Useful Advices - Business

Before you consider entering into the international market, do as much research as you can. It is a whole new world outside the U.S., and it is very easy to make a fatal mistake. The following are just some of the marketing areas that must be considered.

The

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

market entry requirements or barriers to entry. Social or religious limitations that may affect your business. For example, the MGM Grand in Las Vegas had to rebuild its multi-million dollar entrance that was a tiger's mouth, because it was offensive to Chin

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

Examples of combination products may in

se customers.

International demographics will undoubtedly be much different from your domestic market. You also need to know the exact market size and be able to conduct effective international market segmentation and international positioning. This will req

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

uire you to know the current market, market statistics, and market history.

You must have affordable media strategies for consumer or business-to-business marketing. You need to know about the licensing requirements. You have to find appropriate and affordab

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 channels of distribution within the foreign market that can deliver your product where and when you want it delivered.

You may not have protection of intellectual property in foreign markets (copyright, trademark), and that could be a costly problem. You mu

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

Combination pro

t carefully examine your product or service to determine whether there is a profitable international market. Your calculations of cost of goods sold or cost of sales, pricing, and revenue potential must be accurate in the international market.

Consider wh

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

ether there are available or a lack of local resources. Also, can you secure enforceable contracts with customers, vendors, and distributors in the foreign market. You need to consider stfing, training, and labor laws in the area. For example, there are very

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

strict labor laws in Europe which make it very difficult to terminate an employee.

You must prepare and effective marketing collateral and global branding strategy. For example, GMC had to change the name of the car named NOVA in Mexico, because NOVA transl

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

ted to "no go." Obviously, that was not a good name for a car.

Learn about international distribution agreements that must comply with foreign laws. Find out if you will need to localize you product or service to make it marketable in the foreign market.

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

Localization is often required in U.S. markets also. For example, Wal-mart had to build horse barns for its store located in the Amish district of Pennsylvania so that Amish customer had a safe place for their horses and wagons while they shopped.

There are o

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

her local customs, cultural idiosyncrasies, and mannerisms that must be observed in foreign business. Otherwise you may offend people, and they will not want to do business with you. These cultural diffences will probably be apparent in the negotiating styles

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

Following aspects would a

There may even be cultural differences about shaking hands or making eye contact. Also, many other cultures know about American history, and they are insulted if you know nothing about their history.

In additional to the marketing concerns, there are larger

dd to the challenges in developing combination products:

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

concerns about the government and monetary policies in the foreign market you are considering such as:

• Gross domestic product growth
• Per capita income
• Foreign trade risk factors
• Monetary policies
• Trade policies
• Foreign inv

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

stment policies
• Economic growth
• Political attitude toward U.S. business
• Government stability
• Customs regulations for imports and exports
• Tariffs
• Many documents used in international trade

The are so many complicated is

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

ues involved in international marketing that they cannot all be addressed here. It is strongly recommended that anyone considering international marketing try to learn as much as possible about business in the foreign market, and hire an international business

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

consultant that has many years experience in that market. To start that process, the following is a list of some good sources of information:

Embassies
http://www.empage.org/index.html
www.embassy.org

Department of State
http://travel.state.g

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

Professional from academic institutions, pharmaceutical industries, health care indust

v
Bureau of Consular Affairs
American Citizen Services
Ph: (202) 647-1488, (202) 647-5225

http://travel.state.gov/passport_services.html
Ph: (202) 663-1225

www.stat-usa.gov
National Trade Data Bank
Ph: (202) 482-1986

http://ww

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

.state.gov/www/background_notes/
U. S. State Department Background Notes

Department of Commerce
www.ita.doc.gov
International Trade Administration

Central Intelligence Agency
http://www.odci.gov/ciz/publications/bactbook/index.html

The Ce

.

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

nters for Disease Control and Prevention
www.dcd.gov

The U.S. Chamber of Commerce
http://www.uschamber.org

The U.S. Census Bureau
http://www.census.gov
The Library of Congress
http://www.loc.gov

International Electrical Adaptors and

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

Companies that provide selfless information through particip

elephone/Modem Adaptors, Magellans’ Travel Supplies
http://magellan.com/getcustoms

Dun & Bradstreet
http://www.getcustoms.com

Copyright 2006. Indigo Business Solutions is a registered trade name. The future of your business starts here.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Useful Advices - International Marketing

Related Articles: