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When I was a kid, I knew by heart most of the batting averages and other vital statistics of the Chi

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

cago White Sox, my hometown team. Like most people my age, I relished predicting who would do what,

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

Examples of combination products may in

when his time at the plate was coming up.

Statistics make sports more fun to watch and even to play

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

. But they can be misused, especially in the arena of selling.

For instance, who is the better sale

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

person?

(1) Joe is able to close one out of every two prospects he meets, and this gives him 20 ord

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

Combination pro

ers for the week.

(2) Mary closes one out of three, giving her 25 orders for the week.

In terms of

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

batting averages, Joe stands at .500 and Mary at a less efficient, .333. From this perspective, Joe

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

reigns supreme.

Or does he?

After all, Mary outpaces him in total runs scored, or sales made. In t

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

hat department, she’s 25% more effective, or so it seems.

But we can’t be sure who is the better se

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

ller, overall. That’s a judgment call, and it may require we look at more variables, such as the cos

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

of sales, overall availability of sales leads, who is easier to work with, whose sales are more lik

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

Following aspects would a

ely to stick over a longer term, who requires more coaching from the manager, and so on.

If you clo

dd to the challenges in developing combination products:

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

se nine out of ten sales, but it’s because you’re discounting and cutting your commissions, that may

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

actually portend disaster.

From a personal standpoint, it makes sense to defy statistics and just

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

ocus on dollars earned. Is your income higher, and is it continuing to move upward? That’s all you n

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

eed to know, yet even that can be misleading.

There are times when you might be learning to sell a

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

Professional from academic institutions, pharmaceutical industries, health care indust

very new type of product that defies conventional introductory practices. Consequently, your initial

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

production looks abysmal, but that handicap will disappear, imminently, if you just keep plodding al

.

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

ong.

Keeping perfect scores of your accomplishments may be possible in baseball, but don’t let this

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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