Medical devices must continually innovate. The products have to rapidly change and evolve to be more personalized and connected, leveraging AI and cognitive automation. The constant changes and innovations on device developments, not only represent a big challenge for life science industries and manufacturers, but also for regulators. The complexity of clinical data collected for medical devices is another challenge for device manufacturers and for the clinical development of the product. This complexity is reflected mainly on the design of the CRFs.
Implementing a technology-driven unified EDC platform for medical devices helps with reduced study startup timelines, enhanced patient compliance, improved operational efficiency, data collection and submission thereby enabling the sponsor to make more informed decisions. Effectively, the EDC system builds the sponsor’s roadmap to bring innovative and necessary medical devices to patients faster.