that must
be overcome by the accused infringer. If the examiner’s record of
the patent examination process shows that the examination on the
merits was very thorough and rigorous and the applicant’s arguments
of record clearly distinguish the invention over the best prior
art found and made of record, the presumption of validity in the
eyes of the court is reinforced and more difficult for the infringer to
rebut. In contrast, if the record of the patent prosecution suggests a
weak and shallow approach to the examination, then the validity of
the patent will not seem as sure and the infringer’s arguments that
the patent should have never been issued may be more easily established
before the court. In any case, a patent application that survives
a stringent examination is given a better footing and, for
would-be infringers who take care to do due diligence before they
decide to infringe an application, it may be a factor in dissuading
them from their inclination to infringe the patent.
Knowing what may lie ahead is always an advantage when setting
out on a course to be traveled. My initial article submissions
to OPN, grouped as the Ten Golden Rules of Patent Law, were
intended to acquaint the inventor/patent applicant with some of
the basic stepping stones and some of the pitfalls that await along
the pathway to obtaining patent protection for his invention. This
article looked a little deeper into the patent prosecution process
with the purpose of making the inventor aware of the basis for the
prior art rejections to which his claims would inevitably be subjected.
This was done with the hope that knowing what rejections
lie ahead would motivate the inventor to deal with those rejections
proactively. The time to prepare for the patent examiner’s
rejections based on prior art is during the drafting phase of the
patent application process; that is, the best time to deal with an
examiner’s prior art based rejections is before the examiner communicates
them in the inevitable Office Action, before the patent
is even filed. By proactively preparing for a rigorous patent prosecution,
the applicant will also be working toward the allowance
of a stronger, more durable Letters Patent.
The intention of this series of articles is only to acquaint the
reader with the need to exercise due care and foresight in seeking
patent protection for an invention and to call attention to the
need to deal with rejection proactively in the patent prosecution
process. As such, these articles are not intended as legal advice
but only as a caution that proper legal counsel should be engaged
by anyone seeking to obtain patent protection for an invention.
Perry Van Over is the Founding Member of Perry E. Van Over &
Associates, PLLC, an intellectual property law firm specializing in
patent procurement, licensing and litigation in the technical fields of
surgical instruments, medical devices, molecular biology, pharmaceuticals,
biochemistry and polymer chemistry. He can be reached at 703-
543-6456 or firstname.lastname@example.org.
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 11
SURGEON AS ENTREPRENEUR
A Roadmap to Success for
Surgeon Inventors, Part 3:
Technologies for Development
of Your Ideas
Author: John Kapitan
Traditionally, as a surgeon inventor, you may have waited for
one of the large implant companies to recognize the value of
your new product idea. Then the game began by negotiating
timelines, team structure and ultimately, your royalty agreement.
While this process has been rewarding for some, it has
proven to be disappointing for others. Is there a better way?
What would it look like to maintain control of your design, timeline
and budgets while hitting milestones and advancing your
idea? And what if you could do this while creating intellectual
property along the way to build exponential value?
There is a different paradigm to consider, and that is to do it
yourself with the help of an independent engineering partner. In
most cases you would not consider taking an idea all the way to
the market yourself, of course (especially for product ideas that
will eventually require costly and time consuming clinical studies),
but taking it from a concept to prototype is well within the
realm of possibility on a limited budget and compressed time
There is of late a strong interest in avoiding the type of government
and media scrutiny on industry/surgeon relationships
that is rampant today. Although industry/surgeon collaboration
has proven to be, and will remain, a fundamental piece of new
product innovation fueling the advancement of patient care, that
fact doesn’t seem to satisfy those who are bent on keeping it
front page news.
Considering this current climate on industry/surgeon relationships,
I have noticed that surgeon inventors increasingly
find that carrying their new product ideas further on their own
is proving beneficial if for nothing else than it distances them
from the companies whose products they are using in the OR. As
the logic goes, selective industry collaboration means minimal
government meddling, which means that your friends and
neighbors won’t be reading about you over their morning coffee.
This is an oversimplification, of course, but nonetheless the message
is clear – hold on to your ideas and create as much value as
you can before you begin shopping it around. It will pay off in
How can you produce a prototype of your idea quickly given
the many constraints on your time? And, just as importantly,
how can this be done cost effectively, especially with lots of iterations
in mind? Rapid prototyping helps to address these issues.
Additive Rapid Prototyping
During the course of product development few things are as
exciting as when rapid design-build cycles allow a surgeon
inventor and his design team to see iterations of physical prototypes
real-time. Team members (especially inventors!) love to
hold a prototype in their hands. Perhaps it is the tangible evidence
of all of the late nights spent thinking about, shaping and
reshaping a spark of an idea. With state of the art computer processing
power, software modeling capabilities and rapid prototyping
technology, engineers can turn a sketch into a plastic or
even metal prototype model in a couple of days or less. Multiple
iterations are easily produced. This gives unprecedented speed
and insight into the nuances of a design and allows you, the
owner of the idea, to make decisions quickly based on what you
Recent advances, especially in the rapid metal prototyping
arena, have allowed engineers to start building surgical instruments
and even implants using this technology with remarkable
speed and flexibility. This opens up a whole new realm of possibilities
for the inventor because previously hard to manufacture
designs from the standpoint of traditional machining may now
be possible (and in a fraction of the time it would normally take).
In addition, what was once relegated to making simple “show
and tell” prototypes is beginning to gain more widespread
acceptance for real parts.
What is additive rapid prototyping? How does it differ from
At the core, you can think of additive rapid prototyping as a
way to “grow” a prototype rather than cut it away from stock
material as is the case for subtractive processes like machining.
Why the focus? Why does this matter? There are four distinct
benefits of additive rapid prototyping.
1. Speed – Your prototypes can be made in days rather than
weeks or months. Rapid changes can be made quickly so that
the design team can visualize the idea. Other team members,
including patent attorneys, supplier partners and marketing
and sales professionals may also benefit. This is one way to
jumpstart the marketing process early in the development
cycle before you sink a lot of money into production and testing.
2. Complexity –Designs can be made using additive prototyping
that simply cannot be made with traditional machining.
continued on page 13
12 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
SURGEON AS ENTREPRENEUR
continued from page 12
As an example, note the porous structure in Exhibit 1. This
part would be very difficult, if not impossible, to make with
conventional means. Additive prototyping really shines
where there are complex internal cavities and features or
freeform shapes. In the words of one industry professional,
you can get “complexity for free” due to the fact that there are
no additional expenses incurred for very complex geometry.
Exhibit 1 - Porous lattice structure made with additive manufacturing.
3. Cost – Because there is no expensive tooling or fixtures
involved, startup costs are minimized with additive processes.
Overall cost varies with the type of process and materials
used, but generally I have found a cost improvement over
conventional manufacturing due to the minimization of nonrecurring
startup expenses. For example, many plastic models
can be made for $200 or less. Added to that is the benefit of
producing a series of parts all at the same time in the same
4. Customization – Parts can be made to match a specific
patient’s anatomy if desired. These parts may be produced
quickly and cost effectively, at least when compared to traditional
machining technology. Or customization could mean
producing variations of parts on the fly, as needed.
Additive rapid prototyping is not a cure-all for your development
pains. It will not be applicable for all projects and as a
whole is not always a better way to go than subtractive processes
like machining. Instead, think of additive rapid prototyping
as a suite of complementary processes in the arsenal of development
tools at your disposal.
Weighing the Options
One of the first questions your team should ask when considering
this option should be, “For what will my prototype be
used?” While some parts are useful for concept visualization
only, others can be used for mechanical testing while some may
be used for a cadaver training session or during live surgery. The
range of possibilities is quite large. Your application will in part
drive the type of technology employed to make your part. Other
key considerations are budget and lead time requirements.
Rapid prototyping in plastic has been around for some time, dating
back to the 1980s. At last count, there were over seven different
core technologies for producing rapid plastic parts and
dozens of material choices for several of these methods. In general,
the size of a part made from plastic prototyping is no larger
than ten to 20” per dimension. Parts can be made in color to
help demonstrate a concept.
More recently, additive metal rapid prototyping has garnered
significant focus for its ability to offer a very good material property
match to “real” orthopaedic materials like stainless steel,
cobalt chrome and titanium alloys. Although the field is relatively
new and a limited number of materials are available, new
materials are coming out regularly and the knowledge base is
Two key areas of interest with metal revolve around the ability
to create complex porous structures, both integrated porous
coated implants and fully porous structures. By creating the
porous coating at the time of part build, typical problems seen
with existing porous coating technology are eliminated. Design
boundaries are expanded at the same time. Considering the part
shown in Exhibit 1 above, what other types of porous lattice
structures could one create in the pursuit of the optimal implant
design? According to one publication, “In the medical area, lattices
can replace material in implants. The resulting structures
cost less as well as help facilitate bone in-growth. In general, lattice
structures can reduce weight, transfer heat, absorb impact,
dampen vibration and be engineered to a specific stiffness.” 1
Direct Metal Laser Sintering (DMLS)
The idea of using additive processes is intriguing and the benefits
are certainly compelling. But you’re not sure where to start.
With so many choices in the additive rapid prototyping field,
which one will best fit your needs? A comprehensive review of
the entire field is outside of the scope of this article. Thankfully,
the engineering partner you choose for your team should be able
to help you select the right technology for a given purpose. Shop
around and ask about their experience and knowledge of the
For sake of brevity, let’s focus on one particular technology
which is making significant strides in the medical device industry.
One of the more promising additive metal prototyping technologies
out today is called Direct Metal Laser Sintering. The
process is just as it sounds – metal powder is melted together
into a specific shape using a laser. Using this process, designers
can achieve direct production of functional metal parts by utilizing
a laser to sinter very fine layers of metal powder layer-bylayer
from the bottom up. This produces 100 percent dense parts
that exhibit material properties as good as, and in some cases
better than, traditional machined parts. Examples of medical
continued on page 14
1. Machine Design, “New from the Fab Labs: Lightweight but Superstrong Parts,” Aug 2008.
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 13
SURGEON AS ENTREPRENEUR
continued from page 13
devices utilizing this process include endoscopic devices, general
surgical instruments, surgical staplers and needle systems.
DePuy has been using DMLS technology since 2007 to produce
more than 2,000 parts to date. 2 Although the parts have been
used for samples and for evaluation, instruments and even
implants for surgery are certainly on the horizon. Exhibit 2 is an
example of a part manufactured by this method.
Exhibit 2: Sample implant made using additive metal rapid prototyping.
The value of these technologies to you as an inventor is illustrated
by a real life example. Recently, I used DMLS to produce
two prototype surgical instruments for testing and cadaver
work. These were fully functional metal parts. The prototypes
were made in less than two weeks for about $2,000 per part with
no extra setup charges. By contrast, the cost to machine these
instruments a traditional way would have been $250 per part.
Not bad, until you consider that the extra charges for all of the
programming and set-up amounted to $13,000! Taking this into
account, the effective piece price was almost $7,000 for machining
vs. $2,000 for DMLS – a cost savings of almost $10,000 for one
order. In addition, these parts were made straight from CAD
models without blueprints, so the time and cost of producing
blueprints for manufacturing were also eliminated.
Realistically, there will be challenges to overcome in the pursuit
of additive metal prototyping technologies for production of
implants and instruments for surgical applications. Among the
most important of these is getting FDA comfortable with the
process and materials, since they do not necessarily conform to
ASTM standards for material specification. While FDA does not
approve a particular manufacturing process per se, the entire
manufacturing history of a device including the base material
plays a significant role in establishing safety and efficacy.
Various industry parties are hard at work to establish and document
the merits of additive rapid prototyping for surgical
implants and instrumentation. Stay tuned.
Parts made using the DMLS process are produced in layers as
small as 20 microns (.0008”) thick. Material options include
cobalt chromium, stainless steel and most recently titanium
alloy. Of course, there are limitations which include overall part
size, material availability and the fact that prototypes will often
require some type of post processing in order to have a nice surface
finish and/or improve material properties. Exhibit 3 shows
a part produced using DMLS technology. Note the complex
Exhibit 3: Part with complex
internal geometry made by
For those of you with a track record of developing your own
ideas, or who have already decided that it would be a good idea
to pursue in the future, hopefully you recognize that there are
more tools at your disposal than previously thought and the
field is growing quickly. Whether you have an immediate need
for rapid prototyping technology or a new product idea in mind
that might benefit from it, remember that a careful sifting
through of the options will save time and money. Don’t hesitate
to have your engineering team experiment with various technologies,
and don’t forget to consult with experts in the field.
You may just find that you can stop limiting your design ideas
for the sake of manufacturing and start pushing the boundaries
of what is possible. For those who are still on the fence, there
may be no better time to test the waters. I am confident that you
will find the potential benefits of control, flexibility and value
creation to be compelling.
The author wishes to thank Morris Technologies, Inc.
(www.morristech.com) for all photos used in this article.
John Kapitan is the Founder and President of Kapstone Medical, LLC.
Kapstone is a consulting firm that partners with surgeon inventors
and orthopaedic implant companies to develop and commercialize new
medical devices. John is an experienced design engineer with over 15
years in medical device development and is an inventor on over a
dozen issued patents and patent applications. John can be reached at
704-843-7852 or email@example.com.
2. Medical Product Manufacturing News, “Direct Metal Laser Sintering Speeds Prototype Development,” Sept 2008.
14 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
PRACTICE MANAGEMENT SOLUTIONS
Let’s Get Together: Reasons why
Orthopaedic Practice Mergers
Can Make Dollars and Sense
Author: Doug Free
The adage about strength in numbers can be applied to the concept
of physician practice mergers. In today’s economic and political
climate, it is becoming increasing difficult and costly for many
orthopaedic surgeons to continue going it alone. While many
surgeons fear the perceived costs of practice mergers, such as some
loss of individual autonomy, more and more are finding that the
benefits far outweigh any supposed disadvantages.
The following is an overview of benefits that can flow from the
merger of two or more solo physician practices into an integrated
group. This article is intended for general information purposes and
should not be considered as legal advice. Individuals who need legal
advice should contact an attorney.
Most orthopaedic surgeons may find that developing ancillary
sources of practice revenue is a key component of a financially health
practice. The costs and logistics of offering ancillary services such as
MRI or physical therapy, however, are often beyond the reach of a
solo practitioner. This points up one of the major advantages of
Under the Stark regulations, physicians are able to own and selfrefer
to facilities such as MRI or PT, provided that the services are
rendered in the same building in which the physician otherwise
regularly practices. While it is possible for a solo physician to
accomplish this by developing an ancillary income source within his
building, the costs of doing this independently are often too much for
a solo practitioner, and issues also arise as to whether a solo practitioner
has a sufficient patient flow to support the venture from an
By becoming part of a group, a host of advantages becomes
available. Interestingly, under what is known as the “Centralized
Facility Exception” to the Stark regulations, a group is able to own
and operate an MRI or PC facility, for example, in a location other
than the group’s primary office. There are specific rules governing
how this is structured, but this clearly becomes an advantage for
physicians practicing within a group structure.
Managed Care Negotiations
Physicians in solo practice are severely limited with respect to
their options for negotiating with managed care providers and
insurance providers. Under applicable antitrust laws, it is illegal for
non-integrated physicians to jointly negotiate in any way.
On the other hand, a fully-integrated medical group has the ability
to negotiate with managed care organizations. In addition, given the
increased “footprint” that comes with being part of a group, it is
likely that an insurance company or managed care organization will
be considerably more receptive to the needs and requests of a group
as compared to the needs and requests of a solo practitioner.
It is easy to see why a group of orthopaedic physicians can come
up with more capital (and, therefore, take advantage of more
economic opportunity) than a solo practice physician. This, in turn,
makes it feasible to consider important additions such as EMR or
digital x-ray. Furthermore, due to important economies of scale associated
with practice integration, a properly merged group will typically
discover that many economic redundancies associated with solo
practice have been reduced or eliminated as a result of the merger.
An additional benefit to practice integration exists with respect to
the ability to attract qualified new potential members of the group.
Increasingly, physicians just out of residency are looking for the
strength, security and prestige of a group, as opposed to looking at
solo practice opportunities.
So, how do we do this?
The first step to investigating whether practice integration might
be for you involves identifying a group of physicians with whom
you share a mutual respect in terms of professional abilities and
training. Once this potential group has been identified, it is often
immensely helpful to set up a meeting for purposes of discussing
whether a feasibility study should be undertaken. If there is
sufficient interest then the feasibility study, which is completely
nonbinding, will flush out a host of important issues aimed at
discovering whether or not practice integration indeed makes sense.
In summary, more and more orthopaedic surgeons find that
being part of a group can offer significant advantages that are simply
not possible through solo practice. With proper planning and
structuring, it is indeed possible to merge two or more solo practices
into a successful Integrated Medical Group that will endure and
prosper for many years to come.
Douglas S. Free is a partner with the firm of Kessenick, Gamma & Free,
LLP, which focuses its practice on the business and health law needs of
physicians and medical groups. Mr. Free can be reached at 415-362-6414.
16 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
Senior Vice President of Biomet, Inc.,
President of Biomet Spine • Biomet Trauma
Glen Kashuba is the Senior Vice President of Biomet, Inc. and President of Biomet
Spine • Biomet Trauma. With nearly 25 years of experience in the medical industry, he
has been at the helm of Biomet Spine • Biomet Trauma since April 2007. Prior to
Biomet, Mr. Kashuba had worked for Johnson & Johnson for nine years. He served as
Worldwide President of Cordis Endovascular, Worldwide President of Codman Neuro
Science and U.S. President of DePuy AcroMed, now known as DePuy Spine. Mr.
Kashuba also held several key management positions during his eleven years with
ORTHOPAEDIC PRODUCT NEWS (OPN): You took the helm of
Biomet Spine • Biomet Trauma about two years ago. How would you
summarize those first two years?
Exhibit 1: Biomet’s Pathway To Growth
Glen Kashuba (GK): It is fair to say we had some work to do.
The business had stagnated and the organizational environment
was chaotic. We needed to focus and rebuild the foundation. I
viewed this as the first step on a “Pathway To Growth.”
Fortunately, despite the bedlam, many good people stayed with
the organization. We also hired senior leadership, those who
have worked in the spine and trauma businesses for many years.
We concentrated on the most critical fundamentals: supply chain
management, sales force recruitment and launching new products.
By the end of the first year of the rebuilding process (mid-
2008), we had repaired the business and were in a position to
begin the second phase of the “Pathway To Growth,” a re-launch
of the company. We focused on building our R&D portfolio and
reconnecting with the surgeon community. We increased the size
and breadth of our R&D department. We began several important
new projects with surgeon thought leaders. We actively pursued
internal R&D feasibility investigations with major academic
institutions. Our L&A activities significantly increased. In
addition, we committed to support our product portfolio by
increasing our surgeon education presence.
By the end of the re-launch phase, in mid-2009, we had stabilized
the trauma business and had achieved strong growth in
spine. We feel the re-launch of this company has succeeded.
Now we will move into a new phase, one of accelerated growth
for our spine and trauma businesses, as well as our bracing and
bone growth stimulation lines. (See Exhibit 1.)
continued on page 19
18 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 18
OPN: During the accelerated growth phase, what do you expect spine
surgeons will notice about the Biomet Spine product portfolio?
GK: Spine surgeons will see the impact of our recently released
products. We have rounded out our very successful Polaris 5.5
and 6.35 Thoracolumbar Systems with the introduction of a new
Polaris Deformity System. During July and August we obtained
FDA clearance for all of the options required to perform complex
thoracolumbar surgery. In addition to the new Polaris
Deformity System, we now offer The Trivium Derotation
System that incorporates Enbloc vertebral body derotation via
an innovative, simple correction technique. The system utilizes
the strength of pedicle screw fixation and enables surgeons to
correct most spinal deformities in three dimensions. Surgeons
have responded very well to this system. We have increased our
inventory so that now many more surgeons will have the opportunity
to use our Trivium and Polaris Systems. (See Exhibit 2.)
Exhibit 2: Polaris and Trivium Systems
OPN: During the accelerated growth phase, what do you expect trauma
surgeons will notice about the Biomet Trauma portfolio?
GK: Surgeons will notice a significant number of new products.
Each one will have a substantial number of sets to support surgeons
around the country. Significant inventory is one of the
biggest changes in our trauma business. We understand that a
great product released with a small number of sets cannot make
an impact. Our new product designs include the Phoenix
Ankle Arthrodesis Nail System, our latest addition to Biomet
Trauma’s family of intramedullary nailing systems (See Exhibit
3.); the Forerunner Plating System, a comprehensive plating
system designed for fixation of bony pathology for the foot and
ankle; and the Biomet® Vision FootRing System, a lightweight
radiolucent component-based system capable of a multitude
of customizable constructs ranging from simple fractures to
complex reconstruction. We have received a great response from
surgeons who have used these technologies. Our commitment to
additional inventory will make our products increasingly available,
allowing us to win more surgeons to our product lines.
Exhibit 3: Phoenix Ankle Arthrodesis Nail System
OPN: During the accelerated growth phase, what do you expect physicians
will notice about the Biomet Bracing portfolio?
We will continue to build on the success of our C-Tek®
MaxAn Anterior Cervical Plate System. The system offers an
innovative one-level plate technique that provides a direct relationship
between the bone graft/spacer size and the position of the
plate holes. The implant can obtain a cephalad-caudal sweep of 60°
which allows for screw placement to be close to the endplates.
We also have had a great response to the Solitaire System,
an ALIF spacer designed to provide immediate mechanical fixation
to adjacent vertebral bodies with no anterior column profile.
A shallow screw angle helps provide strong fixation by maximizing
thread contact with cortical bone. The subsidence-resistant
open design helps preserve the endplate. The large, medial cavity
facilitates the fusion process, and a variety of footprints and
heights suit varying anatomies. We will continue to promote this
product to surgeons performing Anterior Lumbar Interbody
Fusion (ALIF) procedures.
GK: As a result of improved process flows, Biomet Bracing customers
can expect faster turnaround for their customized braces.
Biomet Bracing offers a number of new customized braces and
off-the-shelf products including the Performance® Knee Brace
line, Aspen® Spine Braces and Cold Therapy solutions. We are
also excited about our new Biomet Link System (See Exhibit
4.), a DME Billing System designed to minimize the risk and hassle
of supplies management, billing and claims administration.
By automating the entire process, Biomet Link removes the
complications of ordering product, managing inventory, dispensing
product, coding and charging correctly and creating,
submitting and reconciling claims. We believe all of these products
will catch the attention of current customers and those who
have not taken a look at us in some time.
continued on page 20
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 19
continued from page 19
Exhibit 4: Biomet Link System
OPN: What should physicians expect from their Biomet Spine •
Biomet Trauma sales representative?
GK: The healthcare community expects a professional, intelligent,
credible salesperson. We have many superb salespeople
and will continue to build our sales force as we accelerate business
growth. Physicians who have not seen a Biomet Spine or
Biomet Trauma salesperson certainly will meet one in the year
ahead as we continue to increase the size of our sales force. I
have found that the best sales professionals always want to
expand their knowledge. During the accelerated growth phase
of our business, we will train vigorously so that our sales force
may effectively communicate the basic and advanced uses of our
products. Our sales team will continue to be an asset to any
healthcare professional who chooses to use Biomet products.
OPN: Please tell us about Biomet Spine • Biomet Trauma’s commitment
to medical education.
OPN: During the accelerated growth phase, what do you expect spine
and trauma surgeons will notice about the Biomet Bone Growth
GK: The heritage of Biomet Spine • Biomet Trauma traces back
to EBI. In the tradition of EBI, we continue to offer the knowledgeable
service of our dedicated sales professionals who support
these product lines. We have a large number of options in
our bone growth stimulation portfolio. Our extensive line of
non-invasive bone growth stimulation products includes the
Biomet® BHS-mini Bone Growth Stimulator, OrthoPak®2
Bone Growth Stimulator and SpinalPak® II Spine Fusion
Stimulator. As with every other element of our business, we are
actively developing products in this area. (See Exhibit 5.)
Exhibit 5: SpinalPak® II Spine Fusion Stimulator
GK: It is uncommon for a company in the middle of a rebuilding
process to commit significant resources to surgeon education.
However, we did precisely that as we re-launched the company
in fiscal year 2009 – and again in fiscal year 2010 – because we
believe that we have an obligation to educate physicians. We
have confidence in our ability to build effective programs in collaboration
with talented surgeon educators. We remain committed
to conducting a variety of programs involving the best faculty.
Our training meetings provide attendees an opportunity to
gain a full understanding of how Biomet products could contribute
to a physician’s ability to treat his or her patients.
Surgeons should expect medical education to play a prominent
role at Biomet Spine • Biomet Trauma.
OPN: How has the delivery of Biomet Spine • Biomet Trauma products
changed during the transition?
GK: Delivery of products was once one of our most glaring
impediments to growth. Thanks to a lot of hard work by some
very talented people, we now fill orders as well as the best medical
device companies. If a customer places an order today, that
customer will receive that product on-time nearly 100 percent of
the time; two years ago, a customer had a 50/50 chance of receiving
a product on-time. We have turned around this critical element
of our business and are meeting the expectations of our
customers, while growing at a significant rate. That last point is
very important. We are meeting current demand, and we are
planning and building our production capacity for the larger
company we are becoming.
OPN: What are the Biomet Spine • Biomet Trauma objectives for
research and development moving forward?
GK: I have been pleased with the quality of the engineers and
scientists who have joined our company and those who have
continued on page 21
20 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 20
stayed with us. I am also encouraged by the enthusiasm of
renowned surgeon thought leaders who are now creating new
products with us. We will drive innovation in our more traditional
lines with highly experienced surgeon designers and the
strong internal R&D team we have built. We have also begun
some exciting feasibility work involving the use of bone growth
stimulation in degenerative disc disease and vertebral bone fracture.
We are driven to find new therapies for patients.
We have mapped out a long range R&D plan. This has brought
logic and clarity to our portfolio decision-making process, allowing
us to imagine new ideas and create new products. Efficiency
and creativity will define the future of our R&D work.
Exhibit 6: Biomet’s Company Theme - One Surgeon. One Patient.
OPN: At the beginning of the year, Biomet announced a new company
theme entitled “One Surgeon. One Patient SM .” What does this statement
mean to your business?
GK: Over one million times per year, Biomet helps one surgeon
provide personalized care to one patient. We can think of our
work as making one million implants, or attending one million
procedures, but those are abstractions that do not truly describe
the impact our products have on the lives of those patients.
When we recognize that we help one surgeon improve the life of
one patient, and that we do this very meaningful activity over 1
million times per year, we begin to appreciate the value and
importance of our work. When a patient and her family face surgery,
their world stops as they await the outcome of the procedure.
They are relying on everyone in the healthcare system,
including us. This theme reminds us that each action we take in
the manufacture and sale of our products is of the utmost importance,
because it will affect the life of one patient. It inspires us
to remain responsive to each surgeon...this, but the One
Surgeon. One Patient SM does keep us appropriately focused. (See
OPN: What do you expect from your company and your people during
this next phase?
GK: The bad years are behind us. We have made progress on our
“Pathway To Growth.” Now we must continue to execute. We
have set aggressive revenue goals, but not unreasonable ones. I
want everyone at Biomet Spine • Biomet Trauma to take care of
the activities we must accomplish today, but each person must
also stay absolutely focused on planning and working toward
the company we will become.
Our market share is about three percent in most of our businesses.
But we must conduct ourselves as if we are a company
with 20 percent market share. We must…we WILL demonstrate
excellence. This company is emerging; our revenue growth has
begun to move in a very positive direction. I believe that everyone
in the company has begun to accept the view that good
things are happening and each person is making real change.
Those employees who have been with us for years know we
have a different company now. They’re on board. New employees
and new salespeople have joined the organization because
they believe we can become a much larger entity in spine and
trauma. Surgeons who have worked with Biomet for years and
those who newly have come to know us seem convinced that we
are creating something exciting and strong here.
I know we can succeed with continued hard work fueled by
enthusiasm for all the good things this company is today and all
the things it will be. The future looks very, very good to me.
Glen Kashuba is the Senior Vice President of Biomet, Inc. and
President of Biomet Spine • Biomet Trauma. With nearly 25 years of
experience in the medical industry, he has been at the helm of Biomet
Spine • Biomet Trauma since April 2007. Prior to Biomet, Mr.
Kashuba had worked for Johnson & Johnson for nine years. He served
as Worldwide President of Cordis Endovascular, Worldwide President
of Codman Neuro Science, and U.S. President of DePuy AcroMed,
now known as DePuy Spine. Mr. Kashuba also held several key management
positions during his eleven years with Howmedica/Pfizer.
Interested parties may send comments to firstname.lastname@example.org .
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 21
PRODUCT NEWS AND LAUNCHES
Locking Plate for Hallux Valgus
Correction using Ludloff
Globus Medical commenced global launch of the
COALITION ACDF Spacer System, an integrated plate and
spacer for use in anterior cervical discectomy and fusion. The
COALITION technology combines a PEEK interbody spacer
with a titanium alloy plate and two titanium alloy screws. The
delivery system and two-screw design reduce procedural steps,
minimize retraction and lag the spacer to the vertebral
endplates to compressively load the fusion area.
(Globus Medical, Inc., 6/2/09)
SpineMatrix launched Lumbar Matrix Scan, a non-invasive
diagnostic technology that uses bioelectric signals produced by
muscles to accurately identify the source of low back pain.
(SpineMatrix Inc., 6/10/09)
HydroCision launched the SpineJet Percutaneous Access Set
for use in herniated disc procedures. The system uses a high
velocity water jet to cut and remove nucleus material under
local anesthesia and on an outpatient basis.
(HydroCision Inc., 6/15/09)
The new Merete Ludloff plate allows the surgeon to obtain
RIGID LOW PROFILE fixation for Hallux Valgus correction
using the familiar Ludloff osteotomy technique. Previous fixation
with only 2 screws required non-weightbearing post op
care. The Merete Ludloff plate allows for angle stable fixation.
The Merete Ludloff plate is a patented design with locking
and non-locking holes. The straight section of the plate is
placed dorsally on the metatarsal where the plate is fixed to
the bone with two 3.0 mm non-locking cannulated screws.
First screw located through the plate at the apex/rotation
point of Ludloff cut and second non-locking screw is placed
distal after cut completion and lateral rotation for correction.
The screws can be angled up to 12° in the plate in order to run
perpendicular to the osteotomy cut, compressing the osteotomy.
Two locking screws 3.0 mm or 3.5 mm are inserted from
the medial side to gain angle stable locking fixation of the
osteotomy and to allow early weightbearing.
• 3 low profile plate lengths are available (31 mm, 34 mm
and 38 mm).
• Plates and screws are manufactured from Titanium alloy
The patented Merete Ludloff plate has been developed in
collaboration with Steven K. Neufeld, M.D., Orthopedic Foot
and Ankle Center of Washington.
Merete Medical GmbH
LifeModeler released LumbarSIM, an addition to its virtual
prototyping software portfolio. LumbarSIM automatically
creates a detailed lumbar spine model, separating it into
individual vertebral segments and disc forces for use in preoperative
planning for spinal fusion, discectomy and
laminectomy. Reports generated by the software allow for
incorporation of hypertext, plots, live video and model
animation. The software’s operational characteristics are
designed to mirror the workflow commonly found on a personal
(LifeModeler, Inc., 6/23/09)
K2M launched CASPIAN, an all-inclusive system for rigid
posterior fixation in the treatment of complex cervico-thoracic
conditions. CASPIAN provides 2 different polyaxial screw
options, the Mini DENALI® and Mini MESA®, for intraoperative
flexibility. Mini MESA features K2M’s Zero-Torque
Technology® which applies zero twisting forces to the spine
when locking the system.
(K2M, Inc., 6/30/09)
ArthroCare launched the Opus® AutoCuff® Magnum M Suture
Anchor. The device is designed to provide a simpler, faster and
replicable process for performing arthroscopic rotator cuff repair.
(ArthroCare Corp., 7/1/09)
CONMED Linvatec launched the Linvatec Shoulder
Restoration System (SRS) for rotator cuff repair. The SRS allows
the surgeon to intra-operatively choose from multiple surgical
techniques, including single row, double row and transosseous
equivalent fixation. Elements include the PEEK-based
CrossFT Fully Threaded and PopLok Knotless Suture
Anchors and titanium Super Revo-FT and ThRevo-FT
Fully Threaded Suture Anchors.
(CONMED Corporation, 7/7/09)
22 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
PRODUCT NEWS AND LAUNCHES
Integra LifeSciences launched Integra Mozaik
Osteoconductive Scaffold strip in a new smaller configuration,
designed to fill bone voids or gaps in the extremities, spine and
pelvis. When used with bone marrow aspirate, Mozaik may
obviate the need to harvest bone from the patient’s iliac crest.
Integra expanded its Uni-CP Compression System with the
Interaxis locking plate for smaller patient anatomies and the
T-Shape locking plate, designed for increased stability in a
Lapidus procedure or 1st metatarsal-cuneiform fusion. The Uni-
CP plates use Surfix® locking technology to enable placement of
the plate at an optimal distance from the bone, followed by
locking of the screws.
(Integra LifeSciences Holdings Corporation,
7/13/09 and 7/16/09)
Cayenne Medical commenced commercial launch of its
CrossFix System for both open and arthroscopic meniscal
repair. Unlike all-inside meniscal repair devices, CrossFix leaves
no plastic implants behind, thus reducing risk of injury over
time. The device includes an incorporated cannula and depth
limiter to control needle penetration and reduce the risk of
(Cayenne Medical, Inc., 7/16/09)
OrthoDynamix launched ArthroSteer technology in the U.S.
to address joint pain issues from sports injuries, genetic
damage and pre-arthritis by improving access in hip and other
arthroscopic procedures, to eventually include spinal
applications. The platform of disposable instrumentation is
designed to allow surgeons to steer instruments via a multicontrol
device. While the jaw opens and closes, the flexible spine
bends 180° and the jaw rotates 360°.
(OrthoDynamix LLC, 7/27/09)
ThermoGenesis introduced the Res-Q 60 BMC System, an
automated point of care cell processing device for the
concentration of bone marrow-derived stem cells. The company
will initially target orthopaedic regenerative applications
through its distribution partner, Celling Technologies.
(ThermoGenesis Corp., 8/6/09)
Titan Spine commenced limited market release of its
ENDOSKELETON® TT transforaminal lumbar interbody
fusion device. ENDOSKELETON TT has been used in >20 cases
(Titan Spine, LLC, 8/6/09)
Medtronic launched the T2 SCEPTOR Distractible End
Cleats System, a vertebral body replacement, in the U.S. The
system is used with PYRAMESH® C Titanium centerpieces and
additional instrumentation to augment stability in the thoracic
and lumbar spine.
(Medtronic, Inc., 8/12/09)
Wright Medical launched the CORETRAK Articulating
External Fixator for foot surgery. The device is available in the
U.S. and in select ex-U.S. countries.
(Wright Medical Group, Inc., 8/17/09)
VQ OrthoCare launched the OActive Osteoarthritis (OA) Knee
Brace with supporting BioniCare technology, an electrical
stimulation system indicated as an adjunctive therapy for
relieving pain and symptoms associated with knee OA.
(VQ OrthoCare, 8/23/09)
OsteoMed launched the EnCompass metatarsal resurfacing
implant, intended for the treatment of degenerative and posttraumatic
arthritis in a cemented or cementless fashion.
(OsteoMed L.P., 8/24/09)
US Spine announced commercial launch of the Preference 2
Complex Spine System for the treatment of complex
pathologies such as scoliosis, kyphosis, trauma
(US Spine, 8/26/09)
Integra LifeSciences launched 5.5mm Coral cobalt chrome
rods in a range of lengths for use in spinal correction and
fusion. The Coral System now offers 3 rod options, including
rigid and malleable titanium rods.
(Integra LifeSciences Holdings Corp., 9/1/09)
VertiGraft® VG2®Cervical With
LifeNet Health introduces Preservon® ambient temperature storage
for VG2® Cervical. This proprietary and patented preservation
solution is a glycerol-based technology which is proven to
offer the same biomechanical strength, osteoconductivity and biocompatibility
of frozen bio-implants.
• Reduces brittleness associated
with some freeze-dried
• Maintains osteoconductive
• Uncompromised patient
• Eliminates frozen
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 23
Physician Dispensing: A Cost
Savings, Patient Benefit, and a
Revenue Producing Alternative
Author: John McGuire
As physicians continue to seek ethical, legal and sustainable ancillary
revenue sources, they also look for ways to promote better
patient services, conveniences and improved treatment.
Therefore, more and more physician practices are providing onsite
pharmacy programs tailored to their medical office, surgery
center or clinic. Currently, the average physician spends over an
hour per day dealing with pharmacy issues, but typically doesn’t
realize any revenue or compensation for his efforts. Further, pharmacy
issues often create additional work for an office employee or
nurse that will take time away from patients and other productive
functions. Not to mention constant time on the phone, faxing,
inquiries from illegible handwriting and the need for prior authorization
for refills, all of which are a great waste of time.
Many states permit physician dispensing, as long as there is
adherence to state and federal regulations. Properly constructed,
direct physician dispensing can benefit the patients by improving
compliance, resulting in better care, elimination of potential pharmacy
errors, reduced costs for patients and payers, and avoidance
of travel, long lines and wait time at the pharmacy.
Physicians can now help patients avoid these inconveniences
and improve their healthcare and costs by dispensing their medications
before they leave the office, clinic or surgery center.
Dispensing from physician offices also makes doctors more aware
of the drug costs, which creates and promotes more generic substitutions.
For the physician’s practice, direct dispensing eliminates
a great deal of the wasted time and hassle associated with
dealing with a pharmacy. Instead, the doctor and staff can use that
time to create a significant revenue and profit stream for their
practice. Over 90 percent of payers nationwide will reimburse a
dispensing physician. Typically, a dispensing physician can earn
approximately $4 to $8 per prescription. (See Table 1.)
Creating this ancillary revenue can produce approximately
$70,000 to $100,000 in additional annual income for the practice.
Creating a physician dispensing program normally requires a
great deal of detail and start up, and the complexity of the start up
will require most practices to partner with a reputable vendor that
meets all of the necessary requirements and can effectively train,
monitor and improve your profitability at start up and beyond.
Needless to say, it takes time to develop an effective program, but
this responsibility may be delegated to a staff worker or medical
Regardless of the person designated to the task, however, the
success of the operation is directly related to the level of physician
commitment. The most successful operations are those in which
the physicians are directly involved in the selecting and recommending
the medications. In addition, physicians should select
medications that have the best therapeutic value while maintaining
a favorable price point and that remain similar to the products
that have previously been prescribed for patients of the practice.
Limiting the inventory at first allows the physician to become
familiar with the products, services and costs. As the program
Table 1: Monthly Earning Opportunity
1 Prescription Per
1.5 Prescriptions Per
2 Prescriptions Per
2.5 Prescription Per
20 Patients Per Day $2,400 $3,600 $4,800 $6,000
30 Patients Per Day $3,600 $5,400 $7,200 $9,000
40 Patients Per Day $4,800 $7,200 $9,600 $12,000
Based on 20 days per month and $6.00 net per prescription.
Source: Physicians Total Care
continued on page 25
24 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 24
expands, additional items can be added on an individual basis. It
is important to have extra space for storing products to maintain
an adequate inventory for normal prescriptions along with variations
and specialty items. A simple accounting system (which can
be supplied by vendors along with software) will allow for sales
and inventory tracking. It is important to train all staff members
to be familiar with the products that you carry. Although this may
be time-consuming initially, it is an important part of the success
of the dispensing business.
When you begin to search for a Point-of-Care dispensing partner
(vendor), be sure to choose one that has experience as a
DEA/FDA licensed repackager, totally focused on patients and
with the commitment to improving healthcare. Also, be certain
that the vendor will make all medications available quickly and
easily, will provide software or electronic connectivity for claims
and will track and provide refills (which account for over 50 percent
of all prescriptions) and support extensive on-site training
and customer service.
Physician dispensing can improve healthcare costs, services
and patient outcomes while increasing a physician’s practice
income. It also creates higher patient compliance which, it turn,
lowers overall health care costs for patients and payers. It is safe,
legal and endorsed by many organizations including the
American Medical Association.
John M. McGuire, M.A., C.P.A. is Co-Founder/President and Chief
Executive Officer of Surgical Implant Services. Experiences include over
18 years of business and operational activity in the corporate community,
organized medicine, healthcare purchasing and contracting, as well as
the healthcare manufacturing industry. Mr. McGuire brings seven years
of direct experience in the medical device-manufacturing arena, where he
has held positions of increasing responsibility in senior management. He
can be reached at email@example.com.
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 25
PRACTICE MANAGEMENT SOLUTIONS
The Best Asset Protection Is Not
Asset Protection…Is Yours?
Authors: Lori Adasiewicz, Esq;, David B. Mandell, JD, MBA; Jason M. O’Dell, CWM
Too many physicians over the last decade have sought cookiecutter
asset protection plans to give them some peace of mind
that if they ever endure an outrageous malpractice case, they
won’t lose everything. While we admire this commitment to
pro-actively managing risk, we often remind our doctor-clients
that all “asset protection plans” are not created equal. In fact,
many will not even “work” if they ever are relied upon.
Why is this? Essentially, it is due to a basic tenet of asset
protection: any asset protection plan that will truly stand up if
challenged must have economic substance. Taken a step further,
superior asset protection planning would involve tools that are
primarily used by people for non-asset protection purposes. In this
way, the best asset protection plans include tools typically not
thought of as “asset protection tools.” In other words, “the best
asset protection is not asset protection.”
Just Like Tax Planning
While few physicians realize this crucial fact about asset
protection, leading attorneys in the field know it quite well. In
fact, this adage applies not only to asset protection, but also to
Simply put, when determining whether or not a particular
transaction with significant tax benefits is an illegitimate tax
shelter or not, the IRS or tax court uses a simple test: Would a
taxpayer have done this if not for the tax benefit? In other words,
they ask whether or not this transaction was simply done to save
taxes or did it have another economic purpose. If there was such
a purpose, the transaction typically stands; if was only taxmotivated,
This same test applies when evaluating whether or not an
asset protection strategy will be upheld when challenged by a
creditor. Here, the question is, “Did this transaction have an
economic purpose, or was it simply done for asset protection?” If
you are using tools that millions of American use daily for nonasset
protection purposes, you can convincingly answer, “Yes.”
Asset Protection as a Sliding Scale
In the books the authors have written for doctors, including
our latest, For California Doctors: A Guide to Asset Protection, Tax
and Estate Planning, we use a sliding scale to evaluate asset
protection techniques. The lowest (-5) is an asset that is
completely vulnerable and the highest (+5) represents an asset
that cannot be taken by a creditor, even in bankruptcy. This is
important to understand, because every (+5) asset protection
technique, whether in a personal or practice implementation, has
significant economic benefits to the client, irrespective of asset
Asset Protection That Isn’t
Which asset protection tools are not asset protection tools?
Let’s examine a few them briefly.
Qualified Retirement Plans: The term “qualified” retirement
plan means that the retirement plan complies with certain
Department of Labor and Internal Revenue Service rules. You
might know such plans by their specific type, including
pensions, profit sharing, money purchase plans, 401(k)s or
403(b)s. Properly structured plans offer a variety of real
economic benefits. You can fully deduct contributions to these
plans, and funds within them grow tax-deferred. In fact, this is
likely why most medical practices sponsor such a plan.
What you may not know is that under federal bankruptcy
law, and nearly every state law, these plans are protected against
lawsuits and creditor claims – enjoying (+5) protection status.
IRAs are also (+5) protected in bankruptcy, with some limits,
although their state protection depends on the state. For both,
the overwhelming majority of millions of Americans who use
qualified plans and IRAs are not using them for asset protection
purposes. This, then, is a great example of attractive economic
tools that just so happen to have tremendous asset protection
benefits as well.
continued on page 27
26 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
PRACTICE MANAGEMENT SOLUTIONS
continued from page 26
“Hybrid” Qualified/Non-Qualified Retirement Plans: Nonqualified
plans are relatively unknown to physicians, despite the
fact that they are right in the tax code. These plans should be
very attractive to physicians, as they can be terrific hedges
against future tax increases and can be used only in conjunction
with qualified plans. Once again, hybrid plans are generally not
used for asset protection purposes, but they may have such
benefits – depending on how they are structured.
Captive Insurance Companies (CICs): CICs are used by many of
the Fortune 1000, for a host of strategic reasons. In this
technique, the owners of a medical practice actually create their
own properly-licensed insurance company to insure various
types of risks. These risks can include economic (that reimbursements
drop), business (that electronic medical records are
destroyed), litigation (coverage for defense of harassment claims
or HCFA audits) and even medical malpractice (keeping some
risk in the captive and reinsuring the rest). If it is created and
maintained properly, the CIC is like any insurance company. It is
established in a real economic arrangement with its insureds.
Also, CICs can enjoy tremendous creditor protection (+4/+5),
although they are almost never created for this purpose.
Creating Business Entities: Many doctors are still operating their
medical practices in the worst ways possible – as general
partnerships or sole proprietorships. Some have formed a
professional corporation to hold their practice and medical
equipment. This is a good first start, but putting all eggs into one
basket may not be the best solution. Using multiple entities may
be a more appropriate solution for a number of business and tax
purposes, and may also provide better asset protection.
For example, if your practice (or one of the doctors) owns the
building in which the practice operates or medical equipment
used in the practice, it may be advisable to create separate
entities to hold those assets. There are three asset protection
goals of separating the ownership of the real estate and
equipment (RE) from the operating practice.
• First, the RE is a valuable asset that should be isolated from
any liability created by the practice. By isolating the real
estate, you shield it from potential malpractice or employment
liability created in the practice.
• Second, the RE itself may cause liability. That liability could
be in the form of slip-and-fall claims from those coming
and going on the premises. The liability could also be
brought about by damages resulting from the equipment
(or improper use of it by an employee) injuring a patient or
employee. If the RE and the practice are operated by the
same legal entity, all “eggs” are in the same “basket.” This
means that the claim will be against an entity that has
something to lose – all of those valuable assets. By
separating the RE from the practice, you also protect the
practice from these risks.
• If there is a claim against the doctors personally, a business
entity also provides (+2) protection from such claims.
Too many physicians who have implemented generic “asset
protection plans” may be disappointed if they are ever attacked,
as they may be ignored by courts that see no economic
substance. On the other hand, those who implement techniques
such as those described above may be pleased. Not only will
their protection be upheld, but they can help build more wealth
along the way.
Lori Adasiewicz is an attorney and educator who helps business
owners like doctors resolve messes, transitions, protection or complex
tax issues to achieve their personal and professional goals. She is a
founding partner with Bay Laurel Law Group, LLP, a Wealth
Strategies Collaborative (www.baylaurellaw.com). She teaches
professionals at the institutional level on estate, tax and business
issues and is a co-author of For California Doctors
(www.forcaliforniadoctors.com). She can be reached at 650-525-0234
David Mandell is an attorney, lecturer and author of five books for
physicians. Jason O’Dell is a financial consultant, lecturer and
author of two books for physicians. They are both co-founders of the
financial consulting firm O’Dell Jarvis Mandell, with over 1,000
doctor clients nationwide. Mr. Mandell and Mr. O'Dell welcome
readers' questions. They can be reached at 800-554-7233 or at
To see your
in the Product
email your information to
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 27
Controlling Device Costs:
Sustainable Innovation or
Author: David Kirschman, M.D.
Although the outcome of the current U.S. health care reform effort
is far from certain, it is clear that there is a renewed effort to maximize
healthcare access and minimize costs. Whether resource
limits are ultimately determined by governmental policies or private
sector economics, our industry will see greater pressure to
conform to a sustainable cost structure. How should the innovators
of our industry respond to survive and even thrive in an
increasingly populist healthcare marketplace?
In this new paradigm, innovators must be aware that payors,
public and private, have no intention of paying more for new
technology over current technology. In fact, they would very
much like to pay less. In the payors’ calculus, the only good innovation
is one that clearly and immediately lowers their costs. Even
in those instances in which an innovation promises improved
patient outcomes, higher costs are often still met with resistance.
Companies can respond to this situation in one of two fundamentally
different ways: commoditization or sustainable innovation.
The easy response to pricing or reimbursement pressures is
commoditization – to provide current, “tried and true” technologies
at ever lower costs – and this is precisely what many companies
are doing today. Unfortunately, this leads to a “race to the bottom”
at which the meager profits go to a few players with the
greatest economies of scale or the cheapest product investment.
This is a grim vision for our industry which must be avoided.
A far better alternative is to invent better and more cost effective
ways to treat orthopaedic and spinal disease, to go from more
to less, and to skillfully eliminate anything that does not benefit
the patient. After years of wide margins and free-flowing capital,
this shift will come as a shock to many innovators in our industry.
However, the innovation of economically sustainable device technology
can be as challenging as innovating for a new procedure or
Innovating products for cost effectiveness can take two main
forms – direct and indirect effectiveness. Direct cost effectiveness
involves optimizing value within the device itself. This can range
from simple items such as combining multiple functions into one
instrument or reducing parts in assemblies, to making implants
modular to reduce the implant inventory. Indirect cost effectiveness
involves exacting savings from the surgical procedure or
perioperative care around the device. This may be much more
powerful than direct efforts. An example is the use of percutaneous
fusion technology in an outpatient procedure rather than
four open pedicle screws in an inpatient surgery to perform an L4-
The greatest cost expenditures for orthopaedic procedures do
not come from the devices, but by far from the perioperative,
intraoperative and hospital services delivered around those products.
Thoughtful product innovation driven by a fundamental
understanding of the whole procedure and its perioperative care
requirements can have a marked impact on costs. By reducing
invasiveness, a hospital admission can become a 23 hour observation.
By improving implant delivery, a 23 hour observation can
become an outpatient procedure. Anesthesia times can be
reduced. Expensive intravenous medications can be substituted
by cheaper oral medications.
The cost savings realized by payors can be very significant
when cost-effectiveness is designed into a device. Payors, hospitals
and ultimately patients have shown that they clearly recognize
and benefit from such savings. Additionally, surgeons are
gradually becoming more cost-conscious themselves, especially in
the settings of surgeon-owned centers or under cooperative agreements
The old paradigm was to drive technological innovation at a
justifiably greater cost—innovation generally meant increased
costs and this was funded by payor investment. Though this paradigm
has largely ended, there is some good news: For the companies
wise enough to successfully innovate unique, sustainable
solutions and avoid the trap of commoditization, procedural volumes
will continue to increase, the market will continue to expand
and opportunities for success will abound. Our industry will be
much healthier with multiple companies offering unique, costeffective
next-generation solutions instead of a few dominating
suppliers of commoditized last-generation products.
Dr. David Kirschman is the President and Chief Executive Office of X-
spine Systems, Inc., a global leader in spinal implant development. A former
practicing spine surgeon, he transitioned from private practice to
corporate management in 2006. Dr. Kirschman also serves as an adjuvant
associate professor of bioengineering at the University of Toledo. He
can be reached at firstname.lastname@example.org
28 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
Position Paper On
Prepared by ORTHOWORLD Inc.
Published August 5, 2009
As the healthcare reform initiative moves through the halls of
Washington, we will undoubtedly be debating what treatments
do and do not work and what options should be made available
to the American people. When we enter these heated discussions,
it is imperative that the facts be examined that allow
evaluation of medical procedures and their effectiveness in
returning the health and productivity of the citizenry.
Orthopaedic care has clearly demonstrated its efficacy. Without
question. It has changed tens of millions of lives for the better,
Orthopaedic problems and interventions affect us all at one
time or another in our lives. The National Center for Health
Statistics estimates that nearly 108 million American adults
reported bone and joint medical conditions in 2005. 1 That’s
nearly half of all Americans over the age of 18. Musculoskeletal
disorders and conditions are the leading cause of disability in
the U.S. and the most frequently cited reasons for limitations in
daily activities of life, with 15 million Americans aged 18+
limited by arthritis, back or neck problems, fractures, connective
tissue conditions, etc. More Americans report musculoskeletal
conditions than either circulatory (heart disease, stroke, etc.) and
respiratory (emphysema, asthma, hay fever, bronchitis, etc.)
problems and musculoskeletal conditions remain the greatest
cause of lost work days and medical bed days in the U.S.(ibid)
In 2004, an estimated $849 billion was spent in health care
costs and lost wages for Americans with a musculoskeletal
diagnosis. That’s nearly eight percent of our national gross
domestic product.”(ibid) Furthermore, days lost from work
neared 438 million, costing workers $339 billion in aggregate
Among the most prevalent musculoskeletal problems are
arthritis and back pain.
Arthritis afflicts 47 million Americans and by 2030, nearly 67
million Americans (or about 25 percent of the adult population)
could suffer with arthritis. The most common form of arthritis,
osteoarthritis, afflicts 27 million Americans 2 and is the leading
diagnosis underlying the need for joint replacement
Joint replacement has been shown to be one of the most
highly effective procedures in the history of medicine. Of hip
and knee devices implanted ten years ago, more than 90 percent
remain in place and functional. Few appliances devised by
humankind can offer such a longevity claim. Furthermore, study
after study supports the cost/benefit of joint replacement. For
instance, two studies found that the cost of surgical intervention
for knee arthritis averaged $35,000, while costs for non-intervention
neared $104,000. A similar dynamic surrounded hip replacement
with intervention costing $40,750 vs. $223,094 for nonintervention,
largely due to reduced custodial care. 4,5 In 2007,
some 804,000 primary total hip (THA) and total knee (TKA)
replacement procedures were performed in the U.S.(3)
Combined, these two procedures provided the “system” with
lifetime savings of more than $80 billion.
A study in Canada determined that “THA and TKA result in
significant gains in quality-adjusted life expectancy, and can be
considered cost-effective when compared to other elective
surgical procedures.” 6 Researchers in Spain arrived at similar
conclusions, stating that “the costs of both knee and hip replacement
compare favorably with other medical or surgical
According to Burden of Musculoskeletal Diseases in the United
States, “Joint replacement procedures are proven to be one of the
most successful procedures available today. In the vast majority
of cases, the procedure significantly improves quality of life and
the patient’s ability to continue work, activities of daily living,
and recreational activities.”
While many believe joint replacement to be an elderly
“problem,” it is not. Innovations developed by the orthopaedic
community have made joint replacement more accessible to a
younger patient group and more and more younger patients are
benefiting from joint replacement. For example, in 1997, 26
percent of primary total hip and knee procedures were
performed on patients between 45 and 64 years of age. By 2007,
these younger patients accounted for 40 percent of all primary
total hip and knee replacement patients. 4 These patients are the
lifeblood of our future, the workers of tomorrow whose very
health and activity will fuel growth in our economy. We need
them to be active and productive members of society.
Estimated direct medical costs for arthritis and joint pain
patients in 2004 exceeded $281 billion. Some $22 billion was
attributed to the indirect cost of lost earnings for those aged 18
to 64. 1
These younger workers are also the primary age group
afflicted by low back pain. In 2004, for instance, some 74 percent
continued on page 31
30 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 30
of health care visits for low back pain came from those under the
age of 65. These visits were often accompanied by either a
reduced ability to work or a complete inability to work. In fact,
back pain is the most often cited issue in work or walking limitations,
with some 32 percent of sufferers being limited in the
amount or type of work they can do.(ibid)
All told, low back pain is the most frequently cited
musculoskeletal condition, with nearly 62 million adults in the
U.S. reporting having it. One in two Americans experience back
pain at least once a year.(ibid) Estimated direct medical costs for
all spine related conditions reached $194 billion for the years
2002-2004, with annual indirect costs of $14 billion in lost wages.
Just $29 billion of these costs related to the cost of primary and
revision spinal fusions and inpatient discectomy. Most of the
cost derived from nonsurgical therapies.(ibid)
Although some back procedures remain controversial, the
science of spine surgery is young compared to joint replacement.
However, tremendous strides have been made by the scientific,
surgical and technology communities. In fact, a recent study
found lumbar spine surgery outcomes and cost-to-benefit ratios
to be better than or equal to other types of medical implant
surgeries (e.g. joint replacement and coronary artery bypass
graft surgery. 8
Over the past generation, manufacturers and surgeons have
brought invaluable orthopaedic technologies and treatments to
the American public. We have designed and developed stainless
steel and titanium plates that repair fractures that would
otherwise debilitate patients and leave them bed-ridden as is the
case in many third world countries today. As a result of technological
advancement, these fractures go on to heal in 95 percent
Moving into the future, our country will face a potential crisis.
In 1960, we had 4.5 workers for every retiree. By 2040, that
number will drop to 2.2 workers per retiree. 9 Today, some 140
million Americans under the age of 65 work. 10 An additional six
million elderly Americans are working and more and more are
working full-time. 11 These 146 million Americans will experience
more than two million broken bones each year. More than 80
percent of them will suffer with back pain and they will incur
nearly nine million soft tissue disorders and sprains and strains
in a typical year. And, due simply to wear and tear of their aging
joints (and old sports injuries), they will develop painful
arthritis. In turn, they will need fracture repair and joint replacements,
spinal disc replacement and other orthopaedic interventions
to return them to an active and productive life. Denying or
even diminishing this most basic and essential care would not
only do perhaps irreparable harm to them, but also to the nation,
by depriving it of its economic, social and spiritual engine.
1. The Burden of Musculoskeletal Diseases in the United States, 2008.
2. National Center for Chronic Disease Prevention and Health
3. Agency for Healthcare Research and Quality, Department of
Health and Human Services, hcupnet.ahrq.gov.
4. Gottlob CA; et al. The Long-Term Cost-Effectiveness of Total
Knee Arthroplasty for Osteoarthritis. AAOS Scientific Paper #114,
Atlanta GA, February 23, 1996. (From www.onepatient.us -
Figures adjusted to 2007 dollars, and represent the comparative
cost of surgical vs. non-surgical treatment over the life of an
average 70-year-old patient with end-stage osteoarthritis.)
5. Chang RW; et al. A Cost-effective Analysis of Total Hip
Arthroplasty for Osteoarthritis of the Hip. JAMA, 1996; 11: 858-865.
(From www.onepatient.us - Figures adjusted to 2007 dollars,
and represent the comparative cost of surgical vs. non-surgical
treatment over the life of an average 60-year-old patient with endstage
6. Suarez-Almazor; et al. Gains in Quality-Adjusted Life-Years
(QALYs) in patients undergoing hip or knee replacement. Int Soc
Technol Assess Health Care Meet, 1999; 15:57.
7. Espigares, et al. The 134th Annual Meeting & Exposition of
8. Polly; et al. SF-36 Physical Component Scale (PCS) benefit/cost
ratio of lumbar fusion: comparison to other surgical intervention.
9. Health Care Financing Administration.
10. Bureau of Labor Statistics. Employment status of the civilian
noninstitutional population by age, sex, and race, 2008.
11. Population Reference Bureau. Full-Time Work Among Elderly
The above document is purposely not copyrighted
to allow any and all persons to use all or portions
of it in whatever manner they see fit.
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 31
Emerging Orthopaedic Technologies & Treatments
Recent FDA Clearances
June and July 2009
Extrafix External Fixation System
Buttress (Fang) Plate System
Extrafix External Fixation System
Midfoot Screw System
Ellipse Occipito-Cervico-Thoracic Spinal
System, Zyfuse Facet Fixation System
maxMorespine Spinal System
Perpos FCD-2 Facet Screw
Conquest Spinal System; Facet Screw Spinal
Tactile Guidance System - Hip, Restoris
GMK Total Knee
Four Corner Fusion Plate, Foot System
Talos Intervertebral Body Fusion Device
Inertia Pedicle Screw
Clavicle Plating System
Cortoss Bone Augmentation Material
Graft Fixation System
Titan Pedicle Screw
Mercury Spinal System
Anterior Lumbar Plate
Fortex Pedicle Screw (X-SPINE SYSTEMS)
Results from the Spine Patient Outcomes Research Trial (SPORT), a multi-center
study of 607 spondylolisthesis patients, revealed that those who underwent
surgical treatment reported substantially greater pain relief over time vs. those
who did not undergo surgery.
(The American Academy of Orthopaedic Surgeons, 6/1/09)
Study findings indicate that knee replacement provided ~1 year of better quality
of life compared to reports on patients who didn't have the procedure. Analysis of
study results revealed that the year of benefit cost ~US $18,300, well within the
threshold of $50,000 per year of better-quality life generally considered to be costeffective.
(Wall Street Journal, 6/23/09)
Study results revealed that PET scans (positron emission tomography) were 92%
accurate in detecting the presence of infection in prosthetic knee joints.
(Society of Nuclear Medicine, 6/29/09)
Researchers in the U.K. are modifying Raman spectroscopy to observe bones in
vivo, and perhaps achieve a more rapid, reliable way to detect diseases such as
osteoporosis. (Physics World, 7/6/09)
Study results indicate that the biodegradable TruFit CB plug may be used to treat
damaged knee cartilage. The 26-patient study was followed up with MRI and T2-
mapping imaging at intervals for 39 months. (Hospital for Special Surgery, 7/9/09)
Studies suggest that even older individuals who undergo shoulder joint
arthroplasty may be able to return to full participation in sports and activities
within ~6 months post-op.
(The American Orthopaedic Society for Sports Medicine, 7/10/09)
Pre-clinical cadaver tests indicate that Scorpion Surgical's spinal anchoring device
may place less stress on vertebrae than current surgical methods for spine
stabilization. Clinical trials for the device could begin in one year.
Engineering students sponsored by Bioactive Surgical developed a means to
embed a patient's own adult stem cells into sutures used in the repair of
orthopaedic injuries, such as ruptured tendons. The team has commenced animal
model tests of the stem cell-bearing sutures. (Johns Hopkins University, 7/21/09)
Results of a study of vesselplasty in the treatment of 29 patients with vertebral
compression fractures revealed that 100% of patients noted improved pain scores,
93% improved mobility and 62% had a decreased need for pain medication.
Vesselplasty is an image-guided procedure performed under local anesthesia.
(American Roentgen Ray Society, 7/22/09)
Research suggests that specialized blood cells share a common origin with white
blood cells derived from bone marrow, and that these specialized cells may
contribute to abnormal bone formation.
(University of Pennsylvania School of Medicine, 7/24/09)
Study results indicate that levels of vascular cell adhesion molecule 1 (VCAM-1)
are a significant predictor of the risk of hip and knee replacement due to severe
osteoarthritis. (Arthritis & Rheumatism, 7/31/09)
FDA 510(k) Releasable Database, 6/09 and 7/09
32 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
Ticker Track (Based on close of business, 7/31/09)
Ticker 52-Wk 52-Wk Chg vs. Chg vs.
Company Symbol High Low Close Prior Mo. Prior Yr.
aap † AAQ 3.81 1.28 1.79 -1.1% -49.6%
Alphatec Holdings ATEC 5.15 1.10 3.74 12.7% -21.8%
ArthroCare ARTC.PK 35.90 2.89 13.50 25.0% -36.1%
BioMimetic Therapeutics BMTI 14.04 4.69 10.37 12.2% -22.6%
co.don AG † CNW 1.38 0.53 0.86 -9.5% -43.0%
ConMed CNMD 34.98 11.56 17.58 13.3% -42.2%
Corin Group †† CRG.L 2.65 0.57 1.08 10.2% -61.8%
curasan † CUR 5.00 1.72 3.66 -4.4% 33.1%
Exactech EXAC 28.92 10.74 14.25 -1.7% -50.4%
Inion †† IIN.L 0.19 0.00 0.01 0.0% -100.0%
Japan MDM § 7600 2.45 1.24 2.08 -3.7% -29.7%
MAKO Surgical MAKO 10.00 5.23 8.77 -2.8% 17.2%
NuVasive NUVA 58.88 24.17 41.39 -7.2% -26.3%
Orthofix OFIX 30.47 8.65 27.87 11.4% 17.2%
Orthovita VITA 6.65 1.49 6.53 26.3% 143.7%
Osteotech OSTE 5.96 1.31 4.96 12.7% -13.9%
ReGen Biologics RGBO.OB 5.90 1.55 0.94 -55.0% -63.8%
RTI Biologics RTIX 10.38 1.30 4.43 3.3% -46.6%
Smith & Nephew SNN 60.60 30.01 39.65 6.4% -26.1%
Stryker SYK 68.99 30.82 38.88 -2.2% -39.4%
Symmetry Medical SMA 21.99 3.90 8.56 -8.2% -48.8%
Synthes ‡ SYST 145.73 94.69 111.49 14.5% -23.4%
TiGenix † TIG 7.81 3.04 6.17 -12.4% 9.0%
TranS1 TSON 11.96 4.55 6.20 -0.5% -33.0%
Wright Medical Group WMGI 33.26 11.17 13.92 -14.4% -55.8%
Zimmer Holdings ZMH 74.55 30.67 46.60 8.9% -32.4%
Converted from Euro to USD; 1€ = 1.4164 USD.
Converted from British Pound to USD; 1£ = 1.6661 USD.
Converted from Swiss Franc to USD, 1CHF = 0.9229 USD.
Converted from Yen to USD, 1¥ = 0.0102 USD.
In order for a company to qualify for inclusion in the Orthoinvestor Update, orthopaedics must represent
at least 60% of its revenues.
Company Financials †
2Q09 vs. 2Q08
Company Sales vs.
ConMed $95.1 -12%
Arthroscopy $61.6 -14%
Power Instruments $33.5 -9%
DePuy $1,323.0 +6%
Exactech $43.3 -1%
Knees $18.9 -7%
Hips $6.7 +18%
Biologics/Spine $6.9 +4%
Extremities $5.1 +29%
Other $5.7 -18%
NuVasive $88.5 +54%
Orthofix $127.8 +9%
Spine $70.7 +10%
Orthopaedics $32.6 +9%
Sports Medicine $24.5 +6%
Osteotech $23.4 -15%
Demineralized Bone $14.8 -10%
Traditional Tissue $5.4 +4%
Spinal Allografts $1.8 -18%
Hybrid/Synthetic $0.6 -11%
Client Services $0.2 -89%
Other $0.4 +43%
RTI Biologics $25.9 -
At press time, approximately 3,000 orthopaedic surgeons are
members of OrthoMind. (See Exhibit 1.) Participants have generated
conversations around hundreds of posts with thousands of
comments overall. Surgeons can load a variety of images and files as
supporting media. The aggregation of knowledge in this context
accelerates our learning process.
Exhibit 1: Visual representation of OrthoMind members in the U.S.
The current buzz amongst the member orthopaedic surgeons as
it relates to spine sugery and fixation devices includes:
• Instrumentation for thoracic kyphosis
• Total disc replacement as a gold standard
• Consultant relationships with industry
• Surgical vs. non-surgical treatment for spinal stenosis
• Bone graft extenders for lumbar posterolateral fusions
• Artificial disc replacement in the cervical spine
• Industry supported research
• Bryan cervical disc, Charité, Prestige products
• Allograft in cervical spine fusions, VG2 type grafts
• Integrity of research done on Medtronic’s Infuse bone graft
Additionally, users have set up a subspecialty-specific network
for spine surgeons as a focus group.
One of the significant topics of late relates to spine surgeons and
their relationships as consultants. Users cited as an example the
typical disclaimers that often precede the surgeon’s introduction as
an author or speaker:
“….Dr. XYZ serves as a board member, owner, officer or committee
member for the American Spinal Injury Association, North American
Spine Society, AO North America, Computational Biodynamics,
Progressive Spinal Technologies and Applied Spine Technologies; is a
member of a speakers bureau or has made paid presentations on
behalf of Stryker, Medtronic Sofamor Danek and DePuy; is a paid
consultant for Biomet, DePuy, Medtronic Sofamor Danek, Orthofix,
Stryker, Thieme and Vertelink; has received research or institutional
support from AO North America, DePuy, Medtronic Sofamor Danek
and Stryker; has received royalties from Aesculap/B. Braun, Biomet,
DePuy, Globus Medical, Lippincott, Medtronic Sofamor Danek,
Stryker, Thieme and K2 Spine; has stock or stock options in Globus
Medical, Disc Motion Technologies, Zygoloc, Vertebron, Progressive
Spinal Technologies, Computational Biodynamics, Stout Medical,
Paradigm Spine, K2 Medical, Replication Medical, Spineology,
Osteotech, Applied Spine Technologies, SpineMedica, Orthovita,
Vertelink, Small Bone Technologies, NeuCore, Crosscurrent,
Syndicom, In Vivo, Flagship Surgical and PearlDiver.”
Surgeons are discussing results of a study of patients treated with
vertebroplasty and those treated with simulated vertebroplasty
without cement injections. The article, “A Randomized Controlled
Trial of Vertebroplasty for Osteoporotic Spine Fractures,” was
reported in the New England Journal of Medicine. There was some
concern that the implanted cement could place patients at future
risk for additional spinal fractures.
Surgeons are discussing off-label uses for instrumentation, fixation
devices and cementation strategies in complex and revision cases.
Volumes of detail, opinion and commentary abound inside of
OrthoMind. In this community, all inputs are given an equal voice.
Whether the surgeon is a “thought leader” in the profession or
“subject matter expert” or not, any doctor’s comments can spark a
conversation. New ideas are being catalyzed all the time, and with a
heterogeneous group of minds that spans the Orthopaedic profession
and the globe, we believe more innovations are likely to arise
from this collaboration.
More information about OrthoMind can be found at
The members of the OrthoMind Advisory Team, who created OrthoMind,
are all licensed U.S. practicing orthopaedic surgeons who choose to
preserve their anonymity, not out of ulterior motives, but rather to remain
neutral and unprivileged within the OrthoMind community. OrthoMind
was financed personally by individual orthopaedic surgeons. The
project/site was conceived, developed and enhanced, in collaboration, by
Orthopaedic Surgeons who are in solo and academic practices, and who
are alumni or faculty of the Orthopaedic Programs at the Hospital for
Special Surgery, Johns Hopkins, Harvard, Steadman-Hawkins Clinic,
Mayo Clinic and UCLA. Since its inception, OrthoMind has been a
collective effort of like-minded people. There are no trial attorneys,
pharmaceutical executives or angel investors on the OrthoMind team –
only orthopaedic surgeons. Questions and comments can be addressed to
34 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
A Solution for Undercoding or
Miscoding Spine Procedures
Author: Barbara Cataletto, MBA, CPC.
Originally introduced by Business Dynamics in 2007 as a handheld
coding device, CaseCoder has been redeveloped and designed as
a rules-based .net visual database program that utilizes an intuitive
graphical interface to simplify the spine coding process. It is able to
work on any Internet ready phone, PC or laptop.
Created to simplify the process of capturing the correct
reimbursement for spine procedures, CaseCoder offers confident
coding at your fingertips. It is a web-based, procedure driven spine
coding management system, designed to ease the tedious issues of
coding. Twenty years of experience have identified that there is a
significant concern for undercoding and miscoding procedures that
are being performed in the spine field. Due to the complexity of the
coding protocol, as well as the significant number of codes that are
applied to these procedures, the propensity to code incorrectly is
evident. Approximately 20 to 30 percent of cases submitted to
carriers are undercoded, resulting in an immediate reduction in
reimbursement to the physician.
Standard coding procedure for a spine specialist is to provide the
billing staff with surgical notes for coding and claims filing. The
specialist’s billing staff must decipher from the surgeon’s notes
which techniques and devices were used and determine from
hundreds of codes which ones are appropriate for billing. This is a
formidable process for both the spine specialist and the office staff,
yet it is a significant part of the business. Many of the cases that are
commonly miscoded are those that involve instrumentation with
fusion, interbody fusion with implants, inappropriate selection of
procedures based on lesion diagnosis, and deformity versus
degenerative disease selection. The impact of this miscoding can be
as little as $100 to as much as thousands of dollars per case,
depending upon the coding errors. For example, if a surgical case is
coded as a deformity when in fact it is a degenerative spine with
subsequent deformity, the surgeon can possibly lose thousands of
dollars. Similarly, if the physician is to code an interbody fusion at
several levels and forget to bill for an implant at each level, he then
is omitting a significant amount of reimbursement based on his
With CaseCoder, coding can be done immediately following an
operation by simply answering a series of consecutive questions on
this web-based application. This can be accessed via the Internet,
through an Internet phone (Blackberry, SmartPhone or iPhone) or
any PC or Internet ready laptop. As the spine specialist follows the
prompts and checks the boxes for the procedure conducted,
CaseCoder narrows down the coding choices automatically. Within
just a few clicks, CaseCoder provides the specialist with the proper
codes for billing and reimbursement.
Pilot study participants, including spine surgeons and practice
managers, found a reduction in submission errors, faster documentation
set for billing and an increased awareness of prior miscoding.
“Having the ability to walk out of the OR and quickly and easily
code my procedure will be an incredible time saver for me and my
staff,” said Dr. Marc Agulnick, spine surgeon at Winthrop University
Hospital, New York. “Having a product like CaseCoder that can
assure me that my coded claims are now error proof is an incredible
asset to my practice and our financial performance.”
Other applications and benefits:
• Ability to quickly attain preauthorization for a procedure
• Instant billing to shorten turnaround
• Internal audits
CaseCoder is supported by a call center and the appropriate
training via a web based online module. It will be available for
For more information and to view a demo, please visit www.casecoder.com.
Barbara Cataletto, MBA, CPC, is the Chief Executive Officer for Business
Dynamics Limited (www.businessdynamicsllc.com). With over 20 years
of experience in spine billing and collection, she has developed an organization
that is dedicated to the spine community by offering customized
billing services, focused spine education and CaseCoder. She can be
reached at email@example.com or 516-294-4118.
36 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
Use of Spinal Vessel Protection to
Facilitate Anterior Revision
Authors: James J. Yue, M.D.; Buaer Sumpio, M.D., Ph.D.
Patients who undergo anterior surgical procedures in the
spinal column (cervical, thoracic or lumbar) face the possibility of
needing revision surgery. Whether due to infection, improper
positioning of the prosthesis, device failure, adjacent level
changes or continuing symptoms, approximately 15 percent
(range ten to 30 percent) 1 of spinal fusion surgeries fail and the
patient may need a secondary spinal procedure. Careful patient
selection and meticulous surgical technique may decrease the
need for revision surgery. However, even with these precautions,
anterior spinal revision surgery cannot be avoided in many cases.
Revision anterior spinal surgery has inherent risks such as
intestinal, neurological and vascular injury. To mitigate these risks,
access to the spinal disc is usually performed by highly skilled spinal
and vascular surgeons who are familiar with the intestinal,
neurological and vascular anatomy. 2,7 Brau, et al. reported an overall
11 percent (7/63) incidence of vascular injury during revision
surgery. 3,4 In addition to the risk of injury to the aorta, the vena cava
and the iliac vessels, these procedures are also complicated by
scarring around the surgical site. 8 Revision surgery presents a significant
challenge to the access surgeon, since re-exposure of the spine
requires mobilization of the peritoneal sac, which is usually fused to
the anterior abdominal wall muscles, as well as mobilization of the
major vessels and ureter, which at the time of surgery are encased in
fibrous tissue and firmly adhered to each other and the anterior
surface of the spine. Sometimes this can present an enormous
problem depending on the type of revision required. Interestingly
enough, it has been reported that even at only ten to 14 days there is
already a capsule surrounding an intervertebral device. 6
A few papers specifically address the problem of vascular
injury. Unfortunately, the results and reported complications vary
widely. Nguyen et al. 9 reported an 89 percent incidence of vascular
complications at L4/L5 and 40 percent at L5/S1.Wagner et al., 10 on
the other hand, report only one vessel injury in 21 revisions of the
Charité artificial disc 5 while Gumbs et al. indicate three percent
injury. 2 Despite this variance in results, revision surgery is often a
complex procedure and, thus, a device that facilitates the
procedure and reduces the risk of injury to surrounding tissues,
especially blood vessels, would be highly desirable. 11
To address this problem, a new class of product, the vessel
guard, is now available to the spinal surgeon. These products are
indicated as a cover for vessels following anterior vertebral
surgery. The products that are now commercially available
include those in Table 1, and examples are pictured in Exhibit 1.
Table 1: Vessel Guard Products
Product Name Company Construction
PTFE: polytetrafluoroethylene; HPAN: hydrolyzed polyacrylonitrile; PVA: polyvinyl
With each product, a biocompatible, biomaterial-based membrane
is inserted at the conclusion of the index surgical procedure. The
membrane is designed to prevent infiltration of tissue around the
surgical site and surrounding blood vessels. By preventing fibroblast
penetration, vascular wall attachment to the membrane is minimized
and reoperation is thereby facilitated. All of the products take
advantage of non-resorbable biocompatible polymers that are
permanents implants. If revision surgery is required, the vessel guard
would be visible to the surgeon and mobilization of the necessary
tissues, organs and vessels would be facilitated.
Method of Use
After conclusion of the anterior spinal surgical procedure, and
prior to releasing retraction of the vessels, an appropriate sized vessel
guard is placed directly anterior to the vertebra. The vessel guard can
be stabilized to the surrounding soft tissue, periosteum or directly to
the vertebra(e) using sutures. Retraction of the vessels is then released
and they are allowed to lie anterior to the vessel guard. Verification of
pulsatile blood flow and direct visualization of venous return is made.
In the anterior cervical spine, the vessel guard is similarly placed
directly anterior to the vertebra(e) and posterior to the esophagus. If
so desired, the vessel guard can be placed anterior to the carotid
sheath as well. Alternatively, the vessel guard can be placed directly
over an anterior cervical plate again posterior to the esophagus.
Because Replication Medical’s EnGuard and MiMedx’s Paradís
Vaso Shield devices are so new (2009 FDA clearance), no
published clinical data is available at this time. However, some
clinical data exists for Gore Medical’s Preclude device. For
example, when 14 orthopaedic surgeons were asked the following
questions, their responses were very positive.
continued on page 39
38 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 38
Exhibit 1: Vessel guards in example of use
Question Yes No
Did the Gore ePTFE membrane facilitate
the revision surgery?
Did the Gore ePTFE membrane protect the
vessels during the approach/exposure of the
Did the Gore ePTFE membrane provide a clear
plane of dissection against the vasculature during
the approach/exposure of the anterior spine?
Gore also reports data on 21 revision surgeries with an average
time to revision of nine months with a range of between two days
and 30 months. The results were very positive. For example, in 81
percent of the cases, the surgical time to access the spine was
between 30 and 60 minutes, and in 76 percent of the cases, there
was less than 100cc of blood lost. Finally, Gore also reports plane
of dissection data, as shown in Table 2.
Table 2: Plane of Dissection Data for Gore Preclude
Plane of Dissection Near Vessels
Vessel Mobility Near the Anterior Spine
70% 30% 0% 0%
52% 39% 9% 0%
Gore ePTFE Membrane Ease of Dissection From Vessels
Easy Difficult Difficult
78% 18% 4% 0%
Extent of Tissue Attachment to the Gore ePTFE Membrane
None Minimal Some Significant
39% 52% 9% 0%
It is hoped and anticipated that Replication Medical and
MiMedx will publish similar results as soon as they become
available so that a suitable comparison of products can be
There is a definite risk of blood vessel injury while accessing the
spine in preparation for anterior revision surgery. This is due mainly to
the development of fibrotic tissue at the initial surgical site. This tissue
complicates mobilization of the peritoneal sac which is usually fused to
the anterior abdominal wall muscles. Further, mobilization of the
major vessels and ureter is made more difficult because at the time of
surgery they are encased in fibrous tissue and firmly adhered to each
other and the anterior surface of the spine. Thus, the high percentage
of revision surgeries, the risk of vessel damage and the added
complexity of the procedure due to scar tissue have created a need for
a device that will both protect the spinal blood vessels and facilitate
reoperation by forming a permanent visible barrier or plane separating
the blood vessels from the surgical site. These new products seem to be
very successful in meeting this need as they appear to be easy to use
and quite effective in facilitating anterior revision surgery.
1. Chien-Jen Hsu, et al. Clinical Follow Up After Instrumentation-
Augmented Lumbar Spinal Surgery in Patients with Unsatisfactory
Outcomes. J Neurosurg Spine Vol. 5 No. 4. 281- 286 (2006); RWHu, S
Jaglal, T Axcell, et al. A population-based study of reoperations after
back surgery, Spine, 22, 2265-2271 (1997); A D Malter, B. McNeney J D
Loeser, et al. 5-year reoperation rates after different types of lumbar
spine surgery, Spine, 23, 814-820 (1998)
2. Gumbs A, Shah R, Yue J, Sumpio BE. The open anterior paramedian
retroperitoneal approach for spine procedures. Arch Surg 2005;
3. Brau SA, Spoonamore MJ, Snyder L, et al. Nerve monitoring changes
related to iliac artery compression during anterior lumbar spine
surgery. Spine 3: 351-5 (2003)
4. Brau SA, Delamarter RB, Schiffman ML, et al. Vascular injury during
anterior lumbar surgery. Spine J 4: 409-12 (2004)
5. Gumbs A, Hanna S., Shah R, Yue J, Sumpio BE. Revision open
anterior approaches for spine procedures. Spine J 2007:7: 280-285.
6. SBrau SA, Delamarter RB, Kropf MA, Watkins III RG, Williams, LA,
Schiffman, ML, Bae HW: Access Strategies for Revision in Anterior
Lumbar Surgery, Spine 33 (15):1662-1667 (2008)
7. Sumpio BE. “Technique of Anterior Exposure of Lumbar Spine” In
James J. Yue, Rudolf Bertagnoli, Paul McAfee, & Howard An (Editors)
“Motion Preservation Surgery of the Spine: Advanced Techniques
and Controversies,” Elsevier, Philadelphia, PA Chapter 15141-147, 2008.
8. Spate K, Sumpio BE. “Management of Complications of the Anterior
Exposure of the Lumbar Spine” In James J. Yue, Rudolf Bertagnoli,
Paul McAfee, & Howard An (Editors) “Motion Preservation Surgery
of the Spine: Advanced Techniques and Controversies,” Elsevier,
Philadelphia, PA Chapter 16 148-154, 2008
9. Nguyen HV, Akbarnia BA, Van Dam BE, et al. Anterior exposure of
the spine for removal of lumbar interbody devices and implants.
Spine 31: 2449-53 (2006)
10. Wagner WH, Regan JJ, Leary SP, et al. Access strategies for revision or
explantation of the Charite lumbar artificial disc replacement. J Vasc
Surg 44: 1266-72 (2006)
11. Gumbs AA, Shah RV, Yue JJ, Sumpio B Revision Open Anterior
Paramedian Retroperitoneal Approaches for Spine Procedures,” Spine J
Vol 7:3, 280-5, 2007
Interested parties may send inquiries to firstname.lastname@example.org.
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 39
Posterior Lumbar Arthroplasty
Author: Manoj Krishna, FRCS, MCh(Orth)
Anterior lumbar arthroplasty is well-established as a surgical
option in the treatment of discogenic low back pain. Clinical use
has highlighted several problems with this technology, including
a difficulty in revision, continued facet pain, an un-familiar
approach and that its use is limited and patients with facet or
neural pain cannot be considered for the procedure.
There is also a growing consensus that in order to deal with the
degenerative lumbar segment most effectively with surgery, we
need to address all the pain generators in the motion segment –
including the disc, facet joint and neural structures. This is
because one can never be certain which of the structures is
contributing to the patient’s pain. This is highlighted by patients
who develop facet arthritis after successful anterior lumbar
In response to these issues, Disc Motion Technologies
developed the concept of posterior lumbar arthroplasty. The
company was founded by surgeons Manoj Krishna, Tai Friesem
and Bioengineer Dr. Vijay Goel.
The main advantages of posterior lumbar arthroplasty are that
it uses a familiar approach, deals with all the pain generators in a
motion segment, can be used in a wider cohort of patients and can
be easily revised through an Anterior Lumbar Interbody Fusion.
A summary of the goals of posterior lumbar arthroplasty follows.
1. Remove painful disc
2. Restore normal loading across the disc
3. Decompress neural structures
4. Remove painful facets if needed
5. Restore motion to the painful disc
6. Allow segment to assume a physiological position in sitting
The rationale for arthroplasty is to reduce disc degeneration
adjacent to a fused lumbar segment, and provide more physiological
kinetics and load transmission across the disc. The evidence
that it actually does so is emerging from various studies, but is by
no means conclusive at this stage.
A number of devices replace one of the pain generators, but
few that replace all three in one operation.
Several aspects of the motion segment anatomy influence the
design and surgical technique in relation to posterior lumbar
arthroplasty. The end plates are thickest at the rim laterally, and
thinnest centrally. To avoid subsidence problems, devices need to
be placed as laterally as possible.
In order to place a device laterally the lateral most annulus will
need to be removed. This is difficult, as it is a solid structure and
not routinely accessible to shavers which go into the space
occupied by the nucleus.
Placing a device laterally implies that it is more likely to be
angled slightly medially, as there is not enough room in the lateral
disc to accept a 25mm device.
If paired bilateral devices are used, they need to be parallel to
each other or be able to function as one device in a non-parallel
insertion. DMT’s paired disc allows motion even when the
devices are placed non-parallel.
The goal of successful surgery for axial low back pain is to
address the biomechanics of the painful segment, by removing the
pain generators (the disc and facet joints) and restoring axial
loading across the disc space.
The question arises whether we can place a disc posteriorly
without dealing with the facet joints. Replacing the disc alone
would need at least 50 percent of the facets to be removed, thus
requiring significant dural retraction to insert the discs. There
would be a concern the discs may back out without a posterior
tension band. The mobile, damaged facet joints would also
become pain generators.
If a posterior dynamic stabilizer (PDS) and the disc are used
together, then for any movement to occur, their centers of rotation
must be matched. Asynchronous movement will result in strains
on the adjacent segment. Matching the centers of rotation is not an
easy task, as the instantaneous axis of rotation keeps changing
during motion and is not in a predictable location in degenerative
discs, in any case. Extensive finite element studies have been
performed, and confirmed with cadaver studies, to match the
centers of rotation of the disc and dynamic stabilizer.
continued on page 42
40 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 40
The PDS device will need to
provide shear stability throughout its
range of movement. The typical
lumbar segment moves through an
arc in flexion and extension. The term
angular motion is one way of
describing it. The disc/PDS combination
also needs to restore angular
motion to the segment. This is
different from devices that allow only
rotation around a ball and socket, a
jog of movement in a band or pure
The center of rotation studies of
the Total Motion Segment (TMS) are
presented in Exhibit 1, and illustrate how the center of rotation
(COR) of the system closely matches the normal COR.
The devices are all made of
cobalt chrome, as this offers the
best shear resistance. The disc is
a paired metal on metal device,
inserted via jigs on either side of
the dural sac. Even if they are
not parallel, the discs work as a
pair. The posterior dynamic
stabilizer is angulated to
simulate the arc of motion, and
allows 8 mm of movement
between flexion and extension.
(See Exhibit 2.)
To allow for the changing
center of rotation and to ensure that
the PDS devices are placed parallel,
dynamic and static connectors attach
the PDS to the pedicle screws and
complete the construct. We have also
developed a hybrid device that allows
a fusion at one level and a TMS at the
adjacent level, ideal for two-level
DDD, which is very common. (See
The surgical technique is very
similar to that of a bilateral
Transforaminal Lumbar Interbody
Fusion (TLIF) procedure, with
bilateral facetectomies to allow easy
access to the disc and no new training
Exhibit 1: DMT’s Total Motion
Segment System (TMS)
Exhibit 2: DMT’s Multi-Level
Exhibit 3: Two-Level
Degenerative Disc Disease
needed for surgeons. We have developed jigs which allow for
parallel placement of the discs. The pedicle screws also need to be
placed parallel to each other. Surgical time is similar to that of a
The indications of surgery are similar to those of a Posterior
Lumbar Interbody Fusion/TLIF: patients with low back pain
and/or leg pain who have a degenerative lumbar disc with or
without neural compression.
To date, 40 cases of DMT’s TMS arthroplasty system have been
performed by eight surgeons in four countries, with the first case
done by Dr. Kaptonoglu in Ankara, Turkey, in May 2008. There
have been no major complications and no revisions at the time of
writing this article in August 2009.
The clinical outcomes of the first 25 cases are presented in the
table below. This data was presented at the SAS meeting in
London, England, in May 2009. Two cases developed temporary
Oswestry Disability Index 56 32
Visual Analog Scale-LBP 7.88 2.7
Exhibits 4 through 7 depict of a 46 year old female with severe
lower back and leg pain for five years. She had an isolated
degenerative disc at L4/5 with some lateral recess stenosis. She
had an L4/5 TMS, 12 months ago. Her hospital stay was 24 hours.
She has done extremely well, and is now 12 months post-op.
Her ODI dropped from 82 to 2. (Exhibit 3 shows a pre-op MRI
scan, Exhibits 5 to 7 show post-op AP and flexion and extension
Exhibit 4: Case history of TMS patient
Exhibit 5: Case history of TMS patient
continued on page 43
42 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 42
Exhibit 6: Case history of TMS patient
Exhibit 7: Case history of TMS patient
PDS & Disc (FEM)
PDS & Disc (Cadaver)
in vivo (Pearcy et al, 1988)
We have also performed some hybrid cases with a TMS at the
upper level and an interbody fusion at the lower level, with
rewarding initial outcomes.
When we first started, disc retropulsion was a concern, but
that has been unfounded. No discs have backed out.
Long term device subsidence remains a possibility, but again,
not seen in our cases so far. If the devices are implanted in the
lateral part of the disc, and care is taken in disc preparation, this
should not be a major concern.
There is growing awareness that in mobile constructs, whether
for the TMS system or for dynamic constructs, screw loosening
may be a problem in some cases. Solutions will need to be
developed for this.
Matching the centers of rotation of the PDS and the discs and
making sure the devices are inserted in such a way that they work
together requires care during surgery.
Manoj Krishna, FRCS, MCh(Orth) is a spinal surgeon at University
Hospital of North Tees in Stockton-on-Tees, U.K. Learn more at
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 43
VIEWS ON THE NEWS
In this feature, we will highlight recent news or trends that
might significantly impact your future as orthopaedic surgeons.
We’ll print your views in subsequent issues.
Below is a portion of a recent article describing something we are hearing more and more
about. How will this be reconciled with the healthcare reforms currently under debate?
How Health-Care Reform Could Hurt
By Kate Pickert and Ken Stier
Published: Monday, July 13, 2009
Buried in the 850-page House healthreform
draft is a provision that could
in effect ban further construction of
doctor-owned, for-profit specialty
hospitals and prohibit existing ones
from expanding. (The provision would
prevent new facilities from receiving
any Medicare payments and would
limit changes to current facilities.)
… the target of the House
facilities owned by doctors that
perform some of the most lucrative
medical procedures in fields like
orthopedics and cardiology…
Although there is not ample hard data
yet available to prove that specialty
hospitals take a large bite out of
community hospitals’ bottom lines, a
quick scan of the list of the common
procedures performed at the highly
focused institutions suggests just that.
Orthopedic and cardiac care bring in
some of the highest margin
reimbursements from insurers, money
community hospitals use to cover the
cost of low-margin or money-losing
services like burn units, neonatal care
and treating the uninsured. When
healthier, fully insured patients
migrate away from community
hospitals to specialty facilities, their
reimbursements go with them.
Overall profit margins at specialty
hospitals, sometimes as high as 30%,
dwarf those of community hospitals.
Plus, specialty hospitals don’t typically
treat many Medicaid patients, which
bring in some of the lowest reimbursements
(You can read the entire article at
What do you think?
Email your thoughts to email@example.com.
44 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
Spinal Surgery & Cement Systems
Xsight Spine Tracking System
The Xsight Spine Tracking System works in conjunction with the
CyberKnife Robotic Radiosurgery System to eliminate the need
for surgical radiographic markers, or fiducials, in the delivery of
radiosurgery treatments for spinal tumors in the cervical, thoracic,
sacral and lumbar regions, enabling CyberKnife centers to
offer treatment to more patients. The system uses sophisticated
image-registration to robotically track lesions or targets in or
near spinal structures. This enables medical physicists, neurosurgeons
and radiation oncologists to treat cancerous and
benign tumors easily without implanting fiducials. Additional
benefits of the system include the ability to intelligently track,
detect and correct for tumor motion by using continual image
guidance throughout the treatment. The CyberKnife System
delivers sub-millimeter targeting accuracy for tumors close to
the spinal cord and is nearly 100% eligible for all spine cases.
Recent studies have additionally shown that the Xsight Spine
Tracking System has a targeting accuracy of better than 0.75mm.
AlphaGRAFT ProFuse TM
AlphaGRAFT ProFuse TM is
a demineralized bone scaffold
designed to take
advantage of natural trabecular
AlphaGRAFT ProFuse is
available in both block and
chip forms and is made
100% from tissue, which
provides an optimum environment
• Pre-cut, easy to use compressible allograft designed to conveniently
fit Alphatec Spine’s Novel® Spinal Spacers and
AlphaGRAFT® Structural Allografts.
• AlphaGRAFT ProFuse is packaged in the revolutionary
Vacuum Infusion Packaging | VIP system, designed for
enhanced infusion of cells and bone marrow aspirate.
• Natural osteoconductive construct and osteoinductive potential
are ideal for rapid bony ingrowth.
• Compressive properties and shape memory of AlphaGRAFT
ProFuse blocks allow for excellent endplate to endplate contact,
which is necessary for bony fusion.
• AlphaGRAFT ProFuse chips are a proprietary osteoconductive
matrix consisting of cortical/cancellous particles with
excellent handling characteristics.
Alphatec Spine Inc.
Alphatec Spine offers a fully comprehensive solution for the treatment
of vertebral compression fractures. The OsseoFix+ System
was designed to address the physician’s percutaneous vertebroplasty
needs. OsseoFix+ System features include:
• High radiopacity OsseoFix+ Bone Cement (45% Zirconium
Oxide) provides maximum visibility and radiological control.
• Medium viscosity OsseoFix+ Bone Cement enables controlled
• Closed mixing and delivery system prevents exposure to
• 10g, 11g and 13g Targeting Needles with bevel and trocar
stylets address physician preference.
• Delivery Gun length is over 14”, which minimizes exposure
• 10cc of deliverable OsseoFix+ Bone Cement allows for the
treatment of multiple levels.
Alphatec Spine Inc.
1 Data on file at Alphatec Spine
CaseCoder Web-based Spine
Business Dynamics Group introduces CaseCoder, a web-based,
logical spine coding management system designed to ease the
tedious process of spine coding.
CaseCoder works via the Web on any Web accessible device
including smart phones. Coding can be performed in less than one
minute by simply answering a series of logical questions.
Following the prompts and checking the correct boxes for the procedure
conducted, CaseCoder narrows down the coding choices
automatically performing confident coding at your fingertips.
With CaseCoder, the spine specialist sees an immediate return
on investment as it shortens the turnaround time on claims being
processed. By using CaseCoder, the spine practice is able to reduce
coding mistakes ensuring no codes are missed and alerts you of
any coding conflict, thus promoting maximum reimbursement.
CaseCoder will be available for CPT 2010.
Visit us at NASS Booth 563.
Business Dynamics Group
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 45
Anspach Minimal Access
The Anspach Minimal Access Attachment sets a new standard for
direct visualization of the cutting burr in surgical procedures with
limited viewing access. The combination of the 20° angled driver
or straight driver and the most technically advanced bearing
sleeve design available provide the surgeon with the versatility to
address the most challenging minimal access dissections.
The curved Minimal Access Attachment drivers provide direct
connection to all Anspach pneumatic and electric motor systems,
and the straight driver provides direct connection to all motors
except Black Max. All of the drivers enable rapid exchange of
bearing sleeves and cutting burrs through a unique quick disconnect
Bearing sleeves are available in 10cm and 15cm lengths, either
straight or with a 10° curvature at the 4mm diameter distal tip.
Additionally, the bearing sleeves can be indexed radially in eight
positions and telescoped 3mm to offer flexibility for visualization
Visit us at NASS Booth #1307.
The Anspach Effort, Inc.
Tel: 561-627-1080, 800-327-6887
Stabilimax® Dynamic Spine
Offering stability without
fusion, and a simplified
surgical procedure. The
Stabilimax System allows
a simple surgical
approach, reducing potential
decortication for posterolateral
fusion. No interbody
device with reported
complications. And no
nerve root retraction to
place an interbody device.
System’s dual concentric
spring assemblies in the
Dynamic Connector stabilize
the spinal segment
and control motion. The
ball and socket joints are
designed to minimize the
load applied at/on the
bone/screw interface. The Stabilimax surgical technique consists
of pedicle screw insertion, simple attachment of Dynamic
Connector assembly, and controlled tightening of locking screws.
Applied Spine Technologies is conducting a multi-center, randomized,
controlled clinical trial to compare posterior dynamic
stabilization using the Stabilimax Dynamic Spine Stabilization
System to traditional spinal fusion stabilization to treat degenerative
lumbar spinal stenosis. AST has enrolled over 100 patients to
date. Stabilimax is limited by U.S. Federal Law for investigational
See us in San Francisco at NASS! Booth # 605
Applied Spine Technologies
Biocomposites introduces geneX® putty, a synthetic bone graft in the form of an easy to use putty.
geneX putty possesses a consistent controlled negative surface charge. This initiates reproducible
cell activity, driving endochondral ossification as the putty is fully resorbed and
replaced by bone.
geneX putty has been designed with an optimized composition of beta-tricalcium phosphate
and an ultra pure calcium sulfate component, produced by a patented manufacturing process.
Presented in a pre-loaded syringe, geneX putty combines optimized handling and
unmatched migration resistance with unique surface chemistry to trigger osteoblast differentiation
for superior bone growth.
geneX is the only synthetic biomaterial to show spine fusion equivalent to autograft when
used as a stand alone graft material in the clinically relevant ‘Boden’ rabbit model. 1 This
response has previously only been demonstrated using BMPs. Biocomposites was the first
company to bring resorbable calcium composite devices to the field of arthroscopic sports
medicine and this latest first in bone grafting for spine and trauma is a reflection of the company’s
focus to develop biomaterials that stimulate the appropriate cell response in vivo.
Visit Biocomposites at NASS, Booth 2323.
1 Data on file at Biocomposites
® geneX is a registered trademark of Biocomposites Ltd
46 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
FS3 Facet Screw Spinal System
The FS3 Facet Screw
Spinal System is a cannulated
a range of
allows for fast,
reliable and reproducible
over a guide wire
with minimal exposure
resulting in reduced muscle
and tissue trauma. The partially
threaded screw design maximizes compression of the facet articular
processes while the washer applies forces to the bone to
enhance stability. The double helical screw thread design allows
for faster screw insertion without compromising bone screw purchase.
For more information, visit us at Booth #713 at NASS.
Life Spine, Inc.
Cortoss is an injectable, bioactive composite that mimics the
mechanical properties of human cortical bone and the first alternative
to polymethylmethacrylate (PMMA) cement evaluated in a
large-scale, prospective, multi-center, randomized controlled
study used for the treatment of vertebral compression fractures.
Data from the IDE study prospectively comparing Cortoss and
PMMA show that the therapeutic flow and fill of Cortoss results
• A statistically significant improvement in VAS score at 3
months (11.6%, p
CALENDAR OF EVENTS
Sinai Hospital of Baltimore; Rubin
Institute for Advanced Orthopedics
Osteomyelitis and Segmental Bone
Clinical Orthopaedic Society - 97th
Annual Meeting 2009
Point Clear, AL
American Society for Bone and
Mineral Research 31st Annual
AAOS/ASES/OTA The Shattered
Shoulder: Sorting Out the Pieces
(Course # 3903)
Musculoskeletal Tumor Society
American Academy for Cerebral Palsy
and Developmental Medicine 63rd
American Spinal Injury Association
35th Annual Scientific Meeting
Scoliosis Research Society 44th
San Antonio, TX
AAOS Top Orthopaedic
Controversies (Course # 3321)
New York, NY
AAOS Guidelines: Diagnosis and
Treatment of Carpal Tunnel
Syndrome (Course # 5895)
Techniques in Primary & Revision
Total Hip Arthroplasty
(Course # 3323)
4th Annual AAOS Orthopaedic
Practice Management Course
(Course # 3324)
Orthopedic Trauma Association -
Residents Comprehensive Fracture
San Diego, CA
Knee Society Annual Meeting
Orthopaedic Trauma Association
Annual Meeting - 25th Anniversary
San Diego, CA
Association Annual Meeting
San Diego, CA
AAOS/ASSH Nerve Compression
Syndromes of the Upper Extremity
(Course # 3902)
Musculoskeletal New Ventures
Conference Annual Meeting
Physician Assistants in Orthopaedic
Surgery Annual Meeting
AAOS/AAHKS Knee Arthroplasty:
Uni, Total & Revision Insights, New
Techniques (Course # 3325)
American Shoulder and Elbow
Surgeons - Closed Meeting
AAOS Guidelines: Guideline on the
Treatment of Osteoarthritis (OA) of
the Knee (Non-Arthroplasty)
(Course # 5896)
October 29-November 1
SICOT/SIROT 6th Annual
AAOS 42nd Annual Course for
(Course # 3326)
Techniques in Spine Surgery
(Course # 3327)
48 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
CALENDAR OF EVENTS
4th Annual Northern California Bone
and Mineral Symposium
American Association of Hip and
Knee Surgeons 19th Annual Meeting
The JointVentures Conference: An All
Spine and Orthopedic Investment and
San Francisco, CA
North American Spine Society 24th
Annual Scientific Meeting
San Francisco, CA
AAOS/ASSH Advanced Elbow and
Wrist Arthroscopy and Reconstruction
(Course # 3331)
AAOS Guidelines: Guideline on the
Treatment of Pediatric Diaphyseal
Femur Fractures (Course # 5897)
AAOS/OTA Strategies and Tactics in
Orthopaedic Extremity Trauma
(Course # 3332)
American Academy of Physical
Medicine and Rehabilitation Annual
British Society for Computer Aided
Orthopaedic Surgery (CAOS UK)
London, United Kingdom
14th Instructional Course & 37th
Annual Meeting of Cervical Spine
Salt Lake City, UT
AAOS Top 15 Foot and Ankle
Problems: A Case-Based Approach
(Course # 3328)
Cervical Spine Research Society 37th
Salt Lake City, UT
Current Concepts in Joint
Replacement Winter Meeting
Society of Military Orthopaedic
Surgeons 51st Annual Meeting
American Association for Hand
Surgery Annual Meeting
Boca Raton, FL
Orthopaedic Research Society
New Orleans, LA
American Academy of Orthopaedic
Surgeons Annual Meeting
New Orleans, LA
Hip Society and AAHKS 38th Open
Scientific Meeting/16th Combined
New Orleans, LA
AAOS - American Academy of
Orthopaedic Surgeons Annual
New Orleans, LA
Association of Bone and Joint
Surgeons Annual Meeting
Association Annual Meeting
Spine Arthroplasty Society 10th
Annual Global Symposium on
Motion Preservation Technology
New Orleans, LA
April 28-May 1
Pediatric Orthopaedic Society of
North America Annual Meeting
American Association of Orthopaedic
Executives Annual Conference
Arthroscopy Association of North
America Annual Meeting
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 49
THE TOP LINE
The New “Inducement”?
Author: Teresa Ford
It might strike you as odd that I would use the dreaded word
“inducement” in the title of a regular column whose primary goal
is to educate you relative to legal behavior. But I promise you, I use
the term “tongue in cheek.” What is quite serious is the phenomenon
that I reference in the title—that of orthopaedic surgeons
accepting direct employment with a hospital, hospital group or
other health care system. It is a trend that seems to be sweeping the
country. And while it certainly can seem appealing at first blush, it
is like nearly every other business arrangement available to those
of you in this specialty area: fraught with potential pitfalls.
Why it is an Appealing Option
Running an orthopaedic practice has turned into a very complicated
business. From managing the multiple employees or
consultants who are necessary to keep even a medium-sized
practice running efficiently, to staying abreast of legal and
administrative requirements that change with frustrating
regularity, the physician-run orthopaedic practice can be a very
complex and overwhelming undertaking. So who wouldn’t find a
practice that seems to run itself enticing? The list of headaches that
the employee orthopaedic surgeon need not endure is long and
provides a persuasive argument for hitching your wagon to the
hospital or hospital system that promises you a life of doing what
you trained to do; namely, practice medicine. But like anything else
in life, if it looks too good to be true, it likely is. What follows are
some of the most common things of which physicians should take
note when considering whether to enter into an employment
agreement. And, of course, I am going to tell you to ensure that
you have competent health care counsel walking with you
through every step of the negotiating process.
Term and Compensation
The term of the proposed agreement is simply how long the
parties agree that it will last. Consideration of the term in conjunction
with compensation provisions is pivotal is because most of
these agreements work the same way. For the first year or two the
surgeon is guaranteed a fixed salary with no relation to (or impact
by) Work RVUs or other measures of productivity; thereafter,
however, your actual compensation may be based solely on the
income generated by your Work RVUs. While at first this seems to
make sense, the reality is that you are working just as hard for less
money in many instances. If you are working in a new area of the
country and do not have established patient relationships that you
bring to the employment relationship, you are reliant upon the
hospital or hospital system to effectively market and promote
your practice. Sometimes this happens, sometimes it doesn’t. It is
also critical for purposes of your evaluation of the compensation
offer that you know about the demographics in your area as well
as competing hospitals, ambulatory surgery centers and other
potentially competitive entities that could impact your total
income once you are no longer being paid a fixed salary.
It is the norm that employment contracts such as those I am
discussing here require the physician to provide a number of
ancillary services in order to earn his salary. Such services include
functioning as a medical director, assisting with utilization review,
evaluating vendors and vendor contracts, training of support staff
and other administrative functions. These services are viewed by
the hospital not only as a “value-add” but also as justification
under the health care fraud and abuse laws for paying a fixed
salary. While there is much that could be said about these obligations,
the one critical thing to remember is that the proposed
workload must be manageable. If you cannot perform all of the
services that are required under the agreement, you could be found
to be in breach of a material term of your employment agreement.
Intellectual Property, Inventions and Outside Consulting and
This is a major consideration for any physician who works with
the medical device industry in any capacity and who is considering
direct employment of the kind contemplated here. Express carveouts
for the work you have already done, the work you are currently
undertaking and any work you may undertake in the future are
continued on page 51
50 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
THE TOP LINE
continued from page 50
critical. And while the hospital or hospital system may have legitimate
rights to certain of your intellectual property that may be
created as a result of your employment relationship, it is imperative
that the lines for such ownership are very clearly drawn at the
inception of the employment relationship. Another consideration is
fees that are earned from doing outside consulting and design work.
Those monies should belong to you, but the traditional physician
employment agreement will almost always contain language that
provides for those monies to belong to the hospital.
The “Independence” Factor, or Lack Thereof
I would be remiss if I did not at least touch on the psychological
aspect of physician employment situations. If you come to an
employment relationship after being a sole practitioner or a
member of a multi-surgeon medical group whereun the control of
the group rests with its surgeon members, you must consider how
much autonomy you will forfeit if you accept employment such as
that envisioned here. You will answer to hospital administration
in a much more regimented way and certain aspects of your
practice will be under a microscope like never before. If you are
not the kind of personality who likes being micro-managed, this
aspect of such an employment situation should be considered
thoroughly before you make any commitment.
It suffices to say that the “hassle-factor” of managing one’s own
practice, from reimbursement issues, to disclosure requirements,
to HIPAA, has increased dramatically since most of you left your
residencies and fellowships and headed into the full-time
unsupervised practice of medicine. Direct employment may be
the answer if the circumstances are right; just make sure you ask
all of the right questions before you sign on the dotted line!
The Law Offices of Teresa Ford, PC (www.tfordlaw.com), located in
Houston, Texas, specialize in healthcare and medical device issues. Areas
of expertise include healthcare compliance program structuring and
training, as well as advising individual physician clients. Founding
partner Teresa Ford spent many years in the medical-legal arena, most
recently as senior counsel for Sulzer Medica USA Inc. She can be reached
at 832-251-9595 or firstname.lastname@example.org.
Law Offices of
Teresa Ford, PC
Proud to serve the physician community in matters of
health care compliance and business structuring
2500 Tanglewilde, Suite 318, Houston, Texas 77063
tel: 832.251.9595 • fax: 832.251.9599
Not Certified by the Texas Board of Legal Specialization
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 51
FISCAL FITNESS UPDATE
Information obtained after publication of the last issue of OPN allows us to update our estimates for the world’s ten
largest orthopaedic companies. The pie chart below displays the correct information, which includes Arthrex, whose
2008 global sales of $690 million place it in the top ten.
THE 2008 WORLDWIDE ORTHOPAEDIC MARKET SALES
FOR THE TOP TEN COMPANIES AND ALL OTHERS
Johnson & Johnson
Smith & Nephew
*Includes more than 100 companies worldwide.
52 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
Teaching Fracture Repair
Author: Jeanne Dillner
Dr. Zirkle and I returned to Muhimbili Orthopaedic Institute in
June 2009. During our first visit in November 2008, we were
impressed by the number of orthopaedic residents in training
and the level of sterile techniques employed by the surgeons,
operating nurses and technicians. This, along with the 300 SIGN
surgeries performed since November, made Muhimbili
Orthopaedic Institute a clear choice for being invited to participate
in the SIGN Hip Construct project.
Muhimbili Orthopaedic Institute is a 150 bed hospital located
in Dar es Salaam, Tanzania. Established in 1996 under the leadership
of Executive Director and orthopaedic surgeon, Professor
L.W. Museru, the hospital serves as the main referral hospital for
trauma in Tanzania. (See Exhibit 1.) Professor Museru is respected
by both the surgeons and the nursing staff for implementing
a vision of excellence in patient care and providing his staff with
access to training opportunities.
Muhimbili is a government run hospital that treats the poor.
The patients cannot afford to purchase implants to fix their fractures,
and so were remaining hospitalized for two to three
months in traction. More patients were arriving for treatment
each day than were leaving. By law they could not be turned
away. Wards built for 40 patients were filled with 80, resulting in
patients lying on the floor. Having SIGN implants available for
free to their patients made a dramatic difference to the congested
The SIGN program manager for Muhimbili Orthopaedic
Institute is Dr. Edmund Eliezer. (See Exhibit 2.) He takes responsibility
for reporting the SIGN cases, and has done many of the
cases reported since SIGN first began at Muhimbili Orthopaedic
Exhibit 2: Dr. Eliezer checks on a SIGN patient.
Exhibit 1: Muhimbili Orthopaedic Institute before and after SIGN
Planning for SIGN site visits begins two to three months in
advance. To ensure that all interested surgeons get an opportunity
to scrub, Dr. Zirkle sets a goal of four to five cases each day.
He shows the surgeons the surgical technique by doing most of
the first case, and then lets the surgeons take over aspects of the
continued on page 55
54 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
We were able to do so many surgeries each day because
Muhimbili Orthopaedic Institute has three operating suites dedcontinued
from page 54
technique in each following case so that by the end of the site
visit, three to five surgeons are well trained in the SIGN technique.
Dr. Eliezer was well organized and successfully arranged
interesting SIGN IM Nail and Hip cases, as is indicated by the
list of patients for the first day:
Stella, aged 15 years, received a distal fracture to her left
femur when a portion of the brick wall at her home fell
upon her. Her parents brought her to Muhimbili
Orthopaedic Institute where she lay in traction for four
weeks with no healing. She was diagnosed with sickle cell
anemia. Her doctors conferred with Dr. Zirkle and decided
to give additional stability to the fracture by implanting the
SIGN nail using the retrograde approach with minimal
damage to the growth plate.
Sandra is a vivacious female aged 34 years. Even when
experiencing extreme pain, her outgoing and energetic
nature fills the room with joy. Sandra was driving home
from a funeral when her car ran off the road. The car rolled
over, ran into a ravine and Sandra lay in the car for six
hours until she was found and taken to the hospital. She
came to the hospital that morning with a broken hand and
mid-shaft fracture of her right femur. She was immediately
taken to the operating room where surgeons fixed her hand
with k-wire and placed a SIGN nail in her femur.
Frustrated to learn that she would have to be on crutches
for four to six weeks while her injuries healed, she was
reminded that had she arrived seven months earlier, she
would have been placed in traction and remained hospitalized
for several months.
Leonidas is 45 years old and the main breadwinner for his
family. He was a passenger on a motorcycle that was hit by
a car. The impact caused an intertrochanteric and mid shaft
fractures of his left femur. He was the first patient at
Muhimbili Orthopaedic Institute to receive a SIGN hip
construct surgery. The compression screw stabilized the
proximal fracture and the SIGN Nail provided stabilization
to the proximal and mid-shaft fractures.
Nicolas is 75 years old. He suffered a proximal fracture in
his right femur and a proximal tibia fracture on the same
side. The hospital in his home town did not have the facilities
to fix his fracture, so he was referred to Muhimbili
Orthopaedic Institute, 491 miles away. He traveled by bus
to Dar es Salaam and was admitted on May 6. His surgery
took place on June 2. On July 10, five and a half weeks after
surgery, he was at partial weight bearing and the x-ray
icated to orthopaedics and a very well-run operating theater. Dr.
Eliezer works closely with nurse Immaculata Bura, the manager
of the operating theater, to schedule the cases. Nurse Bura is
responsible to ensure good sterile technique and that the instruments
and implants are ready for the cases. She and her assistant
manager, nurse Redemptive, also train the surgical nurses in the
surgical technique so they can anticipate the needs of the surgeon
during each case. Nurse Bura is in regular contact with me
or with Sharon Bender from our shipping department to convey
equipment needs or discuss improvements to inventory control.
The best programs are those with surgeons and medical personnel
eager to learn new techniques for surgery and patient
care. Surgeons, residents and nursing students at Muhimbili
Orthopaedic Institute enjoyed observing the cases even when it
was not their turn to scrub. On the last day of our visit, the residents
presented the post-op reports for the four hip cases and
four SIGN IM Nail cases that were conducted during our three
days of surgery.
The surgeries were well done and everyone learned from each
surgery. The SIGN hip construct is designed to be used without
a C-arm. The surgeons performed the hip cases well and demonstrated
their tactile senses as they used the pilot drill to create a
path for the compression screws. One hip case was a segmental
fracture, which was a challenge because the interlocking screw
had to enter the femoral head after the rotation was determined
by placing the distal interlocking screw.
Under Professor Museru’s leadership, the surgeons are
encouraged to conduct research. Dr. Eliezer received a grant
from the AO foundation to attend the SIGN conference held at
our headquarters in August, where he presented his paper on
the antiseptic properties of honey on non-infected open wounds.
Dr. Eliezer has been invited to summarize the SIGN conference
for the AO Dialogue. Fifth year resident Billy Haonga presented
a paper at the conference on Muhimbili’s experience with proximal
A natural outcome of starting a SIGN program is that the hospital
will teach the SIGN technique to other hospitals in their
region. Professor Museru has added a new concept whereby the
surgeons from Muhimbili will take the SIGN equipment to
regional hospitals that do not yet have orthopaedic surgeons and
care for trauma patients in the outer regions. This way, patients
with long bone fractures can be treated close to home rather than
make the long, painful bus ride like Nicolas. Their excitement to
expand SIGN beyond their hospital walls and improve
orthopaedic care in all parts of their country is energizing.
Jeanne Dillner is Chief Executive Officer of SIGN, a non-profit organization
that designs, manufactures and donates patented, FDA-cleared
orthopaedic implants to hospitals in developing countries. Ms. Dillner
regularly travels to assist Founder and President, Lewis G. Zirkle, Jr.,
M.D., with the training of surgeons on the SIGN IM Nail System.
Since inception nearly ten years ago, SIGN surgeons have given more
than 45,000 patients a chance for renewed mobility. Ms. Dillner can be
reached at email@example.com.
September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 55
New Film Helps Spine Surgery
Patients Get Back On Their Feet
Author: Richard Longland
In 2002, I started to get some really nasty pains in my lumbar
spine. In 2003, I had myriad tests while gobbling NSAIDs like
PEZ candies. My sitting tolerance worsened to the point at
which my quality of life completely evaporated. While getting
physical therapy, which consisted of nothing more than traction,
I consulted with different doctors to obtain the most appropriate
treatment options. Since my L5/S1 disc was desiccated and dark
on imaging studies and the nerve pain was increasing in severity
and location, I whittled my options down to a century-old
procedure (the gold standard of fusion) or the newfangled artificial
The idea of motion preservation seemed to make sense to me.
On June 24, 2004, nearing the end of the Charité clinical trial, I
underwent artificial disc replacement surgery at L5/S1. (See
Exhibit 1.) I was in the hospital for one and a half days and made
a quick recovery. However, in the terrible process leading up to
that day, I spent hours and hours researching my problem, sitting
uncomfortably while online and reaching out to other
patients through discussion boards, e-mail and eventually by
phone. It struck me then that patients must look in so many
places – too many places for even a “healthy” person—to put the
pieces of the puzzle together. I knew there had to be a way that
I could improve the information gathering process for patients,
making it easier, more efficient and comprehensive.
Exhibit 1: The author’s
artificial disc at L5/S1
When I regained my strength after surgery, I used my energy
to launch a website: ADRSupport. Recalling how helpful interactions
with spine patients were to me in my difficult journey, I
launched a global discussion board in which I still contribute as
a patient and community moderator. Today, the ADRSupport
site brings together ordinary people from all walks of life from
over seventy countries, and it also includes medical professionals
like radiologists and medical technicians. I learned a great
deal, as the editor and administrator at ADRSupport still do. It
was a significant learning process that challenged me to take the
next critical step in my life.
Making a Big Step: Literally and Professionally
Starting a non-profit is great if you love paperwork and have
oodles of money. I am not inclined to bureaucracy and have
never won the lottery. Still, I pressed on while cursing the IRS
applications and started the Arthroplasty Patient Foundation, a
nonprofit organization. I immediately focused on solving the
perpetual problem for spine patients: the best way for patients to
learn about new spine treatment technologies. I sensed that film
would be a great medium for delivering intelligence to patients,
so I started producing a unique film that addresses these startlingly
complex challenges. As the founder of the ADRSupport
community, a film maker and a patient, I was in a unique position
to interview patients and explore opposing viewpoints on
As of July 2009, there is a new information resource that could
accelerate the patient/doctor relationship through a film I produced,
called Getting Back on Their Feet. This 75-minute documentary
is the first of its kind in the spinal arthroplasty world.
Featuring candid interviews with seven spine patients, the film
takes viewers through the process of disc replacement surgery
from diagnosis to recovery. The end result is the visual equivalent
of a how-to manual, helpful to both patients and doctors.
This film is a concise medium that crunches down, distills and
conveys complex information expressly for spine patients.
Medical professionals who watch the film will see and hear
what spine patients are looking for in their treatment and consultations.
Patients who watch the film will be able to approach
their doctors with knowledge about treatment options and especially
a much better understanding of possible risks and compli-
continued on page 58
56 ORTHOPAEDIC PRODUCT NEWS • September/October 2009
continued from page 56
cations. Armed with this crucial knowledge, Getting Back on Their
Feet will help patients and doctors use their time together as efficiently
Thoughtful Analysis and Precise Editing
The film also brings out information that one cannot normally
find through traditional research methods. Even though each
patient interview used the same script, there are highly variable
but different responses. As an interviewer, I learned to ask
the right question and even ask the same question in different
ways to glean information the patient may not have thought
One interviewee, Jim, gives his own scale for measuring
progress during post-op recovery. It isn’t the normal advice
that a doctor would think to give a patient. “When you're in the
bathroom,” says Jim, “there are so many things that happen
that you need to do with your body, such as washing your
hands, shaving your face, getting in and out of the shower, putting
on your pants without a grabber or without somebody
helping you, putting on your socks. These are the things to
watch to determine what your rate of progress is. Forget about
the numbers and forget about everything that everybody talks
about. What you can do in the bathroom tells you how much
better you're getting.”
Listening to these patients’ stories helps other patients feel
that they are not alone in their pain. Eileen tells the camera,
“People don’t necessarily understand pain unless they see
blood and guts.” Ken describes the halting of his active lifestyle
as “Taking a race car and putting it up on blocks.” Patients
share their pain in the film in ways that they could not with
their doctors. Both Ken and Eileen recovered from their surgeries
and returned to active lives.
Education and Empowerment
An additional focus of the film deals with patient empowerment—how
people research and obtain information—as compared
to a more traditional patient role of relying on the doctor
for everything. With the intensity of chronic spine pain, it’s all
too easy for some patients to reach the end of their rope and
think, “Just fix me!” Unfortunately, this mechanical way of
thinking can be risky because patients might not do her due
diligence on potential contra-indications.
For example, if the patient presents a long list of health complaints
and defers solely to an orthopaedic surgeon, that surgeon/patient
team may not have the expertise to address all
the causes of chronic pain afflicting the patient. Fortunately, the
film includes a comprehensive list of risks and contraindications
for ADR surgery. After viewing Getting Back on Their Feet,
the patient will learn how to ask more informed questions
about their spinal condition and the surgeon will come to a better
understanding of the patient’s perspective.
An orthopaedist’s busy schedule may not always leave
enough room to address a worried patient’s questions, and a
spine surgeon may have trouble seeing the problem from a
patient’s point of view. Getting Back on Their Feet attempts to fill
gaps on both sides. Doctors can recommend this film to
patients as a follow-up to an initial consultation. Then, instead
of the patient feeling the need to meet with other doctors to
address their concerns, he can return for a second visit with
new knowledge. This makes for a more efficient consultative
transaction for both parties. When a doctor can fully relate to a
patient’s condition, and when the patient can understand her
pain and treatment options, then both parties can concentrate
on what the patient really needs: to get back on her feet.
Richard Longland is the Founder of ADRSupport and The
Arthroplasty Patient Foundation. He can be reached at
firstname.lastname@example.org. ADRSupport was founded in 2004 and
empowers pre- and post-operative spine patients by supporting them
in a global community and helping them identify appropriate treatments
to preserve natural motion in the spine. Its web site and global
community is found at www.adrsupport.org. The new
Arthroplasty Patient Foundation helps patients research and consider
the best solution for their spine dysfunction, whether device-based,
biological, or naturopathic. As a 501(c)(3) organization, it seeks partners
who are truly committed to helping spine patients return to the
highest possible quality of life. Its web site and new film are found at:
To see your products
listed within the
Product News and
email your information to
58 ORTHOPAEDIC PRODUCT NEWS • September/October 2009