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Most people use discussion for their meetings. And it seldom works. Here’s why.

1) No struc

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

ture

Discussion is like conversation in that it is a free-form dialogue without any directi

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

Examples of combination products may in

on. Each person responds to what the last person said. While this can produce entertaining p

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

arty chatter, it seldom leads to agreements or decisions. In fact, in a meeting, discussion

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

an even make things worse. For example, suppose you said:

"We need to talk about the new da

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

Combination pro

tabase."

And then someone says:

"Is that the one that crashed last night?"

"Actually, it

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

was a minor bug."

"It shut down the Chicago office."

"I heard their IT department is being

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

reorganized."

"Hey, what do you call a Chicago organ transplant?"

And so on . . . .

This

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

happens because discussion is a divergent process. Each idea elicits a response from someone

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

else.

2) No equality

Discussion favors those who think quickly. It also favors those who

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

are loud, expressive, intimidating, entertaining, and important. As a result the more aggres

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

Following aspects would a

sive participants do all of the talking while the more reflective ones watch.

This is bad f

dd to the challenges in developing combination products:

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

r many reasons. First, aggressive speakers can easily stampede everyone else into accepting

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

unworkable ideas. Next, the more thoughtful participants withdraw, which deprives everyone f

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

rom hearing their ideas. Thus, a discussion is like an engine that runs without brakes on on

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

ly half its cylinders.

3) No Achievement

As you might expect, discussion seldom leads to a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ything useful. True, the talkers will feel energized by what they said. And the others may f

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

eel amazed by what they heard. But nothing else happened. No decisions were made. No solutio

.

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

ns were found.

Discussion is the least effective and least efficient process for a meeting.

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

Companies that provide selfless information through particip

So what works?

Group processes that include everyone and obtain results through consensus

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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