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Validation Manager - A disruptive turnkey solution for diagnostic test validations

Periodic Reporting for period 1 - VALIDIAG (Validation Manager - A disruptive turnkey solution for diagnostic test validations)

Période du rapport: 2015-05-01 au 2015-10-31

A Finnish software company, Finbiosoft has introduced a unique and disruptive cloud-based software, Validation Manager™, which makes validation of diagnostic tests truly easy, cutting down even 95% of the time needed for validations, and ensuring that validations are conducted according the regulatory requirements. Finbiosoft's solution is substantial both in European and global context, as Finbiosoft is in a unique position to enable i) diagnostic companies to save dramatically time and money to reach markets allowing them to sell more, and ii) laboratories to be able to painlessly evaluate and take into use the best available diagnostic methods.

Finbiosoft's goal is to make Validation Manager™ the de facto tool for managing diagnostic test validations globally. The vision is to achieve a recognized leadership position and revolutionize the way how diagnostic companies and laboratories manage their validations, not only in the human diagnostics but also in other diagnostics fields such as food and drink, veterinary and environmental diagnostics.

In this feasibility study, Finbiosoft will assess the market potential and arising challenges while aiming to expand from molecular human diagnostics to new segments such as clinical chemistry, immunology, food and drink diagnostics etc. Similarly, Finbiosoft will assess how to achieve the desired de facto position in the market. The final outcome of the feasibility study is a comprehensive knowledge on the full potential of the solution in Europe, and a detailed road map and go-to-market model in a written business plan format, which is needed to provide direction to the next phase of development, for external investors and in Horizon 2020 SME phase II application.
Project was executed in 6 months period between 1st of May and 31st of October 2015. Work was conducted by the responsible persons within the company, with the help of external market research organization in Finland, and a hired external freelancer in Germany. In addition to the collection and analysis of the publicly available market information, efforts were strongly focused to gather information directly from the field, from potential customers, partners and key opinion leaders. To complement the literature study, numerous visits to relevant industry exhibitions, industry players and potential customers were conducted in Europe to obtain information necessary for the project. Gathered data was carefully analyzed and refined to provide a view of the market size, trends and growth of the industry, and as a comprehensive market analysis and go-to-market plan.
Results from the project were proven to be tremendously valuable for the company;

i) Thanks to the information gathered, analyzed and documented during the project, Finbiosoft was able to successfully conduct its first external financing round. In October 2015 Finbiosoft closed a major financing round of 1,499 M€ . The information generated within the project was crucial for enabling the investment round.
ii) Based on the information gathered already at the early days of the project, company made an instant decision of extending its product to a new potential business segment and was granted a major R&D funding by National Funding agency for developing solution in this new segment
iii) Due to the decision (ii) of starting to extend product to a new segment, company received immediately multiple new paying laboratory customers, for co-developing solution together and ensuring that the solution would address their needs in the new segment.
iv) Thanks to the work undertaken in the project, company has now a clear vision on customer needs and expectations, and has defined a road map for the development needs for the following two years time. Finbiosoft shall continue the project after the feasibility study and seeks EU SME Phase 2 project for realizing the described business opportunity