Drug-Device Combination Products: Design, Development and Regulatory Considerations

Abstract

Drug-device combination products represent a significant and evolving segment within the healthcare industry, offering novel therapeutic approaches and enhanced patient care. This abstract delves into the multifaceted landscape of designing, developing, and regulating such products. The design phase of drug-device combination products demands a comprehensive understanding of both pharmaceutical and engineering principles. It necessitates seamless integration of drug substances with medical devices, ensuring compatibility, stability, and efficacy. Moreover, considerations such as patient usability, ergonomic design, and manufacturing feasibility play pivotal roles in product development. Development of drug-device combination products involves intricate processes, spanning from concept ideation to commercialization.