Advice You - Business

Language can be an important way people reveal their conscious and unconscious models of the world. Listening for linguistic markers can allow you to build up a reasonably accurate picture of another person’s outlook and understanding of the world. They may not be conscious of how they are presenti

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

ng their worldview, however it is a simple task to match linguistic markers with behaviour and then test for accuracy.

Metaphors that are deeply embedded in our culture are relatively easy to identify because of the number of linguistic markers associated with them. Try the following statement for

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

Examples of combination products may in

size:

“He is mounting an attack (attack) on the fundamental rights we fought (previous battle) for decades to win.(triumph) And let me tell you those tactics (war plans) will not get us to give up (retreat) one inch of ground (territory). I mean, what a pathetic (insult) proposition. Let me

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

throw down this challenge (duel). Let him go and muster his forces (army) and prove what he says about a legion (troops) of Australians demanding a showdown (battle) on this issue. I can tell you this, we will not yield (cede territory) to anyone who wants to destroy (kill) the rights of Australia

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

n workers to withdraw their labour. We will take to the streets (counter-attack) and there will be a river of blood (massive casualties) if he tries”

You can conclude that the metaphor used in the above statement is that of War. You may also have noticed that the speaker isn’t simply playing

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

Combination pro

with words as in a surface metaphor. His argument is structured, performed, voiced, and understood in terms of war. Can you imagine him seeking to accommodate a range of views outside of the ones expressed? Can you see him responding in any way which doesn’t entail a fight, and a winner and loser

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

?

War is the partial framework or template he uses to argue his point and agitate against deregulation of the labour market. It’s a partial framework, or template, because he is using the metaphoric concept ‘Argument Is War’ to structure how he argues and how he makes sense of what he’s doing as h

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 doing it. If it were a complete framework he would be out in the streets with an AK47. It would be real war and the body count would be astronomical!

Sample any of the major social and political debates of today, identify the linguistic markers and you’ll more than likely uncover clear demonstr

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

ations of the Argument is War metaphor. This metaphor may well be the predominant structure we use for the debate of ideas and any exchange that goes beyond the boundaries of polite conversation in our culture.

It surfaces as a deeply embedded cultural metaphor beyond the consciousness of most pe

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

ople who participate in the dialogues of daily life. You may notice its presence wherever there is divergence of opinion: from domestic arguments to the highest matters of state.

Recall the last time you participated in a conversation that became heated and developed into an argument. Picture it i

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

f you can, remember the dialogue or the associated feelings. As you do, begin to notice the exact point of transformation from conversation to argument: the point where you felt your hackles rising, where emotions changed from cooperation to confrontation, where something triggered the fight or may

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

Following aspects would a

be flight response in you. What happened then? What seemed to be at stake? And how did you proceed? Review the following checklist and note when you complied:

you became adversaries

it became important to you, and/or your adversary, that they surrender their opinion and

dd to the challenges in developing combination products:

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

give victory to yours

diversity of opinions produced conflict

you began to plan a strategy on the run and marshal your intellectual forces by coming up with ideas or points you could introduce

you noticed the weaknesses, lack of logic etc. o

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

f the other persons position and you mounted an attack based on those weaknesses

you played with words, introduced red herrings, and tried to manoeuvre the argument to put you in a stronger position

you attempted to defend your position by responding to the arg

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

ments and questions raised by the other person

if your opponent came up with a ‘gob-stopper’ you retreated to safer ground and regrouped for a counter-attack

you both may have got bored, or tired, of the argument and agreed on a stalemate, or called a truce so

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

you could bring in reinforcements at some other time.

you could, with a combination of the above, have achieved victory and won the day

you, or your opponent, may have realised that, by continuing, a greater loss could ensue, and surrendered

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

Professional from academic institutions, pharmaceutical industries, health care indust

i>your argument, or theirs, could have been so supremely logical or forceful that only a fool wouldn’t have sued for peace

Now, here’s a question for you to ponder. What was it that seemed to draw you into behaving as you did during the argument?

Think about other argume

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

nts you’ve had, and notice how an invisible force appeared to hijack the process. And think about the times that you went too far or felt so guilty and embarrassed over your behaviour that you were compelled to offer an apology.

What came over you? Could it have been a little piece of brain

.

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

software playing itself out without you being consciously aware of it? Could you have been hijacked by the Argument is War metaphor?

But, what about instances in which people deliberately apply the Argument is War metaphor to trigger behaviour you wouldn’t ordinarily exhibit in public? Could y

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

Companies that provide selfless information through particip

ou withstand it?

A question on which to ponder. What if you found another equally powerful but infinitely less toxic conceptual metaphor in which to couch your argument? How about 'Argument is a Dance"? How would that influence how you structure and perform your argument?

(c) Desmond Guilfoyl

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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Many manufacturers of truck wash equipment make their equipment look really nice some of the units in fact look rather pretty, powder coated and well designed, but they totally miss the point. Too often people manufacture stuff but never use it in real life. Why does this happen?

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