Advice You - Business

What do I mean by “culturally savvy“? I am not talking about being politically correct, rather I am talking about simply being cognizant that there is a larger cultural impact on how business is conducted t

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

oday than ever before. Cultural differences often exist within the same companies…they certainly exist between different companies. Without question there are different cultural business practices in differ

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

Examples of combination products may in

nt cities or regions within an individual country. These differences are almost exponentially complicated when you start doing business on a global basis. For purposes of this post we will address how to be

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

t blend and manage your internal cultural characteristics with those of your vendors, partners, suppliers, customers and investors who may be located in foreign countries.

The impacts of globalization are

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

eing felt by all of us at some level whether we realize it or not. Moreover as time marches forward it is likely that even businesses that once would have never had to deal with global concerns will. Every

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

Combination pro

ulture has their own unique way of functioning and if you want to remain competitive in the market you will need to develop a cultural sensitivity and maturity to your business approach that may not present

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

y exist.

I have been doing business internationally since the mid 80’s. I have done business in Canada, Central and South America, the Mid-East, Europe and Asia. What I have learned in my travels and exper

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

iences is being culturally savvy can not only shorten your initial time to market, but also help insure that entry into a foreign market is profitable and sustainable. Learning the language (or at least som

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

common pleasantries), customs, values and usual and customary business practices are a must for not embarrassing yourself or your company. False starts in a new country can be very costly and often times t

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

ere a no second chances…

While the basics of cultural awareness mentioned above will get you in the door, it is becoming culturally savvy that will keep you there. I liken international business to acquiri

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

g a new company. It is rarely the acquisition that is a problem, rather it is the post acquisition integration issues, many of which are cultural, that often determine the long-term viability of an acquisit

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

Following aspects would a

on. Similarly it has been estimated that the mortality rate of international joint ventures exceeds 50% within a three year period of time. It is rarely technical competency that is responsible for the high

dd to the challenges in developing combination products:

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

failure rate noted above, rather the reason most often noted for the dissolution of ventures are the problems surrounding the inability to manage and deal with cultural constraints, barriers and conflicts.

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

What works in one culture often times simply does not work in other cultures. In fact, many times what works within one country can deeply offend someone from another country. The bottom line is that it pay

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

s to do your homework well in advance of doing business abroad.

The most effective way in which to insure your success abroad requires a blending of two key components. The first is selecting the right “in

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

country” partners and advisors. These should be locals who know the ropes from a political, regulatory, legal, tax and cultural perspective. The local partners should already have a solid network in place t

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

Professional from academic institutions, pharmaceutical industries, health care indust

at will help you hit the ground running. A common mistake is to just open an office, staff it up and expect to get the same results that you would by opening a branch office domestically. This rarely works

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

nd in fact can be very costly on a number of different levels. The second component needed to be successful abroad is to hire a consultant to advise and train your domestic staff on the finer points of cros

.

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

-cultural integration and interaction. You may select the perfect set of foreign partners and advisors, but if your domestic staff doesn’t understand how to communicate and do business with them on a cultur

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

Companies that provide selfless information through particip

lly acceptable basis the venture will be very short lived.

To conduct business successfully in today’s international marketplace requires a commitment to global team building in a multicultural environment

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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Advice You - Are You Culturally Savvy?

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