Main Subject - Business

When you’re a customer service consultant and coach, it’s just one of the standard nig

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

htmares you have.

Suddenly, every company in the world gets the message and they all

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

Examples of combination products may in

tart monitoring, measuring and managing their customer service efforts. Even the most

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

hard-bitten street vendors and ballpark peanut hurlers become gentle lambs, nuzzling a

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

d comforting us as they never did before.

Then, happily, you’re jolted back to realit

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

Combination pro

, as I was today, entering a taxi at the Las Vegas airport. I thought this ride was go

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

ing to be, at worst, routine. I gave the address to the driver, which is Wynn Road. I

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

ssumed it is well known; named after Steve Wynn, whose hotels, past, present and futur

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

e are sprinkled everywhere in this desert oasis.

I also hinted to the cabbie that the

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

place was near two major intersections. To me, that level of specificity is as good as

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

a global positioning printout, but not to my driver.

He grunted, “I’m not sure where

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

Following aspects would a

that is.”

Next, he started handing me a Thomas Guide and asked, “You wanna look it up

dd to the challenges in developing combination products:

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

My golly, Captain Kirk, who am I; Mr. Sulu, your navigator?

I snapped back, “That’s

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

not my job!”

He snickered, and found a way of fingering through his own guide en rou

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

e to get us to my destination.

I know that today’s companies are trying to offer self

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

service and claim it is the real thing. They implore us to visit their web sites, to u

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

Professional from academic institutions, pharmaceutical industries, health care indust

se telephone automation, too, so they don’t have to supply real human assistance.

But

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

are cabbies taking a page out of the goliaths’ playbooks?

It can only give you hope i

.

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

f your career consists of reforming customer-insensitive behavior. As long as nature c

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

Companies that provide selfless information through particip

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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