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.