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While all niches are different in their characteristics, there are so

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

me rules that stay true to all niches. And although some might say th

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

Examples of combination products may in

at the money is in the list, the money is really in the niche! The ni

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

he you choose is your first stepping stone on your road to success.Th

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

at’s why it’s important to spend time choosing the niche which is sui

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

Combination pro

able for you, and brings in long-lasting profits.

The first rule in

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

niche marketing is that you must define who your target audience is.

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

ou need to create a mental picture of who your customer is. Is he a y

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

oung adult or a baby boomer? Is your potential customer base mainly f

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

male or male? You cannot miss this step because it defines your whole

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

business model and what kind of products you will provide.

Next, yo

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

Following aspects would a

u need to find out what problems your niche are having. Every product

dd to the challenges in developing combination products:

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

solves some problem in some way or another. It could be a craving or

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

desire that needs to be fulfilled, or a niggling problem that goes on

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

for years and years. If your product can solve any of these problems,

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

you’re definitely heading on the right track.

The third rule is to

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

Professional from academic institutions, pharmaceutical industries, health care indust

est your niche. I know it’s a clich?, but you need to test the waters

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

before jumping in! Conduct a survey to find out what exactly what cu

.

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

tomers want to see in your product. Do a market test for your product

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

Companies that provide selfless information through particip

to see if it sells before going on a full-blown advertising campaign

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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