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There are a handful of characteristics successful entrepreneurs possess. The degree to which you have these skills

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

will certainly influence your ability to succeed in a business of your own. Of all the characteristics entrepreneur

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

Examples of combination products may in

have, one that certainly stands tall is the ability to make decisions including those that involve risk. After all

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

the very nature of a true entrepreneur is one that embraces risk.

If you are someone that researches a purchase p

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

ior to making it. You are most likely not one to rush into decisions either. This type of decision making, careful

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

Combination pro

nd cautious, is certainly a great attribute to have as a business person. However you have to realize that much of

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

what an entrepreneur does is defined by a degree of risk. The very definition of entrepreneur is one that “enters 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

w”. If you are a cautious person you need to be aware that there is risk inherent in starting your venture and desp

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

ite all your planning, you will be faced with a handful of decisions almost daily that will involve at least some g

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

mble. As your business grows so will the impact of your decisions. The larger decisions will have an increasing deg

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

ee of risk. This increasing degree of risk however has an upside – an increasing degree of reward if your decision

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

Following aspects would a

turns out to be right.

If you tend to be a little more fly by the seat of your pants in your decision making, then

dd to the challenges in developing combination products:

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

by a very small margin you will actually rank with the majority of entrepreneurs in your response when looking at a

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

study conducted by the Institute of Small Business Empowerment of 100 entrepreneurs. "We have risk taking in our b

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

ood", says entrepreneur Kevin Pearce. Often this risk taking is mistaken in part to be “the reason” the entrepreneu

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

succeeds in their business. This thinking may have some truth however it can cloud the judgement of entrepreneurs

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

Professional from academic institutions, pharmaceutical industries, health care indust

and lead them to believe that all their decisions should have a degree of “gut” or risk to them. Beware of this pit

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

all. Some decisions involve risk, at times a great deal of it but there are a greater number of decisions that can

.

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

be thought through and analyzed to determine on some basic facts, whether or not they are good or bad ideas. Most o

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

Companies that provide selfless information through particip

the day to day business decisions can be determined not through the roll of the dice, but through some simple math

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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