Cases - Business

What is it that stops someone from pursuing a dream?

Fear!

Fear is a great debilitator in the world of entrepreneurialism. I

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 is fear that causes us to halt when we need to step forward. It is fear that views any risk as an insurmountable obstacle. I

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

Examples of combination products may in

is fear that will keep the ‘dream’ alive only in the most private of thoughts.

Eleanor Roosevelt once said, “You gain streng

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

th, courage, and confidence by every experience in which you really stop to look fear in the face. You must do the thing which

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

you think you cannot do.”

Eleanor spoke very wisely when she encouraged others to look fear in the face. So often we have the

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

Combination pro

tendency to recognize fear and then allow that fear to grow until we can hardly breathe when thinking about it.

Mrs. Rooseve

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

t also provided the same encouragement expressed by Nike – Just Do It. She made no attempt to minimize the fear we may experie

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

nce, she simply provided a bold declaration that there is something waiting beyond the fear if we will move through the thing

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

hat instills fear to the other side where we are likely to find courage and success.

Fear is not a rational thing. You cannot

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

explain it away, but you can look for the truth about what you fear the most. In entrepreneurialism this can be accomplished

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

y asking questions of those who have developed a business of their own. It can also be accomplished by researching the risks i

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

Following aspects would a

nvolved in business ownership. Once these steps are taken you may need to ask an unbiased, yet trusted, source to help you hon

dd to the challenges in developing combination products:

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

stly understand your strengths and weaknesses to determine if you can face your fear with a strong chance of success.

It is i

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

nteresting to note that often we fail to trust ourselves enough to make a determination on our abilities to do something.

If

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

ou don’t have someone you can talk with to determine the truth about the fears you may have when contemplating an entrepreneur

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

ial effort you can always begin by taking a notebook and listing your strengths and weaknesses. You can follow that up by iden

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

Professional from academic institutions, pharmaceutical industries, health care indust

ifying the pros and cons of business ownership. Write a letter to yourself about the fears you have and try to determine how m

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

uch truth there is to the fears you’ve expressed.

Entrepreneurialism does require a certain amount of risk and risk can insti

.

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

l a certain amount of fear. You should always seek the truth about yourself and face your fears one at a time. With each small

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

Companies that provide selfless information through particip

victory you come closer to gaining what Eleanor Roosevelt described as “Strength, courage and confidence by every experience.

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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