Frequently, in the firms despite heavy investments, significant timeframes, relevant costs, and frantically resources spent, to enter in a target market, their efforts are not rewarded with the sales.

Especially in the commercially interesting countries the “entry barriers”, or better, the conditions required by Regulatory Authorities are expensive and difficult challenges, but they are key elements in the marketing.

Why does this happen? Why does not a firm reenter from the investment done, even it worked, and it reached important intermediate results?

Probably, there is not only an answer, but a key element is: the strategy.

It is crucial to choose the most appropriate strategy. You can behave rationally, prepared, planned and farsighted, analyzing before the target market, the activity to be carried out inside and outside the company, the regulatory compliance, the possible reference partner and then, basing on data collected, you can choose what to do.

Otherwise, you can rely on a random strategy, without planning and information, basing on rumors and expression without a deep interest, and then you won’t be able to sell the amount desired (and neither foreseen).

Within the strategic activity, which should be planned in order to commercialize Medical Devices, you can’t exclude a regulatory strategy.

Only for you, I disclose how to define an efficient regulatory strategy in 3 steps:

1) Define a Regulatory Intelligence plan, i.e. beforehand you have to collect as much data and information as possible from different sources (guidelines, regulations, expert opinions) in order to create a regulatory scenario that is as exhaustive and realistic as possible;

2) Draw up a Scientific Advice plan, that is the conclusions arising from regulatory intelligence activities. Furthermore, it’s important to define how to interact with regulatory agencies, outlining the various alternatives in order to permit to the decision maker a considered choice;

3) Write a Regulatory Strategy Document, which is a summary of all the activities carried out.   What are the advantages for your firm if you set up a regulatory strategy following these simple steps?   There are several advantages, but let us mention some of these as an example:

  • to avoid unforeseen events, delays, unexpected complaints after the submission;
  • to avoid delays and extra costs for the device or documentation modifications when the design has been completed;
  • to avoid penalties by the competent regulatory authorities.

Clearly, how above described is inserted in a wider marketing strategy focused on target country, concerning not only Quality or Regulatory Affairs. Finally, should be reminded that, regardless of the extension and who plans it, any kind of strategy must be set before the commercialization of the device, not after. Maybe it was obvious, but it was important to clarify it.

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Marisa Testa
RA Manager