Composites boost safety, efficiency in surgical suite

Surgical instruments made from fiber-reinforced nylon by Xenco Medical LLC are being used for spinal procedures as a way to improve efficiency for medical facilities and safety for patients.

Founded in 2011, Xenco developed a single-use composite instrument that is lightweight and has the structural integrity to withstand all the forces and angles wielded by surgeons.

Xenco then attaches an implant device, often made of PEEK or titanium, to each instrument. The implants consist of interbodies, screws and plates that can be used in most cervical and lumbar procedures to stabilize the spinal construct.

There isn't another company like San Diego-based Xenco in the plastics industry, CEO Jason Haider said in a phone interview.

"We're the first to offer the instruments with our implants attached as a single solution. We see ourselves competing with the traditional implant companies," Haider said of companies like Stryker, Medtronic and Zimmer-Bionet.

After surgery, Xenco instruments can be disposed of with other medical waste at a cost of about 9-72 cents per pound or recycled into asphalt through a free Xenco takeback program. Either ​ option costs less than current autoclave processes for sterilizing reusable instruments, Haider said, pointing to the water-intensive and time-consuming steps involved that don't guarantee removal of all contaminants.

Xenco says it takes 300-400 gallons of water and three and a half hours on average to sterilize and repack a tray of surgical instruments, which are typically made of steel and aluminum, for a spinal procedure. Haider puts the sterilization cost at almost $1,000 for each complex tray and says this expense could be eliminated with single-use instruments.

After sterilization of reusable instruments, only about 30 percent packed onto the next surgical tray are likely to be used by the doctor, but all will need to be cleaned again. Eliminating the sterilization and repacking costs for 70 percent of instruments could save a hospital up to $2.8 million, Haider said, pointing to a 2015 study about how a lean 5S approach to operating rooms can improve quality and efficiency of instrument availability.

Haider also looks at the financial implications of reusable instruments compared to surgery-ready systems in terms of patient volumes.

"Some spinal procedures only take two hours total so they miss an entire procedure waiting to sterilize everything," he said.

Then, there's the issue of infections linked to contaminated surgical instruments. Hospitals don't have to disclose this data, but problems sometimes become public. In 2015, Seattle Children's Hospital announced that as many as 12,000 young patients treated at its surgery center since 2010 may have had contact with instruments contaminated with blood and bone due to improper washing. The hospital offered free testing for diseases, including HIV and hepatitis C.

Reusable instruments can also deteriorate from repeated cycles of steam sterilization. Mineral deposits can alter surface properties and hamper precision, Haider said.

"With our instrument, because they're used only once, they're going into the surgeon's hands at peak condition and peak calibration so that when they turn it, they know it's accurate. That's been a big selling point for surgeons," Haider said.

Xenco uses several U.S. contract manufacturers and vendors to produce the instruments and implants and then sterilize, package and label them. The instruments offer the same appearance, handling and performance as its metal counterparts but without the inefficiencies, deterioration and risk of patient-to-patient pathogen transfer, Haider said.

The injection molded instruments cost less than 1 percent of traditional steel and aluminum instruments, Haider added. Xenco gives them away and charges only for the implants, which are competitively priced, he said, noting the company doesn't need a big sales force or maintenance department for the product line.

"By leveraging materials science and gamma sterilization, we've been able to build a single-use model that eliminates the high overhead costs associated with the maintenance and tracking of aging metal instruments," Haider said. "Because of this, Xenco Medical has been able to provide its PEEK and titanium implants to hospitals at lower costs than all of its competitors."

Xenco launched its product line in 2015. A doctor at the UCLA Spine Center in Santa Monica, Calif., used the first disposable plastic instrument with an implant for an anterior cervical discectomy and fusion surgery. Xenco products are now used at medical facilities in 17 states, including teaching institutions like UCLA, large health systems and small surgery centers.

The company receives most orders from distribution partners, but it does have a mobile app, which also tracks shipments.

"We have found the app to be very popular, especially at hospitals with high volumes of trauma cases," Haider said. "The app allows both the surgeon and hospital staff to approximate the arrival of Xenco Medical's ready-to-use instruments and implants and prepare the patient accordingly. We've found that it's impactful in streamlining care."

Packed with a double sterile barrier, the instruments and implants come on PETG trays heat-sealed with Tyvek lids. When the right size is identified, a scrubbed person opens the inner tray with the right supplies.

Xenco invested a lot into research and development to get to this point, Haider said. He credits the composite material's fiber orientation, length and interfacial bond strength with creating durable Xenco instruments.

"Using a combination of aligned and randomly oriented fibers, the material components complement each other to form a cohesive structure," Haider said. "The unique interfacial bond strength allows for a robust interaction between a matrix phase of semicrystalline nylon, with its high impact strength and low internal tension, and a dispersed phase of uniquely oriented fibers that produces a remarkable strength-to-weight ratio. As the surgeon exerts force on the instrument during surgery, the high interfacial bonding is important in transmitting the stress from the matrix phase to the dispersed phase, which maximizes the instrument's overall strength."

Xenco calls this "SET X" technology. Haider said the letters in SET represent safety, efficiency and traceability.

The benefits of surgery-ready implant systems meet goals for delivering streamlined, efficient health care, Haider said.

"The larger medical centers have found a need for this, especially in cases of trauma and to lower infection rates, while the community hospitals and surgery centers found they can boost their turn-over rates," Haider said. "They have chosen us over other companies because they can do more surgeries every week."

Xenco has been focused on spinal surgeries to date. Haider said the product line is fairly comprehensive and Xenco is looking to grow in other areas.

"We did find the greatest inefficiency in spine surgery," he said. "We want to transform that market and we've been really encouraged by it, but I do see us expanding to other orthopaedic specialties after this."