Collaboration among diverse stakeholders is a key driver for medical device research.
The importance of collaboration throughout the Test-Case process was highlighted by Dr. Paul Coplan, Vice President and Global Head of Medical Device Epidemiology and Real-World Data Sciences at Johnson & Johnson. “NEST provides an opportunity for J&J research teams to collaborate with FDA reviewers and researchers at leading healthcare systems in developing EHR real-world evidence to assess safety and performance of devices,” said Dr. Coplan of his team’s experience working with NESTcc.
Joseph Drozda, MD, MACC, Director of Outcomes Research at Mercy, echoed these sentiments and gave insight into RWD generation, saying, “The NEST Test-Cases have provided great practical opportunities for everyone involved to deepen their understanding of real-world data sources, including the FDA.”
Collaboration was a common thread through NESTcc’s Test-Cases, whether they focused on orthopedic or cardiac devices, a urology-focused mobile app, or any of the 16 additional research Test-Case projects.