Cases - Business

Slow and steady used to win the races in past, but rarely a remarkable success story in modern world of deadly competitions. Now they can’t rule, can’t achieve, can

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

’t make things happen. Mostly they are pushed aside mercilessly by those vigorous gentlemen who are always ready to jump forward and hit the target. A bitter truth

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

Examples of combination products may in

to swallow. But there is no other way to super success now-a-days.

SPEED – YOU NEED TO MASTER IT

You have entered a new world. It is a world of speed and manipul

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

tions. Speedier communication, speedier transport, speedier construction – speed everywhere. If you want to walk to your goal it will be ages before you reach there

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

. Bill Gates the richest person of the world wrote a book named ‘Business at the speed of Thought’. Now some people want to move ahead at the speed of thought. Gate

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

Combination pro

s has earned his billions at the fastest speed ever known.

No speed in the world has been able to match the speed of thought. Therefore sit in your study room or o

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

fice and think how you can do a certain task efficiently and at maximum speed. Going fast in life is also a matter of practice. You can’t start running fast immedi

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

ately or can’t race a car at the speed of 100 per km on the very first day of learning. The result will definitely be disastrous. To gain mastery over speed defini

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

tely needs time. And sacrificing efficiency for the sake of speed also proves counter-productive. You may stumble down any time. Work efficiently and gain master

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

over speed with an attitude of tolerance and diligence – your first lesson for super success.

WATCHOUT THE BLOCKS

In real life whenever you try to gain speed you

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

come across with speed breakers and blocks. On the way to progress sometimes the blocks are so massive that it is very difficult to cross over. You can hit them bli

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

Following aspects would a

ndly and bruise yourself. And most of the times you can’t remove them yourself. Here you need the help of others. It means you must maintain contacts with those po

dd to the challenges in developing combination products:

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

erful persons who can be useful to you in the time of trouble – your second lesson for super success. When they help you remove the blocks you can speed up and have

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

a big jump forward.

PERFECT TIMING

A vagabond wanted to shoot down a flying bird for his breakfast. He was a good and experienced shooter. He took aim and was r

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

eady to press the trigger but then he relaxed a little and rubbed his one eye. Bullet roared out of the barrel of his gun but missed the target. Even delay of a sec

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

nd can change the course of the history, make you lose the match. Success researchers have proved that bad timing is the real cause of most of the failure. So be ca

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

Professional from academic institutions, pharmaceutical industries, health care indust

reful to the timing of your action – your third lesson for super success.

DON’T ANTAGONISE

Many persons have a hidden tendency of making enemies everywhere. These

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

enemies keep pouncing and putting new hurdles everyday. And when you are fighting constantly you rarely get time for construction or economic development. If you co

.

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

stantly abuse and criticize a person how can you expect him to support you for success? Whenever his time comes he will hit you hard to avenge the insult. So what

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

Companies that provide selfless information through particip

should an ambitious person do? He should motivate his juniors, praise his pears, respect his seniors and flatter the powerful - your fourth lesson for super success

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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