Eira Kelo
R&D Manager
Reagena Oy
Finland
R&D Manager with 20 years of experience in the In Vitro Diagnostics (IVD) industry at Reagena, specializing in the development of lateral flow rapid tests and enzyme immunoassays from concept to CE registration. The assays developed by Reagena are designed to assist in the diagnosis of zoonotic infectious diseases, including tick-borne encephalitis (TBE), borreliosis, neuroborreliosis, and hantavirus infections.
Topics
Tips for the feasibility phase
Developing Health Technology
Innovation
6.2.2025 15:30 - 16:00 | Hall 204-205 - Mylab
The product development process starts with the initial planning of the concept and the identification of input requirements. During the feasibility phase, critical materials and preliminary functionality are evaluated. Key aspects also include the assessment of the regulatory and quality requirements, market and business opportunies, available resources, preliminary risk factors, and potential collaboration options. The feasibility phase helps in determining whether a proposed project is viable, and if further product development is justifiable. This phase can take months or even years, depending on the complexity of the product and regulations, but it reduces risks in later phases of development.