Subjects - Business

This article was originally called "Do You Need a Business Plan?"

The title was changed because in truth, every business needs a business plan. It’s a common misconception that business plans are used only for raising capita

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

l, as in "my bank wants to see a business plan before they will approve a loan," or, "I need a business plan so I can get venture funding."

But a business plan is really just what it sounds like: a plan for running your business. I

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

Examples of combination products may in

’s an essential tool for making sure that nothing is overlooked.

The business plan will usually be divided into sections relating to the key activities of your business, such as Sales, Hiring, Manufacturing, and so on. In each sectio

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

you will list the major goals and tasks to be accomplished, and the steps needed to accomplish them. The steps should be in the form of a schedule, with a clear description of when each task will be done, who will perform the tas

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

, and what resources are needed. For very small businesses you may plan a year in advance, but a more typical planning timeframe is three to five years. Obviously your plan will be more detailed for the first year, and things will

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

Combination pro

change over time - I’ll discuss that a little later.

In additional to these "operations" sections, your plan will have some informational sections that will be used in setting the operational goals. For example, what is the marke

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

opportunity that your company is pursuing? How do you know that the opportunity is real… what research have you done? Who are your major competitors, and what are their strengths and weaknesses? The information sections are espec

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

ally important if you are using your business plan to raise capital, but they should not be neglected even if your company is self-funded. The information you gather about the market and your competitors is literally the foundation

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

f your business plan.

The final key piece of your business plan is the financial section. At its simplest, this is just a running budget showing your projected expenses and income on a month- by-month basis, for the next 1 to 5 ye

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

rs. You can create this with a spreadsheet program.

In the operations section of your plan, you included a schedule of tasks, and that schedule should match your financial plan. For example, if you said that you would start adver

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

ising in April, you would spend $1500 per month, and the result would be a 20% increase in sales, then the $1500 per month advertising expense, as well as the increased sales, should be included in your financial plan.

Banks and ve

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

Following aspects would a

nture firms will require the financial plan to be in a specific format; you may need an accountant to prepare this. But even if that’s the case, start will a financial plan that you create and understand. Make sure the financial pla

dd to the challenges in developing combination products:

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

matches your operational plans, and be sure you understand how every number was determined!

You’ll learn a lot in creating your business plan, and avoid many mistakes. But that’s just the start. Once your business plan is comple

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

e, don’t put it away! Consult it regularly. Be sure that you are on schedule to accomplish your operational goals. Be sure your actual income and expenses match your financial plan. And if reality doesn’t match your plan, figure o

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

t why and adjust the plan accordingly.

One small business owner initially projected that 65% of her business revenue would come from services her business provided, and 35% from product sales. Six months after the business was laun

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

hed, she discovered that, although total revenue was very close to the plan, the ratio of service to product revenue was exactly the reverse of what had been projected. This raised several possibilities. Perhaps not enough effort

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

Professional from academic institutions, pharmaceutical industries, health care indust

as being spent to promote the service side of the business. Or perhaps the product portion of the business was a simply bigger opportunity than originally thought, and more emphasis should be placed there! In either case, the owne

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

needed to do some additional thinking and update the business plan based on what she had learned. She talked to clients, met with product suppliers, and eventually decided to expand this portion of her business, resulting in signif

.

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

cantly faster growth than originally projected.

Based on experiences such as this, I recommend that small businesses review their business plan at the end of each quarter, and that they conduct a thorough update of the plan at le

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

Companies that provide selfless information through particip

st once a year.

Want to learn more about business plans? A great place to start is SCORE, a free resource for small businesses and a partner with the US Small Business Administration

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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