International plan for medical device

International plan for medical device

A business development strategy in Eastern Europe for glaucoma eye drops.

Challenge

A SME developed a glaucoma product which was a class IIB medical device. The company had already established some business relationships in Western Europe and it wished to expand into Eastern Europe and the Balkan countries.
The product was innovative and clinical studies endorsed its safety and efficacy.

Solution

We performed a technical audit of the product to thoroughly appreciate its differential aspects and its impact on the disease.
We learned how the business had been developed in existing countries and we aligned ourselves with the company’s internationalisation policy.
We designed a specific business plan which included a study on potential local partners, the conventions and trade fairs to attend and the regulatory requirements in non-EU countries.

Result

The company performed its business activities based on the report we provided it with. It contacted possible partners, attended key medical conventions and assured itself that it met the minimum regulatory requirements.
We monitored the set-up in detail and we were involved in key negotiations up to the point where distribution contracts were signed.
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