Quality by Design approach in the development of a magnetic transducer for biomedical measurements: preliminary results on Design Space configuration

Abstract

The concept of Quality by Design (QbD) has been widely used by the pharmaceutical industry since 2004, changing the focus on inspections to embrace greater control in the manufacturing process. This new approach contributed to lower production costs and higher quality of medicines. This work discusses the first steps towards the implementation of a QbD approach aimed at ensuring the quality of a biomedical device under development. This device will be applied as a non-magnetic metallic foreign body localization system for surgical removal guidance. It should be highlighted that a new approach was used to define the Design Space, based on fuzzy logic rather than the typical statistical techniques.