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One of the most powerful tools in a negotiator’s toolbox is silence: absolute, blank-faced, quiet. It can be used when confronted

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

with a tough situation, when given news that is too good to be true, or when you just don’t want to say anything stupid.

Many o

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

Examples of combination products may in

f us feel compelled to fill the air with words and noise; in fact, it seems that we fear silence. Silence can be uncomfortable; t

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

is is particularly true for talkative people (i.e. extroverts). What makes it worse is that talkative people are usually talking

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

about themselves; this is exactly what you don’t want to do when you negotiate. Fast talking, extroverted sales people may be the

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

Combination pro

worst negotiators on the planet.

So why do we dread silence? I am not a therapist, but I think it is because we fear that someon

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

e might catch us at our game or see us for what we really are. Silence is a stark naked reality.

Silence can buy you time to thi

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

nk. When you find yourself in a tricky spot in a negotiation, stop everything, shut up and listen. It makes you look smart and it

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

gives you time to think about what you should do next. Meanwhile, because you are not talking you are not making any concessions

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

or giving information to the other side.

It takes practice to be silent. One trick is to stop talking and take notes slowly, whi

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

h looks really intelligent (although you could be just doodling). Silence can be uncomfortable for the other party as well; what

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

Following aspects would a

you want is for them to speak first and fill the empty space with information to help you. By definition, when you are silent you

dd to the challenges in developing combination products:

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

are a better listener. When you are silent it also cues the other side to speak. Silence can force the other party to “anchor” (

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

.e. state their position) first; this can create a strategic advantage for you.

An abbreviated form of silence that is very effe

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

ctive is to incorporate long pauses in your speech. This can be almost as uncomfortable as pure silence. Long pauses can trap the

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

other party into finishing your sentences and bumping their jaws. Practice by pausing for a five second count between your key po

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

Professional from academic institutions, pharmaceutical industries, health care indust

ints; it will seem like an eternity to the other party. Expect them to leap forward filling in the silence; let them speak.

Afte

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

r you master silence, you may occasionally find that others may play the same game as effectively as you. At some point staring a

.

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

each other waiting for the other to speak seems pointless. In this case, you can just restate what you said previously. Often th

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

Companies that provide selfless information through particip

is restatement challenges the other party to reply. Listen to what they say.

“Silence is a fence around wisdom”. (German Proverb

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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