Dry Powder Inhalers in the Age of Digital Health: Current Status, Regulatory Considerations and Future Perspectives

Dry powder inhalers (DPIs) are established drug–device combination products in which therapeutic performance is governed by the interaction between formulation properties, device engineering, and patient-specific inhalation behavior. Although advances in particle engineering and inhaler design have improved dose delivery and aerosol performance, real-world effectiveness remains limited by variability in inspiratory flow, inhalation technique, and disease state. These challenges underscore the need for a systems-based approach that recognizes DPIs as integrated delivery platforms rather than conventional dosage forms. The emergence of digital health technologies, including embedded sensors, connectivity, data analytics, and software-driven feedback, has enabled the development of digitally enabled or “smart” DPIs. Such products have the potential to function as connected combination products, supporting inhalation monitoring, adherence assessment, and personalized therapy. From a regulatory perspective, the integration of digital components introduces considerations related to software as a medical device (SaMD), data integrity, cybersecurity, interoperability, and lifecycle management, as outlined in evolving FDA and EMA digital health and combination product frameworks. This review summarizes the current status of DPI technology in the context of digital health integration, with emphasis on formulation–device–patient interactions, clinically relevant digital functionalities, and performance evaluation. Key regulatory expectations for development, validation, and post-market oversight of digital DPIs are discussed, including alignment with quality by design and risk-based regulatory approaches. Finally, future perspectives are presented to identify scientific and regulatory gaps that must be addressed to enable next-generation digital DPIs capable of delivering reliable, patient-centric, and outcome-driven inhalation therapy. Keywords: Dry powder inhalers; Digital health technologies; Software as a medical device; Regulatory consideration; Quality by design