University of Michigan professor James Geiger used the FlexDex instrument for the first time in an operation at the University of Michigan Hospital. Image credit: Marcin Szczepanski

ANN ARBOR-In an era of rising healthcare costs, a new $500 surgical instrument developed by the University of Michigan is competing to replace a $2 million robot for certain minimally invasive surgeries.

The first product of UM startup FlexDex Surgical-a simple, ergonomic and intuitive "needle driver" for sutures in the body-has been used for the first time in a series of surgeries. FlexDex has begun to sell its products throughout the United States. The platform is also expected to expand the use of minimally invasive surgery, which allows patients to recover faster.

"This is the culmination of 10 years of hard work, and knowing that the performance of the device fully meets our expectations and affects the lives of patients in a positive way-it is an amazing feeling. We have always seen the potential, but now it has Crystallization," said Jim Geiger, a pediatric surgeon who is the Daniel H. Teitelbaum MD Professor of Surgery at the UM School of Medicine and a pediatric surgeon at the UM CS Mott Children’s Hospital.

FlexDex is a fully mechanical platform that can be installed on the surgeon's arm. It uses a unique engineering method to make the tip of the instrument imitate the direction of movement of the surgeon's hand.

Geiger is the co-founder and co-inventor of FlexDex, and Shorya Awtar, an associate professor of mechanical engineering. Michigan medical surgeons, including Geiger, have used needle drivers in multiple laparoscopic and thoracic surgeries. Going forward, FlexDex technology will be used for a long list of surgeries, including hernia repair, hysterectomy and prostatectomy in UM and other regions.

Minimally invasive surgery is much less traumatic than traditional open surgery. The surgeon will make a smaller incision. They use laparoscopic cameras to observe the inside of the body and use specialized, smaller instruments to perform operations. The patient recovers faster and heals less damage. But the instruments available to surgeons are either cumbersome or expensive, or both.

"FlexDex provides robotic functions at the cost of traditional handheld laparoscopic instruments. We break the paradigm where surgeons and hospitals must choose between high cost/high functionality and low cost/low functionality," Awtar said. "Our mission is to democratize minimally invasive surgery and expand its use in the United States and around the world."

The technology was originally a basic research funded by the National Science Foundation in Awtar Laboratory. The team and others founded the company in 2014. They see their platform as a breakthrough in surgery and engineering. The fully mechanical system of FlexDex is equivalent to remote control without electronic equipment.

"It's a bit like the transition from a mainframe computer to a smartphone. You hardly need a manual to use it. It's very intuitive," Awtar said.

For example, to perform internal sutures, surgeons can choose old-fashioned straight rod instruments that can make complex tasks such as sutures and knots ergonomically difficult to learn, Geiger said. Or they can use the high-tech Da Vinci surgical system, which is a robot-assisted method, which is not available in all hospitals due to cost reasons. Learning how to use robotic assist systems requires a lot of training.

Technically speaking, the design of FlexDex is very simple. This is all mechanical, not electronic. One of its key innovations is the instrument's patented "virtual center", which positions the device's center of rotation at the same point as the surgeon's wrist.

Geiger demonstrated: "If I move my hand up, the tip of the device will rise. Wherever my hand moves, the tip of the instrument will move with it." There is no other instrument on the market that can operate like this.

FlexDex co-founders (from left), Shorya Awtar, Greg Bowles and James Geiger. Image credit: Marcin Szczepanski

Researchers say the origin story of FlexDex is a testament to the power of the university environment to bring basic research from the laboratory bench to the bedside. When Awtar met Da Vinci Surgical Systems at a healthcare conference, he found a job in industry.

"I was surprised by the complexity of this technology," he said. "At the same time, I have a strong intuition that this function can be implemented more simply and economically. In terms of its price, this technology cannot cover patients worldwide."

After joining UM in 2007, Awtar established contact with Geiger, who was always looking for a solution to the same problem.

FlexDex plans to release more tools for its platform in the coming year. It has raised nearly $10 million through SBIR grants from the National Science Foundation and Series A and B private investments. UM owns equity in FlexDex Inc., and founders and universities can obtain financial benefits from the sale and use of FlexDex products.

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