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One of the deeply rooted myths about how managers achieve success is that they are single-minded and quick in their decision-making. The literatur

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

e of management has created a macho image about making tough decisions fast.

This is not a true picture of successful managers. They know it is wi

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

Examples of combination products may in

e to put off the big decisions as long as possible.

The experienced manager knows there is a price, some degree of irrevocability attached to an

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

y decision. Therefore, he will develop as many options as possible for the truly important questions to be resolved and hold off making critical d

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

cisions as long as possible. That enables him to move with a shifting environment of facts, pressures and opportunity. It also prepares the way

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

Combination pro

for responding to the critics and second-guessers by saying, "Yes, we considered all of the options as long as we could."

Most of us heard at M

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

ther's knee, "Never put off until tomorrow what you can do today." The most successful decision makers frequently break that rule.

When he was vi

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

ce president of the United States, Aaron Burr flew in the face of the Puritan admonition when he advised: "Never do today what can put off 'til

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

omorrow. Delay may give clearer light as to what is best to be done."

Some 100 years later, President Calvin Coolidge declared: "Four-fifths of al

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

l our troubles in this life would disappear if we would only sit down and keep still."

TIME SOLVES MANY PROBLEMS

Mangers will find that with time

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

all problems do not require answers. The simple passage of time will solve many problems. They may simply pass away or answer themselves. Furthe

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

Following aspects would a

rmore, good answers are not always immediately available.

We can all learn from the parable about two men sentenced to die by the king. Upon lear

dd to the challenges in developing combination products:

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

ing of their fate, one man became terrified, but the other remained calm. The calm one said, "Your Majesty, if you will let us live, I will teach

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

your horse to fly."

The King considered the proposition for a moment and replied, "You have one year to teach my horse to fly. If you succeed, yo

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

r lives will be spared; but if not, you will be executed."

After the two condemned men left the presence of the king, the terrified one demanded

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

of his companion, "Why did you do that? You cannot teach a horse to fly. You have only prolonged the inevitable. Now we have a whole year to dr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ad our deaths."

"Well," replied the calm one, "four things can happen in one year. The horse could die. The King could change his mind. He cou

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

ld die. Or the horse just might learn to fly."

The wise careerist will recognize that he must use common sense when applying positive procrasti

.

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

ation. It is like salt. A little brings the cooking to its best; too much spoils it all. Procrastination must never be used as an excuse for acti

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

Companies that provide selfless information through particip

on.

Common sense says that procrastination in decision making can be a very valuable management tool, provided it is conscious and controlled.

XX

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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