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One of the worst things I have discovered in Business Negotiation is tha

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

t so often one party will over sell leaving very little on the table for

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

Examples of combination products may in

the other party. Sure you shake hands and look them in the eyes when 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.

mpleted but you wonder if they can perform or if they have over promised

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

Will they deliver on that promise or will they fall short and then what

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

Combination pro

?

No one has time to waste in the courtroom and so often that is where

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

lopsided deals end up. That makes no sense when you have a business to r

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

un. We see this most often when negotiating with salesmen or foreign-bor

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

thinking folks who are not so into the Western World’s win/win scenario

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

s.

It has always been my observation that in a win/lose negotiation tha

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

t more time will need to be spent in the future to offset the problems c

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

Following aspects would a

reated by sacrificing the other party in order to take everything off th

dd to the challenges in developing combination products:

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

table for your company leaving them nothing but crumbs. Negotiating fro

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

m a win/win perspective makes sense and so in Business Negotiation it be

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

hooves each side to be careful if you win too much or aggressively grind

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

on the other party to the point they get nothing.

Because if you truly

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

Professional from academic institutions, pharmaceutical industries, health care indust

need performance for your operation from the other party and they cannot

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

afford to fulfill their end of the deal, well everyone loses in the end

.

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

and you could be put in a position of scrambling to make things happen

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

Companies that provide selfless information through particip

and end up in court with the defaulting party. Consider all 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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