Orthopedics This Week - 2020

VOLUME 16, ISSUE 1 | JANUARY 7, 2020
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4Randy Theken’s New Com-
pany and Return to Ortho-
pedics >> Randy Theken, one of
the most influential entrepreneurs in
modern orthopedics has returned, in a
big way. Here is what he is up to now.
And here is what he’s been doing since
he sold his Theken Spine, Theken Disc,
and Therics to Integra LifeSciences in
2009. You will be amazed and inspired.
Welcome back Randy. We missed you.
8The System Is Sick, so Dr.
Choi Made a House Call >>
Insurance companies lobbying to take
even greater control over the health-
care pricing. A group of orthopedic
surgeons led by the one of orthopedics
emerging young leaders, Dr. Daniel
Choi, and with the support of AAOS
are fighting back. Let’s help them. Here
are the details.
12Gustke v. Thornhill: Simu-
lation Training: This is the
Future >> Who would you trust
more—a resident with predominately
simulation training or a resident with
predominately real patient training? It’s
not a simple answer. Simulation may
be the future, but there are some very
important nuances to pay attention to.
Great debate. Important reading.
WEEK IN REVIEW
BREAKING NEWS
16 Groundbreaking BMP-2 Based
Trauma Product in the Works
................................................................
19 “X-ray Vision” Guidance System
Cleared for U.S. Distribution
................................................................
19 Victims Can Sue Ortho Clinics if
Data Hacked
................................................................
20 Here Is the FDA’s New Commis-
sioner: Stephen Hahn
................................................................
21 First Photon Counting Imaging
System Cleared by FDA
................................................................
22 Top Hospitals & Associations Sue
CMS Over Price Transparency
Rule
For all news that is ortho, read on.

ORTHOPEDICS THIS WEEK
VOLUME 16, ISSUE 1 | JANUARY 7, 2020 2
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Orthopedic Power Rankings
Robin Young’s Entirely Subjective Ordering of Public Orthopedic Companies
THIS WEEK: We start 2020 much as we’ve started every year of the Trump regime. Dramatically. The U.S. killing of Iran’s
top general has the world on edge. The equity and bond markets wobbled on the news but stabilized quickly. Bottom line, as
in 2019, investors are habituated to Washington drama, expect the Fed to keep everything humming along and buy on dips.
Reminder, this is the Year of the Rat in the Chinese calendar. Naturally, the markets are hoping there is no rat in the upcoming
China trade announcements.
RANK
LAST
WEEK
COMPANY
TTM OP
MARGIN
30-DAY
PRICE CHANGE
COMMENT
1 8
MicroPort
Scientific
6.15% 24.00%
Big news, aside from the pending Phase One of the China
Trade deal. Shanghai-based MicroPort may be spinning off its
CardioFlow division. Investors bought on the rumor.
2 4 NuVasive 10.10 5.53
NuVasive let CFO Rajesh Asarpota go. Replacement
is Matthew K. Harbaugh. Harbaugh was CFO for
several years at Mallinckrodt.
3 2
Johnson &
Johnson
25.90 3.52
JNJ makes a further bet into the future of surgical robotics
by acquiring Verb Surgical. Financial terms are secret.
4 3 RTI Surgical 1.71 40.43
Massive leap in market value—up more than 40%. What's
going on? Key new hires are certainly part of it, but also
good reimbursements news for SI fusion implants.
5 7
Zimmer
Biomet
17.58 0.30
Morningstar ratings service announces that the
"Turnaround takes hold, raising fair value estimate."
Nice way to kick off the new year.
6 5
Smith &
Nephew
20.53 9.75
Among the 26 companies that make up OTW's Power
Rankings, London-based Smith & Nephew is the 10th best
value largely on the basis of strong future earnings.
7 1
Integra
LifeSciences
16.78 (6.82)
Big drop in the Power Rankings this week as investors
took profits in IART to start 2020. It's early for news, but
Wall Street thinks IART will grow sales 5.0% in 2020.
8 9 Medtronic 21.52 1.73
Medtronic Spine had one of its best years in 2019. Can
they keep the momentum going in 2020? Most likely "yes"
on the strength of Mazor and the growing robotics suite.
9 NR Orthofix 4.23 3.51
Kenny is the new President of OFIX's global spine business.
That's good news. But Wall Street wonders if OFIX can rebound
from a tough 2019 and 3 missed quarters in a row.
10 6
Pacira
Biosciences
7.68 (3.50)
PCRX ends the year with tantalizing news—EXPAREL,
with FDA consultation, has been tested as a nerve block in
the pediatric setting. Important addition to EXPAREL label.

ryortho.com | 1-888-352-1952
Robin Young’s Orthopedic Universe
PSR: Aggregate current market capitalization divided by aggregate sales and the calculation excluded the companies for which sales figures are not available.
TOP PERFORMERS LAST 30 DAYS
LOWEST PRICE / EARNINGS RATIO (TTM)
LOWEST P/E TO GROWTH RATIO (EARNINGS ESTIMATES)
WORST PERFORMERS LAST 30 DAYS
HIGHEST PRICE / EARNINGS RATIO (TTM)
HIGHEST P/E TO GROWTH RATIO (EARNINGS ESTIMATES)
LOWEST PRICE TO SALES RATIO (TTM) HIGHEST PRICE TO SALES RATIO (TTM)
COMPANY SYMBOL PRICE MKT CAP 30-DAY CHG
1 RTI Surgical RTIX $2.64 $195 40.43%
2 Dynatronics Corp DYNT $0.93 $8 27.42%
3 OrthoPediatrics Corp. KIDS $47.49 $794 24.88%
4 MicroPort Scientific 853 $1.19 $1,926 24.00%
5 CryoLife CRY $27.40 $1,028 12.11%
6 Smith & Nephew SNN $48.07 $21,032 9.75%
7 Flexion Therapeutics FLXN $19.66 $751 5.87%
8 NuVasive NUVA $77.49 $4,035 5.53%
9 Nevro Corp NVRO $118.04 $3,660 4.61%
10 Johnson & Johnson JNJ $144.28 $379,727 3.52%
COMPANY SYMBOL PRICE MKT CAP P/E
1 Johnson & Johnson JNJ $144.28 $379,727 22.62
2 Medtronic MDT $113.88 $152,642 26.44
3 Integra LifeSciences IART $57.26 $4,917 26.95
4 Zimmer Biomet ZBH $148.81 $30,608 27.46
5 Globus Medical GMED $58.32 $5,797 28.69
COMPANY SYMBOL PRICE MKT CAP PEG
1 MicroPort Scientific 853 $1.19 $1,926 1.51
2 Integra LifeSciences IART $57.26 $4,917 2.04
4 Stryker SYK $209.59 $78,464 2.90
5 Medtronic MDT $113.88 $152,642 3.47
COMPANY SYMBOL PRICE MKT CAP PSR
1 Dynatronics Corp DYNT $0.93 $8 0.13
2 Xtant Medical Hldgs XTNT $1.53 $20 0.28
3 RTI Surgical RTIX $2.64 $195 0.69
4 Aurora Spine ASG.V $0.20 $8 0.73
5 Lattice Biologics LBL.V $0.02 $2 1.21
COMPANY SYMBOL PRICE MKT CAP 30-DAY CHG
1 Xtant Medical Hldgs XTNT $1.53 $20 -7.27%
2 Integra LifeSciences IART $57.26 $4,917 -6.82%
3 SINTX Technologies SINT $1.51 $4 -4.43%
4 SeaSpine Hldgs Corp SPNE $12.51 $239 -3.70%
5 Pacira PCRX $44.68 $1,865 -3.50%
6 Conmed CNMD $111.11 $3,153 -3.18%
7 MiMedx Group MDXG $7.17 $794 -2.32%
8 Aurora Spine ASG.V $0.20 $8 -2.14%
9 Alphatec Holdings ATEC $6.82 $418 -1.02%
10 Zimmer Biomet ZBH $148.81 $30,608 0.30%
COMPANY SYMBOL PRICE MKT CAP P/E
1 CryoLife CRY $27.40 $1,028 396.53
3 Pacira PCRX $44.68 $1,865 149.43
4 MicroPort Scientific 853 $1.19 $1,926 80.53
5 Conmed CNMD $111.11 $3,153 75.12
COMPANY SYMBOL PRICE MKT CAP PEG
1 CryoLife CRY $27.40 $1,028 198.26
3 Smith & Nephew SNN $48.07 $21,032 5.77
4 NuVasive NUVA $77.49 $4,035 5.33
5 Zimmer Biomet ZBH $148.81 $30,608 5.16
COMPANY SYMBOL PRICE MKT CAP PSR
1 SINTX Technologies SINT $1.51 $4 38.69
2 Flexion Therapeutics FLXN $19.66 $751 33.32
3 OrthoPediatrics Corp. KIDS $47.49 $794 13.80
4 Nevro Corp NVRO $118.04 $3,660 9.45

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Randy Theken’s New Company and Return to
Orthopedics
BY KIM DELMONICO
Randy Theken, one of the most
influential and important entre-
preneurs in modern orthopedics, has
returned to the industry he helped
create.
For most of us, the last time we saw an
article about Randy was 2009, when
he sold Theken Spine, Theken Disc,
and Therics to Integra LifeSciences
Holdings Corporation for more than
$200 million. That company is now
one of the key components of Sea-
Spine Holdings Corporation, under
the direction of another legendary
entrepreneur—Keith Valentine of
both Sofamor Danek and NuVasive,
Inc. fame.
Theken’s restlessly inventive mind
found a number of interesting outlets
while he was waiting out his five year
non-compete. And now, he is back.
Welcome back, Randy. We missed you.
By the way, been up to anything?
A Lot, Actually
In fact, selling his companies created
the opportunity for Theken to take his
talents and energy in some very inter-
esting directions.
One of the most notable projects is
Theken’s partnership with developer
Steve Coon. Together they revital-
ized major swaths of northeastern
Ohio, which has struggled with high
unemployment and deteriorating
cities—like Youngstown, Akron and
Canton—for decades. In Canton,
Theken and Coon restored and then
converted beautiful buildings from
the 1930s into The Historic Onesto
Lofts and Bliss Lofts. Their efforts are
helping to attract new investment
and interest to downtown Canton
and Akron.
Theken also became a partner in a
group of assisted-living centers and
then jumped into the consumer prod-
ucts world by investing in and becom-
ing a major owner of a Chicago-based
acne medicine company.
Finally, Theken embarked on what is
probably one of the secret passions of
a majority of biomedical engineers and
entrepreneurs all over the world—buy-
ing and selling exotic vehicles—every-
thing from Ferraris to Porsches to Lam-
borghinis.
Why? Because he was “bored and it
looked like a good business.”
Over these past few years, through Fox-
trot Auto, Theken bought and sold over
All photos courtesy of Randy Theken and Dove Audio Visual

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150 vehicles. Theken says the exotic car
industry delivered some of his greatest
returns on investment. For example, in
2010, Theken bought four of the first
super Ferraris ever made. A 1984 Fer-
rari GTO, F-50, F-40 and Enzo. Theken
bought the Enzo for $1.2 million and
sold it for around $2.8 million.
What was the key to his success? Theken
said that he got in at the right time—and
that the key is finding vintage, numbered
vehicles with very low mileage.
Theken’s success in renovating and
redeveloping a beautiful historic
buildings, assisted-living centers,
skincare lines, and exotic cars speaks
to a remarkable and truly unique
individual—someone blessed with
not only tremendous capabilities but
a passion for treasuring what is time-
less, beautiful and, ultimately, the best
of what people can do and become.
Who Is Randy Theken?
Randy Theken (pronounced “taken”)
was born and raised in Northeast
Ohio. A hard worker from a young
age, Theken recalls pumping gas at
his family’s service station beginning
when he was barely able to reach the
top of a gas pump at seven years old.
Theken started his first company,
Satellite Communication, to install
large uplink satellite dishes when he
was still in college.
After graduating from high school,
Theken spent two years working at
a fossil fuel nuclear power company.
Theken recalls spending every lunch
break hanging out in the office of a
programmer who worked on the site.
Theken recalls his fascination with
the computer and the programmer
telling him every day, “Kid, save your
money, go to college.”
Which he did.
At the University of Akron, Theken
majored in engineering and credits Rick
Nemer, an electrical engineering profes-
sor, and Glen Njus, Ph.D., a biomedi-
cal engineering professor, for setting
him on the path to becoming who he
is today. Dr. Njus gave Theken a job in
his lab that helped him pay for college
and instilled in him a love for engineer-
ing. Under the tutelage of Dr. Njus,
Theken graduated University of Akron
with bachelor’s and masters’ degrees in
electrical, mechanical, and biomedical
engineering.
Theken Companies
In 1992, he founded Theken Orthopae-
dic, a company that provided mechani-
cal testing, product development, and
FDA regulatory services. From 1992 up
through about 2000, over 125 ortho-

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pedic companies made the trek to
Akron, Ohio, to do their implant testing
because of Theken.
Sixyearslater,hefoundedThekenSpine
to focus on spinal implant and device
development. Theken Spine developed
its own extensive distribution network,
inventory supply chain, and marketing
team—growing to approximately $60
million in revenue.
In 2003, he founded Theken Disc to
specifically focus on R&D develop-
ment of next generation spinal arthro-
plasty devices. Theken Disc created the
first polymer-based artificial disc with
embedded microelectronics.
Finally, in July 2005, Theken purchased
Therics, LLC, from Princeton, New Jer-
sey-based Tredegar Corporation. Ther-
ics designed, developed, and manufac-
tured a variety of synthetic bone sub-
stitute products using its 3D-printing
patents—Therics was one of the origi-
nators of 3D-printing.
In 2009, Integra LifeSciences, acquired
three of Theken’s companies (Theken
Spine, Theken Disc, and Therics). A
new division within Integra was cre-
ated (Integra Spine) and Theken was
appointed its President. Theken oper-
ated Integra Spine through 2010, after
which point, he had a five-year non-
compete within the medical arena.
The Theken Terminal Building
Everything Theken does, he does with
style. In 2005, he purchased the histor-
ic Akron airport terminal building from
the city of Akron to use as his company
headquarters.
Theken spent two years and millions
of dollars renovating and restoring it to
its original art deco splendor. Restoring
the terminal was a labor of love: Theken
worked for months to match the origi-
nal 1929 terrazzo floors and had cus-
tom windows made to match the origi-
nals. Theken tracked down the makers
of the original light poles that stood
on the property. A footnote on blue-
prints that Theken obtained from the
city noted that Union Metal of Canton,
Ohio, which had been around since the
1860s had manufactured them. Theken
met with Union Metal and found out
that it still had the original castings.
Theken had the light poles recast and
put them in the identical spot.
The renovation of the terminal build-
ing earned Theken awards in Akron
and Cleveland, including the 2011 Dis-
tinguished Preservation Achievement
Award from the Cleveland Restoration
Society and Best Commercial Rehabili-
tation co-winner from the Ohio Heri-
tage awards.
Randy Returns to Orthopedics
With…FOUR Companies
With four new orthopedic companies it’s
safe to say that Randy Theken is back.
In 2014, Theken founded NextStep
Arthropedix. NextStep is an Akron,
Ohio-based medical device manufacturer
focused on designing, developing, manu-
facturing, and distributing joint replace-
ment implant products such as hips,
knees, and shoulder implant systems.
NextStep is bringing 3D-printing to
the field of joint replacement implants.
Since the 2017 launch of its iNSitu Hip
System, NextStep’s innovative compo-
nents have been implanted into 4,500
hips. NextStep developed a 3D-printed
acetabular cup system to improve upon
traditional, plasma-spray coated cups.
The issue being the risk that a plasma-
sprayed implant might delaminate in
the patient.
In January 2019, NextStep released its
newly-developedhipsystem,TheBlade.
NextStep currently has five products on
the market with an additional six at the
FDA waiting clearance.
In 2017, Theken launched Slice Man-
ufacturing Studios, a full-spectrum

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contract manufacturing studio—
offering development, prototyping,
mechanical testing, final production,
and sterile cleaning and packaging.
Slice’s new 30,000 square foot labo-
ratory and manufacturing facility
is located next to Theken’s historic
airport terminal facility that houses
NextStep Arthropedix.
In 2018, Theken founded LaunchPoint,
a corporate innovation division that
focuses on the development of ortho-
pedic devices, materials, and technolo-
gies. The Ohio Development Services
Agency’s technology-based economic
development initiative, Ohio Third
Frontier, awarded LaunchPoint an ini-
tial $3 million matching fund and Ə
Ceramics is one of LaunchPoint’s first
strategic investments.
Ə Ceramics manufactures and markets
an advanced Mg-PSZ ceramic for the
orthopedic implant market. In 2019,
Theken acquired this technology from
BioPro Medical, an originator of the
material 30+ years ago.
Ə Ceramics now owns the propri-
etary compounding, manufacturing,
FDA Master Files, IP, and methods for
this ceramic material. Theken’s goal
is to provide a hip component mate-
rial which would be superior to cobalt
chrome (CoCr). The Mg-PSZ does not
have any risk nickel allergy complica-
tions, which has happened with CoCr,
while also being able to resist biofilm
infection. According to Theken, retriev-
al studies have demonstrated that this
ceramic material is truly superior.
Of course, Ə Ceramics is jumping into a
market which is currently dominated in
the U.S. by CeramTec GmbH, a German
company, and in Japan by Kyocera—
which is entering the U.S. market with
their ceramic components in 2020.
Collectively, Theken’s four companies
are known as the Theken Group.
Words of Wisdom From Theken
Theken has been successful, given back
to his community, been an integral part
of healing hundreds of thousands of
patients and built a life of enduring
value and integrity.
What would Theken advise those who
aspire to follow in his footsteps?
Theken told OTW, “A lot of people
go after what they are passionate
about—but at the end of the day, one
should consider what their God-gift-
ed talent is. What’s the one thing that
you do well with the least amount of
effort? So many people follow their
passion—and that’s great. They may
get there, and they may not. But at
the end of the day, if you go do what
you’re really God-gifted at with the
least amount of effort, you will be
successful.”
And…“Stay humble.” Wise words,
from Randy Theken. ♦
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The System Is Sick, so Dr. Choi Made a House Call
BY KIM DELMONICO
The House of Representatives, that is.
Young Daniel E. Choi, M.D., Dip-
lomate, American Board of Ortho-
paedic Surgery and Chair, Young
Physicians Section, Medical State
Society of New York went to Wash-
ington, DC in November to do what-
ever he could to protect orthopedic
physician’s interests in the fight over
“surprise billing.”
His timing could not be more urgent.
“The system is very sick right now,”
Dr. Choi explained to OTW. And, for
a variety of reasons, the issue of sur-
prise billing has become the battlefield
where Dr. Choi and other physicians
are pushing back on insurance com-
pany encroachment.
In addition to his other accolades, Dr.
Choi is a Founding Member and sits
on the Board of Directors of the Asso-
ciation for Healthcare Social Media
(AHSM) and has created a website
dedicated to this cause. This website
was created “as a grassroots effort by
physicians concerned about insur-
ance companies hijacking surprise
billing legislation to increase their
profits.”
Dr. Choi is not alone.
Joining him are Dustin Corcoran, CEO
of the California Medical Association,
and Phil Schuh, Executive Vice Presi-
dent and CFO of the Medical Society
of the State of New York and the full
force of American Academy of Ortho-
paedic Surgeons (AAOS), led by Dr.
Kristy Weber.
Dr. Choi believes that the insur-
ance company’s proposals to address
surprise billing will actually push
healthcare costs higher, threaten the
survival of physician practices, con-
tribute to physician burnout, and
ultimately lead to fewer available
healthcare clinics for consumers.
Choi, joining with 20 doctors from
various specialties, created a video
about the upcoming federal surprise
billing law decisions. It went viral on
Twitter.
It’s a Race to Control Billing – and
Patients
“Surprise billing,” as most physicians
know, refers to invoices patients receive
for out-of-network medical care servic-
es that they believed were covered at
the time of care but, surprise! find they
are not.
Surprise billing is the surprise health-
care issue in this funding cycle.
(L to R): (1) Daniel E. Choi, M.D. (Medical State Society of NY); (2) From Left to right: Amy Cho, M.D. (American College of Emergency Physicians), Jim Ficke, M.D.
(American Academy of Orthopaedic Surgeons), Purvi Parikh, M.D. (Medical State Society of NY, Allergy and Asthma Network), Carolyn McClain, M.D. (American Col-
lege of Emergency Physicians), and Daniel E. Choi, M.D. (Medical State Society of NY, American Academy of Orthopaedic Surgeons); (3) Representative Richard Neal
(D-MA, 1st District), Chairman of the House Ways and Means Committee, Jim Ficke, Daniel E. Choi, M.D. / Courtesy Daniel E. Choi, M.D.

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Everyone, Republicans and Democrats
alike, are against it.
“Surprise billing” itself is not the battle.
The fight is whether the insurance “fix”
or the physician “fix” becomes law.
One compromise piece of legislation
on the table is a median in-network
rate, with an arbitration option for bills
above a certain benchmark.
AAOS is in favor of the Independent
Dispute Resolution (the arbitration
option) but they maintain that this
will be undermined by the median in-
network rate, which is determined by
insurers.
Most observers expect the fix debate
to extend into 2020—if not indefi-
nitely. Which benefits the insurance
companies.
Surprise Billing is an Insurance
Company Fabrication
Surprise bills happen when insurance
companies choose to deny all or part
of bill coverage for an unscheduled or
emergency medical service provided by
an out-of-network doctor, often at an
in-network facility. According to Project
HOPE, a global health and humanitar-
ian relief organization, up to one in five
emergency visits results in a surprise
medical bill.
The Patient Protection and Affordable
Care Act of 2010 (ACA) has provisions
to protect against surprise billing. The
ACAspecificallyrequiresinsurerstopay
these bills. However, insurance com-
panies are also allowed to determine
“usual and customary rates” (UCR) for
out-of-network services.
It turned into a loophole.
The American Medical Association
(AMA) told lawmakers at the time
that leaving payment details up to
insurers would lead to inflated costs.
The AMA was right. As Dr. Choi and
his lobbying physician colleagues
make clear, the insurers have driven
a truck through this ACA loophole
at the expense of both patients and
doctors.
The Insurer “Fix” for Surprise Billing
Private insurance companies are
lobbying lawmakers to employ a
“benchmark” billing process, which
would give insurance companies the
power to determine a fixed charge
based on their determination of
what an average cost for those ser-
vices would be.

ryortho.com | 1-888-352-1952
Dr. Choi and his colleagues, on behalf
of all orthopedic physicians are advo-
cating for arbitration to negotiate
costs to consumers at no expense
to the consumers themselves. Choi
argues that the arbitration approach
can prevent insurance companies
from putting a finger on the scale of
healthcare costs for the sole benefit of
insurers.
In December, American Associa-
tion of Orthopaedic Surgeons Presi-
dent Kristy L. Weber, M.D., FAAOS,
released a statement saying, “The
AAOS thanks Congress for its dedica-
tion to finding a solution that removes
patients from the middle of medical
billing disputes.”
“We appreciate that the new ver-
sion of the bill includes Independent
Dispute Resolution (IDR) as well as
a lowered threshold for access to
this critical process. These positive
improvements, however, are over-
shadowed by the committees’ con-
tinued use of the median in-network
rate—a number controlled by insur-
ers…Even when filtered through
arbitration, the use of this rate as a
benchmark is tantamount to govern-
ment rate-setting.”
“It will allow insurers to systematically
drive down in-network rates to serve
their bottom line, consequently harm-
ing patient access to care throughout
the country. Furthermore, the new
90-day waiting period between dis-
putes for the same procedure type
undermines the effectiveness of the
IDR process which sole purpose is
to bring both sides to the table and
incentivize fair, reasonable offers.”
Weber went on to communicate AAOS
concerns, saying that “As Congress
evaluates this proposal and considers
passing legislation before the end of
the year, AAOS urges it to incorporate
proven solutions like the fair market
IDR standard employed successfully
in New York. Using an independent
database outside of physician or
insurer control is the only way to pro-
tect access to care while saving con-
sumers millions of dollars and taking
patients out of the middle.”
Senate Bill Supports the Insurers “Fix”
In June 2019, a Senate Bill was
approved, with full backing by Health,
Education, Labor and Pensions Com-
mittee Chairman Lamar Alexander
(R-Tennessee.) If this bill passes,
benchmarking will be used to resolve
surprise bills. Out-of-network provid-
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ryortho.com | 1-888-352-1952
ers would be forced to accept a pay-
ment based on local median rates for
similar services provider by other in-
network physicians.
Physician lobbyist groups, like Doctor
Patient Unity, argue that insurers are
being given the ability to unethically
manipulate out-of-service medical
fees. The surprise billing issue exists
as a byproduct of favoring insurance
profits over patient well-being, so a
balanced solution that does not con-
centrate power with the insurance
companies is needed to effect lasting
change. A group of orthopedic sur-
geons (allied with medical providers
from a list of other specialties) have
been calling for change that benefits
patients. These groups have gone
to Capitol Hill and spread the word
via social media, using the hashtag
#patientsbeforeprofits.
The American Medical Association
and the American Hospital Associa-
tion think benchmarking is a form of
price fixing. Benchmarking, they say,
puts control of the financial aspects
of doctor patient care in the hands
of private insurance companies, to
the benefit of only those companies.
An increasing number of lobbyists
representing medical providers are
opposing this bill, as there is signifi-
cant concern it will decrease doctor
compensation by giving insurers an
advantage in negotiations.
The Physician/Patient “Fix” – The
New York Model
New York was one of the first states to
address surprise billing by implement-
ing in 2015 a “baseball-style” arbitra-
tion model. It cut out-of-network bill-
ing 34% and resolved an estimated 57%
of consumer complaints.
Under the so-called “baseball-style”
arbitration system, any physician’s bill
and insurance company coverage offers
are reviewed by a third-party arbiter.
That arbiter sets the healthcare costs
using an independent charge database
called FAIR health. Not the insurance
company.
The loser in the New York process pays
arbitration costs. It’s called the Indepen-
dent Dispute Resolution (IDR) process.
AAOS is on the record supporting the
IDR process.
Georgetown University reviewed the
effects of New York’s surprise billing
law, almost five years after its enact-
ment, through interviews with state
regulators, insurance companies, doc-
tors, hospitals, consumer advocates,
insurance company representatives,
physicians, and expert observers. It
reported that, overall, the law was
“working as intended to protect con-
sumers from a significant source of
financial hardship.”
Dr. Choi’s and Dr. Weber’s Fight on
Behalf of All Orthopedic Physicians
If federal law does not allow arbitration
in cases of billing surprises, said Dr.
Choi, it will hurt doctors, the vitality
of private practices and clinics, and the
number of providers available nation-
wide.
In addition, said Dr. Choi, surprise bill-
ingexacerbatesalreadyurgentproblems
of physician burnout and the increas-
ing suicide rates among orthopedic
doctors—in part due to the pressures
of massive amounts of student loans,
along with decreased time for patients
and increased time required for elec-
tronic documentation.
“People are really just not happy prac-
ticing medicine,” said Choi. He fears
that benchmarking laws could cause
more and more doctors to abandon the
field, limiting the availability of care for
those in need.
Dr. Weber went on to communicate
AAOS concerns in their December
statement, saying that “As Congress
evaluates this proposal and considers
passing legislation before the end of
the year, AAOS urges it to incorporate
proven solutions like the FAIR market
IDR standard employed successfully in
New York. Using an independent data-
base outside of physician or insurer
control is the only way to protect access
to care while saving consumers millions
of dollars and taking patients out of the
middle.”
Will Congress listen to the physician
advocates or the insurance company
lobbyists?
Let’s lend AAOS and Dr. Choi our sup-
port. ♦

ryortho.com | 1-888-352-1952
Gustke v. Thornhill: Simulation Training: This is
the Future
BY OTW STAFF
This week’s Orthopaedic Crossfire®
debate was part of the 35th Annual
Current Concepts in Joint Replace-
ment® (CCJR®), Winter meeting,
which took place in Orlando. This
week’s topic is “Simulation Training:
This is the Future.” For is Kenneth A.
Gustke, M.D. – Florida Orthopaedic
Institute, Tampa, Florida. Opposing is
Thomas S. Thornhill, M.D. – Harvard
Medical School, Boston, Massachusetts.
Fares S. Haddad, M.D., F.R.C.S. – Uni-
versity College Hospital, London, Unit-
ed Kingdom is moderating.
Dr. Gustke: I’m in favor of simulation
training. I think it is the future.
Historically, resident and fellow train-
ing has followed the apprenticeship
model where trainees enhance their
skills under supervision by more expe-
rienced mentors.
In this model, residents got to do many
surgical procedures and work long
hours with no hour restrictions. And
we were less aware of legal ramifications
and complications. Also, the hospitals
weren’t all over us about surgery times.
This historical training model is now in
conflict between best surgeon training,
patient safety and OR efficiency.
Reduced resident work hours in the
United States has meant decreased
learning opportunities and longer
learning curves for our residents. Mul-
tiple studies now report that residents
are actually graduating without suf-
ficient exposure and technical ability
to perform some key procedures well
(Zuckerman, et al. JBJS-Am, 2005; Bell,
et al. Ann Surg, 2009; Mauser, et al. Int
Orthop, 2014).
One interesting study surveyed senior
orthopedic surgeons who took on
junior associates that just finished their
residency training program and asked
them what they thought (DiSegna, et al.
J Surg Orthop Adv, 2018). The consen-
sus of those surveyed said that junior
associates had inferior technical skills,
required more assistance completing
cases and had more major operative
complications. Their recommendation
was that the residency training pro-
grams have competency milestones and
also increase the role of simulators.
Attending orthopedic surgeons as part
of this paradigm have learned new pro-
cedures by going to conferences like
this. Watching how surgery is done.
Maybe watch a surgery in person.
Watch a video. Or perhaps do a proce-
dure at a cadaver course. And then they
go do surgery on a patient.
Cadaver labs, which probably are the
best mechanism that we have today,
lack pathology, have minimal repetitive
practice opportunities and they’re very
expensive.
So, the advantage of simulation train-
ing is that you’re able to learn new
skills with no impact on patient care.
You can practice as often as you want.
You have no time pressures. You can
make mistakes and you get feedback.
You can also improve your perfor-
mance prior to actually working on
patients. These also can be adjusted
for fidelity so that the skill level of the
learner can be appropriate for that par-
ticular training.
The classic example of a simulator—a
flight simulator—there’s no pilot in the
world that’s flown a plane without going
through a simulator first. And they have
to keep retraining on simulators.
In medicine we do have simulators.
They’reeitheroneofthreetypes.They’re
mannequins, screen-based simulators,
or virtual reality simulators. They have
mannequin simulators for advanced
life support; infant care. And they are
RRY Publications LLC

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Advertisement
increasingly being incorporated into
training programs to supplement clini-
cal learning.
Arthroscopic type simulators teach
triangulation, meniscectomies, ACL
[anterior cruciate ligament] reconstruc-
tions and give you the ability at the end
of the procedure to have your technique
critiqued.
There are also open-based simulators
that are now being used for total joints.
They use 3D glasses, simulator screens,
and most importantly, haptic guidance.
So, you can actually have tools in your
hands which are the same tools that
you would use in the operating room
attached to a haptic arm. You can actu-
ally feel the texture of the bone and
going through a cutting slot so that you
can actually learn how to do a total knee
replacement before you ever get to the
operating room.
The other type of simulators is those
that use virtual reality goggles. These
are fun, but they lack realism and hap-
tic feedback. So, you’re actually simu-
lating doing the procedure with some
tools in your hand, but the problem
is you can’t feel texture. You can’t feel
actually going through a bone or cut-
ting a bone.
The real question is going to be wheth-
er simulators improve clinical perfor-
mance. There are 14 studies now in
the literature on knee, shoulder and
hip surgery that demonstrated major
constructive and transference valid-
ity and an improvement in technical
skills.
There’s a randomized blind study with
an arthroscopic simulator that shows,
again, that they do provide skill transfer
(Howells, JBJS-Br, 2008; Cannon, JBJS-
Am, 2014). But in order for simulators
to be effective they must be realistic.
They have to have quality of device
that’s similar or better than cadav-
ers. They have to have haptic or force
feedback to give a sense of texture and
shape of bone. And they must provide
spatial orientation.
So, in summary, we need to change
the surgical skills training method for
orthopedic surgeons. Because we have
to be cognizant of patient safety and
efficiency. I think it’s a perfect method
to supplement clinical learning and
decrease the learning curve.
They will replace real experiences with
guided experiences. And over time,
they will get more realistic.
You may wonder why the two persons
debating are old and we’re talking about
the future, when, perhaps, we don’t
have much future of our own. But the

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two of us each have about 40 years of
experience with residency and fellow-
ship training.
So, I think we’re qualified. The only
difference is I can see the future more
clearly.
Dr. Thornhill: I’ve got a bit of a prob-
lem—the fact is that simulation is here
to bridge the increasing gap in resident
education.
I do simulation. I was involved in start-
ing it, but I have one serious concern.
The challenges Ken talked about—the
technology, the sub-specialization,
the workload, the financial pressures,
and also the ASCs [ambulatory surgi-
cal centers] and satellites—oftentimes
don’t have residents and they don’t get
the exposure with the easiest cases to
really do.
The elephant in the room, though, is
duty hours. Malcolm Gladwell talked
about “10,000 hours” in his book Out-
liers: The Story of Success and if you
stratify, 48 weeks, 80 hours a week in
5 years, they get about 25% surgery,
under 5,000 hours of surgery, which
does not meet Malcolm Gladwell’s stan-
dards.
More work in less time. Fewer patient
interactions. Reduced operative experi-
ence. And the OR constraints for the
attendings now—their outcomes are
being measured, time is money, and it
takes time to educate a resident.
Here’s my concern. Simulation cannot
recreate the stress of independent sur-
gery on real patients. We call it “The
relaxed attitude of the non-combat-
ant.” As a resident, I was very sure
when I had an attending with me.
When I did it myself for the first time,
I wasn’t as sure.
William Halsted believed in complete
immersion. Interns should be interned.
Residents should be resident. The
fact is that you graded responsibility
with every other night call. Then you
advanced when the faculty told you you
should. It was see one, do one, teach
one.
My American philosopher, Yogi Berra
said, “The future ain’t what it used to
be.”
There are whole bunches of different
types of simulation. Ken went through
them. I think the most important thing
is we use mannequins, we use cadavers,
we now have full procedure simulators,
virtual reality, artificial intelligence and
a whole bunch of things.

ryortho.com | 1-888-352-1952
But they don’t really give you the
recreation of what happens to a
patient who is under anesthesia in
your hands. It’s called a learning
curve, I think, because if you get
in trouble in surgery and you can’t
become more calm, you’re going to
be a problem.
And when you get your comfortable
zone and those surgeons in the audi-
ence will know, it’s a wonderful feeling
you have knowing that whatever you
do, you can get out of it. There’s sort
of a moral hazard…we treat cadavers
extremely well. But if you really harm
them or a mannequin, it’s not like a real
patient.
I like Henry Ford’s quote about the
need that we must innovate much more
than we do now with simulation. Henry
Ford said, “If I’d listened to the custom-
ers, I would have given them a faster
horse.”
And now we have virtual reality and
…Ken showed some in orthopedics…
one in the airline industry which he
talked about…these simulators are ter-
rific. People have actually been able to
fly planes.
Now the residents expect simulators.
They get into medical school. It’s part of
the USMLE Step II and Step III. Nation-
al requirements. It’s required. Yesterday
at the Brigham we had Dr. David Martin
from ABOS talking about all of the new
requirements. This is something that’s
coming. Simulation is clearly going to
be here.
We have a boot camp where all the
interns have an uninterrupted month.
There’s a curriculum based on par-
ticularly orthopedic skills to make
sure that when they start their PGY-2
they’re all roughly at the same level.
Our core curriculum has a combina-
tion of labs and exercises. And there
is the progressive credentialing experi-
ment based upon the milestones.
Our boot camp basically is full time.
They have stuff in basic skills, fractures,
arthroplasty and arthroscopy. Much of
it by simulation.
So, the “see one” is now practice many
on simulation showing competency.
Do one, teach one. The fact is Halsted’s
thing now includes simulation, coach-
ing, curriculum and validated assess-
ment.
My major concern is it not a surrogate
for operating on live patients.
Moderator Haddad: Ken, can you actu-
ally teach the patient interaction, the
patient journey, and the reality of deal-
ing with the problem live under stress?
Dr. Gustke: Absolutely not and I
totally agree with Tom that this is the
first step to get the resident or fellow
to the operating room with a learning
base that is higher than what they come
with currently. You still have to have the
real patients, the real tissues, blood in
the field…all the issues that we all go
through on a surgical basis.
It’s hard to simulate every single sce-
nario that you’re going to have in the
operating room. I totally agree that this
is not a substitute for training. This is an
assistant to get the doctor to the operat-
ing room in a better fashion.
Moderator Haddad: We have agree-
ment that simulation has a role. Tom,
what bits are missing? What do we need
to fill around simulation? The hours are
only going to go down…the outlook of
the residents is going to change?
Dr. Thornhill: It’s getting us through
both areas. The fact is …ASCs and sat-
ellites, everybody there works for you,
and people work together…you go to
many of the academic medical centers
where the residents train and you can
learn inefficiency. You’ll have a different
scrub nurse every time and it becomes
very frustrating. But it is also one of the
burdens of all of us. It is what we must
do in order to have the next generation
of orthopedists work. Simulation ain’t
there yet.
Moderator Haddad: In terms of sur-
geons getting more robotic, more com-
puter-assisted tools, is this going to
become more relevant to arthroplasty?
Dr. Gustke: Yes, I think it because we
get more information on screens. If we
can actually have simulators that go
through the balancing aspects of total
knee replacement, for example, and
show different scenarios on the screen,
I think that will be better and help them
utilize this information.
Dr. Thornhill: You’ve got to have a
downside for everything and whether
it is showing competency in simulation
and transferring over to the operating
theater, or whether it is some other
downside in terms of advancement, if
you don’t pass those requirements. It’s
the real people that I think are impor-
tant.
Moderator Haddad: Gentlemen, I
think we’ve learned that simulation is
important, but it’s not the whole answer.
Thank you very much. ♦
Please visit www.CCJR.com to register for the 2020 CCJR Spring Meeting — May 17-20, in Las Vegas.

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COMPANY
Groundbreaking
BMP-2 Based Trauma
Product in the Works
Boston-based biotechnology com-
pany Theradaptive, Inc. and
Japanese orthopedic biologic com-
pany ORTHOREBIRTH Co. Ltd. have
announced an exclusive license agree-
ment to develop and market a product
called THX-14.
The product is composed of Theradap-
tive’s proprietary material-binding bio-
logic, Bone Morphogenetic Protein
2 (tBMP-2) and ORTHOREBIRTH’s
510K-approved void-filling material
ReBOSSIS. If approved, THX-14 will be a
groundbreaking product, the first regen-
erative therapeutic for traumatic bone
injuries and congenital skeletal defects.
Under the terms of the agreement,
ORTHOREBIRTH will be responsible
for THX-14 development and com-
mercialization in Asia and Theradap-
tive will be in charge of American
development and marketing, with joint
responsibility for international clini-
cal studies and coordinating launch
events. Theradaptive will receive mile-
stone payments and additional royal-
ties on any ongoing product sales in
licensed territory.
In a recently completed preclinical study
by Theradaptive, THX-14 was observed
to strongly induce bone regeneration and
demonstrated superiority over autolo-
gous bone marrow. No serious adverse
events were observed. Theradaptive aims
to continue clinical research, with a phase
I/II human study planned for 2020.
Around 16,000 people die every day
from traumatic injuries and musculo-
skeletal injuries account for 16% of the
Advertisement
David Stewart, VP R&D, Todd Heil, Sr. Engineer / Courtesy Theradaptive, Inc.

ryortho.com | 1-888-352-1952
global burden of disease, according to
the World Health Organization.
Luis M. Alvarez, Ph.D., Theradaptive’s
founder and CEO, told OTW, “We are
thrilled to partner with ORTHORE-
BIRTH for the development of THX-14.
This partnership places the power of a
global development network behind
a therapeutic delivery product that is
poised to revolutionize the orthopedic
repair market.”
Alvarez continued, “For many years,
promising therapeutics have been
hindered by the challenges of deliver-
ing those therapeutics precisely. For
orthopedic applications, THX-14 aims
to solve this problem by combining
our material-binding bone growth fac-
tor (tBMP-2) with ORTHOREBIRTH’s
void filling material. THX-14 has the
potential to become the first regenera-
tive treatment for congenital skeletal
defects, as well as the most effective
repair solution for traumatic orthope-
dic injuries.” — KD
Trainer Rx Now
RecoveryOne, Raises
$12M, Announces
New Leadership
Walnut Creek, California-based
Trainer Rx has changed its name
to RecoveryOne, raised $12 million and
expanded the number of executives in
the C-suite.
Trainer Rx, founded in 2014, is a leader
in musculoskeletal recovery. The com-
pany hopes that this name change will
signify both expansion and a focus
shift “to align with health plans and
value-based health systems that share
its objective of enabling their members
with the most effective, cost-efficient
means of recovery.”
The $12 million funding round was led
by Cigna Ventures. There was significant
participation by existing investor 7wire
Ventures and personal participation by
members of the management team.
Mark Luck Olson, CEO of Recov-
eryOne, told OTW, “We are thrilled
to have closed on our latest round of
financing and to have launched a new
company name and strategy. Our new
brand, RecoveryOne, reflects our mis-
sion to empower people struggling with
musculoskeletal conditions to achieve
optimal recovery, ultimately reducing
personal and economic burden.”
“Our new team, comprised of very sea-
soned experts, will continue to break
down barriers to accessibility and deliv-
er our evidence-based solutions to our
members when and where it best suits,
driving greater adherence and better
outcomes.”
RecoveryOne’s new leadership team
includes three new executive vice presi-
dents and two new vice presidents:
• Miriam Beecham, Executive Vice
President and Chief Product Officer
• Dustin Eggers, Executive Vice Pres-
ident and Chief Commercial Officer
• Joseph Kinnett, Executive Vice
President, Enterprise Sales & Mar-
keting
• John Araki, Vice President of
Finance and Administration
• Sean Kinsman, P.T., D.P.T., Vice
President of Clinical Operations
Beecham will lead the company’s
commercial product roadmap and
all aspects of customer experience,
developing, curating and applying
content to the Recovery One pro-
grams and enhancing user experi-
ences.
Eggers will execute the company’s
expansion of strategic relationships
with health plans and value-based
health systems.
Kinnett will focus and building the
RecoveryOne sales team and oversee
the implementation of new enterprise
agreements within health plans and
risk-bearing entities.
Araki will focus and capital fundraising
and financial planning.
Kinsman will ensure RecoveryOne’s
care pathways are evidence based, drive
expansion into clinical care, and over-
see clinical operations.
The new team will work closely with
CEO Mark Luck Olson and Chief
Technology Officer Chris Hughes,
who joined the company in 2014.
— KD
(L to R): Mark Luck Olson, CEO; Miriam Beecham, Executive Vice President/Chief Product Officer; Dustin
Eggers, Executive Vice President/Chief Commercial Officer; Joseph Kinnett, Executive Vice President, Enterprise
Sales & Marketing; John Araki, Vice President of Finance and Administration; Sean Kinsman, PT, DPT, Vice
President of Clinical Operations / Courtesy of RecoveryOne

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Össur, Alfred Mann
Team Up on Mind-
Controlled Prosthetics
Össur, based in Reykjavik, Iceland,
and the Alfred Mann Foundation
(AMF) of Santa Clarita, California, have
agreed to allow Össur to develop and
license AMF’s implanted myoelectric
sensor (IMES) to explore the potential
of mind-controlled prosthetic technol-
ogies.
According to AMF, the sensors are
“implanted in muscles that directly con-
trol the desired movement of a bionic
prosthetic limb. The implants sense a
small electrical charge in the muscle
tissue and send information wirelessly
to the prosthetic limb when the user
intends to make specific movements.
As a result, the bionic limb responds
with the desired movement in virtually
the same way that a sound arm, hand or
leg would respond.”
“The world’s first-in-man cases to ini-
tially evaluate the IMES technology
were conducted in 2014 on upper-limb
amputees from the US military, using
i-Limb bionic prosthetic
hands produced by Össur.
In 2015, two lower-limb
amputees from Iceland
had IMES units surgi-
cally implanted into their
residual muscle tissue and
demonstrated their abil-
ity to control their Össur
leg prostheses with their
intentions.”
“As the IMES system
served as a bridge between
the amputee users’ neuro-
muscular system and their
artificial limbs, the learn-
ing process took place
subconsciously, continu-
ously and in real-time for both users.
The IMES system has also successfully
been used in another pilot study to con-
trol an entire bionic arm in amputees
who had undergone targeted muscle re-
innervation (TMR) surgery.”
“We are proud to see our technologies
taking a step towards the market, which
is an essential part of our mission,” said
John Petrovich, president and CEO of
the Alfred Mann Foundation. “I can
think of no better partner to carry on
the future development of the IMES
system. Össur has the most extensive
lineup of devices capable of using the
system, and more importantly they
have the vision to see that mind control
will be an important part of the future
of bionic prosthetics.”
Jon Sigurdsson told OTW, “Össur
has long been aware that AMF’s tech-
nology is the furthest developed, the
most practical and the one closest to
the market solution allowing for mind
control of prosthesis. The world’s first-
in-man cases to initially evaluate AMF’s
implanted myoelectric sensor (IMES)
system were conducted in 2014 on
upper-limb amputees from the US
military, using i-Limb bionic prosthetic
hands produced by Össur.’
‘In 2015, AMF and Össur collaborated
on the first lower limb cases where two
lower-limb amputees in Iceland had
IMES units surgically implanted into
their residual muscle tissue and dem-
onstrated their ability to control their
Össur leg prostheses with their inten-
tions. The IMES system has also suc-
cessfully been used in another pilot
study to control an entire bionic arm in
amputees who had undergone targeted
muscle re-innervation (TMR) surgery.”
“The encouraging insights from the
studies and advancements that AMF
have made to the IMES system has since
then convinced us to extend our col-
laboration to further develop the sys-
tem and pursue larger-scale clinical tri-
als for continued exploration of mind-
controlled prosthetic technologies.”
Asked what this collaboration look
like in one year, he added, “We hope
that the expanded clinical trial, using
Össur’s Bionic prosthetic technologies
and the IMES system will begin by late
2020.” — EH
Courtesy of Össur and Alfred Mann Foundation

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“X-ray Vision”
Guidance System
Cleared for U.S.
Distribution
Chicago-based Augmedics Ltd, says
its xvision Spine augmented real-
ity (AR) guidance system is the first
AR guidance system to allow surgeons
to visualize the 3D spinal anatomy of
a patient during surgery as if it were
“X-ray vision”. The “vision,” accord-
ing to the company, allows the surgeon
to navigate instruments and implants
while looking directly at the patient
instead of a remote screen.
On December 23, 2019, the company
announced FDA 510(k) clearance for
the system. it took the agency over eight
months to review the clearance request.
Game-Changing
“Game-changing” is how Frank Phillips,
M.D., director of Rush University Medi-
cal Center’s spine division, described
the technology’s ability to “visualize the
patient’s spinal anatomy in 3D, coupled
with live CT images as a retina display.”
The company said a study at Rush
positioned 93 screws in the thoracic
and sacro-lumbar areas of five cadav-
ers, comparing the actual screw tip
position and trajectory to the virtual.
“Results revealed 98.9% accuracy using
the Heary (thoracic) and Gertzbein
(lumbar) scales.”
The platform consists of a transparent
near-eye-display headset and all ele-
ments of a traditional navigation sys-
tem. It determines the position of sur-
gical tools, in real time, and a virtual
trajectory is then superimposed on the
patient’s CT data. The 3D navigation
data is then projected onto the sur-
geon’s retina using the headset, allow-
ing the surgeon to simultaneously look
at the patient and see the navigation
data without looking at a remote screen
during the procedure.
Phillips added that the efficiency and
accuracy this AR technology “enables
in placing spinal implants without
looking away from the surgical field—
as well as the ability to ‘see the spine’
through the skin in minimally invasive
procedures—differentiates the Xvision
from conventional spinal navigation
platforms. The economics of the Xvi-
sion system are also compelling in both
the hospital and the surgicenter envi-
ronment.”
Company Founder & CEO, Nissan
Elimelech, said in the release that Xvi-
sion “is our first product of many to
follow that will revo-
lutionize surgery,
as it gives surgeons
the information they
need, directly within
their working field of
sight, to instill tech-
nological confidence
in the surgical work-
flow and help them
do their jobs as effec-
tively and safely as
possible.”
To see this Israeli-developed technol-
ogy in action, click here.
Founded in Israel in 2014, the com-
pany was funded by $8.3 million from
Swiss-based AO Invest (headed by for-
mer Synthes President and CEO Michel
Orsinger), Israeli Innovation Authority,
Terra Ventures and other undisclosed
investors. Distribution of the headsets
are expected to begin in the U.S. in
early 2020. — WE
Victims Can Sue
Ortho Clinics if Data
Hacked
The Georgia Supreme Court has
ruled that the victims of a data
breach at an orthopedic clinic may sue
the clinic for damages.
Georgia’s highest court concluded that
“the plaintiffs’ negligence claim should
not have been dismissed” and “the inju-
ry the plaintiffs allege that they have suf-
fered is legally cognizable.” This ruling
reverses the Georgia Court of Appeals
decision affirming the trial court’s deci-
sion to grant the clinic’s motion to dis-
miss the plaintiffs’ negligence claims.
Georgia courts have previously held
that plaintiffs failed to show a legal-
ly cognizable injury where personal
information is exposed but has not
LEGAL
xvision Spine system (XVS) / Courtesy of Augmedics Ltd.
Negative Space / Source: Pexels

ryortho.com | 1-888-352-1952
fallen into criminal hands or been
used to the consumers’ detriment.
However, the Georgia Supreme Court
found that the facts in this case differ
because there are allegations of large-
scale criminal activity and the plain-
tiffs’ personal information was not just
exposed, it was actively stolen by a
hacker.
In June 2016, an anonymous hacking
group known as the “Dark Overlord”
hacked into Athens Orthopedic Clinic,
P.A.’s computer databases. Dark Over-
lord stole the personal information of at
least 200,000 patients, including social
security numbers, addresses, birth
dates, and health insurance details. The
group demanded a ransom, but Athens
Orthopedic Clinic refused to pay.
Dark Overlord then made some of the
personal information available for sale
on the “dark web.” The group also
made some of the personal information
available, at least temporarily, on Paste-
bin, a data-storage website designed
for the sharing of large amounts of data
online. Athens Orthopedic Clinic noti-
fied its patients of the breach in August
2016 and advised patients to set up
anti-fraud protections.
In January 2017, three of the hacking
victims sued the clinic. The plaintiffs
“sought class certification and assert-
ed claims for negligence, breach of
implied contract, and unjust enrich-
ment.” The plaintiffs sued for dam-
ages based on costs related to credit
monitoring and identity theft protec-
tion, as well as attorneys’ fees. The
plaintiffs also asked the courts to pro-
vide injunctive relief under the Geor-
gia Uniform Deceptive Trade Practices
Act” and “a declaratory judgment to
the effect that the Athens Orthopedic
Clinic must take certain actions to
ensure the security of class members’
personal data in the future.”
The district court dismissed the lawsuit
in June 2017, and the Georgia Court of
Appeals affirmed that decision, ruling
that “costs of prophylactic measures”
were “not recoverable damages.”
This new Georgia Supreme Court deci-
sion means that the case can move for-
ward. However, the court did suggest
that it should be up to the legislature
to determine how best to handle such
cases in the future.
Incidents of cyber hacking have been
on the rise and are being actively inves-
tigated. Nathan Wyatt was recently
extradited from the United Kingdom
to the Eastern District of Missouri
and arraigned on December 18, 2019.
Wyatt is alleged to have a role in “The
Dark Overlord” hacking in Missouri
dating back to 2016. He faces charges
of aggravated identity theft, threatening
to damage a protected computer, and
conspiring to commit those and other
computer fraud offenses.
For OTW’s previous coverage of this
cybersecurity case, see “Can Clinic
Data Breach Victims Sue if No Financial
Loss?” — KD
Here is the FDA’s
New Commissioner:
Stephen Hahn
Acancer doc is now FDA Commis-
sioner.
The U.S. Senate confirmed Stephen
Hahn, M.D., on December 13, 2019 on
a 72-18 bi-partisan vote.
Hahn is a radiation oncology expert and
was recently the chief medical executive
of the University of Texas MD Anderson
Cancer Center in Houston. He’d been a
professor of radiation oncology at the
Center since January 2015. Before MD
Anderson, he was at the University of
Pennsylvania.
Senators reportedly pressed Hahn that
he would put science, data and public
health over politics, and be willing to
stand up to the president as well as large
corporations with significant lobbying
power. His hearing addressed opioids,
drug pricing and generics, but the main
focus was on vaping.
Industry and Professional Support
Hahn had the support of AdvaMed, the
medical device industry’s top lobbying
group, several physicians and research
organizations and five previous FDA
commissioners. The American Asso-
ciation for Cancer Research (AACR)
commended the Senate for confirm-
ing Hahn. Hahn has been a member of
AACR since 1999.
While not brandishing normal Wash-
ington, D.C. political experience, Hahn
is no stranger to healthcare politics
while leading the MD Anderson Cancer
Center in a financial turnaround.
Hahn reportedly told Senators that
running an academic medical center
Stephen Hahn, M.D. / Courtesy of mdanderson.org

ryortho.com | 1-888-352-1952
is similar to running a government
agency.
He said both are “big complex, public-
health-driven, research-driven organi-
zations.” MD Anderson employs about
21,000 people. The FDA has about
17,000 workers.
Views on Approval Process
As a clinical trialist, he offered sena-
tors his views on modernizing the FDA
approval process.
He said he is interested in reconsidering
what endpoints are used in clinical trials
and discovering new ways to expedite
the product-approval process, with the
understanding that “those approaches are
validated” and the current gold standard
of the product review process is upheld.
“In the new era where science is moving
so quickly, the agency should be more
efficient, and we should have more agil-
ity,” Hahn said.
AdvaMed issued this statement: “Dr.
Hahn is an excellent choice to lead
FDA, and we congratulate him on his
swift and overwhelming bipartisan
confirmation. During the confirma-
tion process, Dr. Hahn demonstrated
his deep understanding of the agency’s
mission to protect and promote the
public health and the role of innovation
in improving patient care. His back-
ground as a physician, researcher and
administrator will serve the American
people well at this vital agency. We look
forward to working with him on behalf
of the patients our industry serves.”
4th FDA Commissioner Under
Trump
How long will this one last? Dr. Hahn
is the fourth FDA Commissioner under
Trump. The first, Scott Gottlieb, M.D.,
stepped down in April and was replaced
by acting commissioner Norman
Sharpless, M.D. Last month, Sharpless
returned to his previous post as direc-
tor of the National Cancer Institute,
and Brett Giroir, M.D., a top official at
the Department of Health and Human
Services, succeeded him as acting FDA
commissioner.
Hahn is reportedly a longtime Repub-
lican donor, backing all of the Repub-
lican presidential nominees dating
back to Mitt Romney. He did not
support Trump. Don’t tell the White
House.— WE
First Photon Counting
Imaging System
Cleared by FDA
EOS Imaging SA’s EOSedge has
become the first general X-ray
system powered by a high-resolution
photon counting detector to be 510(k)
cleared by the FDA.
The system is an updated version of the
company’s previously cleared EOS sys-
tem that used gaseous detectors.
In a November 29, 2019 press release,
the company said the system provides,
“local and full body, weight-bearing,
low-dose biplanar exams of adult and
pediatric patients, allowing for undis-
torted images and precise anatomical
measurements of patients in functional
positions.”
EOSedge
The FDA clearance document states
the EOSedge is a “digital radiography
system comprised of an acquisition
workstation, a gantry including an
electrical cabinet housing the system
power and communication controls,
and an acquisition software to obtain
diagnostic images.”
“Two sets of detectors and X-ray
tubes are positioned orthogonally
to generate frontal and lateral imag-
es simultaneously by scanning the
patient over the area of interest.
If desired, the Micro Dose feature
enables image acquisition for assess-
ing global skeletal deformities in
follow-up exams.”
“The diagnostic images are stored in a
local database and are displayed on a
high-resolution medical-quality non-
diagnostic monitor. The diagnostic
image can be transmitted through a
DICOM compatible digital network for
printing and archiving.”
Courtesy of EOS Imaging SA

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Commercial Launch
The clearance follows the commercial
launch of EOSedge in Europe, Canada
and Australia in early December. The
system was unveiled at the Radiological
Society of North America 2019 Annual
Meeting December 1 in Chicago.
The Paris, France-based and publicly
traded company founded in 1989 said
it is targeting a $2 billion annual mar-
ket opportunity. Over 350 system are
installed in more than 30 countries
generating more than 1 million patient
exams annually. EOS imaging has cor-
porate locations in the U.S., France,
Canada, Germany, and Singapore, and
has over 175 employees. — WE
Top Hospitals &
Associations Sue
CMS Over Price
Transparency Rule
Four national medical organiza-
tions joined three hospital plain-
tiffs in filing a lawsuit
against the United
States Department
of Health & Human
Services (HHS). The
lawsuit challenges
a recent Centers for
Medicare & Medicaid
Services (CMS) rule
that requires hospitals
to publicly disclose
the rates they negotiate
with insurers.
On November 15,
2019, the CMS
announced a final rule
which requires hospi-
tals to publicly disclose
the rates they negotiate with insurers.
The ruling goes into effect on January
1, 2021.
The final rule requires hospitals to
post their standard charges online in a
machine-readable file. Hospitals will be
required to disclose the standard charg-
es for all items and services, including
professional charges for physicians and
other practitioners. Under the rule,
hospitals must publicize online 300
payer-specific negotiated rates for ser-
vices that patients are likely to shop
around for. Hospitals that fail to pub-
lish the negotiated rates online can face
penalties, including a fine of up to $300
per day.
On December 4, 2019, four national
medical organizations joined three hos-
pital plaintiffs in a lawsuit against HHS
challenging this final rule in the United
States District Court for the District of
Columbia.
The four national organizations filing
suit against HHS are the American
Hospital Association (AHA), the Asso-
ciation of American Medical Colleges
(AAMC), the Federation of American
Hospitals (FAH), and the National
Association of Children’s Hospitals,
Inc. (CHA). Joining the national orga-
nizations are the Memorial Commu-
nity Hospital and Health System, the
Providence Health System–Southern
California d/b/a Providence Holy Cross
Medical Center, and Bothwell Regional
Health Center.
The healthcare and hospital organiza-
tions argue that HHS lacks statutory
authority to require and enforce this
provision.
The organizations also argue that the
rule violates the First Amendment
because it is not narrowly tailored and
mandates speech in a manner that fails
to directly advance a substantial gov-
ernment interest and because it com-
pels public disclosure of individual
rates negotiated between hospitals and
insurers.
Finally, the rule would be, according to
the AHA, AACM, FAH and CHA, con-
fusing to patients and unduly burden-
some to hospitals. — KD
Source: https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Guidance - https://www.aha.org/ - https://www.aamc.org/
https://www.fah.org/ - https://www.childrenshospitals.org/About-Us/About-the-Association - https://mchhs.org/ https://www.provi-
dence.org/providence - https://www.brhc.org/

ryortho.com | 1-888-352-1952
Is it Time to Call Aging
a Disease?
Would our treatment for osteo-
arthritis (OA) change if we
addressed aging as a disease—complete
with diagnostic and treatment reim-
bursement codes?
Two professors, Richard Faragher, Pro-
fessor of Biogerontology at the Univer-
sity of Brighton and Stuart Calimport,
Honorary Fellow at the University of
Liverpool and the Imperial College of
London, raised that provocative point
in their article “Why Ageing Should be
Classified as a Disease” published in the
journal The Conversation.
Yes, We’re Heading There
Surprisingly, we may be heading exact-
ly to the point as the scientific focus of
pharma and biologic companies moves
from specific disease targets like OA
to genomic and molecular diagnostics
where the process of aging could well
be treated as a codable “disease-state.”
From the early 1900s to, arguably,
between 2010 and 2020, the dominant
paradigm of drug and biologic discovery
was to target a disease state and then seek
a therapeutic to address that disease.
For more than eight decades, that meant
that small molecule drugs and vaccines to
treat arthritis and other diseases of aging.
In the mid-1990s, intracellular inhibi-
tor therapies and epigenetic drugs
became the rage and pulled therapeu-
tics into molecular and cellular mecha-
nisms of action.
Today, we are early into phenotype-
based biologic and drug discovery tech-
niques. Now the targets are oligonucle-
otide therapeutics, genome editing and
pharmacogenetic diagnostics.
And…among the very promising areas
of research is cell senescence including
the resultant release of the raw mate-
rial of osteoarthritis and other diseases
of aging—inflammatory factors and
enzymes.
The ICD System Won’t Work in an
Era of Genomics and Molecular Diag-
nostics
In light of the direction of medical sci-
ence, Drs. Faragher and Calimport
argue that the current system of clas-
sifying disease is out of date.
“The International Classification of
Disease (ICD system began in the 19th
century and is regularly updated. It
provides the codes used to classify and
report medical diagnoses and proce-
dures. And it is central to understand-
ing the causes of illness and death
around the world.”
The classification system is rooted in
defining and grouping pathologies and
diseases that, because of the “natural
process” versus “disease” dichotomy,
means that ageing changes are coded
haphazardly—they are incomplete and
inaccurate, and they overlap.”
The doctors argue that the ICD sys-
tem should cover every pathology
and disorders related to aging. The
problem, they say, is that lack of
classification and staging means that
pathological aging changes are not
recorded and, therefore, treatments
are overlooked—like atrophy, calcifi-
cation and so forth.
According to Faragher and Calimport,
if the ICD coding systems were updated
for aging, “current treatments, includ-
ing diet and exercise, could be effec-
tively applied. And there are several
drugs, old and new, that could be used
to prevent or reverse ageing.”
And, if aging is treated, what would be
the implications for OA?
Next ICD Update Is January 1, 2022
Disease classification codes are sup-
posed to reflect the latest in science and
medicine.
Is it time to seriously consider aging as
a disease classification? — RRY
BIOLOGICS
Wikimedia Commons and Jean Bajean

ryortho.com | 1-888-352-1952
Linking Genetics to
Disease – Mid-Course
Adjustments
In their 2012 PLOS Genetics paper,
“Comparison of Family History
and SNPs for Predicting Risk in Com-
plex Disease”, authors Do, Hinds and
Francke predicted the lifetime morbid-
ity risk and heritability of liability risk
for 24 diseases.
Number 1 on the list was coronary
artery disease with a 40% lifetime mor-
bidity risk and a 49% heritability of risk
liability. Last on the list was Crohn’s dis-
ease with a 0.5% lifetime morbidity risk
and a 56% heritability risk liability.
The implications were obvious. By
applying sophisticated statistical meth-
odologies to genomics, metabolomics
and other ‘omics fields researchers
could rapidly find associations and,
perhaps, causation elements for a wide
range of disease states.
And, given demand for novel studies
with p-values under 0.05, these papers
were comparatively easy to get pub-
lished.
Yes, the quality of those associations is
highly dependent on effect size, back-
ground noise and sample size.
But hey, published! How do you spell
“Tenure?” G-E-N-O-M-I-C-S.
Tangled up in Causation vs Correla-
tion
To feed the explosion of interest in
genetic variants and their potential dis-
ease associations, biobanks sprang up
around the world (in our research we
found about a dozen) to collect, store,
and use genetic data from thousands of
human samples related to diseases (the
Finnish National Institute of Health
and Care’s biobank collects specimens
and measurements from patients with
different diseases, the UK biobank col-
lects samples and physiologic measures
for approximately 500,000 people).
And the global medical science research
community began to move into the
brave new world of correlative, ‘omics
scientific inquiry. Before 2010, said
Nature Magazine citing data from Sco-
pus and the Web of Science, fewer than
100 papers published per year on the
subject of genetic associations with dis-
ease.
By 2015, the number of such papers
had increased to about 200. In 2019,
so far, more than 500 papers have been
published.
New Nature Article Alleges Gene
Based Hack and Sloppy Genomics
Research
A December 10, 2019 article in the
journal Nature titled: “The Gene Based
Hack that is Revolutionizing Epidemi-
ology” describes the downside of this
genomic research land rush.
Author David Adam wrote: “As
genetic data have piled up, a flurry
of Mendelian randomization stud-
ies have emerged that don’t make
the grade. Some have relied on mis-
leading data, and others have failed
to sufficiently test the assumptions
on which Mendelian randomization
relies. It’s time, many in the field say,
to tighten things up.”
Adam put a portion of the blame for this
sloppiness on overreliance on what he
called a “hack”—Mendelian random-
ization and, specifically, the increasing
habit of researchers to throw crazy ideas
against the wall to see there is are ANY
correlations between those ideas and
genetic variants.
Instead, said Denize Atan, an ophthal-
mologist at the University of Bristol,
genomics researchers should “Have a
robust hypothesis and some supporting
evidence before you start. You think,
‘Where did they get that idea from?’ It
just seems to come out of the blue.”
Added Sonja Swanson, an epidemiolo-
gist at the Erasmus University Medical
Wikimedia Commons and U.S. FDA Comparative Genetics Lab

ryortho.com | 1-888-352-1952
Center in Rotterdam, “It doesn’t take
much to just hit the buttons and say,
‘here’s a numeric answer to my ques-
tion.’”
One study which claimed to have
found a genetic link between smok-
ing while pregnant and underweight
babies with orofacial clefts, was panned
by epidemiologists because the stud-
ies were biased towards finding some
effects in the genes being examined.
The genetic variants the authors used
in their Mendelian randomization had
not shown up in larger, more com-
prehensive genomic wide association
studies (GWAS).
In other words, the researchers looked
at the data narrowly and, in effect,
hacked their way to a published paper.
Correlations vs Causation
Each person has approximately 3 bil-
lion pairs of personal DNA information.
Tools like high-throughput genotyping
and precision reference mapping will
someday make this data and all of its
disease associations available to ortho-
pedic physicians.
Guaranteed.
It will be critical, therefore, for physi-
cians to keep their BS antennae tuned.
This land rush is happening in aca-
demia currently. It is only a matter of
time before this information seeps into
your clinic and office.
It may get there without FDA approval,
clearance or license because it starts
with correlative associations rather than
causative data.
We’ll just have to be as aware of Men-
delian hacks as we are of P-Value hacks.
— RRY
Age Not an Issue
in Meniscus Repair
Results
New work performed at The Ohio
State University Wexner Medical
Center in Columbus has found some
interesting associations when it comes
to activity level and the success (or lack
thereof) of meniscal repair.
The study, “Meniscus repair five-year
results are influenced by patient pre-
injury activity level but not age group,”
is published in the December 2, 2019
edition of The Knee.
Co-author David C. Flanigan, M.D., an
orthopedic surgeon at Wexner Medical
Center explained to OTW why he and
his team decided to tackle this subject,
“We wanted to look at the effect of age
on meniscus repairs, and if activity level
was a significant driver in the results
after meniscus repair.”
Flanigan and his team then collected
data for 225 patients (11% of whom
were sedentary, 63% recreational ath-
letes, 26% competitive athletes; 72%
cutting-pivoting sports and 28% of
whom participated in non-cutting or
non-pivoting sports) who were treated
with meniscal repair. The team then
assessed each patient for symptomatic
failure and asked to participate in a
subjective knee function survey (Knee
Osteoarthritis Outcome Score, KOOS,
and International Knee Documentation
Committee Subjective, IKDC-S, scores.
On average, the research team was able
to collect 5.4 years of follow-up data.
Flanigan and the team found that 20%
of the patients experienced repair fail-
ure overall with no association with any
particular age group (<40 vs. ≥40 years)
or level of activity.
When the research team looked at the
IKDC-S scores for sedentary patients,
they found that changes in the scores
were not associated with a particular
age group but were lower among sed-
entary patients as compared with rec-
reational or competitive athletes. The
KOOS-ADL scores were independently
associated with age and were higher
among patients who were older than
40 years. The team did not find any age
associated differences with regards to
LARGE JOINTS
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KOOS-pain, KOOS-sport, or KOOS-
QOL scores. Finally, the team found
that sedentary status was independent-
ly associated with lower KOOS scores
for all sub-scores.
Dr. Flanigan provided more insight
into this interesting lack of age associa-
tions to OTW, “Age doesn’t impact the
results of meniscus repairs. More active
patients, regardless of age, have better
results. this may be due to increased
internal drive and motivation to return
to activity. Sedentary patients, regard-
less of age have poorer patient reported
outcomes.”
“Meniscus repair is successful regard-
less of age. Age should not be a limiting
factor for surgeons to consider menis-
cus repair. Sedentary patients may not
get as much improvement and may
need counseling that they may have
some persistent symptoms or discom-
fort.” — EH
Over 1.5 Million
Arthroplasty
Procedures in AJRR
Database
The American Joint Replacement
Registry (AJRR), managed by the
American Academy of Orthopaedic
Surgeons (AAOS), has released its 2019
Annual Report on hip and knee arthro-
plasty patient outcomes. The report,
now in its sixth year, includes data from
1,525,435 hip and knee arthroplasty
procedures performed between 2012
and 2018.
James A. Browne, M.D., chair of the
AJRR Publications Committee and
editor of AJRR Publications said,
“Highlights in this annual report
include new analysis of timely top-
ics including dual mobility hip bear-
ings and cementless fixation in total
knee arthroplasty, exploration of
the impact of patient comorbidities
including smoking, and more sophis-
ticated survivorship analyses with
adjustment for age and sex, along
with other findings.”
This year’s AJRR Annual Report show-
cases new or enhanced Registry capa-
bilities and offerings including:
• Increased tracking and moni-
toring of patient outcomes with
longitudinal patient information
through the expansion of the
Registry analytics platform, Reg-
istryInsights®. Now, participat-
ing hospitals, ambulatory surgery
centers, and individual surgeons
have the ability to view their
respective dashboards displaying
their data compared to the AJRR
national benchmark.
• Enhanced capture of patient-
reported outcome measures
through continued support of the
RegistryInsights® PROM plat-
form and partnerships with third
party vendors with the expanded
Authorized Vendor Program.
• Additional opportunities for sites
to track performance measure-
ments and use Registry data in
national quality improvement
(QI) programs.
• Peer-reviewed publications and
presentations based on AJRR
Registry data.
Dr. Browne told OTW, “Patient comor-
bidities are well known to influence
the outcome and survivorship of hip
and knee arthroplasty. With this year’s
annual report, we decided to begin
to explore how patient comorbidities
influence the registry data by look-
ing at one specific comorbidity that is
potentially modifiable—smoking. An
association was seen between current
or former smoking and decreased sur-
vivorship of both primary total hip and
knee arthroplasty.”
Asked how much more sophisticated
the survivorship analyses are, he told
OTW, “We first published survivor-
ship curves last year. This year’s report
builds on this initial work and refines
the methodology we use to calculate
the curves by adjusting for patient age
and sex. This is an iterative process and
we plan to continue to critically evalu-
ate how we present the data. Readers
should expect the level of sophistica-
tion to continue to increase as the AJRR
grows and matures.”
To read and download the complete 2019
report, visit the AJRR website. — EH
The American Joint Replacement Registry

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