Advice You - Business

Negotiating is no game. It is not for the weak or the fragile. It takes assertiveness and someone who feels comfortable in the m

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

ano-a-mano world of business. Can women negotiate the deal as well as their male counterparts? Absolutely! In some cases, they

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

Examples of combination products may in

ay even do a better job. Women have a definite edge at the negotiating table because of their instincts and natural power of pers

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

uasion.

Women usually look for a win/win in negotiations. In Getting to Yes, the classic book on negotiation by the Harvard Nego

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

iation Project, it was reported that the win/win strategy work best in negotiations. In order to avoid future resentments, all pa

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

Combination pro

ties should come away feeling good about the resolution of a problem.

Traditionally, it is thought that whoever is on the other s

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

ide in negotiations is the adversary. However, women tend to want to develop a relationship with the other person and take into a

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

count the needs and difficulties of both sides. Women also tend to collaborate and help one another if problems arise.

What trad

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

itional businesses have missed for far to long is the understanding that personal relationships, not the contract, profit margin,

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

r delivery date is what give one the competitive edge. Historically, women have been seen as poor negotiators because they are in

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

luenced by the other party’s situation. But if the truth were told women will more often than not work with their adversaries to

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

Following aspects would a

reach a solution that is good for everyone involved.

Negotiating is a critical skill for all women aspiring to succeed in the bus

dd to the challenges in developing combination products:

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

ness world. For those women who feel they are not good negotiators, they simply need to remember their natural talent of persuasi

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

on. Keep in mind even good negotiators will sometimes make mistakes. The key to avoiding these mistakes are: (1) attack the pro

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

lem and not your adversary; (2) try to come up with several options; (3) never treat negotiations as a contest; (4) never threaten

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

and (5) never give in to something that is contrary to what you believe is ethical.

The playing field for women in this arena has

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

Professional from academic institutions, pharmaceutical industries, health care indust

never been level. But women who have empowered themselves with the skills, knowledge, and confidence to negotiate at top levels

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

ave chosen a path that ultimately challenge the entrenched structures which have always hampered them. Women from childhood have

.

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

been conditioned to be excellent negotiators. So ladies, do not be afraid to step up to table and negotiate with the big boys. Ma

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

Companies that provide selfless information through particip

ter the art of negotiating, use it with confidence, and the only limits to what you can achieve will be those placed upon yourself

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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