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Optimal Data Analysis in Medical Device Trials

With increasingly more rigorous regulatory requirements for medical devices and diagnostics and a rapidly growing marketplace, the industry needs more efficient ways to manage the growing amount of data amassed in clinical trials. Greater adoption of more-advanced data management technology will improve trial efficiency and foster improved collaboration between device researchers and the medical community to speed new products to market.

This paper explains the differences in medical devices and drugs in terms of clinical development, the regulatory pathway, and procedures for analyzing medical device data. The paper also covers challenges for medical device development and data analysis, and includes a case study of how a medical device company resolved its data management issues.