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Caution! After reading this article, you may need to adjust your product or service, your advertising, your websi

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

te, or your target audience a little (or all of them). Fortunately, none of these are set in stone and can usuall

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

Examples of combination products may in

y be changed quite easily.

I'm sure you realize it's impossible to meet everyone's needs. So you need to select

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

a target group and attempt to appeal to them and them alone.

This may seem simple at first glance. But, take it

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

to heart; it really is a sure-fire way to increase your sales. Just focus in on one specific area. It is impossi

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

Combination pro

ble for any one product or service to fill everyone's needs.

You may be a little skeptical. If this is the right

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

way to do business, why don’t more (or any) of your competitors do it? It’s a good question, and here are a few

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

answers.

1. Your competitors are probably greedy, so they don’t want to take a definitive stance. They want all

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

the customers they can get. Their business is plain vanilla. There is nothing unique about them.

By targeting a

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

select audience, it does seem like you will have to turn away some clients. But the reality is you can’t appeal

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

to everyone anyway. By trying to appeal to everyone, it is likely that you won’t appeal too much of anyone. Diff

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

Following aspects would a

erentiating is the key to success in business.

As Jack Trout put it in “The 22 Immutable Laws of Marketing”, “Whe

dd to the challenges in developing combination products:

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

n you try to be all things to all people, you inevitably wind up in trouble.”

2. Many businesses are afraid to se

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

t themselves apart. This is due in part to being afraid to step aside form the pack. Different scares them. Uni

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

que is risky. They have the “follow the herd” mentality.

3. It can take some effort to come up with a well artic

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

ulated message. And, if it doesn’t work, they will have to revise it. So this takes even more effort.

4. Some o

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

Professional from academic institutions, pharmaceutical industries, health care indust

f the best messages include a promise. Promises are risky. Therefore, most people won’t make them.

You stand

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

a better chance of becoming an acknowledged leader in a smaller niche than in a larger one. If you look around at

.

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

your competition, it is likely that no one has segmented the market and gone after a smaller niche. That means t

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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