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Many inventors come up with a great idea and wish to sell this idea to another

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

company in trade for royalties for use of their patent. This makes sense beca

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

Examples of combination products may in

use the inventor does not have to start his own company and go thru all the ri

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

sks to build the device and can sit back in his home workshop and come up with

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

his next invention or innovation. Often these inventors when making an agreem

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

Combination pro

ent do not put in the contract that they want audit rights to the company’s bo

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

oks which will be mass producing and bringing to market this innovative invent

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

ion that they thought of.

Recently I was asked by a think tanker; “I need mor

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

e insight on the audit rights you talked about?”

Well if this company starts

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

selling your invention, how will you know how many they sold? So how can you t

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

ll if they are being honest with you about the amount of royalties (per unit s

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

Following aspects would a

old) monies you will receive? If they are giving you per unit stipend then you

dd to the challenges in developing combination products:

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

would need to be sure that they told you of "ALL" actual sales, whether they

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

were from the Internet, mail order, infomercial or in retail stores.

You see

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

the music industry does similar things to make sure the artists get paid. So d

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

oes the insurance industry as many times the risk is gauged by the amount of g

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

Professional from academic institutions, pharmaceutical industries, health care indust

ross income for exposure calculations. If the totals are in error or misrepres

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

ents then the artist, insurance company or you the inventor gets ripped off. T

.

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

his is why I advice that you put into your contracts when selling your idea, s

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

Companies that provide selfless information through particip

imple audit rights so you get paid what they agreed too. Think on 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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