Advice You - Business

One of the most aggravating situations, which can happen in negotiation is when your

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

party fails to understand the true intentions and the cultural nurturing of the oth

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

Examples of combination products may in

r parties. This happens often when dealing with foreigners from other nations who ha

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

ve different ideas of what a negotiation means.

For instance dealing with a Middle

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

astern Businessman or an Asian Company. Often your negotiating team will find themse

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

Combination pro

lves in a negotiation with a Win-Lose other party who wants to win the negotiation a

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

d would prefer you to lose, if you win too well that is okay with them but they woul

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

d sincerely prefer to leave no crumbs on the table for you at all and if you find yo

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

rself in such a hostile environment you may find the negotiations drag out for month

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 and you must spend your time on development of friendship and not negotiating busi

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

ess only.

Then there are the negotiations where you try to assist the other party t

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

Following aspects would a

o make sure they get enough of what they want to insure performance and you get what

dd to the challenges in developing combination products:

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

you want as well. Yet as soon as the contracts are signed that is when the real nego

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

tiation starts and you find the other party was totally uninterested in fulfilling t

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

eir written contractual performance, but wishes to hold you fully accountable to you

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

r written promise and even things you did not say, which they conveniently misinterp

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

Professional from academic institutions, pharmaceutical industries, health care indust

eted as a quote; “Misunderstanding” of course if that were the case you know good an

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

d well that would have been in the contract.

Now then these situations happen often

.

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 international business dealings and so you must be careful to understand culture,

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

Companies that provide selfless information through particip

win/win, win/lose and after negotiated contract negotiations. 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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Do your leaders ever force timelines on projects? Does the bear... well, you know what I mean. Leaders everywhere want to be macho and disguise leadership under a heavy coat of demands. Read on and see the cost of such demands in the Vietnam War and how it relates to your organization.

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Advice You - Business Negotiation and the Win-Lose Turning to a Lose-Lose in the Courts

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