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Many people quake in fear at the idea of writing a business plan. They imagine in the

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

ir mind a 100-page document full of charts and financial figures. While it's possible

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

Examples of combination products may in

to create a business plan of that magnitude when trying to get capital for your busi

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

ness, a typical business plan for self-employed people should be less than 10 pages.

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

The purpose of a business plan, for a self-employed person who is financing his own

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

Combination pro

business, is to have a central repository for all strategic thinking about the busine

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

ss for the coming year or two. Here's what should be included:

-- Your business idea

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

in three sentences.

-- Your target audience.

-- The challenges that your target au

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

dience faces.

-- The benefits of using your products and services to meet those chal

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

lenges.

-- Your company brand and image.

-- Your projected revenue and expenses for

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

a year.

-- If you project more expenses than revenue for the first year, a statemen

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

Following aspects would a

t about where the money will come from to pay for those expenses.

-- A list of your

dd to the challenges in developing combination products:

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

major competitors, and how you are different from them.

-- At least six marketing te

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

chniques you're planning to use over the coming year, when you plan to implement them

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

, and what results do you expect from them.

-- A list of people who you will need to

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

hire to implement your business plan or marketing plan (unless you have the business

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

Professional from academic institutions, pharmaceutical industries, health care indust

skills and time, yourself, to do all the work).

You should review your business pla

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

n, and update it, annually. I recommend reviewing the marketing section of your busin

.

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

ess plan quarterly, so that you can gauge the success of your marketing campaigns.

-

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

Companies that provide selfless information through particip

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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