Advice You - Business

Do you want to start a business on a small scale? Pay as you go and not borrow any money? Basically you want to test the idea out and see if it has potential. Then why do y

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

ou need a business plan? The most important reason is this. If you cannot flesh out the idea and write it down on a sheet of paper, then it’s not a viable business idea, and yo

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

Examples of combination products may in

u should move on to the next project. Notice I did say a sheet of paper. One sheet. Of course you can use two or three but the basic simple business plan should be just that, si

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

ple.

You cannot take this plan to the bank and expect to get a loan for your business. In fact you should not even show it to friends or relatives. This plan is for your eyes on

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

ly. It is to define your business idea. A simple business plan will give you a starting point that will grow with your business.

Here’s the basic setup that you need to have.

<

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

Combination pro

trong>1. The business Name.

That may seem obvious, but give it some serious thought. Always expect this small business to turn into the next global enterprise and you

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

don’t want to stick it with something that’s hard to spell, or that’s not relevant to the business.

2. The Vision statement.

What is your purpose for starting

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

his business and what do you expect to achieve. Define what the business does.

3. The Objectives.

Define what dollar amount you want to reach in the first year

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

. This is a simple plan so don’t try to do a five year projection at this point. Take the average selling price of your product. This can be a range of products or services, what

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

ver you’re selling. How many sales do you expect to make in a week, call that your base, then multiply the base by 52. Don’t think about how long it may take to get to that base,

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

that’s your first goal. Once you achieve the base goal then all you have to do is repeat it.

4. SWOT – Strengths, Weaknesses, Opportunities, Threats

Identify

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

Following aspects would a

your strengths and think of ways you can use your strengths to grow your business. The things you know and enjoy doing. On the other side is your weaknesses, the things you don

dd to the challenges in developing combination products:

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

t know or don’t enjoy and you may want to hire someone to do it, such as writing a sales letter. What opportunity are you taking advantage of and what other opportunities may a

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

rise once you get going. Threats can come from competition and from lack of information. Do your research. Who is your competition and how can you improve on what their doing. D

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

you need a permit or license? Find out now, not after your business gets rolling.

5. Marketing How are you going to market your product? What type of adverti

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

sing do you plan to use and how much will it cost?

6. Financials

Setup a spreadsheet with the basics. Your starting cash and a list of your expenses based on t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e information you gathered going through the steps above. Include a section for your sales and you have a good picture of your cash flow.

This plan is a starting point and is in

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

tended to help you define your idea. It will force you to ask yourself the questions you need to ask. It should also help you realize, if you still have more questions than answe

.

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

s that you need to do more research before starting the business. As the business grows use the plan to maintain your focus. Change the plan as you go, refer to it frequently an

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

Companies that provide selfless information through particip

d keep it updated. When you need a full blown business plan, you will have the foundation ready to plug in. I will wish you good luck, but a good plan will guarantee your success

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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Are you TIRED of Setting GOALS and NOT achieving them? Are you sabotaging yourself? Do you know WHY you want what you say you want?

As a business owner, it only makes sense to protect your personal assets from company debts and liabilities. The question is: what’s the best way to do that? If you’re going back and forth between the limited liability corporation (LLC) and the S Corporation (standard corporation), you’re certainly not alone!

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