media kit · 2020-05-14 · reach your target market: otw’s readers are 60% orthopedic surgeons...
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Media KitWinner of four consecutive MORE Awards from the American Academy of Orthopedic Surgeons and rapidly becoming the gold standard of orthopedic journalism, Orthopedics This Week is the industry leader delivering the most crucial product, reimbursement, surgeon and regulatory news of the week along with insighful opinions and fair-minded analysis. With more print and online options, advertisers have more ways to influence and connect with the opinion leaders and decision makers in orthopedics.
A newsletter
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VOLUME 6, ISSUE 8 | MARCH 16, 201016increasingly unpredictable and inconsistent. The FDA is exerting a chilling effect on innovation.
Pete McNerney, a senior venture capitalist speaking at the Town Hall meeting, summed it up best. “We have lost our abil-ity to evaluate regulatory risk,” said McNerney
McNerney told Shuren that venture capital is usually the only source of capital for companies with, “No sales, no profits and few fixed assets. The pri-mary assets they have are passionate people and intellectual property. Without venture capital they would not exist.”
“I am here because the venture community is moving away from investing in medical technology,” said McNerney.
He backed that up by noting that venture capital investment in medi-cal devices in the U.S. has declined by greater than one-third over the last two years, a decline that is more dramatic for companies raising their first round of capital. The Town Hall meeting in Minne-sota was the first of three big shows scheduled for Minneapolis, Boston in June and Los Angeles in October. If you’re going to try the show out on the road, Minnesota is a good place to start. The audience was polite, well mannered and finished on time. The Boston and LA crowds may notbe so well behaved.
It’s asking a lot of someone who has business before the FDA to be criti-cal in a public forum. Imagine a small town where the local constable is the licensor, inspector, prosecutor, judge and jury. Such is the
power of the FDA.
One brave spine surgeon, John Sher-man, M.D., lectured Shuren about inconsistent reviewer requirements that sank Disc Dynamics.
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FDA Town Hall Meeting in Minnesota/Orthopedics This Week
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VOLUME 6, ISSUE 8 | MARCH 16, 201010
devices and related products and is also based in Salt Lake is partnered with Eagle Condor. Innovasis provides Eagle Condor with office space as well as access to its line of implants and in-struments. Innovasis’ products are de-signed for such difficult pathologies as deformities, degenerative conditions, trauma and tumors, making the pair a match made in orthopedic heaven.
“Dr. Felix had a high interest in hu-manitarian work in third world coun-tries,” explains Dave McKean, V.P. of Operations for Innovasis. “His desire to involve his wife and children in this work caused him to seek a humanitar-ian group who could offer opportuni-ties for the family while the doctors were in surgery.” He explains that with the partnering Eagle Condor was able to expand its mission be-yond dental and maxillofacial care to orthopedics. “It was a perfect fit for Innovasis to find a group who shared a similar mission and values.”
The amount of instruments Innova-sis provides is impressive. According to McKean, for every Eagle Condor expedition, the company sends along as many as seven suitcases of instru-
ment boxes, spinal screws, rod sets, bone filler, rod cutters and any other key instruments the surgeons may re-quire. “The materials are all donated.” McKean adds that the transporting of hundreds of thousands of dollars of this hardware onto regular commer-cial airline flights is always a thrilling experience. “To this date, nothing has ever been lost or stolen, but Innovasis is always willing to take this financial risk in order to help.”
Exchanging Ideas, Inspiring Hope
“Sharing new techniques in surgery is always welcomed by our Peruvian doctor associates,” adds McKean. In fact the Peruvians doctors are able to observe and generally work alongside their American counterparts, receiv-ing hands-on training in cutting-edge orthopedic procedures. “By operating with the Peruvian doctors we know their skills have improved which continues service to patients after the Americans have left.”
Of course, it’s also the Americans who benefit. “It is evident that the Peruvian humanitarian expeditions by Innovasis have a profound effect on our engi-neers and staff,” says McKean. “When expedition members return and share their experiences with our employ-ees, it brings a tremendous sense of fulfillment to those who designed and created our products.”
Eagle Condor encourages surgeons’ spouses and children to take an active role in the expeditions and make these trips a family affair. While surgeons are in the OR, families are working on village improvements, for example, constructing a school for 44 children. This simple building saved the village children a daily four hour walk to the
VOLUME 6
, ISSUE 8
| M
ARCH 16, 2
010
1-877
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450
| w
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picture of success
week in review
breaking news
5Pe
arlDive
r Rais
es Ind
ustry
Sales F
orecas
t FLarg
e joint
implan
t supplier
s sold $3 bil-
lion of p
roducts in
the fi
rst quart
er
of 2010, b
eating P
earlDive
r’s $2.87
billion fo
recast
by 4.6%. P
earlDive
r
is rais
ing 2010 sa
les fo
recast
s 2% to
$3.03 billion fo
r 2Q10 an
d for th
e full
year fr
om $11.95 billion to
$12.23 bil-
lion. H
ere ar
e the d
etails.
10Dr. J
eff’s T
ravell
ing
Medicin
e Sho
w FJef
f
Shuren, M
.D., cam
e to
a Town H
all Meet
ing in M
innesota
to sell a
more
open, co
nsisten
t and
transpare
nt FDA. M
innesota
is home
to more
than 300 m
edica
l firm
s. So he
also go
t an ea
rful. H
ow did he re-
spond? Read
on.
14Fly
ing O
rthop
edic
Care
to Pe
ru FEagl
e Condor
Humanita
rian an
d In-
novasis,
a spinal i
mplant a
nd device
manufac
turer ar
e brin
ging t
reatm
ents
to villag
ers of P
eru an
d chan
ging v
il-
lagers
lives…
.and th
eir own. S
ome-
times
to get b
ack to
med
ical b
asics
you
have to
travel
.
18Sarc
omas:
Wha
t Do
You K
now? F
Let’s ra
ise
the index of su
spicion
for bone a
nd soft t
issue s
arcomas,
say
Drs. Ja
mes Witti
g and M
artin M
alawer.
These ar
e nuan
ced ca
ncers, a
nd if not
handled
properly, c
ould go undete
cted
for months.
33Dr. J
effrey
Anglen
FHe
has worked
in South
Africa a
nd knows how
to set u
p a study s
o that
you have
answ
ers to
someth
ing mean
ingful.
This is D
r. Jeff
rey Angle
n, Chair
man of
Orthopaed
ics at
the I
ndiana U
niversi
ty
School o
f Med
icine.
22CT Spine R
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atting
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Active
Kids, Stro
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ip Bones
For all n
ews t
hat is
Ortho,
read on.
1-877-817-6450 | www.ryortho.com
VOLUME 6, ISSUE 8 | MARCH 16, 201018
try would serve in lieu of an inspec-tion by the FDA and vice versa.
Use of a Science Task Force
The agency established an internal task force to incorporate new scien-tific information into the decision making process in a transparent and predictable manner. That task force’s report will go out for public
comment this summer. The Center recently established the position of Deputy Center Director for Policy whose function is to en-gage in strategic policy development and coordination. Shuren said that they are staffing that center up and expect to announce the new Direc-tor’s name later this summer.
Shuren: “I have no bench”
Shuren commented on his staff-ing needs and made it clear that in several important categories he has “no bench”. When a reviewer leaves the Center, there is often no back-up staff member to step in. Shuren did not offer details as to how he plans to address this problem and certain-ly, as he mentioned in the meeting, the range of new medical technolo-gies makes it harder and harder to find reviewers with the specific ex-pertise necessary to properly evalu-ate applications.
Innovation to Promote Health
The mission of the FDA and CHRD is to protect the public’s health and promote patient access to innovative medical products.
Those two FDA mission statements have often moved in different direc-
tions. The public outcry, for exam-ple, that occurs when an approved product harms a patient is, said Shuren, far greater than when an un-
known class of patients is not getting timely access to a new technology.
Shuren, however, linked the two missions in his talk. He said that access to new technologies is impor-tant in order to protect the patient’s health. pendulum has swung far to one side or the other. To fulfill our mandate, we must embrace both parts
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