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Business opportunities are often based on broad trends, such as:

• demographic, such as the "graying" of America (creating opportunities in health services, for example);

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

• sociological developments, like the "green" movement, with its emphasis on recycling and environmental sensitivity, and;

• cultural changes caused by changing economi

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

Examples of combination products may in

conditions and technological developments.

Opportunities can also frequently be found in current and developing business trends such as:

• the globalization of business

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 need for outsourcing created by downsizing, and

• the burgeoning service economy.

The Internet and rapid growth of e-commerce have certainly created changes in

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

he process of buying books and CD’s, trading stock, delivering information, and bidding on collectibles. Where do you see the next process to be transformed in a major way

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

Combination pro

by the Internet?

Let’s do a brief case study in opportunity:

Neighborhood Coffee Shop

I live in the eastern section of town, which is growing rapidly, and food and busi

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

ness services are not quite keeping up. The "East" is fairly isolated from the rest of the city by water, an interstate highway, and an industrial park, forming a separate

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

and distinct market. “People” are saying that the East desperately needs a good coffee shop. (Who are these people? Are they just in our immediate circle? Are they represe

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

tative enough of the area to extrapolate from?)

Let us analyze some factors which indicate the opportunity potential of an idea:

* The "window of opportunity" is opening

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

, and will remain open long enough.

We cannot be the only entrepreneurs that perceive these opportunities. How long before the need becomes compelling enough for others t

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

jump in?

* Entry is feasible, and achievable with the committed principals.

Two friends want to be partners with me in a venture; one is managing a coffee shop across t

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

Following aspects would a

wn, and willing to manage a startup. Between us, we could muster the capital for a coffee shop.

* The proposed venture has some competitive advantage.

We were among the

dd to the challenges in developing combination products:

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

first to locate in the new area, and are very active in the local business community. We know of an ideal site, and the building manager is a friend. She is willing to sub

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

contract the beverage and light-meal/dessert services the building provides tenants.

* The economics of the venture are "rewarding and forgiving.”

Materials costs are a

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

mall percentage of revenues; site preparation and equipment costs are minimal.

* We can break even at what seems to be an easily achievable volume.

We may even want to c

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

onsider a more upscale atmosphere based on what some say is the difference between a “coffeehouse” and a “coffee shop:” About two bucks a cup… A coffee shop is a place to

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

Professional from academic institutions, pharmaceutical industries, health care indust

rab a quick bite and a cheap cup of coffee.

Eric Gerber of the MSN Network’s Sidewalk suggests that “A coffeehouse is a place to wax philosophical — Mozart or Bach, Faulk

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

er or Fitzgerald, Xena or Hercules? — while seeing just how complicated you can make a simple drink like coffee: double latte espresso-chino with half decaf Jamaican Blue

.

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

Mountain dark roast, extra low-fat foam and a Frangelica drizzle, please.”

The conditions for starting a neighborhood coffee shop seem favorable, but there must be more t

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

Companies that provide selfless information through particip

at we can do to critically evaluate the venture while improving our chances of success. That “more” is market research, and do not leave the business launch pad without it

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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Want to know how to advance in your career? Learn the four simple and profound steps you need to take to make your new career a reality.

Human resource management and staff motivation are still very important and are in fact the often-ignored-keys to success in this exciting and yet chaotic information age.

This is not an eight hours per day job. You have to be flexible and to meet and extend your clients' wishes. And being available for them when they need advice or just a reassurance (although is late in the evening or during the weekend) will do your business and your reputation a lot of good. And in this business a good reputation means more than expensive publicity in magazines or on the radio.

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