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We all know what communication is. Because we all know the theory and example from school... a sen

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

der, a receiver a channel and the message. Than there is noise and interference, interpretation, e

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

Examples of combination products may in

tc etc. All true.

But there is one characteristic of human communication that if often forgotten.

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

And that is the very simple rule that communication takes time and you can’t speed it up. It’s li

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

ke a pregnant woman due to give birth; do not tell her to hurry up!

Organizations should see comm

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

Combination pro

nication as an asset in which they need to invest, because if you invest in communication everythi

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

ng else will benefit from it. Because Communication is not a primary business process but it does

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

feed nearly everything in your organization and therefore (good communication) harmonizes the mai

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

n business processes. Think again about the woman giving birth: we do not want her to smoke, nor

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

drink excessively. Then we also encourage her to rest and to control her diet. Much of the child w

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

ll be the product of the balanced care and nutrition of the mother.

Yet speed and numbers rule in

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

Following aspects would a

business much more often than quality and the nearly invisible attributes of a sound communicatio

dd to the challenges in developing combination products:

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

n.

Visit the internet and search for something like – project delayed – and you will find a serie

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

s of reasons why this or that project didn’t finish on time. But not often you will read about ins

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

ufficient resources. What you will find out is that partners didn’t understand each other at first

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

or... also recurring... that (initial) design and (final) product didn’t match. Yes it is about t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he sender and the receiver and the code and the channel, we all know it. But what we forget is tha

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

t... it takes time. Do not hurry it, because you will feel the consequences in the end.

What you

.

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

could do?

Think about the soccer team which is loosing and the coach does not uses the opportunit

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

Companies that provide selfless information through particip

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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