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We communicate on many levels but there are two primary methods of sharing information with others. Th

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

ey are verbal communication and non-verbal communication. About 7-10 % of our total communication in a

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

Examples of combination products may in

ny given day is verbal. This may change slightly depending on your career, age and what is going on in

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

your life.

Estimates have been given as a result of research into non-verbal behavior, that 40-50% of

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

all of our communication messages that are sent, are send via, non-verbal routes. Verbal communicatio

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

Combination pro

n comes from a persons conscious mind while non-verbal messages come from their unconscious mind. If t

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

here is an inconsistency in either of these two messages, in other words if you are getting clear non-v

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

erbal acceptance but verbal resistance, go with the non-verbal signals.

Let’s assume a spouse or signi

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

ficant other asks their partner what is wrong and they say “nothing”.

The words are clear enough. Not

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

hing means nothing, right? Well, maybe so and then again maybe not. It depends on the emotional conten

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

behind the words that will determine it’s accuracy. It is difficult to describe the emotional impact

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

Following aspects would a

of non-verbal messages with the written word, but I will try, to give you another example.

A husband/b

dd to the challenges in developing combination products:

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

oyfriend/wife/girlfriend etc etc etc. asks their partner, do you love me? And the partner says, YES OF

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

COURSE I LOVE YOU. Now these words can only be interpreted one way. Well yes and no and it depends.

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

There are people telling people today they love them and they don’t even know what the words mean. I

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

overheard two young teenagers (maybe 14 or 15) the other day telling each other, “OH I am so in love wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

th you!”

Many people seem to get broad-sided in relationships from time to time because they say thing

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

s like, “I never knew that was important to you,” Or, “I didn’t know you were unhappy.” Or, “I didn’t r

.

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

ealize you were so upset.”

To see what is really going on with another person requires that you look b

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

Companies that provide selfless information through particip

oth at the words but, that you also look beneath the words to the emotional content driving the message

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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