Advice You - Business

Signs, Signs, Everywhere there’s signs, these lyrics recorded by Telsa reminded me what separates exceptional leaders from the a

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

verage leaders -- the ability to find and read signs. This awareness to signs allows these leaders to think both creatively and strateg

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

Examples of combination products may in

ically.

First, what makes an exceptional leader? In the book Fail-Safe Leadership, the authors Linda Martin and Dr. David Mutchler in

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

00 pages boil leadership down to the ability to get results within clearly articulated core values. The how of getting results o

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

r what some may call performance continues to vex many businesses and individuals.

Examples in history are endless. George Washington

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

Combination pro

ead the signs of the future of the America’s by surveying potential land as to what would be desirable for the incoming colonists. From

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

his creative ability to read the signs, he was able to strategically purchase land that he later sold for a profit making him a wealth

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

man.

In today’s business world, such leaders as Jack Welsh, Bill Gates, Steve Jobs, Oprah Winfrey and Mary Kaye all demonstrated the

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

ability to read the signs before others even saw the signs. Successful entrepreneurs such as industrialist Andrew Carnegie to Fed Ex F

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

under Fred Smith saw the signs and made millions of dollars when others believed their endeavors would fail. Another example closer to

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

Chicago and Northern Indiana, is local business owner and entrepreneur, Dean White, who followed Washington’s footsteps. He saw his rec

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

Following aspects would a

ently purchased hundreds of farming acres supporting businesses in the forthcoming decades. Mr. White is now a billionaire because he s

dd to the challenges in developing combination products:

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

w and read the signs before the intersection of U.S. 30 and I-65 was still a dream at the Indiana Department of Transportation.

Readin

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

g signs is not magical, but a developed skill. The first step is to increase your individual awareness to your environment. Taking a c

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

urse such as Neuro-Linguistic programming, spending 10 minutes a day in reflection and staying current with tomorrow's business trends

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

will improve your natural awareness. Also, focus should always be on the positive, the possibilities, instead of the negative. Learn to

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

Professional from academic institutions, pharmaceutical industries, health care indust

embrace joy first instead of misery.

Next, follow the words of Marcel Prost who wrote that the true voyage of discovery is not seek

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

ing new landscapes, but seeing with new eyes. Look at everyday happenings from a new perspective by changing to different lenses o

.

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

filters. Continually ask yourself if your reaction is one of conditioning?

The signs are all around and many may tell you what to do

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

Companies that provide selfless information through particip

and what you can’t do. Your challenge as a leader is three fold: Find the Signs, Read the Signs and Possibly Rewrite the Signs.

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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Advice You - Exceptional Leaders Know How to Find and Read the Signs, Do You?

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