A huge concern for hospitals, surgeons and of course, patients is the potential for infection after a surgical procedure. According to the Centers for Disease Control and Prevention, on any given day, one in 31 hospital patients has at least one healthcare-associated infection. Reusable surgical devices that are inadequately sterilized can pose an infection risk.
Jason Haider, Founder and CEO of Xenco Medical, decided to do something about that. In 2011, he established Xenco with the concept of sterile-packaged, single-use, pre-loaded spinal implantation devices and delivery systems.
“Xenco has been primarily committed to addressing the inefficiencies in both the central sterile processing of hospitals as well as the inefficiencies within the O.R. due to reused improperly sterilized instruments,” Haider said. “I founded Xenco to tackle both the risk of infection due to metal instruments that had complex geometries, which made it cumbersome to properly clean after every procedure, as well as the surgical delays due to improper processing of metal trays.”
The company does not charge for the instrumentation, only for the implant that comes pre-loaded in the instrument. Their manufacturing process and inventory storage enable them to have a lower overhead than traditional companies.
“Once our instruments are made, they’re sterile packaged and have a five-year expiration date,” Haider said. “So we don’t need to constantly go through stats and look for missing or broken instruments, which adds a huge overhead, which then gets translated into the implant cost.”
Xenco’s Case for Single-Use
Aside from reducing the risk of cross-contamination from inadequately sterilized reusable instrumentation, Haider notes that a single-use device saves time by eliminating the sterilization process and is better for the environment by reducing waste like water and chemicals.
“Studies, including some that were done by the University of Chicago as well as the Virginia Mason Medical Center, have found that on average it takes about three and a half hours to sterilize everything you would need for that case,” Haider said. “Considering the average anterior cervical procedure can be done in one and a half hours, you’re losing an entire case by waiting for this process to be completed. And that’s not only a huge revenue loss for the center itself, but it takes a lot out of the day of the surgeon.”
Xenco’s instruments can be disposed of alongside other medical waste or recycled into asphalt thanks to a take-back program the company offers for free. The cost of disposal is less than a dollar per pound, which is less than it costs to sterilize reusable devices with an autoclave process.
|Xenco says having the implants pre-loaded onto the instruments
makes a streamlined surgical procedure.
Moving on from Metal
Surgeons have been dedicated to metal instruments thanks to the strength of materials like titanium and aluminum. Xenco took a material science approach and came up with a composite that is as strong as metal, but is disposable and cost-effective.
Xenco instruments are produced from a composite polymer of nylon plastic and glass fibers, and have unique interfacial bond strengths, allowing the instrument to be resilient during a surgery.
“It can take a huge amount of force and withstand that by transferring the load onto the glass fibers and allowing the instruments to remain durable, just like a metal instrument would,” Haider said. “By having the two working in concert, the surgeon can have the ergonomics that come along with a nylon plastic, but the strength of glass fiber. The glass fibers are embedded in the nylon plastic, and as force is exerted, the force is transferred into those glass fibers so that it doesn’t propagate through the nylon plastic. This can give the surgeon the strength that he needs in the instrument without the weight.”
In terms of the intraoperative efficiency, having the implants pre-loaded onto the instruments allows for a more streamlined surgical procedure. Instead of having the surgeon find the proper implant and thread it onto a metal inserter that has gone through the wear and tear of multiple uses, Xenco instruments come with the implant pre-loaded so that it is perfectly calibrated. The objective is to reduce the risk of error during the procedure and create a more productive operating room.
Manufacturing the Instruments
Xenco instruments are made from a composite polymer and not metal, that allows the company to scale manufacturing and use injection molding instead of traditional machining practices.
“Because it’s injection molded, the cost for us is significantly lower than if it was a machined metal instrument, and that’s what allows us to charge only for the implant and encourage the hospitals to dispose of them afterward,” Haider said.
The sterilization step is done as part of the manufacturing process prior to and during packaging.
Part of the process is done in-house, and Xenco uses contract manufacturers as well. They have a unique supply chain that moves their products through various stages at different companies.
“We oversee every step of that, because it’s such a new process,” Haider said. “It requires leveraging the resources of different specialists to perform tasks like the gamma sterilization, for instance, which we don’t do in-house.”
Keeping it Simple
Xenco’s objective was to not readapt the surgical process.
“What we wanted to do was make sure that our devices function in the same way as metal systems so that once a surgeon has it in his hands, it is incredibly intuitive and there’s no learning curve,” Haider said. “All of the work is done on the back-end, with the manufacturing on our side, but the actual use is just a more efficient version of what surgeons are used to.”
For inventory management convenience, Xenco has introduced vending machines for their instruments in hospitals. These are in a trial phase and have been deployed in two California hospitals, with plans to grow.
“The vending machines that we’ve launched are powerful Wi-Fi enabled systems that include a 42-inch touch screen monitor so that users can not only browse through the available inventory, but watch on-demand tutorials on each product through a virtual assistant that we’ve built into our software,” Haider said.
Xenco implemented real-time monitoring and access to inventory level information to keep the machines stocked. It’s a solution that Haider hopes will be particularly helpful in rural health care facilities that aren’t easy to reach.
The company plans to continue offering solutions for the spine segment, with long-term plans to expand products to other markets.
Images courtesy of Xenco Medical
Heather Tunstall is an ORTHOWORLD Contributing Editor.