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Everyone does it

Humans have the tendencey to communicate with each other. This can happen in obvious and in not so obvious ways. We speak, we write. However, we can also communicate without even using words at all. If

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

words are used to communicate content, this nonverbal communication speaks about our relatishonsips. This is probably even more important than getting the message across. We are meta-communicating - communicating about commun

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

Examples of combination products may in

cation! When words just don’t do it

When we are talking to a person we also need to make it clear how the content of our message is to be interpreted. The way we do this speaks about the relationship we have to this person,

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

or at least the way we think of this person. Words cannot do this. It is easier to show than it is to speak about our emotions. The meaning of our words is created throguh body language. In the de Saussurian meaning this langu

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

(in opossed to the parole) is used for nonverbal communication. We use it all the time. Most of the time we are not even aware of using it. Touching somebody during the conversation means something completely different than n

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

Combination pro

ot touching our partner in conversation. It is just not possible to communicate without using non-verbal language - written word is the only exception.

Are we aware?

Most of the body language is communicated on an unc

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

nscous level. Yet it has an extensive influence to the quality of our message. From this we can conclude that it would be a good idea to become conscious of our - and what is of even greater importance - other’s body lingo.

W

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

e can learn to use our body language for a purpose and to understand the body language of others. We also have to be aware that body language is interpreted culturaly - its meanings differ in different cultures. The interpreta

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

on depends on the situation, the culture, the relationship we have with the person as well as the gender of the other. What this means is that not a single signal of our body has the same meaning in all parts of the globe. Thi

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

s is an important point and should be taken into account. The language of our body is integrally connected to the spoken language and our complete behavioural pattern. With all this put together, various signals can also compl

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

ment each other to strengthen the meaning of what we communicate. Some social groups have devloped a specific body language which is very explicit because the use of words is difficult in a given situation. These are mostly mi

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

Following aspects would a

ority groups in cultures where there is a great history of prejudice of the dominant culture.

Feelings matter

Body language is used especially to express feelings. For instance if we are fond of someone, it is often d

dd to the challenges in developing combination products:

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

ifficult to say that directly to the person. It is, on the other hand, easier to make our feelings clear (intentionally or unintentionally) through body language. The opposite is also true. We may say that we ARE angry through

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

words yet our body language may be saying loud and clear that we are NOT. This can be very confusing for the recipientof the message. The situation is usually described as giving out double messages - one message in words and

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

an opposite message in body language. It is also difficult to lie or cover up our feelings through body language. We may give their true feelings away by not being aware of their body language. Research has shown that most peo

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

le pay more attention to, and believe more readily, their impression of how a person acts through body language than what is said through words. As a consequence we tend to doubt, or put a question mark behind, the spoken word

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

Professional from academic institutions, pharmaceutical industries, health care indust

s if they do not correspond with the language of the body .

Awareness of how we communicate = Vital

Only a small part of how we come across to another person is decied by the words we speak (according to research, les

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

than 5%). It is of vital importance that we know and (to a certain extent) control our body language. The recipient of our body language will have a feeling that is often difficult to describe, to put into words or to prove t

.

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

hat something was communicated. But it was. We have all surely said to ourselves: ‘I think he/she does not like me’ or ‘I do not really believe what was said’. It is called intuition and body language plays a very big role as

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

Companies that provide selfless information through particip

t gives us messages about the other person that we can interpret at an intuitive level. We need to get to know our own body language first. We should learn about it so that we can recognise it in others as well as in ourselves

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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