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A wise and dear mentor once said to me "Given enough information your intuitive sense will be validated." Intuition some sugges

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 comes from our gut brain as described by Dr. Hawkins in his book Get Out Of Your Own Way or by others as an unknown se

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

Examples of combination products may in

nse that has always been with us.

Whatever the source, intuition is the gut brain for business. For example, have you ever met a pot

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

ential client and felt immediately that this was a good fit or conversely met a prospect and couldn't get away from him or her

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

ast enough. Why did you have those strong feelings? And more importantly, why did you listen to them?

What happened when you failed t

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

Combination pro

o listen to your intuitive sense? Did you experience an internal "I told you so!?" Maybe, after ignoring your gut brain becaus

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

e you were afraid of being judgmental, you took a chance and the end result confirmed your intuition. Nowhere is this sense, intuitio

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

, more needed than in today's business environment.

With the beginning of a New Year and the desire for greater business success, now

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

is the time to take a few moments and record all those intuitive hits and misses. As you reflect, you should begin to measure the imp

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

act of going with your gut brain or ignoring this invaluable capacity for building your business.

Why should you listen to your intui

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

ive sense beyond your own hits and misses? Given that the Small Business Administration (SBA) in 2004 identified the launch of 580,900

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

Following aspects would a

new employer businesses and the closing of 576,200 suggests that the small business failure rate is equal to the small business succe

dd to the challenges in developing combination products:

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

ss rate. As a business coach, I am sure that the are many reasons for small business failure, but I believe that in many cases, these

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

entrepreneurial innovators failed to ignite intuition and leveraged the power of intuition within their businesses.

The intuitive cap

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

city grows with our own experiences hence why information is necessary to validate this sense. When we are young, so is our intuitive

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

sense. As we grow older and gain additional experiences, our gut brain has the ability to make more connections and deliver us this f

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

Professional from academic institutions, pharmaceutical industries, health care indust

eeling.

In business, we must not ignore these feelings. When we use these feelings in conjunction with a solid decision making proces

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

, we can "work smarter and not harder" as we strive towards achieving our desired results. Our intuition helps us to prevent miss step

.

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 provided we are willing to hear the messages from this "gut brain."

So as another year begins, maybe it is time to truly start list

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

Companies that provide selfless information through particip

ening to your intuition and use this unrecognized sense to make the New Year even more successful for your business and personal lives

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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