Innovative Sterilization Technologies - ONE TRAY®
Redefining Efficiency

If one were to drown out all the noise that surrounds the ancient Japanese martial arts form of “Aikido”, its concept blooms into a philosophy. It’s more cerebral than it is physical, a game of chess, so to speak, where strategy but most importantly, “efficiency” is the operative word. Efficiency allows optimal utilization of the opponent’s momentum by redirecting their strength to your advantage. Akin to the concept of “Aikido” is the philosophy practiced by the folks at Innovative Sterilization Technologies, where converting a looming disadvantage into an advantage is the way to go. All in all, “optimal efficiency” is the operative word at every turn, where ‘Less is More.’

In the field of sterilization of surgical instruments, while timesaving, cost reduction and surgical efficiencies have been a distant dream for hospitals, surgeons and OEMs, Innovative Sterilization Technologies is at the nexus of disrupting the market with the highly efficient filtered vent sterilization containers— ONE TRAY®. “We consider ourselves a small company and function as one from the top-down, utilizing a distributorship model in sales for instance, and ultimately get exactly what we want out to the marketplace in a form that can be understood by the market,” says Scott Cohen, Founder/CEO, Innovative Sterilization Technologies (IST). Simple it may sound, cliché it may seem, but “efficiency” has been the mantra for success as far as Team Cohen is concerned. There is not an ounce of “cliché” however in the stir that Cohen’s small but driven and efficient team has brewed up in the market they operate in.

For over 40 years, surgeons haven’t had a choice but to work with sterilization container technologies that take close to three hours in the sterilization process. Evidently, hospitals had been far from gleaning any value or savings from these conventional methodologies. They didn’t have a choice, until now. Thanks to IST’s ONE TRAY^® Sealed Sterilization Containers, efficiency and lower global sterilization costs have become a tangible reality. Having hitched the wagon of its reputation to the star of efficiency, IST is empowering hospitals with a technology that promises both cost savings along with a more efficient and faster way to process that instrumentation. It stands to reason that over 1,400 hospitals and 400 surgery centers have expressed great confidence in the use of this innovative technology. However, according to Cohen, IST is just getting started.



Enter ONE TRAY^®

As a sterilization container company, IST was born with a singular focus on changing the game for surgical facilities that are experiencing unprecedented demands for cost controls and improved efficiency. While many facilities are wasting money on archaic practices and redundant infrastructure, IST is challenging the orthodoxies by improving the processing of surgical instrumentation and supplies. The surgical facilities can now leverage ONE TRAY^® Sealed Sterilization Containers—sealed containers delivering faster sterilization processing capability of medical devices—to improve the utilization of medical devices and reprocessed supplies. The efficient technology underpinning ONE TRAY^® Sealed Sterilization Containers has been cleared by the FDA with a 4 minute at 270-degree sterilization cycle with no required dry time and a defined shelf life. This is a huge advantage as all the other technologies require a dry time to ensure sterility maintenance. Moreover, ONE TRAY^® Sealed Sterilization Containers can be stored per the facilities procedures.

From the technology standpoint, ONE TRAY^® marks its uniqueness for being cleared with mitigation of the typical dry time in the autoclave. This significantly shortens the sterilization cycle. Used to hold temperature tolerant medical devices during steam sterilization cycles, the patented ONE TRAY® design leverages the thermodynamic behavior of steam to efficiently and expeditiously attain sterility within a sealed container. The number, relative size, and positioning of the filtered vent configuration create a flow pattern that assures the expeditious and complete dispersal of saturated steam throughout the container.

For example, in a day where eight total joints are scheduled, facilities and surgeons are saving time and money. ONE TRAY^® is saving hospitals close to $300 per surgical case, over $2,000 per surgical day by just reducing the number of containers needed to process/reprocess

“Our technology is efficient compared to other sterilization technologies—be it a sterile wrap or competitive containers. All other companies take about two and a half hours for instrument sterilization in the autoclave. On the other hand, our technology requires only about 20 minutes for the same,” extols Cohen

It is important to highlight that ONE TRAY^® is not a catch-all for hospitals. As Cohen summarizes, it is a tremendously better answer for the sterilization of OEM sets, hospital-owned assets, i.e., surgical positioners, high-end specialized instrumentation, retractor sets, and more. ONE TRAY^® is laser-focused on presenting shorter turnaround time for utilizing the same assets more often in a day than investing capital to buy more assets. ONE TRAY^®’s rise to prominence can also be attributed to its ability to reduce the SPD’s/OR’s need for redundant instrument/set/power purchases saving facilities significant monies. It has been adopted by multiple hospitals as a replacement for immediate use steam sterilization (IUSS). “Besides being as fast as IUSS, ONE TRAY^® is a container that can be stored per the facilities procedures. Utilizing our technology, hospitals become more efficient, which paves a better way to turn over the instrumentation facilities have rather than buying more instrumentation,” adds Cohen.

The Next Innings

While ONE TRAY^® has reaped significant results for both IST and its customers, the company is excited about the trajectory of its partnership with K1 Medical’s EZ-TRAX™ solution for internal container configuration, currently focused on total knee and total hip arthroplasty cases. As the number of knee and hip replacements rise rapidly every year, IST is primed to instill efficiency in this field. IST has partnered with an internal K1 Medical and EZ-TRAX™ to organize OEM knee and hip into ONE TRAY^®/EZ-TRAX™ universal sets. Venturing into this realm started with CMS’s nod to outpatient total knee and hip replacements along with the anticipated domino fall of the OEMs. While total joint replacements in Ambulatory Surgery Centers (ASC) are increasing in popularity, Cohen states that 55 percent of all knee and hip replacements in the next five years will be conducted in an outpatient setting. At the forefront of this trend brewing in the industry, IST is all pumped to equip ASCs and hospitals with EZ-TRAX™ for surgical set customization—a patented advanced organization system providing users a customized solution to improve the management of medical devices throughout the entire perioperative process. With necessary attributes for reusable medical device packaging systems, including biocompatibility, chemical resistance, and dimensional stability, EZ-TRAX™ utilizing ONE TRAY^® as the container, the system can reconfigure all of the OEM instrumentation into three trays with three levels. EZ-TRAX™ can take most OEM knee or hip layouts on the market and reconfigure that layout to the 3 container/3 level ONE TRAY®/EZ-TRAX™ System. “IST is the only company that is putting a technology like ONE TRAY® and its efficiency of 20-min processing time, along with a configuration that works for not only the hospital market but also the ASCs,” informs Cohen. “We have been quick to tap into this huge market opportunity for processing knee and hip instrumentation in ASCs as well as in hospital settings. There’s no other offering that caters to the multiple high-volume knees and hip replacement in an ASC.”

While the average number of trays provided by other OEMs range from 5-7 with another 6-11 levels inside these trays, IST has reconfigured the instrumentation to three trays with three levels with an aim to eliminate the time and costs incurred by processing those additional containers. ASCs are now able to process instrumentation within 20 minutes instead of two and a half hours. With EZ-TRAX™ utilizing ONE TRAY^®, IST is not just committed to aligning the sterilization process with the whole continuum of the surgery but also setting up the case for the surgery. “According to our recent study, on the front-side of surgery, there’s a gain of 5-7 minutes by reducing the “hunting and pecking” of instrumentation set up from our EZ-TRAX™ sets over the other OEM sets,” reveals Cohen. The same time savings occur on the back-side, he adds, surgical employees can tear down the case to get to the next case faster, where they garner another 5-7 minutes of time savings by managing fewer cases and trays. “For example, in a day where eight total joints are scheduled, facilities and surgeons are saving up to 80 minutes in that surgical day, which boosts their productivity as they are able to add additional cases or utilize that time in more important ways. We are saving hospitals close to $300 per surgical case, over $2,000 per surgical day by just reducing the number of containers needed to process/reprocess. In a nutshell, it’s all about more output in less time through the same amount of resources,” Cohen informs.



"Our technology is efficient compared to other sterilization technologies—be it a sterile wrap or competitive containers. All other companies take about two and a half hours for instrument sterilization in the autoclave. On the other hand, our technology requires only about 20 minutes for the same"

An important aspect of the sterilization process in ASCs involves cleaning and decontamination of the instrumentation using a big industrial washer that has the capacity to accept about two-thirds of the traditional OEM TJA set and takes about 45 minutes before getting instrumentation ready for assessing and putting back into the sets. “With 11 trays having seven containers, a severe “bottleneck in processing” will occur as SPD professionals are unable to fit just one of those full sets in their small washer. It would take two washer runs of 45 minutes each to complete the cleaning of just one OEM set. With our ONE TRAY^®/EZ-TRAX™ system consisting of just the three individual levels of instrumentation, a facility can process two full EZ-TRAX™ sets in one of the washer cycles. This brings in over 75 percent efficiency to the entire process,” explains Cohen. “Maintaining that continuum of knee and hip surgery, we address the efficiency at every point across a surgery, from processing to the actual surgical case to cleaning and decontamination of the instrumentation, utilizing our universal knee and hip sets.”

All Set to Capture the Market

With its significant time and cost savings, IST has a unique value proposition in place. Now, it is only a matter of penetrating the market. Having started with a vision that “there’s a faster way to manage knee and hip replacements,” the company is rolling out the innovative design features and performance benefits in the market by the end of this month. Cohen and his team are fueled just as much by their passion for the company as they are for the technology that is keeping them at the forefront. The dynamic team of 17 direct employees wearing multiple hats displays a strong culture, continuous innovation, and a passion for the company’s mission to reach a new high in the efficiency levels within the sterilization process.

Cohen remains optimistic on the current climate of the orthopedic market and looks forward to expanding in this realm. These expansion plans involve working with implant manufacturers to help them in the sterile processing domain as well. Cohen also reveals plans of partnering with an off-site sterilization company that would allow managing, cleaning, and inspecting the knee and hip instrumentation at an off-site sterilization facility. “In doing so, we can take charge of putting a box around the processing of orthopedic knee and hip instrumentation and providing solutions for everything, except the surgery,” he concludes.