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Cross-cultural Management is a system designed to train and make known to people in the global

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

business about the variations of cultures, practices and preferences of consumers around the gl

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

Examples of combination products may in

be.

Cross-cultural Management poses as a challenge for companies from all over the world who p

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

rticipate in the global market. As time passes by, the diversity in culture, practices and pref

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

erences significantly increases, and so is the need for cross-cultural management, to be able t

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

Combination pro

bridge the communication gaps for every culture.

As the competition becomes rigid, the need 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

survive becomes a difficult test for most companies. Each must compete and at the same time fo

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

rmulate strategies that would make them stay alive. One is alliance with other companies, (not

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

ecessarily of the same country, culture, or preference).

Because of the increasing immigration

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

counts, the global marketplace has become culturally diverse. And in order to survive, a compan

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

must be highly productive and at the same time innovative. It is a manager’s key function to p

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

Following aspects would a

romote and maintain a system of communication to best understand the others’ cultures and prefe

dd to the challenges in developing combination products:

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

ences, and at the same time keep pace with time zones, trends and updates so as not to get off

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

he global market tracks or lose out to rivals.

Before embarking on a global marketplace, a new

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

bie company must first be aware of the consumers to whom it will introduce its products and ser

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

ices. Thus, an intensive research about varied cultures and preferences of the possible target

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

Professional from academic institutions, pharmaceutical industries, health care indust

arket in the world market is very necessary.

Communication is the foremost tool needed to deal

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

with the stiff market competition. And, through cross-cultural management, people are trained

.

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

o see other cultures and are exposed to various practices to be able to familiarize themselves

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

Companies that provide selfless information through particip

n the preferences in products and services of various cultures.

Copyright 2007 Ismael D. Tabij

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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