Advice You - Business

This is a question that has no absolute answer. In many aspects of life an entrepreneurial spirit is u

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

seful. For our purposes, we will stick to the commercial and business areas and narrow the field of po

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

Examples of combination products may in

ssible answers within this scope.

I believe that theoretically any person can be a successful entrepr

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

eneur. Unfortunately, this is far from true in the real world. Most people do not have the mix of driv

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

e, ambition, passion, fearlessness and creativity requisite in most successful entrepreneurs. Look at

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

Combination pro

the lifestyle and career choices made by the vast majority of people. An aversion to risk, fear of fai

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

lure and lack of confidence eliminate most people doing anything more than dreaming about seeking entr

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

preneurial opportunities.

It is very difficult for people to change. The successful entrepreneur is b

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

asically a risk taker, willing to put themselves, their ideas and egos on display in a highly competit

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

ive marketplace. They will hear the word no so often that they must become inured to that horrible lit

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

tle two letter word. Disappointment becomes their constant companion. Yet, they have a unique ability

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

Following aspects would a

to keep pushing their project along, always seeing the glass is half or more full and a way will be fo

dd to the challenges in developing combination products:

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

und.

If success were easily achieved we would enjoy a whole lot more of it. I am always struck by how

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

negative so many people are in every aspect of their lives. I have never seen a successful entreprene

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

r have a negative personality. It is an instant eliminator for anyone seeking to launch an 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

rial career.

So, we can be confident that successful entrepreneur’s are a different breed. The do not

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

Professional from academic institutions, pharmaceutical industries, health care indust

fear failure. The belief they possess in themselves, their opportunity and the benefits they will ach

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

ieve from successfully launching their product is palpable. It drives them to overcome obstacles and f

.

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

ind answers when none seem plausible. Anyone can attempt to become an entrepreneur. However, the evide

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

Companies that provide selfless information through particip

nce is powerful that success requires a unique set of personal attributes not possessed by most people

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 - Is it Possible for Anyone to Be A Successful Entrepreneur?

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