Reusing metal instruments could be draining hospitals of both time and resources, argues Jason Haider. To address what he calls an “antiquated medical device supply chain,” he founded Xenco Medical to offer surgical instruments and implants packaged together in sterile, single-use systems. Packaging is key to the company’s strategy.
“As the inefficiencies of reused metal devices have necessitated repeated sterilization and the cumbersome transport of heavy metal trays after each surgery, both hospitals and outpatient surgery centers have had to compromise on the cost effectiveness of their care,” he tells PMP News.
Haider estimates that sterilizing and transporting such reusables after each operation requires a minimum of 3.5 hours to complete. “With the sterilization costs alone approaching $1000 for each surgery, the lost surgical time due to the unavailability of instrument and implant sets is particularly costly to small facilities with limited resources and patient volumes such as outpatient surgery centers,” he says.
With Xenco Medical’s solution, he calculates that disposing the single-use surgical instruments could range “from 9 cents to 71 cents, and the savings from sterilization alone averages from $850 to $950 dollars per case.”
He describes Xenco Medical’s single-use systems as “the first composite-polymer systems of their kind. Because of the unique nature of both the interfacial bond and the orientation of the components inside the composite polymer of Xenco's instruments, they are capable of withstanding very high loads without any deformations forming in the fiber-matrix interface. Because of these material properties, the instruments have the same appearance, handling, and performance as metal instruments without the associated inefficiencies, deterioration, and risk of patient-to-patient pathogen transfer.”
Above: Xenco Medical's pedicle screw system
When asked how the total cost of ownership compares with that of implants and reusable metal instruments, Haider says that “because Xenco Medical’s products exist within a new manufacturing paradigm, the cost of ownership of Xenco Medical’s products is dramatically lower than that of reusable metal instruments and their corresponding implants. Using a specific injection molding process, Xenco Medical’s instruments allow for inexpensive scaling, eliminating the need to invest exorbitant sums of money to manufacture and inevitably repair metal sets of instruments.”
To help surgeons select the appropriate supplies, Haider says that single-use size trial kits enable surgeons to assess the size of implant needed. “The instrument footprints in these packages of trials and rasps correspond to the implant footprints. Each height trial or rasp tip is inserted sequentially into the intervertebral space until the desired fit is achieved.”
Once the right size is determined, the surgical team identifies the corresponding Xenco Medical interbody device size for implantation and opens a single package containing the right supplies, Haider says.
“The implants are pre-loaded to their insertion devices, so there is no need to load them to any instrumentation. The insertion device is discarded after implantation,” he says.
Instruments and implants are grouped in packages according to size and the instruments typically needed for standard spinal, cervical, lumbar, and other surgical procedures. “The contents of every package are assembled to make the procedure as intuitive as possible and based on standard spinal procedures,” he says. “Each interbody implant package has an implant pre-attached to a corresponding inserter, so that a surgeon simply needs to insert the spinal implant into the intervertebral space and then turn the handle to release the interbody. For complex systems such as our pedicle screw system, we have packaged a streamlined, single-use system of every essential tool required. Our pedicle screws are sterile packaged separately to allow for variability.”
If additional instruments are needed during a procedure, “the surgeon’s support staff simply opens the additional instruments required from their package, regardless if it was planned going into the operation,” he adds.
To ease inventory concerns for hospitals, Xenco Medical stocks several weeks’ worth of inventory for surgeries and replenishes items immediately after each case. “This allows for surgery-ready systems, which has been important for trauma, he says. “In the case that a hospital does not have room for any inventory, we have a mobile application called TraumaGPS that allows surgeons to request any Xenco Medical inventory they need delivered by their dedicated sales representative with real-time ETA and GPS tracking,” he says.
Double sterile barriers are employed. “The instruments and implants are housed in PETG trays that are heat-sealed with Tyvek lids,” he says. “PETG/Tyvek have been used for sterile-packaging medical devices for many years, and this combination provides for a robust sterile barrier that is capable of withstanding a multitude of package weights and configurations. Both Tyvek and PETG are also resistant to gamma irradiation used in the sterilization process and have excellent biocompatibility properties.”
Xenco Medical’s PETG trays are designed to be ergonomic, Haider says. “The outer lid can be easily removed from the outer tray by OR personnel. The inner tray can then be dumped onto the sterile field. A scrubbed person will then open the inner package,” he says. The packages are also designed “to have a product presentation consistent with other products normally handled in the operating room, so personnel are easily instructed by our brochures or salesforce.”
All Xenco Medical packages containing either or both instruments and implants are marked with UDI. “Our implantable devices inside the sterile packages are marked with both part numbers and lot numbers,” he says.
PMP News asked how the solution would satisfy hospital systems looking to improve their sustainability programs, environmental footprint, and/or reduce waste. “Xenco Medical has leveraged materials science to manufacture lightweight yet remarkably durable instruments that have a smaller carbon footprint than heavy metal instruments, which are not only ecologically costly to manufacture but environmentally demanding to maintain,” Haider says.
For example, “through its Water Sense Initiative, the EPA has specifically noted that water waste at hospitals accounts for 7 percent of the total commercial water consumption of the nation,” he continued. “In addition to that, the agency has listed medical process rinses among the most water-demanding. Taking note of this, the EPA has made efforts to help hospitals curb their water consumption. Each steam sterilization cycle requires an average of 300 to 400 gallons of water, and every complex surgery with reusable instruments requires several of these cycles. Water waste is only one component of a cycle that involves the release of detergents and electricity-intensive operations. The ecological impact of maintaining reusable systems aside, their energy-demanding manufacturing process and their deterioration have a significant environmental impact.” He also points to a study published in January of this year in the Journal of Endourology found that single-use urological instruments had a carbon footprint of 4.43kg of CO2 per surgery while reusable urological instruments had a carbon footprint of 4.47kg of CO2 per surgery.
Above: Jason Haider, founder and CEO of Xenco Medical. Photo by Grace Miller.
Haider says that after being “extremely encouraged by the overwhelming response our implant systems have received from surgeons and healthcare facilities across the country,” the company is planning future launches. “Though I can’t reveal too much, we will be announcing a launch early this summer,” he says. “This will be a breakthrough interbody implant, which could easily have an entire following on its own. In addition to that, we have been developing logistics-based technologies that will further amplify the impact our systems have in streamlining inventory management at hospitals and outpatient surgery centers.”