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There are three key elements to making good business decisions. These elements will help you to evaluate and get your creative thoughts flowing. When your home based

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

business is confronted with an opportunity (which even in the worst case scenario is an opportunity), you need to be ready to evaluate and make the tough decisions ne

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

Examples of combination products may in

essary for your company’s survival.

3 Key Elements for Making Good Business Decisions:

** Determine what exactly is the business opportunity or challenge.

*

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

* How will it shape and change my home based business?

** Will it benefit everyone involved?

Determine what exactly the Business Decision is.

What I normall

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

do is to put down in writing the business opportunity or challenge that has come up. Clarifying exactly what is it that I need to decide on. Look at this opportunit

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

Combination pro

as if you are not really in your home based business but merely an observer. Step outside of your business and look at it from an outsider’s point of view.

I know t

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

hat it is very hard to do but many times I find talking to someone who isn’t involved with my home based business will help. This will help you remove at least some o

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

your emotions. This is important when making delicate business decisions because the moment we put our emotions into the mix we lose our logical side of the equation

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

.

Write down everything positive and negative about the situation. Organize your writings into columns of positives and negatives to make it easier to see. Also ther

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

will be times when you will need to make a neutral column which will not really add very much weight to either side of the columns until you make a business decision

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

then it will usually become a positive.

Try to look at each side of the decision and take time to analyze as many consequences as possible.

How will it Shape and

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

Following aspects would a

Change my Home Based Business?

Some questions to consider will be how and in what way does this business opportunity shape or change my business? Will it fit in

dd to the challenges in developing combination products:

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

o my life plan and business goals that I created before the business cam

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

e into reality?

Be sure that this business opportunity fits into your full plans for your home based business. If not then you do not have a match. If it does fit in

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

o your plan will it help you in the way you want or is it just a quick fix which may cause problems down the road?

Remember the more emotion you have about the decis

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

on the harder it is to make rational and good business decisions! Try to remove yourself from the emotions as much as possible. I find that a diversion of some sort m

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

Professional from academic institutions, pharmaceutical industries, health care indust

ight just remove a lot of the emotion.

Will it Benefit Everyone Involved?

Will my business decision benefit everyone involved? If so how? If not, why not? Wh

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

n you have made a good decision you will know it by the beneficial outcomes for all parties involved. Your home based business will profit as well as your employees a

.

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

nd family members as well.

Conclusion:

When you have made the right business decisions it will fit into your life plan and business goals without a question.

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

Companies that provide selfless information through particip

You will have a great feeling of resolve and peace. All parties involved will have benefited from your decision and your home based business will continue to flourish

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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