Useful Advices - Business

Do you have a great idea for a business? Sure you do, who doesn’t, but the questi

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

on is how do you raise the capital to start this great business or fund your new

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

Examples of combination products may in

invention. Perhaps it is a technology device or perhaps it is a simple solution t

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

at is needed and you intend to fulfill that niche?

Hey, let’s face it there have

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

been some wacky inventions or ideas, which have made millions right? Indeed, the

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

Combination pro

Hoola Hoop for instance, but that is just one idea of 1000’s, which have retired

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

their creators rich.

Okay so you have a perfect invention and for the sake of ar

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

gument let us say it is a Automatic Dog Frisbee Thrower Machine. The Frisbee fire

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

s off and spins some 100 feet and the dog runs and gets it. Then the dog returns

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

he Frisbee and puts it into the shoot like the hopper of a Tennis Ball Machine, a

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

gain away goes the Frisbee. After 3-times it gives the dog a treat and after ten

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

Following aspects would a

times it fills the water bowl up; great invention right?

Yes, smart thinking, no

dd to the challenges in developing combination products:

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

you need funding, perhaps 500,000 to a million dollars to make the machine, mark

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

et it and start your company. Now they you design a perfect business plan and sta

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

rt submitting it to venture capitalists. But wait, you see they do not want you b

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

siness plan, they want only an executive summary.

So be smart and save the trees

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

Professional from academic institutions, pharmaceutical industries, health care indust

, send them two-pages of summary and call them back in a week. They are intereste

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

d in maximizing return on investment. They want all their money back in times ten

.

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

in 3-years and then perhaps sell the whole company out or take it public. So if y

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

Companies that provide selfless information through particip

ou want VC money, you need to know that up front first off. 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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Buying a business is a complex and legally binding event. Take a moment to read this article before you put anything in writing!

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Useful Advices - Venture Capitalism and Funding Your Idea

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