Chasing the holy grail of using real-world evidence in regulatory decision-making for medical devices: an interview with Paul Coplan, Johnson & Johnson

Real-world evidence (RWE), drawn from real-world patient data and experiences, offers a wealth of information that complements traditional clinical trial data. For medical devices, this approach provides regulatory agencies and manufacturers with a more comprehensive understanding of a device's safety, effectiveness, and quality as used in clinical practice, which is referred to as 'real-world.' Yet as the medical device industry continues to embrace RWE, its integration into regulatory decision-making is still in its infancy. In this interview, we speak with Paul Coplan (Vice President and Head of MedTech Epidemiology & Real-World Data Sciences, Johnson & Johnson) to learn more about...