Integrating Quality by Design (QbD) in Medical Device Manufacturing - Concept, Benefits, and Challenges

The medical devices industry, as well as the pharmaceutical industry, is slowly but indisputably accepting the concept of Quality by Design into its design and development product phases, and is introducing the statistical tools and methods of the concept into its process verification and validation phases as well. The Quality by Design concept or approach has found its implementation in the medical devices life cycle management, under the guidance of risk regulations by the International Conference on Harmonization. Since the importance of successful implementation of this concept is ever more evident in industry, this white paper will therefore discuss the concept and its possible implementation in the medical devices industry, along with the benefits and concerns expressed by the manufacturers.