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Have you seen the local automotive parts companies in your town

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

? They have vehicles, which deliver parts to the various shops

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

Examples of combination products may in

s needed. These auto parts stores need to be involved in the co

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

munities they serve and it would serve them well to indeed do 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

little Public Relations or PR from time to time.

Of course the

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

Combination pro

can do the usual; sponsor a soccer or little league team, but

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

hat else can they do? Well as a case study lets throw out a new

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

concept; have the auto parts store join a local neighborhood bu

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

iness watch program? Why you ask? Well let us look at their bus

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

ness model for a moment;

AUTO PARTS COMPANIES: These companies

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

drive around all day to dealerships, auto maintenance facilitie

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

Following aspects would a

s, and utility companies. They have many drivers, two-way dispa

dd to the challenges in developing combination products:

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

ch and cover lots of territories. Their vehicles are driven by

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

oung high energy people who can really add excitement to the gr

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

ups and who have friends who party a lot and are more apt to co

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

mit crimes. It is good to have these drivers warn their friends

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

Professional from academic institutions, pharmaceutical industries, health care indust

and acquaintances of this new program; it serves as a deterrent

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

Now can you see why this makes sense and it costs them nothin

.

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

to participate in it and look at the valuable community goodwi

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

Companies that provide selfless information through particip

l it will generate too. Perhaps you might consider this in 2006

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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