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The line in the sand has been drawn. You’ve vowed to never step foot back into that office alive again after working the same dead end job for ten

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

years. It’s time to start that business you know for sure will succeed. All you need is to dedicate those sixty hours a week to your own bottom li

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

Examples of combination products may in

e. There’s only one roadblock. You have no money and the bank has already denied you for several other loans. All is not lost. Seek the help you

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

need from those venture capital firms or angel investors you have heard so much about at meetings.

A venture capital firm is a collection of invest

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

rs looking to throw their money into the next great idea that will grant them generous returns. With their money, your restaurant, retail store, or

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

Combination pro

latest invention transforms from a day dream into a reality. Several options of repayment, ownership, and terms are discussed between you and your

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

angel investors on how you will reward them for believing in your idea. First, you have to win their confidence.

The most important part of your b

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

siness is your business plan. Before you approach a venture capital firm, do your homework. Transfer it from your brain to paper. Your goal is to

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

create a business plan that will motivate investors to write your company name on that blank check. Also, in writing your business plan, you will d

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

scover how much you know or don’t know about the adventure in which you will embark. Or you may find the concept is not as fabulous as you imagined

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

Start with research. Intense study uncovers little known nuances about your new chosen industry and fills holes in your concept. Identify your c

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

Following aspects would a

ompetitors. Dissect their company products, services and policies. What don’t they offer that you can implement into your business concept? Find

dd to the challenges in developing combination products:

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

niche in the market that will set you apart from others who may be seeking the same clients, customers and investors you want to attract.

Next, ex

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

mine the industry trends. Analyze the data. Find out when sales and profits are at their lowest. Are you merging into the gift basket business th

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

t suffers during the summer, after mother’s day? Brainstorm ideas you can include in your plan to overcome those industry wide obstacles.

Use your

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

data to make logical predictions of future industry trends. Can you predict a disaster like the “dotcom” failure at the end of the twentieth centur

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

Professional from academic institutions, pharmaceutical industries, health care indust

y? Your potential investor friends will want to be shown the money. Show it to them in standard financial and cash flow statements.

Now, come bac

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

to the beginning and write a two-page summary of the company. This will serve as the introduction to your business plan. Some experts call it the

.

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

Executive Summary. I call it the sales pitch.

Your summary will be the first section investors read about your business. If it doesn’t sell them,

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

Companies that provide selfless information through particip

then it becomes the last thing they read about your business.

Take your time, do your research and make sure your business plan sells, sells, sells

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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