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Screaming, yelling, ranting, raving, cursing, throwing items across the table, hanging up the phone in your ear ... Many of us have difficulty with negotiators who do

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

these things.

These outrageous behaviors can shake us up, intimidate, scare, or upset us.

Why? The most common explanation is that our fight-flight response is evo

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

Examples of combination products may in

ked. Fighting rarely gets us moving toward a meaningful agreement. Fright can cause us to make compromises or give concessions we would otherwise never entertain.

Wh

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

Do They Do It?

Why do some negotiators rely on outrageous behavior to get their way? Because they can ... or because they have in the past.

But, we don't have to a

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

llow this behavior to cause us to give in.

Feigned Emotion

Some negotiators act as if they are emotionally upset when they really are not.

Usually, this negotiator

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

Combination pro

is the sophisticated, high level, manipulator who is looking for an advantage. His intention is calculated. The results sought are pre-planned.

Tantrum Behavior

The

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

overwhelming majority of screamers are just stuck in a tantrum behavior pattern. As a child, they threw tantrums and got what they wanted. As an adolescent, they pre

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

sed the bounds of behavior. As an adult, they just act like big babies who must have what they want!

What Can We Do?

Whether the outrageous behavior is fake or real

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

, we can deal with it without making serious compromises.

Silence is first. Not engaging a screamer ... letting the screamer go uninterrupted works many times. Some

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

egotiators simply want to be heard. Genuinely upset, some negotiators become quite compliant after they have vented. In fact, sometimes the boomerang effect can set i

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

n ... that is, a screamer after venting will accept whatever is offered, and may even give more than expected.

Avoid Taunts. Many times we fall into taunting behavio

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

Following aspects would a

r as a defense, "Are you finished?" ... "Yell a little louder!" ... "Who do you think you are talking to?" These responses do not help. We must avoid these taunts, se

dd to the challenges in developing combination products:

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

ure in the knowledge that our objective of a negotiated agreement is primary. Mirror Behavior. This probably sounds contradictory (and probably is) but sometimes shou

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

ting back can be the answer. This technique has limited utility but when effective is best used as an out of character response. People who almost never yell can use

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

irroring effectively on really important issues.

Feel, Felt, Found. The feel, felt, found technique works well with outrageous behavior because at its core, this tec

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

hnique seems to validate the unaccepted behavior ... and then provides enlightenment. Feel ... "I understand how you feel." This is the validation or commiseration ph

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

Professional from academic institutions, pharmaceutical industries, health care indust

se. Felt ... "Many people in your position would have felt the same way." This is the generalization phase. Your irate counterpart is in league with many other (ill-i

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

nformed) people. Found. "But understanding ... (Point A, B, C) ... most people have found our position is quite reasonable." The A, B, and C are the features, benefit

.

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

, and additional appeals that support our position.

Positive Outrageous Behavior. Give them a reason to laugh. Goofy behavior, funny statements, and strange response

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

Companies that provide selfless information through particip

s that cause laughter can many times disarm the worst tantrum behavior pattern.

Good luck dealing with difficult negotiators ... we all need it!

Bio

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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