The Mission of the Research and Development department is the conception, design and development of new products along with the continuous improvement of the existing ones, according to the overall company strategy and Product Development pipeline.
The typical inputs for a new R&D project are the marketing analysis of the competitor’s products and the clinical laboratories needs.
During the Design Conception phase of the Product Development Project, these needs are “translated” into a theoretical assay model and into analytical and diagnostic properties (sensitivity, specificity, precision, accuracy etc) which constitute the technical requirements for the new or improved product. The project activities scheduling and cost estimation also take place in this phase.
Other four phases are needed for a project to generate an industrial product.
During the Design Feasibility phase, raw materials for the new assay are generated or carefully selected from reliable suppliers. Assay reagents consisting in unlabeled or fluorescently labeled target specific DNA sequences are first in silico designed using dedicated software and then synthesized. The Feasibility phase ends with a prototype test that must satisfy a minimum acceptable level of analytical parameters.
During the Design Verification phase the assay performance is optimized, thus defining the conditions that allow to reach the target level of analytical and diagnostic parameters. In this phase, the optimized prototype performance is also verified on real clinical samples. The deliveries of the Verification phase are “recipes” for the manufacturing and the quality control of small-scale lots of the new product.
During the Design Validation phase, the performance of such pilot lots is tested on real clinical samples in parallel with a “golden standard” method and results are compared and analyzed.
Finally, during the Design Transfer phase, the know-how and manufacturing procedures on one side and control procedures and acceptance criteria on the other side are transferred to the Production and to The Quality Control Departments, respectively, to allow an industrial scale manufacturing of the new product.
EuroClone Diagnostica and its R&D Department, are certified: ISO 13485:2012. that specifies requirements for a quality management system, for an organization that has to demonstrate its ability to produce and provide medical devices.
ISO 13485:2012 consistently ensures to meet customer and regulatory requirements, applicable to medical devices and related services.