On a recent visit to Michigan, we stopped by the offices of FlexDex, makers of a really innovative instrument platform for minimally invasive surgical tools. The FlexDex system is designed to overcome the limitations of traditional laparoscopic devices that rely on triggers, buttons, and knobs, but may even end up competing with immensely more expensive robotic surgical systems such as DaVinci. We were intrigued by what we saw in the firm’s short video released a few months ago that gave a quick peek at how the technology works. But technologies that promise to improve the ergonomics and intuitiveness of existing tools need to be tried to really understand their benefits, so that was why we had to make a visit.
Anyone who has tried using laparoscopic tools knows how clunky they can be, requiring years of specialized training before surgeons can attain proficiency. Intuitive, easy to use controls is partially why robotic surgical systems have become so popular, but they cost millions, require lots of effort to setup and maintain, and are not beneficial in a host of situations.
The FlexDex system is purely mechanical and relies on a few brilliant ideas developed in good part by Shorya Awtar and colleagues at the Precision Systems Design Lab of University of Michigan’s Department of Mechanical Engineering. We’ve seen pretty cool tools that can flex in unusual ways at TU Delft in The Netherlands, but achieving intuitive control has remained a critical challenge. A major technological achievement within the FlexDex is the idea of a “virtual center,” a way of transferring the motion of the wrist to the same motion of the instrument at the tip of a shaft. Additionally, an unusual “three-axis gimbal” that connects to a click-on wrist band and an “infinity handle” provide remarkable ergonomics and efficiency of motion control at the distal end. This technology was spun out as a start-up, FlexDex Surgical, along with co-founders and co-inventors Dr. James Geiger and med-device entrepreneur Greg Bowles.
Rotating the infinity handle spins the tool the same amount of degrees, and flexion is achieved by simply bending the wrist. This is impressively intuitive and really does feel like one’s hand movements are transmitted to the tool. A wide squeezable trigger on the handle activates the tools, such as opening and closing a gripper.
This performance was made possible by the company’s R&D engineers Deepak Sharma, James Licht, and Zach Zimmerman. While the articulating end-effector faithfully follows the surgeon’s wrist, the only aspect requiring getting used to is that the tool shaft moves opposite to the forearm, which laparoscopic surgeons are already accustomed to.
Spending a few minutes with a lap-trainer and peg board you realize just how little effort is required to use the FlexDex. The motion is soft and fluid, and there’s no clicking or other usual noises produced by the mechanism inside. One can reach down or up, so one can work quite extensively within the abdomen without having to take uncomfortable arm positions. Interestingly, any tremor of the hands as you use the device doesn’t translate into jerking motion of the tool at the end of the shaft. We didn’t think we’d ever be able to say this about a purely mechanical laparoscopic instrument.
We were still trying the final prototypes and the final product is supposed to turn out looking even more finished than what we were using, but it already felt like a ready to use device. The technology has the capability to integrate a way of adjusting how much motion is translated to the distal tool, so for more delicate work one would be able to turn down some sort of controller and have the tool respond more gently.
It takes just a few minutes to instruct someone on how the device works and after just a bit of practice it starts to feel like second nature. Having tried using conventional laparoscopic tools in the past with discouraging results, in our eyes the FlexDex has set itself far apart from the competition. It provides the agility, strength, and intuitive operation that’s completely unlike anything else.
To ease any doubts, take a look at this video of a novice suturing on a practice board after just a short training:
The company is planning to launch the product this August and has hired a properly ISO certified manufacturer to make the first product line.
Initially the FlexDex will be a fully disposable device, but the company expects to soon release a reusable version. Being a completely mechanical tool, under FDA classifications it’s just a Class I medical device like a pair of surgical scissors. As FDA’s recent denial of a 510(k) clearance to TransEnterix has shown, surgical robotics still has to meticulously prove itself to the regulators.
All this means is that the FlexDex is coming to an OR near you and we believe that it may dominate the industry surprisingly fast.