3D printed drug delivery devices: recent promises and challenges

INTRODUCTION: 3D printing (3DP) has gained decent pace in the past decade in the pharmaceutical and biomedical fields. The approval of 3D-printed medical devices has gained more attraction than that of 3D-printed drug products. However, concerns related to cost-effectiveness, efficacy, and large-scale manufacturing are still prevalent, thus challenging the mainstream development of 3D-printed drug delivery devices. AREAS COVERED: Drug delivery devices and scaffolds, along with the possibilities involving artificial intelligence (AI), machine learning (ML), and automation, for personalized applications. The regulatory guidelines, as well as a glimpse of drug delivery devices under clinical trials, are discussed. EXPERT OPINION: Although 3DP offers patient-tailored, on-demand products, its clinical adoption is hindered by regulatory barriers, limited standards, and scalability issues. Integrating AI/ML could offer real-time adaptive clinical manufacturing; however, the guidelines for these disruptive technologies are often unclear. With patient-centric manufacturing, 3D-printed devices and scaffolds could play a key role in personalized medicine, delivering targeted and effective therapies.The transition from proof-of-concept to real-world testing underscores the growing feasibility and clinical relevance of 3DP technologies. With rapid progress in bio-responsive materials and AI-driven design tools, 3D-printed delivery platforms are expected to improve in adaptability and therapeutic effectiveness for next-generation personalized therapies.