Medical Plastic Data Service Magazine



Our 30th Year of Publication
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Global Market

International Market Exploration For Medical Devices

Mr. Amit Dave,
M. Pharm, MBA,
Former CEO - Brazil Operations/ Vice President Export – Zydus Cadila/Claris Lifesciences

In the first article in this series, we have touched up on broad background of the need and role of Regulatory laws. In the next article, we saw the perspective of the Regulatory outline. The article elaborated the concepts of QRS, denoting Quality, Risk and the Systems which will make the final product fool proof. This outline will be followed by product specific norms and Handling norms (HP). The total concept will thus be represented by QRS HP formula.

The next article discussed and described the starting point of Regulatory norms of any country which is Product Classification. We saw Classification of Medical Devices in the major countries and understood that this classification outline is fairly common across the major countries of the world.

In today’s article, now we will see the commercial aspects of the international market. Here we are starting with the market selection (or country selection). Before that, the article explains the logical reasons about why one should choose and go for a market outside India rather than sticking to India market only.

Happy reading!!


Now when we have seen some very broad aspects of International registration as well as their similarities with the Indian regulatory guidelines (current and planned for the future implementation), we will see here about commercial and market aspects for the International arena.

Why to explore international market

In the USA, export means to send goods to Mexico. On the other side, almost all the European countries think of export from the beginning. The main reason of this basic thinking difference is because of the domestic market size. US domestic market size is big enough while almost all the European countries have smaller market size. Since the market size is in parallel to the population, a good comparison of population of the USA with that of European countries will reveal this fact. USA population is 33 crore while almost all the countries of Europe have less than 5 cr population baring exceptions like Germany, France, the UK, etc.

A similar thinking process has been observed in India. Domestic market being large enough, the Companies think of Export strategy only at a later stage. So why should a Company think of Export?

The first reason is market opportunity size. If we consider only nearby countries, without going too far, and consider their total population, that itself is almost equal to the population of India. In other words, market size of only nearby countries will double the size of the market opportunity available. And incidentally, regulatory aspects are comparatively simpler in these nearby countries.

The second reason is market realization. Even in “not very rich” nearby countries, product realization for Medical Devices is better than that in India. This higher realization very well covers extra expenses spent for these markets. Transportation cost (by sea) to many of these countries is lesser than domestic transport costs if planned smartly.

The third reason is less competition. Outside India, competition is generally lesser. This is one reason of higher realization, of course.

Distances generally scare a common person. We always think that Export means far off and distant markets. However, on little consideration, one will find out that Ahmedabad to Kolkata is comparable to Ahmedabad to Dubai; and Delhi to Chennai is comparable with Delhi to old CIS countries.

To summarize, factors like large market opportunity, better realization, less competition, and reachable distance go in favour of overseas markets. These are reasons enough to include Export in the strategic planning of a progressive forward-looking company.

The next step is the market selection.

How to select target Export markets

The common practice followed here, albeit wrongly, is the herd mentality. Since a competitor is going to market X, a company also decided to go to the same market. In doing so, either we miss a better opportunity, or we probably follow the mistakes done by a competitor. Also, no readymade shortcut solution is available here. A company must make its own independent decision in this regard, and some simpler way of decision making should be followed. One such suggestive method is explained below.

• Decide the criteria or factors which are important for your decision.
Examples are Regulatory simplicity, Better realization, Larger market size, Political stability, Initial contacts available in a country, Language barrier, and so on. This is a good list. The decision maker can add / substitute some of these criteria.
• Give priority and weightage to these criteria, from high to low. Total weightage should be adjusted to 100, for ease of calculation.
• Consider countries of a sub continent or a geographical area first for evaluation, and put them in an excel table in the first column.
• Put criteria on top of the table and put weightage in the second row (demonstrated below).
• Now start evaluating each country under consideration after gathering some information, internet exploration and using known sources of information.

A table will be ready which will be a good way of selection judgement. An example is demonstrated below. Please see the table carefully, including explanations. This will clarify the basic methodology.

Evaluation of East African countries for Medical Devices

  Market Size (Population) Regulatory Scenario Compettion Known Contact Political / Economical Stability Language Total
Weightage 25 20 15 15 15 10 100
Country List              
Ethiopia 20 10 7 3 3 10 53
Kenya 10 13 8 10 10 10 61
Uganda 10 10 8 5 9 10 52
Tanzania 11 8 8 5 7 10 49
Explanation Ethiopia has highest population. (E 11 cr; Tanz 5.5 cr; Kenya, Uga 5 cr each) Based on web search and pers knowledge Taken as an example, assuming info from known contact Assumed that the Co. has a contact in Kenya, who can connect with Uga, Tanz Ethiopia not stable All English  

It is clear from the table that Kenya is the first choice. (The reader is, however, requested to consider this as an example only, and not a recommendation.)

By changing criteria or weightages and by internal discussions, a Company can easily derive a logical and correct conclusion by this method (which is adopted from some consultancy company models)..

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