Introduction of a Blood Group Serological Device: Evaluating the Product Development Process Based on User Needs

Abstract

Blood group serological medical devices produced in Hungary are in the focus of this paper. The first Automatic Coombs Test Analyzer (ACT) was constructed approximately 20 years ago. There is a huge competition between the blood group serological devices applying different types of techniques (e.g. microplate, card or spin tube technique) which can carry out all the applied methods (e.g. direct agglutination, enzyme, antiglobulin or Coombs, or Polybrene method). Therefore, the continuous development of such an instrument is inevitable. Involving users can result in ideas that may have serious impact on the product development process. Within the confines of our research five focus groups including thirty-five participants from three Hungarian laboratories were conducted in order to gain user opinions and expectations regarding the Advanced ACT. As a result the optimal ratio between automation and being able to control the results manually was pointed out to be a crucial factor of the users. A possible solution was shown to eliminate or at least decrease the potential stress mentioned by them.