Advice You - Business

The avoiding approach to negotiating is characterized by losing, leaving, and withdrawing.

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

No commitments are made, and behavior is impersonal. Use this approach when you would get h

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

Examples of combination products may in

rt by staying or when you want to change the ground rules. It is useful when issues are tri

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

ial and is helpful when the other side has much greater power. Its disadvantage is that the

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

problem is left unresolved, and this can result in nothing getting done if too many problem

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

Combination pro

are swept under the rug. In the avoiding approach, at least one of the parties displays 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

ubtle reluctance or unwillingness to resolve the issues. This approach is of little use for

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

those working with organizations as it strains relationships and prevents the building of t

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

ust between the parties involved. Using this approach can also increase the other party’s r

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

sistance to negotiation.

Under the accomodation approach, the parties are yielding, and th

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

y try to avert conflict. The accommodating negotiator undervalues his own worth and accompl

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

Following aspects would a

shments and places top priority on maintaining peaceful relations with others. It is a “don

dd to the challenges in developing combination products:

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

t rock the boat” philosophy used when there is a need to concede on small points in order t

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

gain on major points later. It is helpful when the other side is right and you should give

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

in, or when preservation of the relationship is more important than negotiation. Among its

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

roblems are that it creates potential IOU’s for future negotiations. Furthermore, it may ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

d you a major loss on important issues and can lead to a habit of concession on many issues

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

hence decreasing your power and reputation. This approach gives away too much by overly em

.

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

hasizing the relationship between the parties. Accommodating may satisfy the other party wh

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

Companies that provide selfless information through particip

le your interests suffer. Use this approach when appropriate, but do not make a habit of it

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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Advice You - Negotiation: The Benefits of Avoiding and Accodmodating

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