Advice You - Business

I regularly meet small businesses, including those in the start-up phase, who recognize that exporting will be an important part of their long-term growth strategy. I'm pleased to see this level of awarene

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

ss, even when they are still struggling with final product formulations, financing, staffing, etc. because eventually every company needs to consider outside markets.

To make the transition into exporting

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

Examples of combination products may in

easier when the time comes, there are some things companies can consider now to lay the groundwork for international expansion.

1. Design your marketing materials for growth. Soon you may

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

need to mail your brochure to another country or lug your pop-up display to an overseas trade show. Unusually shaped mail-outs cost more in postage and large displays often can't be included in checked lug

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

age and must be shipped separately. Avoid the necessity of re-vamping your marketing collateral by taking future export needs into consideration now.

Regarding the content of your marketing material, if y

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

Combination pro

u don't plan to localize it to each region, keep it simple. For example, don't overly promote the nationality of your product. Canadian companies commonly do this and that little maple leaf on the corner o

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

f your brochure, or on the product, can be a big turn-off in American states, especially when patriotism is at its peak. Instead, focus on your product or service and the benefits it will confer on potenti

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

l buyers.

The same goes for your web site. It must be professional and compelling, and convey that you are a global company. In many cases you will be expanding first into English-speaking countries so yo

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

r site doesn't need to be translated and it may not need to be localized. If this is the situation, just keep in mind the needs of foreign web surfers seeking more information about you, your company and y

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

ur products/services. They want to know:

* Do you ship to my country?

* Can I buy your product in my country? If so, where?

* What is the price in my currency?

* How long will it take to ship?

* Can I

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

access your service (i.e. consulting services) by phone or e-mail or do you need to visit my country in person?

* Are you available to provide your services in my country?

* Are you/your product well est

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

Following aspects would a

ablished in your domestic market?

* Can I trust your company?

2. Get into the habit of developing written policies. Eventually you will be working with a foreign partner - a sales repres

dd to the challenges in developing combination products:

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

ntative, distributor, licensee, - but will want to maintain as much control as possible over how your company is portrayed, how it is positioned in the market and how your partners conduct themselves. Clea

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

ly written company policies regarding discounts, promotions, control over intellectual property, hospitality expenses, etc. will be crucial to providing guidance.

Once everything is collected into one pla

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

e it makes it much easier to make the required modifications and develop a handbook for your overseas representatives. (This is also good practice if you plan to expand your staff to different geographic l

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

cations domestically.)

3. Implement a foreign exchange strategy. Chances are you are already paying for stock or inputs in a foreign currency (likely U.S. dollars or Euros). Soon you will

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

Professional from academic institutions, pharmaceutical industries, health care indust

be receiving revenue in those currencies. Exchange rate fluctuations can significantly affect earnings yet most companies do not manage their foreign exchange exposure. A simple hedging strategy can prote

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

t against those cost and revenue impacts but you need to speak with an expert about it to develop a plan. Additionally, these same professionals can often offer much better exchange rates on wire transfers

.

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

and drafts than traditional banks. With these systems in place, and a developed relationship with a trusted f/x advisor, it will be much easier to expand once you start exporting.

It pays to think ahead.

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

Companies that provide selfless information through particip

ven if exporting is a couple of years into the future, consider how the actions you take now will impact or influence your export plans.

Copyright © International Strategies Ltd. 2006. All rights reserved

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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