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Do you ever wonder if you will really succeed with your small business? You may have a number of special traits, but how well developed are they? There are

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

qualities of endeavor and achievement that are common to successful business owners. Ask yourself these questions to see if you have what it takes.

1. H

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

Examples of combination products may in

w will the business affect your family? The first few years of business startup can be hard on family life. The strain of an unsupportive spouse may be

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

hard to balance against the demands of starting a business. There also may be financial difficulties until the business becomes profitable, which could take

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

months or years. You may have to adjust to a lower standard of living or put family assets at risk.

2. How will you support your family while building u

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

Combination pro

your business? This question must be worked out according to each persons’ individual circumstances. Many people start out on a part-time basis. Then

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

when their incomes reach a certain level they will switch over to full time. Granted, if you take this "safer and surer" approach, it may take you longer to

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

reach the goals you set for your new business, but you will save yourself (and those who depend on you financially) a lot of anxiety. Ultimately, like the t

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

rtle in the race who moved ahead slowly yet steadily, you will have a greater chance of reaching the finish line.

3. How well do you get along with diff

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

rent personalities? Business owners need to develop working relationships with a variety of people including: customers; vendors, staff; bankers; and pr

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

fessionals such as lawyers, accountants and consultants. Can you deal with a demanding client, an unreliable vendor or cranky staff person in the best inter

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

Following aspects would a

st of your business?

4. How good are you at making decisions? Small business owners are constantly required to make decisions under pressure.

5.

dd to the challenges in developing combination products:

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

Do you have the physical and emotional stamina to run a business? Business ownership can be challenging and exciting. But it is also a lot of work. Can

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

ou face 12hour work days for six or seven days a week?

6. How well do you plan and organize? Research indicates that many business failures could h

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

ve been avoided through better planning. Good organization of: financials; inventory; schedules; production; can help avoid pitfalls.

7. Do you have th

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

drive to maintain your motivation? Running a business can wear you down. Some business owners feel burned out by having to carry all the responsibility

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

Professional from academic institutions, pharmaceutical industries, health care indust

on their shoulders. Strong motivation can help to survive slowdowns, as well as periods of burnout.

8. Do you have the discipline to do what has to be d

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

ne? When working for someone else, it becomes routine to rise early, be well-groomed and get to the office on time. However, a significant number of peo

.

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

le starting up a small business at home all too often find themselves at 10:00 in the morning in their bathrobes, drinking a second or third cup of coffee.

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

Companies that provide selfless information through particip

Make no mistake, starting a successful small business is hard work. BUT, it is also highly rewarding! Attack the challenge head-on and success will be yours

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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Here's a tip for giving temporary office space a look of permanence. Discover 'executive suites'.

Sooner or later, it happens to every business owner. A customer, that you thought was really great because they praised and flattered you, has suddenly turned into the most difficult customer you have.

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