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Simplify to Succeed: Instrument Reduction in the OR

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.”

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