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When we realize that virtually every aspect of our business and personal life requires negotiation, the benefit of being a better, more efficient negotiator is clear.

Negotiating skills are not usually part of our formal educati

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

on, though we use these skills all day, every day. These skills are at the very core of both our professional and personal lives. It doesn’t matter if we run General Motors or the corner snowball stand or our households, we all 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

ve to communicate and convince effectively.

What is negotiation, anyway? Negotiating can be explained as simply as “working side by side with other to achieve some beneficial result.” Luckily, it is a practical skill that can be

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

learned. It is not a genetic trait we’re born with, like blue eyes or black hair. So no matter what our age or our position in life, if we develop a certain attitude about negotiating, pay attention to honing our skills, then our

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

life will run smoother.

Some things to remember when developing a negotiating strategy:

• Act collaboratively, not competitively. It is not “me against you.” When we see the other person as a bargaining partner, we are aware th

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

Combination pro

t everyone must come away with a benefit. It is a big mistake to think someone is going to give you something for nothing. So try to determine what it is the other person might want, in exchange for what you want. And then presen

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

your case to show them that, if they will help you get what you need, you will help them get what they need. Make “Mutual Benefit” your mantra.

• Personalize the situation; deal as individuals, not as institutions or corporatio

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

s. You are not talking to “the Tchula bank” but to Charlie Smith, the person sitting in front of you, who represents the bank. Flesh and blood Charlie Smith. Realize that you negotiate on behalf of yourself, representing the comp

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

ny. When you see the other person in this light, you are able to look them in the eye. This eye contact

• Increase your expectations. You usually get what you expect to get. If you don’t think you will get the promotion, you pro

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

ably won’t. If you don’t think you will land the contract, you probably won’t. There is no way you will put your best effort forward if you think, in the back of your mind, you won’t succeed anyway. So you might as well act as if

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

you expect to get whatever it is you want. You will be pleasantly surprised when you do! You see, when you truly expect to get what it is you are seeking, others see this in you.

• Know what you want. Sounds simple, doesn’t it?

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

Following aspects would a

But surprisingly, there are many times when we go in to a negotiating session saying, “Let’s see what they offer us.” Why let the other person decide what you will get? Nobody knows your business or your life as you do. Being abl

dd to the challenges in developing combination products:

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

to state specific proposals gives you strength.

• Stay focused on the real issues. Decide what you absolutely want to come away with; what extra’s it would be nice to come away with; and what you can do without if you need to g

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

ve them up to reach an agreement. Why do you need to determine these things in advance? Because in the “heat of battle” you won’t be able to focus on these issues so easily, and you could be very surprised at what you didn’t get

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

r at what you gave away.

• Prepare. Do you homework; thoroughly research the person or company with which you’ll be dealing. Is the company an innovative one or a staid one? Is the person with whom you are negotiating known for

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

eing creative or for being more traditional? With all the information available on the Internet today, there is virtually nothing we can’t find out beforehand. Whether we are researching a corporation or a person. Just Google-ing

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

Professional from academic institutions, pharmaceutical industries, health care indust

someone is likely to bring up something we didn’t know. And of course, there is the old-fashioned way: just ask. Ask industry colleagues (non-competing ones) or acquaintances. It should not surprise you how much people like to ta

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

k about what and who and how much they know!

• Make time your ally. Try to know your counterpart’s deadline without giving away yours. Why? Because if I know your deadline to solve a problem or come to an agreement, I can stall

.

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

ny decision up to the point I know you have to make a decision. Most concessionary behavior and settlement action occur close to someone’s deadline; don’t let it be yours.

These are just a few of the many points necessary to kno

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

Companies that provide selfless information through particip

ing more about the negotiating process. Will practicing negotiation skills take time and effort? Of course. But becoming a more efficient, smarter negotiator will bring you many rewards in both your professional and personal life

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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