Biomedical Translation Potential of Shape‐Memory Polymers: Design Considerations, Emerging Applications and Challenges

ABSTRACT Shape memory polymers have emerged as promising smart materials for biomedical applications owing to their ability to undergo shape changes in response to external stimuli. The significant deformations, wide temperature ranges, and minimally invasive techniques render them appealing for various biomedical applications. However, despite the accelerating pace of academic advancement and the numerous patents granted, a gap persists in translating laboratory findings into clinical applications. This work adopts a holistic, translation‐oriented approach rather than offering a general overview of the field. Accordingly, the review begins with a benchmarking comparison of SMP‐based devices with conventional clinical technologies, followed by the identification of clinically relevant SMP architectures and key design considerations for biomedical implementation. It then highlights emerging biomedical applications across different therapeutic areas, integrating representative case studies. A stimulus‐responsive perspective (thermal, water, pH, light, and enzyme) is used to compare material composition, mechanisms involved, fabrication strategies, functional performance, outcomes, and limitations, thereby strengthening translational understanding. While thermally activated SMPs currently dominate prototype research, future progress should prioritize multi‐stimuli SMPs. Finally, it outlines major challenges limiting clinical adoption and emphasizes the need for improved durability, standardized validation, and rigorous clinical evaluation to enable reliable translation of SMP technologies into practical biomedical devices.