Grand Challenge: Applying Regulatory Science and Big Data to Improve Medical Device Innovation

  title={Grand Challenge: Applying Regulatory Science and Big Data to Improve Medical Device Innovation},
  author={Arthur G. Erdman and Daniel F. Keefe and Randall Schiestl},
  journal={IEEE Transactions on Biomedical Engineering},
Understanding how proposed medical devices will interface with humans is a major challenge that impacts both the design of innovative new devices and approval and regulation of existing devices. Today, designing and manufacturing medical devices requires extensive and expensive product cycles. Bench tests and other preliminary analyses are used to understand the range of anatomical conditions, and animal and clinical trials are used to understand the impact of design decisions upon actual… 

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