Useful Articles - Business

Of course, mistakes are important. Two facts put those you make in perspective. One, everyone who plays the game makes mistakes. Two, that you make mistakes is not ne

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

arly as important as what you do about them.

That’s hard to remember when you are wallowing in the bed of regret, second-guessing and even being eaten alive by fear t

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

Examples of combination products may in

at usually follows on the heels of a mistake.

Nevertheless, it is true. “The way you follow up on the errors you make has a greater impact on the future of your caree

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

than what you did or didn’t do wrong,” according to Ramon Greenwood, head of CommonSenseAtWork.com.

It is worthwhile to restate the axiom that everyone who is out th

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

re making an effort to get things done makes mistakes.

Carly Fiorini refused to delegate authority and tone down her style while she traipsed around the world like a

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

Combination pro

et-set celebrity. She made the mistake of defying her board of directors at Hewlett-Packard when they asked her to change her ways and she got booted out as CEO.

Koda

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

k lost its market dominance when it failed to anticipate the success of Polaroid.

On the other hand, Coca-Cola made a major miscalculation when it decided the world n

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

eded a new flavor of its favorite beverage. When the market said, “You made a mistake” the company quickly turned its back on “New Coke.” Ford Motor Company pulled off

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

a “Lulu” by producing a dud, the Edsel automobile. It lost no time in dumping the mistake when buyers turned thumbs down.

So, mistakes are bound to occur, even among

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

he best of us.

TURN MISTAKES INTO LEARNNG EXPERIENCES

“Smart careerists learn early in the race to capitalize on mistakes by turning them into learning experiences,” s

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

ys Greenwood.

When he was chairman of Quaker Oats Company, William Smithburg declared, “There isn’t one senior manager in this company who hasn’t been associated with

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

Following aspects would a

a product that failed, or some project that failed. That includes me. It’s like learning to ski. If you’re not falling down, you’re not learning.”

The next time y

dd to the challenges in developing combination products:

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

u make a mistake, keep in mind the following nine steps that achievers take when they goof up.

1. Don’t panic. Follow the admonition of the television commercial, “N

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

ver Let Them See You Sweat.”

2. Stop long enough to clear your head. Then act pronto.

3. Get the facts so you can define the mistake.

4. Answer these questions. What i

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

the worst thing that can happen? The best outcome? Will the mistake really make any difference one week, one year, five years later?

5. Report the mistake to the b

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

ss immediately. It is far better for you to tell him about your mistake than to have it come from others. Help the boss keep it in perspective. A Confucian proverb a

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

Professional from academic institutions, pharmaceutical industries, health care indust

dvises, “Be not ashamed of mistakes and thus make them crimes.”

Let the boss and your colleagues know you regret the error. Nothing is likely to infuriate your super

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

isor and colleagues more than your appearing not to care when you make a mistake.

6. Accept the responsibility for your mistakes.

7. Feel the pain and mourn a little,

.

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

ut for only a little while. You will feel better later.

8. Perform a post-mortem. Look at the facts. How can a repeat performance be avoided? What did you learn fro

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

Companies that provide selfless information through particip

the experience?

9. Forget the mistake; give it a decent burial, but remember the lessons learned.

Remember, the only truly unforgivable mistake is to repeat a mistake

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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