Advice You - Business

To morning commuters, the hulking truck encircled with barricades and traffic cones may be nothing more than a road-clogging nuisance.

For Kerem Tepecik

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

and Dale Vith, two men who’ve made a good living by changing light bulbs forty feet above the pavement, the so-called “bucket truck” is more ominous.

“

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

very time I go up, I wonder if this is the day I’ll die”, says Tepecik, a married father of two. “We call it the “prayer bucket”.

Naturally, spending h

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ours swaying in the Texas wind while dismantling high voltage light fixtures as angry drivers on the street below zoom past, the two electricians shared

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

single thought. “There’s got to be a better way.”

“After a couple of near-death experiences, where a truck nearly fell on me or on him”, says Vith, th

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e pair began to learn the truth of Edison’s dictum, “Invention is one percent inspiration and 99% perspiration.”

Taking a cue from “High masts” (200 foo

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

light poles used on freeway cloverleaf overpasses) with their built-in lowering systems, Vith and Tepecik spent nights and weekends designing and buildi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ng prototypes of their “Retropole”, a patented crank-and-rail attachment which safely disconnects and lowers the light for servicing.

The system is now

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

n church parking lots, fast-food drive-thrus, and at the headquarters of a nationally-famous family restaurant chain, whose management is in the process

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

of rolling out “Retropole” in locations nationwide.

Following a soft launch in May/June '05, the new company’s small staff has been thrilled by the reac

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ion on the part of customers of every size.

With retail prices under $1000, the systems pay for themselves the third time a light bulb is changed. Easy

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

DIY maintenance and low cost of operation (bucket trucks charge $200-$300 for minor service calls, whereas the bulbs are sold for $20 at home improvemen

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

stores) appeal to maintenance staff.

Perhaps more significant, though, is the invention’s positive impact on property value.

“For every dollar a prope

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

rty’s annual maintenance cost drops, ten dollars is added to the property’s value” explains Tepecik.

The implications of this have lead two major Texas-

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ased manufacturers to gear up for enormous production runs.

“Kerem and Dale are two good guys who worked hard to bring a terrific idea to life. How oft

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

en does an idea come along that helps with so many issues-safety, environment, and so on, that also helps large businesses save a fortune?” says Sherman

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

llen, marketing director of the Dallas based Retropole, llc.

He notes that “bucket trucks” are leaky behemoths which cause concrete and landscaping dama

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ge, and, in terms of fuel, the 13-ton monsters “make Hummers look like econo-boxes.”

In an ironic twist, the success of Retropole will keep Vith and Tep

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

cik in the “prayer bucket”, since the one-hour installation of the mechanism requires one final ascent for removal of the light fixture.

Tepecik says he

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

’s considering a sign on the truck that says “I’m never coming here again.” http://www.retropole.com

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Advice You - Near-death Experience is the Mother of Invention for Two Dallas Electricians

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