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Paper finds generic devicces ‘closser than

n they aappearr’
By AMAND DA PEDERSEN N
Medical Deevice Daily Senio
or Staff Writer

A new white
w paper frrom Fuld (C
Cambridge, Massachuset
M tts), a researcch and consuulting firm inn the
field of business
b and competitivee intelligencee, suggests thhat generic mmedical devices are “clooser
than theyy appear.”

The papeer, written by


y Laura Ruth h, PhD, a dirrector with F
Fuld’s pharmmaceutical annd healthcaree
practice, concludes th
hat several market
m forces, including changing diistribution chhannels,
increasin
ng economic pressures, responsive leegislation, paatent expirattions, and tecchnology
innovatio
ons, will act as catalysts toward the acceptance
a oof device gennerics at a faaster rate thaan
ever befo
ore.

The papeer highlights one compan ny in particu


ular, Genericc Medical D Device (GMD D; Gig Harbor,
Washing gton), that lau
unched the Universal
U Sliing System ffor female sttress urinaryy incontinencce,
a class III medical dev
vice, during the summerr of 2009.

In 2007 GMD
G reportted FDA cleaarance of a universal
u surrgical mesh, also a class II device,
intended to support tiissue growth
h in open or laparoscopicc proceduress common foor hernia reppair
(Medicall Device Daiily, May 14, 2007). Earliier that samee year the coompany received a CE m mark
and a EC
CDeclarationn of Conform mity allowingg it to sell itss universal circumcision clamp in alll
Europeann Union coun ntries (MDD
D, Feb. 9, 2007).

Shawn Lunney,
L GMD D VP of salees and markeeting, is quotted in the whhite paper sttating that
GMD’s mission
m is to
o develop and d bring to market
m “cost-eeffective equuivalent meddical devicess that
provide equivalent
e ou
utcomes at substantially
s lower cost.”” Lunney sayys GMD loooks for produucts
in the hospital that haave a bad priice/value balance and thhe next innovvation in lifee cycle doesnn’t
gain any significant patient
p valuee. He adds thhat generic ddevices are ppossible in alll device classses
but simpller ones beco ome commo odities and phhysicians haave more braand preferennce with
sophisticated high-en nd devices.

The FDA A says there is no such thhing as a genneric medicaal device thatt is equivaleent to the
meaning of generic drugs.
d A genneric medicall device doe s not have a regulatory ppathway
like a gen
neric drug an
nd it is not a commonly used term inn healthcare,, according tto the paper.
But, the paper
p suggessts that desp
pite the lack of
o FDA acknnowledgmennt or officiall label, lowerr-
cost geneeric devices are one sectoor of the heaalthcare induustry that is llikely to grow due to
economic pressures.

A generic asthma albuterol inhaler is an example of a generic medical device that manufacturers
have developed, Ruth notes in the paper. There are other types of devices, such as the female
urinary incontinence sling, that are likely to grow in their respective markets.

GMD’s Universal Sling System competes with existing brand devices, such as the Gynecare
TVT Obturator System Ethicon Endo-Surgery (Blue Ash, Ohio), Boston Scientific’s (Natick,
Massachusetts) Lynx System, Caldera’s (Agoura Hills, California) Desara, and Coloplast’s
(Minneapolis) Aris and Supris.

“The doctors seem interested and we are building commercialization,” Lunney says. After a year
on the market, GMD says organizations can save 25% to 50% by using their slings versus a
branded sling. One Texas hospital reports a $50,000 savings after one year and other organizat-
ions are saving roughly $20,000 in a period of less than a year, according to the white paper.

GMD launched in December 2006 calling itself the first to offer commonly used and efficacious
surgical products as generic products.

GMD plans to follow the same formula used by the generic drug industry to develop and
distribute alternatives to standard-of-care devices, offering payors, clinics, hospitals and
physician-owned surgical centers the benefit of medical devices with equivalent safety and
efficacy, but at lower prices.

Richard Kuntz, president/CEO of GMD, told Medical Device Daily in 2006 shortly after the
company made its official launch that he got the idea for the company a couple years earlier
while he was traveling and found a newspaper article slipped under his hotel room door about
Medicare predicting bankruptcy by 2019, seven years earlier than previously predicted (MDD,
Dec. 12, 2006).

“I didn’t understand why the medical device industry had not followed in the pharmaceutical
industry’s path of when a product patent expires offering a generic alternative,” Kuntz said. “It
was sort of a ‘duh’ – as my kids say – and a ‘Why not?’”

So that’s exactly what GMD set out to do.

“Many of the medical devices commonly used in today’s healthcare organizations have under-
gone few, if any, changes in the decades since they were first introduced to the market,” Kuntz
said. “Nevertheless, purchasers of medical devices continue to pay a premium for these
commoditized products and are demanding alternatives. Like with generic pharmaceuticals,
GMD will be offering medical devices that are equivalent, if not better, than their branded
counterparts and at prices that will be attractive to hospitals, physician-owned surgery centers,
Medicare and third-party payors.”

In the pharmaceutical industry, once the patent on a brand name drug expires, competitors are
allowed to develop, market and sell generic alternatives as long as they offer the same safety and
efficacy as their branded counterparts, thus avoiding the standard high development costs: R&D
expenses, costly clinical trials, protracted governmental approval and marketing costs. As a
result, these companies are able to sell equivalent versions of brand name products at
significantly reduced prices.

And by reducing the costs of some drugs, generics make room in the system for new products,
the generic manufacturers contend.

In Fuld’s white paper, Ruth notes that one reason generic devices have failed to achieve market
acceptance is group purchasing organizations (GPOs). According to the paper, the funding
relationship between the hospital GPO medical device distribution channel and medical device
manufacturers has historically been a market force that can prevent lower-cost alternative
treatments from entering the market. Typically, manufacturers who are selling products to a GPO
can also be paying a GPO’s operating expenses, which creates a conflict of interest.

However, according to the paper, further examination of market forces, such as distribution
channels, pricing, technology innovation, and patents, explains why generic medical devices
have developed and why they can continue to develop in the future.

Relatively simple devices, such as the female urinary incontinence sling and asthma inhaler, are
evidence of where generic medical devices can develop, Ruth noted in the paper. Patent
expirations and scientific research studies demonstrating equivalent outcomes between brand
technologies are indicators of where generic medical devices can develop, the paper concluded.

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