Integrating the design thinking approach into pharmaceutical product development: emphasizing nanomedicine innovation.

Abstract

Objective: To perform a narrative review that critically examines the application of design thinking (DT) in pharmaceutical product development, with emphasis on its role in advancing nanomedicine innovation and patient-centric drug design.

Significance of review: DT offers a human-centered, iterative alternative to the traditional linear R&D model. Its integration into pharmaceutical development addresses challenges such as high attrition rates, limited patient input, regulatory complexity, and scalability, thereby improving translational success. This review adopts a conceptual and narrative approach, analyzing the five stages of DT, Empathize, Define, Ideate, Prototype, and Test, within the context of pharmaceutical development.

Key findings: The application of DT fosters tangible benefits in pharmaceutical innovation, including empathy-driven product design, targeted problem framing, and iterative prototyping aligned with user and regulatory needs. Case studies such as Doxil^®, ABRAXANE^®, and mRNA-based COVID-19 vaccines illustrate established successes, while emerging examples, including CRISPR-based therapeutics and extracellular vesicle (EV) nanocarriers, underscore the forward-looking potential of this methodology. Together, these examples highlight how DT accelerates development timelines, mitigates risk, and enhances patient and regulatory alignment.

Conclusions: Integrating DT into pharmaceutical product development enhances innovation by fostering interdisciplinary collaboration, reducing costs, and increasing the likelihood of successful translation to market. Its strategic application in nanomedicine provides a transformative pathway for next-generation therapies that are safer, more effective, and aligned with patient expectations and evolving regulatory frameworks.