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Virtually every day we read how some upstart, “Hot” company has launched into the stratosphere and is creating huge s

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

ales and growth – practically overnight. They make big waves and attract lots of attention.

It’s a little sickening

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

Examples of combination products may in

or the hardworking, everyday entrepreneur. Don’t you think?

Perhaps you’ve wondered if it’s possible to create the s

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

me kind of growth in your business. Maybe you’ve felt for a long time that your company is poised for explosive growt

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

.

You’ve known you need to “take it to the next level.” But, you’re unsure just how to get there.

So, what’s the fi

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

Combination pro

st step to the next level in business growth?

First, change your mindset. Rid yourself of any preconceived notions y

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

u have about business growth.

Cleanse your mind of everything you thought you knew about building a business. Sure,

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

hat information will come in handy down the road.

But today you should open your mind to new possibilities. In other

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

words…

“Take the caps off!!!”

Remove any limitations or boundaries you may have placed on what you think your busin

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

ss can do. Then, you can begin the process of growing your business.

Stop for just a minute and let your imagination

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

run wild. Envision your business and what you think it can become.

Where do you see yourself – and your business in

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

Following aspects would a

90 days, 6 months, and in 3 to 5 years?

What does it look like? What kind of clientele is it serving?

What are your

dd to the challenges in developing combination products:

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

sales numbers? How about your profits – the money you get to take home or reinvest in your business.

Do you have a n

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

mber in your mind? Can you imagine it being even bigger than that?

Perhaps 20%, 30% or 50% higher than that? How abo

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

t double, triple or quadruple that amount?

I hope you can see the possibilities. And not limit yourself.

Now, ask y

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

urself the following questions. Spend significant time answering them.

* Thinking about where you would like to be w

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

Professional from academic institutions, pharmaceutical industries, health care indust

th your sales, on a scale of 1 to 10 with 10 being exceptional, how would you rank your current sales?

* What would

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

ou say is the greatest challenge in your business right now?

* If you had to guess, what would you say is the major

.

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

ause of this current challenge?

* What are your top 3 business goals for this year?

* How committed are you to achi

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

Companies that provide selfless information through particip

ving your goals?

Write down your answers and study them. This IS the first step to the next level in business growth

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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