Advice You - Business

Expanding your business in international markets involves risks that should be meticulously calculated. It requires additional steps to your planning process, but the results can be very rewarding!

Having solid operations at home is usually a first step to a successful international expansion. Mastering the production, and the overall business experience, will give

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

you the initial confidence to attract strategic partners.

Begin with a thorough marketing plan, which will serve as a reference to all individuals involved with the business. The document should include all aspects of the product or service life, from complete research to launch, implementation and execution. This will be key for your business plan.

Starting with

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

Examples of combination products may in

a comprehensive research plan
A detailed research plan will help you make informative decisions on the objectives and strategies. It will also help you decide how to enter that market, whether by finding a local partner to distribute your goods, or by opening sales offices and importing your products, or by building facilities to produce your goods in the new ma

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

rket.

The analysis of the macro environment is one of the most important steps of international planning. This involves a clear understanding of the political, social and economic climate of the target market. Search for trends and forecasts of variables like the exchange rate, inflation, unemployment rate, purchasing power, import barriers and tariffs, and importa

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

t socio-political events. You need to understand what affects your audience and the industry in general. These issues will hugely impact your operations, and your business model should make provisions for them.

Next, compile information about the audience you want to reach: gender, average age and income, geography, preferences, decision and purchasing process, etc

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

Combination pro

. Based on cultural background, consumers in other markets have a different perception of products, brands and related services. This will dictate the level of adjustment required to your line of products and how you will promote it to that audience. The importance of understanding diversity cannot be overemphasized. A common mistake that many companies make is to

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

lump many countries together into regions. Each country on every continent has very individualized habits and traditions that you should take into consideration.

Another important element of your research should be the accessibility of local expertise to support your operations. Search for partners that can complement your business model in areas such as sales, op

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

rations, supply chain, legal, accounting and distribution. Also investigate the availability of local talent to manage and run your operations. Allowing for a fast and dynamic local decision-making process is vital for a successful expansion.

Then you should examine the competitive environment using the “SWOT” analysis technique. At this time, investigate all publ

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

ic information available about your top competitors, and get a clear knowledge of their Strengths and Weaknesses. Find out the barriers for entrants, be aware of your limitations as a new player, and know potential cultural pre-concepts that may affect you as a foreign brand. With this information in hand you will be able to compare and elaborate on your Opportuniti

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

es and Threats. You want this section to be very objective, with clear bullet point lists.

Setting the basis
The next step is to quantify your targets. This should include your transaction volume and revenue targets; most multinational companies use the US dollar as the official currency for revenue reports. Due to exchange rate fluctuations, it is recommende

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

to track results in both local currency and the US dollar. Create multiple columns with targets for the year, and also broken down by quarter. On a separate chart, break it down further by distribution channel such as intermediaries, in store, online, etc. Detailed reports will help you understand market seasonality and channels.

After conducting thorough researc

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

Following aspects would a

h and setting your targets, you are ready to develop your key marketing objectives. Use this opportunity to figure out the macro course of actions that will enable your company to reach its numeric targets. Be realistic; think through objectives that are both aggressive and achievable. Some important objectives at this stage usually involve branding, product develo

dd to the challenges in developing combination products:

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

pment and distribution channel mix. List a minimum of three but no more than six or seven key marketing objectives for the year. Consider hiring your local manager before or during this stage; the involvement of this professional in the planning process can be very valuable for the success of your international expansion.

Next, work on the strategies and activities

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

in support, which are the means to realize your objectives. Start with the ‘communications message’, the sentiment you want associated with your brand. Use in-country assistance to consolidate a single powerful message that should be reflected in all points of contact with customers such as brochures, advertising, website, stores, press releases, etc. Sometimes a

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

essage that is successfully communicated at home is translatable, but in most cases it will require adjustments to the native culture, which is why the use of local assistance is vital.

Then, develop the key marketing strategies, supported by tactics and programs to execute them. In essence, strategy is how resources are distributed and utilized to achieve your key

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

objectives. Tactics and programs are important to make the strategies action-oriented.

As you work through your six or seven strategies, focus on delivering distinctive value to your customers through your programs. You don’t have to limit the number of programs and tactics under each strategy. Keep them focused, with clear implementation facts and time schedules.

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

Professional from academic institutions, pharmaceutical industries, health care indust

All should be visually organized, so your team can envision how the tactics and programs relate to each strategy, and how all strategies will contribute to the overall objectives. Bear in mind the resources and marketing funds available for the year.

Finish your plan with a detailed budget chart, breaking it down by activities and costs, in both currencies. In th

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

future, a year-over-year comparison will be helpful to evaluate the results and calculate return on investment.

A marketing plan is not a static document. Revisions should be made at least quarterly, as your team becomes more knowledgeable about the new market. In addition to the numeric targets, it is useful to establish parameters to measure the effectiveness of

.

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

your strategies, tactics and programs. Determine what to evaluate, and establish standards of performance, but be careful with misleading comparisons between different markets. This exercise will allow you to take corrective action, adjusting your marketing strategies to be more competitive during the year.

These are the basics of effective international marketing

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

Companies that provide selfless information through particip

planning. Once implementation is in place, have your mind set for future expansions, developing a business model that can be recreated in other countries, with proper adjustments. And finally, be sure to involve your team throughout the process, and make allowances for cultural distinction in management style!

© Lima Lerch Consulting 2006-2007. 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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