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For years, surgeons have called for companies to reduce the number of instruments in trays to support more efficient procedures. During his OMTEC 2014 keynote, Robert Bray, M.D. said, “The instrument design—I can’t say this enough—needs to support efficiency of use of the instruments, the least instruments and the easiest to sterilize. That’s what’s going to win,” he said, adding that engineers should stop thinking about what the surgeon wants based on what the surgeon has used in the past.
Instead, Bray urged engineers to educate their customers and create a simpler, quicker surgery option.
Listening to the voice of your customer is an almost-guaranteed way to succeed, and different companies are taking different approaches to responding to their customer’s needs regarding instrument reduction. Companies like Stryker, with its Mako investment, are looking to next generation technology to aid surgeons with intelligent instruments. Others, like Medtronic with its launch of Spine Essentials and acquisition of Responsive Orthopedics, seek to simplify surgical procedures, reducing the cost for providers with fewer instruments and implant sizes.
To get a better understanding of the ways that companies are streamlining their kits, BONEZONE spoke with three OEMs that have launched products designed to capitalize on the shift toward simpler surgeries with fewer instruments.
Premia Spine
In April 2016, the ProMIS Fixation System was introduced to the market. The minimally invasive (MIS) pedicle screw fixation system offers surgeons a choice of screw placement techniques within one instrument kit. Surgeons can select a Skin-to-Screw placement, a reusable Jamshidi Technique, a Tap-Shidi approach or a k-wireless dilator technique. The ProMIS is able to offer all of these techniques while simultaneously reducing the number of instruments and the steps required for successful surgery, due largely to an innovative screw driver equipped with an integrated k-wire and tower for direct screw placement.
“We worked very closely with a German surgeon on the development of the kit,” says Ron Sacher, CEO. “The idea started with the Jamshidi Technique.”
There are about 11 steps in the Jamshidi Technique. One focus for Premia was development of a direct skin-to-screw technique that would eliminate all of the steps associated with the Jamshidi. To do that, the patented screwdriver became crucial. Adding the k-wire and tower to the screw driver meant that all elements of the Jamshidi were being brought to the point of incision in a single instrument. That meant that surgeons could place the pedicle screw without having to swap instruments.
Sacher explained that his company wanted to target a specific type of surgeon with this system.
“We were looking for surgeons who were well versed in MIS procedures and were looking for an advanced MIS system that would allow them to more efficiently get through a procedure,” he says.
Premia was reading the tea leaves in a number of ways when they developed the ProMIS Fixation System. First, they looked at the heightened regulatory scrutiny coming from FDA in the form of UDI. Many spine-focused OEMs feel that the UDI regulation on direct marking will force their segment into offering only sterilized implantables. Second, Premia was seeing the blunt implications of a power shift to payors and providers. Finally, they saw the need for a different type of innovation, one that extends beyond implantable benefits and into patient care and OR efficiency.
“There’s not only a push for instrument reduction in the OR, but also a push toward sterile implants,” Sacher says. “All of that movement is trying to reduce cost from the system. By taking the implants out of the equation, you immediately reduce the size of the kit tremendously.”
Adjusting the number of instruments required for a surgery not only reduces system costs, it also speeds surgery time, creating opportunities for effective use of OR time. That’s a major benefit to the system.
“If we overlay those capabilities with what’s going on in the market—which is, a shift away from hospitals and toward outpatient settings—you start to see the benefit for these types of technologies,” Sacher says. “Patients can be admitted in the morning, undergo advanced MIS spine surgery and go home in the afternoon.”
Sacher adds that from a surgeon perspective, they could be performing four to six surgeries per day while leveraging fewer instruments. That not only drives cost out of the system but potentially creates additional revenue, too.
DJO Surgical
The Exprt Revision Knee was inspired by feedback. Surgeons were complaining to DJO representatives that the knee revision segment had grown overly-complex. Operating inefficiencies abounded, causing an increase in cost components. Kristin Barnebey, Senior Director, Global Marketing of DJO Surgical says that no one had taken a step back and asked whether the process could be simplified.
“As surgeons get more experience doing revision knees, and build upon that competency, they use fewer and fewer instruments,” Barnebey says. “The problem is that companies are still largely providing that erector tray of instruments that typically coincide with revision knee surgery.”
Barnebey says that DJO’s inspiration for the two-tray Exprt system came from surgeons who were already simplifying their own revision knee procedures. OR staff were only bringing in the instruments they would need to use for the procedure, making abundantly clear what the excess instrumentation was.
DJO consulted with surgeons to identify which instruments were necessary and which were, in fact, excess in a revision knee. During the evaluation, erector trays of instruments were set in front of the surgeons. In response, the surgeons were literally plucking instruments from trays and hurling them over their shoulders.
“They knew what they were doing,” Barnebey says. “We wanted to mimic what they were doing; we wanted to capture that efficiency. The average selling price for revision knees is between $13,000 and $15,000; some are as high as $30,000. That’s a significant burden to the system.”
The advent of bundled payments also spurred DJO’s Exprt. Barnebey says that while bundles haven’t impacted revision knees yet, she’s anticipating that payment model will become increasingly common versus fee-for-service.
“Continued price pressure and transparency is being dictated by hospitals. People are taking notice of cost,” she says. “We saw an opportunity with overall pricing. We wanted to reduce our burden on the healthcare system.”
According to Barnebey, the Exprt is 50% to 75% less costly than competitive traditional knees. That said, Exprt will not replace all of its competition. Barnebey readily admits that the system has limited indications.
Previously, DJO did not have a presence in the revision knee space. Some would view that as a disadvantage, but Barnebey says that her company viewed it as an opportunity to approach a problem with a clean slate.
“We were able to really listen to the surgeons when they said that the surgery had become too complex,” she says. “There were inefficiencies everywhere. The sterilization costs alone were quite high. A traditional revision knee set can be eight to ten trays. You have to look at the cost and the impact of all of that.”
DJO wanted to shake up the market and jar loose some of those inefficiencies, making the segment leaner as a whole and less burdensome on the healthcare system. Instead of merely targeting the C-Suite, DJO sought to build a grassroots, surgeon-backed marketing strategy.
“The market has changed so dramatically, and surgeons have changed their employment relationships with providers, so that surgeons now care more deeply about the cost of their implants. They have a vested interest in making a cost difference,” Barnebey says.
As the industry lurches forward, she says that every manufacturer will have to become cognizant of the value-added component of their products and services. The strategy of offering competitive systems with fewer instruments will become more common, she adds.
“Surgeons understand the price component better than they ever have,” says Barnebey. “When you continue to increase instrumentation options, what does that do to the price? Everyone is looking to drive inefficiencies out of their process, especially as we move toward outpatient joint replacement settings.”
United Orthopedic Corporation (UOC) USA
Making surgery simpler is not a new trend. It’s just that companies are paying more heed to the tenets of cost-savings and value-added products as orthopaedics continues to feel the twin pincers of regulatory scrutiny and price pressure. The question of how companies respond to those factors is more prominent.
Patient specific instrumentation (PSI) has been one strategy. The issue with PSI is lead time and, potentially, cost. Calvin Lin, President of United Orthopedic Corporation USA (UOC), notes that PSI requires the patient to receive an MRI or CT scan. He adds that once the order is placed, it can take up to four months for a surgeon to receive the instruments.
UOC isn’t currently pursuing opportunities in PSI at this time. Lin says they have their own system.
“First of all, what we have been focusing on in total knee replacement is reducing the number of trays used during a procedure: most of our competitors use around six or seven trays. Several years ago, we reduced that number to four with our U2™ Knee System, and now with our U2™ Knee All-in-One Block and Modular Disposable Trial, we can achieve the same results with just 1.5 trays.” he says. “By redefining our instruments and using more disposable trials, we were able to significantly reduce our instrumentation.”
A 2012 study found that during each total knee replacement procedure, a tray carrying 363 instruments was provided, while fewer than 50 of those instruments were routinely used. While that doesn’t mean that the instruments are unnecessary, it does raise the question of waste. Lin adds that he has seen reps manually reducing instruments for years, placing only needed instruments into the set. While the set may be heavy, it will also be far more efficient.
Echoing the sentiments of DJO and Premia Spine, Lin says that his company has noticed the increased weight of cost in decision making. He also cited the influence of bundled payments.
As UOC was looking through its portfolio of products, evaluating where it could make improvements, Lin’s team pinpointed the U2 Knee System, which has been on the market for a decade. Over the course of the last ten years, surgeon and distributor feedback was positive. However, the feedback also indicated the need for a new system.
Rather than trying to improve upon an implant that has an approximately 97% success rate, Lin’s team wanted to focus on instruments.
“We’re planning to launch our disposable trays in 3Q16 (as part of the U2 Knee System),” he says. “We want to see how surgeons respond. We think that this is a need, especially because of bundled payments. We believe cost and efficiency will be more important topics and want to take the lead as we move in that direction.”
The revised U2 Knee with fewer instruments works because UOC USA combined a femoral sizer with an AP cutting technique (All-In-One Block). The instrument reduces the surgical procedure by two steps. By wrapping several steps and instruments into one cutting block and utilizing the aforementioned disposable trays, UOC USA removed 156 instruments from the U2 Knee System.
Lin believes that changes in the marketplace will create opportunities for new partnerships between manufacturers and providers. Hospital systems that have longstanding relationships with certain OEMs may be incentivized to locate new, more efficient partners. By reducing trays, UOC USA thinks it can save hospitals money in a bevy of ways, including something as simple as tray processing, which can run as high as $50 to $100 per tray.
Meanwhile, many OEMs are behind the times. Lin says that he still sees companies bringing nine trays to a primary surgery, which he feels may not help the surgeon or the hospital staff save time in the OR.
“Surgeons will always want to do surgeries faster. Time is money. We work very closely with surgeons and OR staff to make sure our systems are easy to use,” Lin says. “It’s surprising how often overlooked simple enhancements to procedures can be – small changes, such as minimizing tray usage, can save hours of time and reduce cost long-term.”
Conclusion
According to research from American Academy of Orthopaedic Surgeons, more than 33% of the Amercian population has a musculoskeletal condition requiring medical attention. As the workload increases for orthopaedic surgeons, there is a greater need for effective surgery sets. Finding a way to reduce the burden that instrumentation can place on the system is a focus for much of the healthcare system.
Combating the cost associated with instrumentation in the OR has been front of mind for several OEMs. Companies like ConforMIS, Conventus, DePuy Synthes, Exactech, Flower Orthopedics and Zimmer Biomet have all recently launched instrument-reducing surgery sets.
Other companies will find alternate ways to reduce the cost of instrumentation. For instance, CrossRoads Extremity Systems launched their EcoSMART Program to combat excess in the OR and to create cost-savings for their customers. Instead of offering disposable instruments, the company is sticking with durables, but purchasing the instruments back from hospitals, reconditioning and repackaging them in new kits.
“By looking deeper, by finding ways to reduce the trays, we can save hospitals time and money,” Lin says. The companies that can respond to the challenges of their customers, and respond with an appropriate instrument reduction, helping their customers’ bottom line, will remain relevant in a pressured marketplace.
Questions about this article? Email Julie Vetalice.
Photo Courtesy of Caltorque Medical Products
