Strategic approaches for selecting regulatory pathways in drug-device combination products: A comprehensive review

The pharmaceutical industry is witnessing a significant shift from traditional dosage forms toward drug-device combination products (DDCPs), driven by the need for enhanced patient compliance, targeted drug delivery, and improved therapeutic outcomes. DDCPs integrate drugs with medical devices, offering novel delivery mechanisms that transcend the capabilities of conventional formulations. This article reviews the intellectual property landscape protecting DDCPs, highlighting the strategic importance of securing both drug and device patents to safeguard innovation. Regulatory considerations, with a focus on the U.S. Food and Drug Administration (USFDA) and the European Medicines Agency, are examined, including key guidance documents, approval pathways, and compliance requirements. An overview of USFDA-approved devices used in DDCPs provides insights into current market trends and therapeutic applications. The article also outlines critical aspects of the design and development process for DDCPs, including material selection, device engineering, drug-device integration, and testing protocols. Finally, a business model framework is proposed for the successful design, development, and commercialization of DDCPs, emphasizing cross-functional collaboration, strategic partnerships, and early regulatory engagement.