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It was C.D. Jackson, Publisher of Life Magazine who once said “Great ideas need landing gear as well as wings.” The sad truth is that most people plan trips and vacations better than they plan their business v

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

entures. It seldom occurs to them that a business plan can help—tremendously. Consider the different audiences who may read your business plan as your great idea takes off. Bankers are primarily concerned ab

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

Examples of combination products may in

out having their loans repaid. While they will say that they are interested in a company’s long-term prospects because they want to establish long-term relationships, bankers want to be assured of a company’s a

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

ility to keep up a loan repayment schedule. Margins on business loans are so low that banks can’t afford to have too many go sour. Therefore, the emphasis should be on cash flow—past, present, and future. 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

vestors are most interested in factors that can help predict growth, because growth is essential for them to get an attractive return on their investment. These factors include the market’s likely future, the m

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

Combination pro

nagement team’s experience, evidence of fast-growing sales, and so forth. They want to see their investment go into marketing rather than R&D expenses. The existence of tangible assets is less important to inve

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

stors because they aren’t as concerned with being “repaid” in the same way.

Strategic partners are important. Increasingly, smaller growing companies are seeking out large corporations to provide expansion re

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

sources—mainly in the form of investment funds, distribution outlets, and production expertise. Corporate executives have their own agenda. They are most interested in finding new products and/or services that

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

an be integrated into the corporation’s existing offerings. Such issues as cash flow and sales-force planning are less important because corporations figure they can compensate for these needs. The business pla

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

n should be concise but devote significant detail to the strategic issues of importance to the corporate partner. Your large customers are also important. These tend to be major corporations seeking long-term

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

and significant purchasing relationships. The customers want evidence that a smaller company is going to be around to provide the product and/or service promised and also warranty or maintenance service. For t

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

Following aspects would a

hese readers, the business plan should emphasize the company’s past record of performance and ability to satisfy customers. “Love letters” and names of reference accounts can be especially helpful.

More than a

dd to the challenges in developing combination products:

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

ny other single group, potential key employees are looking for reassurance on a variety of issues. They want to know that the company has a history of success and that it can achieve substantial growth in the f

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

ture. In other words, potential key employees are looking for signs of both security and opportunity, especially if they are going to be getting stock in the company. A business plan that satisfies one of the p

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

reviously described audiences may well be appropriate for these individuals.

A business plan intended to guide your company’s middle- and upper-level managers usually needs to be more detailed than other plans

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

A plan of 60 pages or more isn’t unusual. A company looking to acquire your company is primarily interested in its past and present record of growth and accomplishment. If the acquiring company’s executives c

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

Professional from academic institutions, pharmaceutical industries, health care indust

an be excited about the past and present, they will figure that they can provide input that will solidify the future. Moreover, it’s the past record of sales and profits that help determine the company’s value.

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

A business plan similar to that submitted to a bank would be useful in this situation. If you are still wondering why your company should have a business plan, the reasons are quite simple.

1. A business pla

.

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

, first and foremost, should sell you on the business.
2. A business plan sells others on the business. When someone asks you for a business plan, they are really saying, “Sell me on this business. “Turn m

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

Companies that provide selfless information through particip

e on.”
3. A business plan gives you confidence.
4. A business plan improves your chances of success.
And with all of this going for you, your business works with both wings and landing gear!

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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