Lessons Learned and Challenges Ahead in the Translation of Implantable Microscale Sensors and Actuators

Annu Rev Biomed Eng. 2025 May;27(1):211-233. doi: 10.1146/annurev-bioeng-110122-121128. Epub 2025 Feb 6.

Abstract

Microscale sensors and actuators have been widely explored by the scientific community to augment the functionality of conventional medical implants. However, despite the many innovative concepts proposed, a negligible fraction has successfully made the leap from concept to clinical translation. This shortfall is primarily due to the considerable disparity between academic research prototypes and market-ready products. As such, it is critically important to examine the lessons learned in successful commercialization efforts to inform early-stage translational research efforts. Here, we review the regulatory prerequisites for market approval and provide a comprehensive analysis of commercially available microimplants from a device design perspective. Our objective is to illuminate both the technological advances underlying successfully commercialized devices and the key takeaways from the commercialization process, thereby facilitating a smoother pathway from academic research to clinical impact.

Keywords: biosensor; drug delivery system; implantable microdevice; microcatheter; microstent; neural interface; translational research.

Publication types

  • Review

MeSH terms

  • Biomedical Engineering
  • Biosensing Techniques* / instrumentation
  • Device Approval
  • Equipment Design
  • Humans
  • Microtechnology* / instrumentation
  • Prostheses and Implants*
  • Translational Research, Biomedical*