Orthopedic biomaterials and drug-eluting stents are only the first hint at the potentially transforming nature of combination products: device/biologic combination products that may bring a revolution to clinical therapy and to the device industry. In vascular medicine, catheter-based delivery of cardiac gene therapy may become a significant advance, yet with scant clinical evidence of efficacy and only anecdotal physician experience using catheter delivery systems, the field remains all promise. Many device executives think they see a path emerging, largely due to fundamental changes in the dynamics of their industry that are moving device business models closer to that of their pharma industry cousins.