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Effective communication is not a one-way street. It involves an interaction between the sender and the receiver. The responsibility for this

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

interaction is assumed by both parties. The speaker can solicit feedback and adjust the message accordingly. The listener can summarize wha

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

Examples of combination products may in

was said for the speaker and continually practice the empathetic process.

Feedback is a major source of information which tells you how yo

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

u are perceived by others and how your behavior is affecting them. This exchange must exist for true communication to take place. An effecti

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

e communicator solicits feedback from the receiver in order to check for understanding and to remove as many barriers from the process as po

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

Combination pro

ssible. The communication process is complex, but giving and receiving feedback, especially critical feedback, ranks as the most personal an

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

threatening aspect of all. This is unfortunate, as most research on motivation suggests that feedback is one of the biggest motivators for

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

change.

This in mind, some people are still reluctant to receive feedback for a number of reasons:
1. damaging self-image

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

2. causing defensiveness
3. creating vulnerability

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

4. telling us statements we do not want to hear
5. exposing feelings which are uncomfortable

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

Interestingly, there are similar concerns for those giving the feedback:

1. uncovering emotions both people do not wish to deal with

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

Following aspects would a

. exposing someone else’s vulnerability
3. causing defensiveness or anger, thus hindering communication
4. People like to hear wha

dd to the challenges in developing combination products:

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

t is consistent with their own views and resist ideas contrary to their belief structures. As professionals, if we knew we were doing someth

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

ng ineffectively, wouldn’t we automatically try to improve the deficiency?

5. Criticism implies that we could be wrong. It takes an ope

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

n mind to be able to listen to an opposing view.

To be truly effective, feedback must be seen as an interaction in which both parties have

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

eeds that must be taken into account. Most people do not have the opportunity to learn feedback skills. We more or less give critical feedba

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

Professional from academic institutions, pharmaceutical industries, health care indust

ck in the same way as we get it, roughly or ineptly, and that makes us fear it even more.

In order to alleviate fear associated with feedba

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

k, it is important to understand what effective feedback consists of. Effective critical feedback is information that: may be heard by the 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

eceiver and not cause defensiveness, may cause pain or conflict but keeps the relationship intact and open, supports the feedback process fo

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

Companies that provide selfless information through particip

future interactions, does not assume that the giver is right and the receiver is wrong, and has give and take; is an invitation to interact

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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