Lessons Learned and Challenges Ahead in the Translation of Implantable Microscale Sensors and Actuators.
Jae Young Park, Nikolas Barrera, Tianyu Bai, Ellis Meng, Hui Fang, Hyowon Lee
Author Information
Jae Young Park: 1Weldon School of Biomedical Engineering, Purdue University, West Lafayette, Indiana, USA; email: hwlee@purdue.edu.
Nikolas Barrera: 4Alfred E. Mann Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, California, USA; email: ellis.meng@usc.edu.
Tianyu Bai: 5Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire, USA; email: hui.fang@dartmouth.edu.
Ellis Meng: 4Alfred E. Mann Department of Biomedical Engineering, Viterbi School of Engineering, University of Southern California, Los Angeles, California, USA; email: ellis.meng@usc.edu.
Hui Fang: 5Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire, USA; email: hui.fang@dartmouth.edu.
Hyowon Lee: 1Weldon School of Biomedical Engineering, Purdue University, West Lafayette, Indiana, USA; email: hwlee@purdue.edu.
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.
