The role of real-world evidence (RWE) in medical device safety continues to grow, shaping regulatory decisions. On MD+DI's Let’s Talk MedTech podcast, Dr.?Jijo James?highlights how?Johnson & Johnson?worked with NEST to secure the first-ever FDA label expansion based entirely on RWE. This collaboration demonstrates the value of real-world data in advancing medical innovation and improving patient outcomes. As #RWE continues to gain traction, we’re excited to see its impact on the future of #medtech.
Chief Medical Officer, MedTech & Interventional Oncology at Johnson & Johnson; Board of Directors, Medical Device Innovation Consortium (MDIC)
Several years ago, I heard an industry colleague, heart patient, and healthcare advocate Heidi Dohse say, “You think about product life cycles. I only have ONE life cycle.” This profound statement still resonates today as we continue to prioritize patient safety and champion healthcare innovation.? ? I recently joined Omar Ford on the MD+DI Let's Talk MedTech Podcast to discuss how Johnson & Johnson is putting patients first. We spoke about reducing medical device-related disruptions in the OR with the Device Briefing Tool (DBT) in collaboration with Ariadne Labs and securing the first-ever FDA label expansion based exclusively on real-world evidence (#RWE) in partnership with the National Evaluation System for health Technology Coordinating Center (NEST).? ? A common thread among these examples is the critical importance of listening to and capturing the patient voice. At #JNJ, we seek to incorporate patient perspectives into our benefit-risk assessments, which ultimately informs our research and development processes to create more patient-centric products that truly meet their needs.? ? I encourage you to tune in to the full episode to hear more about how #JNJ is transforming medtech and putting patients first. https://lnkd.in/egfgjiC7?? ? #PatientSafety #MedicalDevices #MyCompany #Medtech?