The objectives were all met to various extends during the unfolding of the project.
The clinical study strategy development proved to be the trickiest point to tackle. Indeed, our device being a Class I / Custom made device, the framework for conducting clinical studies in that context is not so clear. A global clinical strategy was defined, including clinical evaluation and early market introduction of the product, and long term clinical follow up once on the market. This strategy is based on both EU regulatory framework evolution (introduction of new MDR), product and industry specific circumstances, and business imperatives.
The country-based service model assessment was executed and yielded positive results. Ten countries were originally targeted (Switzerland, France, Germany, United-Kingdom, Belgium, Italy, Spain, Portugal, Austria). A first overview was done for each country. The full assessment was completed only for the countries where the best business potential was identified. For the country-based service model assessment, the following points were of interest:
a) the number and size of O&P centres,
b) their current process for liner-fitting and production,
c) the current cost for liner fitting and production as well as
d) shipping possibilities and cost
A full analysis combining the 4 above points was executed for Switzerland, France, Belgium. If it remains to be deepened, an overview analysis was performed for Germany, the UK, Spain, Italy, Portugal and Austria.
From this, an internationalisation strategy was developed. This strategy includes not only target entry date for each country, but also export strategy, scheduled sales and manufacturing growth plan, human resources plan, and execution strategy.
Substantial efforts were also invested in the patent strategy monitoring. Most of these efforts went towards the building of a competitive patents landscaping system. Through this system, over 150 patents were reviewed and analysed, drawing crucial insights for the future technology developments of the company.
