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A business plan is a must. The process of creating one forces you to organize your dreams and goals into a specific strategy. It brings forth issues you may have forgotten – maybe no

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

t thought of at all yet. It helps organize your efforts and focus them on the ultimate goal: Success.

The business plan is a solid, non-negotiable tool to measure progress. It actu

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

Examples of combination products may in

ally simplifies your life. Why? It removes the emotion from decision making. As a business owner, you will be making a lot of decisions. All of them will impact your business.

Let

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

’s consider marketing. I love marketing as an example. There are millions of ways to market a business. Some are costly and others are not. Some are appropriate and others are not.

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

Let’s say that Mr. Marketer has contacted you with the latest and greatest marketing opportunity available. The opportunity is a commercial. You get so many minutes a day to air yo

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

Combination pro

ur commercial on XYZ radio. The investment is anywhere between $2,000.00 and $15,000.00 and a 12 month contract is required.

You listen to the benefits, get the cost and make a decis

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

ion. What is the decision based on? Is it based on fear that someone else will do it and you will be left behind? Is it based on finances? Is it because today you are in a really g

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

ood mood? None of these are good tools for decision making.

A more appropriate tool is your business plan. You already decided what marketing options you are going to pursue. You a

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

re monitoring their results routinely and know they are as planned. The questions are

1. Is this marketing option appropriate for me? 2. Does it fit anywhere in my marketing plan?

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

3. Does it fit within the marketing budget? 4. Do I need to give up something else to make it fit? 5. If so, will it be worth it?

Anyway, you get the idea. There could be many

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

more questions. The bottom line is that the business plan assists you in making objective and appropriate decisions for the business. The ultimate goal is success. A poor decision

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

Following aspects would a

could slow down progress or ruin it altogether. Conversely, you could jump forward so fast you achieve your goal well before you planned.

If you haven’t done this already I strongly

dd to the challenges in developing combination products:

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

suggest that you do. Be aware, the process itself can be very overwhelming. Rest assured it is well worth it. Unless you have partners with a stake in the business, do it on your own

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

. A business plan is unique to the owner(s). A big part of development is research; delegate as much of that as you can. Make sure to give specifics as to the type of information yo

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

u need and also a finish date.

This is only a suggestion; you don’t have to do this. As far as I know, unless you are seeking loans or investors, it isn’t required. It is in your be

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

st interest to do one. I know a lot of people who have never done this for their business. I have also seen them struggle routinely with decisions. It is sad. They are very bright

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

Professional from academic institutions, pharmaceutical industries, health care indust

people who work really hard. They deserve to succeed.

Food for thought: You can drive down the road aimlessly and hopefully, eventually get there OR you can create a specific action

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

plan and speed up the process.

If you have decided to create your own business plan either get a book that walks you through the process or hire a professional to compile information

.

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

for you. Don’t waste your time trying to figure it out. Find someone who has already done it, wrote a book about it, and simply follow the steps.

The book I used is “Kick Start You

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

Companies that provide selfless information through particip

r Dream Business” by Romanus Wolter. It basically held my hand and walked me though every single step. The plan was created without even knowing it until reaching the final chapters.

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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