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Spinal Surgery, Cement Systems - Orthoworld

September/October 2009


Biomet Spine • Biomet Trauma

After several turbulent years,

Biomet Spine • Biomet Trauma is

September/October 2009

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

Phone: 800.526.2579

www.biometspine.com, www.biomettrauma.com

Upcoming Issue

November/December 2009

Hip & Knee Surgery

Submissions or inquiries regarding future issues of

OPN can be emailed to usopn@orthoworld.com.

Published in the U.S. by: ORTHOWORLD Inc.

8401 Chagrin Road, Suite 18

Chagrin Falls, OH 44023 USA

T: 440.543.2101

F: 440.543.2122

W: orthoworld.com

Editor in Chief: John Engelhardt - john@orthoworld.com

Assistant Editor: Julie Vetalice - julie@orthoworld.com

Editorial Consultant: Ann Monk - ann@orthoworld.com

Production Coordinator: Amy Beth Stagl - stagl@orthoworld.com

Sales: Ramonde Smith - ramonde@orthoworld.com

Every effort is made to ensure that information given in this magazine is accurate

but no legal responsibility is accepted by the Editor or Publisher for errors or omissions

in that information. Readers are advised to contact manufacturers directly.

Views expressed by contributors are not necessarily shared by OPN.

Copyright © 2009 Pelican Magazines Ltd and ORTHOWORLD Inc.

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September/October 2009

FROM THE EDITOR

Dear Doctor

EDITORIAL

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

EXECUTIVE INTERVIEW

Glen Kashuba, Senior Vice President of Biomet, Inc., President of

Biomet Spine - Biomet Trauma

PRODUCT NEWS AND LAUNCHES

ARTICLE

Physician Dispensing: A Cost Savings, Patient Benefit, and a Revenue

Producing Alternative

PRACTICE MANAGEMENT SOLUTIONS

The Best Asset Protection Is Not Asset Protection… Is Yours?

EDITORIAL

Controlling Device Costs: Sustainable Innovation or Commoditization?

POSITION PAPER

ORTHOWORLD Position Paper On Healthcare Reform

FUTURETECH

Emerging Orthopaedic Technologies & Treatments

ORTHOINVESTOR UPDATE

Including Ticker Track & Company Financials

SURGEONS SPEAK

OrthoMind Buzz: Surgeons Speak

FUTURETECH

A Solution for Undercoding or Miscoding Spine Procedures

FUTURETECH

Use of Spinal Vessel Protection to Facilitate Anterior Revision Surgery

ARTICLE

Posterior Lumbar Arthroplasty

VIEWS ON THE NEWS

PRODUCT FEATURES

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

GIVING BACK

Teaching Fracture Repair in Tanzania

GIVING BACK

New Film Helps Spine Surgery Patients Get Back On Their Feet

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 3


FROM THE EDITOR

Dear Doctor,

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

that orthopaedic

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

forward.

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

representing you.

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

your feedback.

John A. Engelhardt

Editor in Chief

4 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


Healthcare Reform: An

Orthopaedic Surgeon’s

Perspective

EDITORIAL

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

industry.

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

their needs.

continued on page 7

6 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


EDITORIAL

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

http://rsc.price.house.gov.

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

X,XXX,XXX).”

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

Letters Patent.”

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 perryvanover@cox.net.

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

schedule.

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

multiple ways.

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

see.

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

traditional machining?

Growing Parts

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

build.

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

growing.

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

area.

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.

Regulatory Challenges

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

internal geometry.

Exhibit 3: Part with complex

internal geometry made by

DMLS.

Conclusion

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 jkapitan@kapstonemedical.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.

Ancillary Services

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

practice integration.

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

economic standpoint.

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.

Capital

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.

Recruitment Advantages

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.

Conclusion

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


EXECUTIVE INTERVIEW

Glen Kashuba

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

Howmedica/Pfizer.

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


EXECUTIVE INTERVIEW

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


EXECUTIVE INTERVIEW

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

Stimulation portfolio?

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


EXECUTIVE INTERVIEW

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

Exhibit 6.)

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 usopn@orthoworld.com .

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 21


PRODUCT NEWS AND LAUNCHES

Locking Plate for Hallux Valgus

Correction using Ludloff

Osteotomy

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

Ti-6Al-4V.

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

Tel.: 49-30-77-99-80-149

www.merete.de

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

computer.

(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

neurovascular injury.

(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

to date.

(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

and tumors.

(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

PRESERVON® Technology

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

products

• Maintains osteoconductive

properties

• Uncompromised patient

safety

• Eliminates frozen

storage

LifeNet Health

Tel: 888-847-7831

www.AccessLifeNetHealth.org

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 23


ARTICLE

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

assistant.

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

Patient

1.5 Prescriptions Per

Patient

2 Prescriptions Per

Patient

2.5 Prescription Per

Patient

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


ARTICLE

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 jmcguire@sisgpo.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

tax planning.

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,

it fails.

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

protection.

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.

Conclusion

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

or info@baylaurellaw.com.

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

odell@ojmgroup.com.

To see your

products listed

in the Product

News sections

email your information to

usopn@orthoworld.com

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 27


EDITORIAL

Controlling Device Costs:

Sustainable Innovation or

Commoditization?

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

device class.

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-

5 fusion.

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

with hospitals.

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 info@x-spine.com

28 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


POSITION PAPER

ORTHOWORLD

Position Paper On

Healthcare Reform

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,

forever.

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

earnings.(ibid)

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

procedures. 3

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

procedures.” 7

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


POSITION PAPER

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

of cases.

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.

References

1. The Burden of Musculoskeletal Diseases in the United States, 2008.

2. National Center for Chronic Disease Prevention and Health

Promotion, www.cdc.gov/ARTHRITIS/data_statistics/

arthritis_related_statistics.htm.

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

osteoarthritis.)

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

APHA, 2006.

8. Polly; et al. SF-36 Physical Component Scale (PCS) benefit/cost

ratio of lumbar fusion: comparison to other surgical intervention.

2005.

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

Increases. 2006.

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


FUTURETECH

Emerging Orthopaedic Technologies & Treatments

Recent FDA Clearances

June and July 2009

Extrafix External Fixation System

(EXTRAORTHO)

Buttress (Fang) Plate System

(EMINENT SPINE)

Extrafix External Fixation System

(EXTRAORTHO)

Midfoot Screw System

(EXTREMITY MEDICAL)

Ellipse Occipito-Cervico-Thoracic Spinal

System, Zyfuse Facet Fixation System

(GLOBUS MEDICAL)

maxMorespine Spinal System

(HOOGLAND SPINE)

Perpos FCD-2 Facet Screw

(INTERVENTIONAL SPINE)

Conquest Spinal System; Facet Screw Spinal

System

(LIFE SPINE)

Tactile Guidance System - Hip, Restoris

Multicompartmental Knee

(MAKO SURGICAL)

GMK Total Knee

(MEDACTA)

Four Corner Fusion Plate, Foot System

(MEDARTIS)

Talos Intervertebral Body Fusion Device

(MEDITECH ADVISORS)

Inertia Pedicle Screw

Clavicle Plating System

(NEXXT SPINE)

(ORTHOHELIX)

Cortoss Bone Augmentation Material

(ORTHOVITA)

Graft Fixation System

(PARCUS MEDICAL)

Titan Pedicle Screw

(SPINAL EDGE)

Mercury Spinal System

(SPINAL ELEMENTS)

Anterior Lumbar Plate

(SPINAL USA)

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.

(IsraelNN, 7/16/09)

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


ORTHOINVESTOR UPDATE

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.

($MM) Prior

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 -


OrthoMind Buzz:

Surgeons Speak

SURGEONS SPEAK

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

product

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

www.orthomind.com.

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

admin@orthomind.com.

34 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


FUTURETECH

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

contracted positioning.

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.

Exhibit 1:

Screen shot

from CaseCoder

interface

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

CPT 2010.

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 contact@businessdynamicsllc.com or 516-294-4118.

36 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


FUTURETECH

Use of Spinal Vessel Protection to

Facilitate Anterior Revision

Surgery

Authors: James J. Yue, M.D.; Buaer Sumpio, M.D., Ph.D.

Introduction

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

New Products

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

Gore

Preclude®

EnGuard

Paradís Vaso

Shield

Gore

Medical

Replication

Medical

MiMedx

Group, Inc.

Expanded

PTFE

HPAN/

Dacron

30Wt% PVA

membrane

FDA

Clearance

Yes, 510(k)

Yes, 510(k)

Yes, 510(k)

PTFE: polytetrafluoroethylene; HPAN: hydrolyzed polyacrylonitrile; PVA: polyvinyl

alcohol.

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.

Clinical Results

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


FUTURETECH

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

anterior spine?

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

Clearly Moderately

Visible Visible

Moderately

Obstructed

Vessel Mobility Near the Anterior Spine

14 0

13 1

14 0

Totally

Obstructed

70% 30% 0% 0%

Clearly

Mobile

Moderately

Mobile

Moderately

Immobile

Totally

Immobile

52% 39% 9% 0%

Gore ePTFE Membrane Ease of Dissection From Vessels

Moderately Moderately

Easy

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

made.

Conclusions

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.

References

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;

140:339-343.

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 usopn@orthoworld.com.

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 39


ARTICLE

Posterior Lumbar Arthroplasty

Author: Manoj Krishna, FRCS, MCh(Orth)

Introduction

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

arthroplasty.

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

and standing

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.

Anatomical Considerations

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.

Biomechanical Considerations

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


ARTICLE

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

translation.

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

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

Exhibit 3.)

Surgical Technique

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

Hybrid Construct

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

TLIF procedure.

Clinical Experience

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

neuropraxia.

Pre-Op

Post-Op

Oswestry Disability Index 56 32

Visual Analog Scale-LBP 7.88 2.7

Case Study

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

x-rays.)

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


ARTICLE

continued from page 42

Exhibit 6: Case history of TMS patient

Exhibit 7: Case history of TMS patient

L4-L5 Disc

Intact (FEM)

PDS & Disc (FEM)

Intact (Cadaver)

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.

Challenges

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

www.spinalunit.org.

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

Doctor-Owned Hospitals

By Kate Pickert and Ken Stier

Published: Monday, July 13, 2009

Time.com

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

legislation…for-profit health-care

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

available.


(You can read the entire article at

www.time.com/time/nation/article/0,

8599,1909946,00.html)

What do you think?

Email your thoughts to usopn@orthoworld.com.

44 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


PRODUCT FEATURES

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.

Accuray

Tel: 888-522-3740

www.accuray.com

OsseoFix+ System

AlphaGRAFT ProFuse TM

AlphaGRAFT ProFuse TM is

a demineralized bone scaffold

designed to take

advantage of natural trabecular

bone properties.

AlphaGRAFT ProFuse is

available in both block and

chip forms and is made

100% from tissue, which

provides an optimum environment

for bony

ingrowth.

System Features

• 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.

Tel: 760-494-6000

www. alphatecspine.com

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

cement delivery.

• Closed mixing and delivery system prevents exposure to

fumes. 1

• 10g, 11g and 13g Targeting Needles with bevel and trocar

stylets address physician preference.

• Delivery Gun length is over 14”, which minimizes exposure

to radiation.

• 10cc of deliverable OsseoFix+ Bone Cement allows for the

treatment of multiple levels.

Alphatec Spine Inc.

Tel: 760-494-6000

www. alphatecspine.com

1 Data on file at Alphatec Spine

CaseCoder Web-based Spine

Coding System

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

Tel: 516-294-4118

www.CaseCoder.com

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 45


PRODUCT FEATURES

Anspach Minimal Access

Attachment

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

system.

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

during dissection.

Visit us at NASS Booth #1307.

The Anspach Effort, Inc.

Tel: 561-627-1080, 800-327-6887

www.anspach.com

Stabilimax® Dynamic Spine

Stabilization System

Offering stability without

fusion, and a simplified

surgical procedure. The

Stabilimax System allows

a simple surgical

approach, reducing potential

complications. No

decortication for posterolateral

fusion. No interbody

device with reported

complications. And no

nerve root retraction to

place an interbody device.

The Stabilimax

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

use only.

See us in San Francisco at NASS! Booth # 605

Applied Spine Technologies

Tel: 866-594-3116

www.appliedspine.com

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.

Biocomposites Ltd.

Tel: 910-350-8015

www.biocomposites.com

1 Data on file at Biocomposites

® geneX is a registered trademark of Biocomposites Ltd

geneX® putty

46 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


PRODUCT FEATURES

FS3 Facet Screw Spinal System

Cortoss

The FS3 Facet Screw

Spinal System is a cannulated

screw system

that accommodates

a range of

patient pathologies

through a

percutaneous or

open approach.

Intuitive design

allows for fast,

reliable and reproducible

access

and implantation

over a guide wire

with minimal exposure

and dissection,

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.

Tel: 847-884-6117

www.lifespine.com

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

in:

• A statistically significant improvement in VAS score at 3

months (11.6%, p


CALENDAR OF EVENTS

September 2009

September 10-11

Sinai Hospital of Baltimore; Rubin

Institute for Advanced Orthopedics

Osteomyelitis and Segmental Bone

Defects

Baltimore, MD

www.deformitycourse.com

September 10-12

Clinical Orthopaedic Society - 97th

Annual Meeting 2009

Point Clear, AL

www.cosociety.org

September 11-15

American Society for Bone and

Mineral Research 31st Annual

Meeting

Denver, CO

www.asbmr.org

September 15

AAOS/ASES/OTA The Shattered

Shoulder: Sorting Out the Pieces

(Course # 3903)

Webinar

www.aaos.org

September 22-24

Musculoskeletal Tumor Society

Annual Meeting

Boston, MA

www.msts.org

September 23-26

American Academy for Cerebral Palsy

and Developmental Medicine 63rd

Annual Meeting

Scottsdale, AZ

www.aacpdm.org

September 23-26

American Spinal Injury Association

35th Annual Scientific Meeting

Dallas, TX

www.asia-spinalinjury.org

September 23-26

Scoliosis Research Society 44th

Annual Meeting

San Antonio, TX

www.srs.org

September 26

AAOS Top Orthopaedic

Controversies (Course # 3321)

New York, NY

www.aaos.org

September 30

AAOS Guidelines: Diagnosis and

Treatment of Carpal Tunnel

Syndrome (Course # 5895)

Webinar

www.aaos.org

October 2009

October 1-3

AAOS/AAHKS Innovative

Techniques in Primary & Revision

Total Hip Arthroplasty

(Course # 3323)

Rosemont, IL

www.aaos.org

October 2-4

4th Annual AAOS Orthopaedic

Practice Management Course

(Course # 3324)

Albuquerque, NM

www.aaos.org

October 7-10

Orthopedic Trauma Association -

Residents Comprehensive Fracture

Course

San Diego, CA

www.ota.org

October 8-10

Knee Society Annual Meeting

Boston, MA

www.kneesociety.org

October 8-10

Orthopaedic Trauma Association

Annual Meeting - 25th Anniversary

San Diego, CA

www.ota.org

October 10

Orthopaedic Rehabilitation

Association Annual Meeting

San Diego, CA

www.orthorehabassoc.org

October 13

AAOS/ASSH Nerve Compression

Syndromes of the Upper Extremity

(Course # 3902)

Webinar

www.aaos.org

October 13-14

Musculoskeletal New Ventures

Conference Annual Meeting

Memphis, TN

www.mnvc.org

October 19-23

Physician Assistants in Orthopaedic

Surgery Annual Meeting

Scottsdale, AZ

www.paos.org

October 22-24

AAOS/AAHKS Knee Arthroplasty:

Uni, Total & Revision Insights, New

Techniques (Course # 3325)

Rosemont, IL

www.aaos.org

October 21-24

EuroSpine

Warsaw, Poland

www.medicongress.com

October 24-27

American Shoulder and Elbow

Surgeons - Closed Meeting

Washington, DC

www.ases-assn.org

October 28

AAOS Guidelines: Guideline on the

Treatment of Osteoarthritis (OA) of

the Knee (Non-Arthroplasty)

(Course # 5896)

Webinar

www.aaos.org

October 29-November 1

SICOT/SIROT 6th Annual

International Conference

Pattaya, Thailand

www.sicot.org

November 2009

November 1-5

AAOS 42nd Annual Course for

Orthopaedic Educators

(Course # 3326)

Lisle, IL

www.aaos.org

November 5-7

AAOS/CSRS Contemporary

Techniques in Spine Surgery

(Course # 3327)

Rosemont, IL

www.aaos.org

48 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


CALENDAR OF EVENTS

November 6-7

4th Annual Northern California Bone

and Mineral Symposium

Monterey, CA

www.cme.ucsf.edu

November 6-8

American Association of Hip and

Knee Surgeons 19th Annual Meeting

Dallas, TX

www.aahks.org

November 10

The JointVentures Conference: An All

Spine and Orthopedic Investment and

Partnering Conference

San Francisco, CA

www.jointventuresconference.com

November 10-14

North American Spine Society 24th

Annual Scientific Meeting

San Francisco, CA

www.spine.org

November 12-14

AAOS/ASSH Advanced Elbow and

Wrist Arthroscopy and Reconstruction

(Course # 3331)

Rosemont, IL

www.aaos.org

November 18

AAOS Guidelines: Guideline on the

Treatment of Pediatric Diaphyseal

Femur Fractures (Course # 5897)

Webinar

www.aaos.org

November 19-21

AAOS/OTA Strategies and Tactics in

Orthopaedic Extremity Trauma

(Course # 3332)

Rosemont, IL

www.aaos.org

November 22-25

American Academy of Physical

Medicine and Rehabilitation Annual

Assembly

Austin, TX

www.aapmr.org

November 27-29

British Society for Computer Aided

Orthopaedic Surgery (CAOS UK)

Annual Meeting

London, United Kingdom

www.caosuk.com

December 2009

December 2-5

14th Instructional Course & 37th

Annual Meeting of Cervical Spine

Research Society

Salt Lake City, UT

www.csrs.org

December 3-5

AAOS Top 15 Foot and Ankle

Problems: A Case-Based Approach

(Course # 3328)

Houston, TX

www.aaos.org

December 3-5

Cervical Spine Research Society 37th

Annual Meeting

Salt Lake City, UT

www.csrs.org

December 9-12

Current Concepts in Joint

Replacement Winter Meeting

Orlando, FL

www.ccjr.com

December 14-19

Society of Military Orthopaedic

Surgeons 51st Annual Meeting

Honolulu, HI

www.somos.org

January 2010

January 6-9

American Association for Hand

Surgery Annual Meeting

Boca Raton, FL

www.handsurgery.org

March 2010

March 7-10

Orthopaedic Research Society

Annual Meeting

New Orleans, LA

www.ors.org

March 10-13

American Academy of Orthopaedic

Surgeons Annual Meeting

New Orleans, LA

www.aaos.org

March 13

Hip Society and AAHKS 38th Open

Scientific Meeting/16th Combined

Open Meeting

New Orleans, LA

www.hipsoc.org

March 10-14

AAOS - American Academy of

Orthopaedic Surgeons Annual

Meeting

New Orleans, LA

www.aaos.org

April 2010

April 7-11

Association of Bone and Joint

Surgeons Annual Meeting

Washington, D.C.

www.abjs.org

April 21-25

Mid-America Orthopaedic

Association Annual Meeting

Austin, TX

www.maoa.org

April 27-30

Spine Arthroplasty Society 10th

Annual Global Symposium on

Motion Preservation Technology

New Orleans, LA

www.spinearthroplasty.org

April 28-May 1

Pediatric Orthopaedic Society of

North America Annual Meeting

Waikaloa, HI

www.posna.org

May 2010

May 2-4

American Association of Orthopaedic

Executives Annual Conference

Anaheim, CA

www.aaoe.net

May 20-23

Arthroscopy Association of North

America Annual Meeting

Hollywood, FL

www.aana.org

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 49


THE TOP LINE

Employment Agreements:

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.

Ancillary Obligations

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

Design Work

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 tford@tfordlaw.com.

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

email: tford@tfordlaw.com

www.tfordlaw.com

Not Certified by the Texas Board of Legal Specialization

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 51


FISCAL FITNESS UPDATE

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

Others*

22%

Aesculap

1%

Arthrex

2%

Biomet

6%

DJ

2%

Johnson & Johnson

13%

Zimmer

11%

Synthes

9%

Stryker

16%

Sofamor Danek

10%

Smith & Nephew

8%

*Includes more than 100 companies worldwide.

52 ORTHOPAEDIC PRODUCT NEWS • September/October 2009


GIVING BACK

Teaching Fracture Repair

in Tanzania

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

wards.

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

Institute.

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


GIVING BACK

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

showed healing.

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

femoral fractures.

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 jeanne@sign-post.org.

September/October 2009 • ORTHOPAEDIC PRODUCT NEWS 55


GIVING BACK

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

disc replacement.

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

disc replacement.

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


GIVING BACK

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

as possible.

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

about.

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

info@arthropatient.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:

www.arthropatient.org.

To see your products

listed within the

Product News and

Product Feature

sections

email your information to

usopn@orthoworld.com

58 ORTHOPAEDIC PRODUCT NEWS • September/October 2009

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