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An Entrepreneur is an individual who chooses to go into business by himself. Often entrepreneurs decide to stay a one-person company to keep deci

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

sions and quality of work under control. These single entrepreneurs are often called solo entrepreneurs, too. These entrepreneurs are often refer

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

Examples of combination products may in

red to as free agents, freelancer, self-employed, sole proprietor, or home based business owner (although not all single person entrepreneurs are

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

home-based). This often depends on the professional field they work in.

Being a one person business does not mean being completely on your own.

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

These entrepreneurs often collaborate with other businesses or build alliances with other entrepreneurs or consultants. It all depends on their

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

Combination pro

business needs. Outsourcing of basic work or certain project related work is the closest these businesses get to in regards to having “staff”. B

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

sinesses run as one-person companies often have owners that meet certain characteristics. What are typical Solo Entrepreneur characteristics?

-

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

The desire for personal freedom that allows them to adopt the lifestyle of choice.

- The drive and passion to implement the business plan and to

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

fulfill their personal dreams.

- The willingness to go the extra mile and the desire to succeed

- They are very passionate about what they do.

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

- Being committed to their venture.

- Comfortable working alone and an above average usage of new technologies such as the Internet or Voice ov

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

er IP (VOIP).

Why the “one-person company”?

Many entrepreneurs are “refugees” from the large corporate world, while others choose to be self-em

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

Following aspects would a

ployed in a “one-person company” as a change from a traditional-based small business with employees and increased management responsibilities. Be

dd to the challenges in developing combination products:

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

ng unemployed after another wave of outsourcing to India can also trigger the desire in people to become self-employed and especially to stay a “

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

one-person company”. Especially the political games played in larger corporations increase the desire to completely get a way from the same. Bein

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

g flexible and able to implement decisions without having to worry about the “internal political players” is a driving force to work alone.

Othe

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

reasons:

- A general change in attitudes to be more in control of individual choices and actions that affect life.

- Getting out of the daily

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

Professional from academic institutions, pharmaceutical industries, health care indust

rat-race and away from working in large companies, climbing the corporate ladder in search of more money, and more (political) power.

- To be ab

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

le to choose the tools of trade and not being forced to do things in an inefficient way.

What drives the “one-person company” owner to be succes

.

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

ful?

Freedom: The biggest reason for leaving the corporate world is the freedom an individual gains when working for himself. Being employee mak

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

Companies that provide selfless information through particip

es the entrepreneur feel like being in a prison. The freedom to decide when to work, where to work, and who to work with makes all the difference

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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