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Holistic Perspective to the Drug-Device Combination Product Development Challenges

  • Yaroslav Menshenin,
  • Romain Pinquié,
  • Pierre Chevrier

摘要

The steady growth of life expectancy calls for a new view on the importance of MedTech combination product development. One can envision that to keep a higher quality of life, more people would require some form of therapy depending on their individual state of health. This would require more medical devices of different types and complexity to be designed for specific drugs. However, from a holistic perspective, several challenges emerge in the development of drug-device combination products. An additional layer of complexity appears due to the increasing complexity of the MedTech devices, as they interact with the other systems and products in the design environment. This paper discusses those potential challenges and proposes ways to mitigate them. The primary focus of this work is on the drug delivery systems, such as autoinjectors.