Experts in the orthopedic industry say the perfect “migration storm” is well underway for joint replacement surgeries, as the procedures move away from being performed at hospitals and increasingly at ambulatory surgery centers (ASCs), in which patients go home the same day as surgery. However, one speed bump in the migration has been adapting the complex logistics of getting the highly specialized surgical instruments to ASCs, rather than hospitals. Warsaw-based startup RAZOR Medical Instruments believes it has solved the problem for hip replacements, and a recent dose of $2 million in funding could open the door to knee and shoulder procedures too.
One challenge in the migration of joint replacement surgeries to ASCs has been how surgical instruments are traditionally handled. Typically, the instruments—designed specially for the particular joint that’s being replaced—are reused, because they’re so expensive. After each surgery, the hospital staff must reprocess the instruments, which involves cleaning and sterilizing them before the next surgery. They arrive ready for the next surgery in a sterilization tray, about the size of a small suitcase.
RAZOR President Bruce Khalili says it costs about $1,000 to reprocess a single case. The instruments are also sometimes misplaced, damaged or not properly clean when they’re delivered to the operating room (OR).
“ASCs are significantly more efficient than the hospital OR; many patients and surgeons now prefer ASCs, as the patient typically goes home the same day,” says Khalili. “But they lack the reprocessing and storage capacity of the hospital.”
After four years of development, 16 iterations of prototypes and more than 40 cadaver labs with 80 different surgeons, RAZOR believes it perfected its first product to hit the market: the Single-Use Acetabular Reamer for hip replacement surgery. As evident in its name, the instrument is designed to be used once, then tossed. The method eliminates the reprocessing time and cost, as well as the need to store the cases.
“RAZOR develops instruments that are precisely clean and sterile upon delivery,” says Khalili. “This also eliminates the potential of carrying contamination from one surgery to the next, therefore, the chance of infection after surgery should go down.”
Khalili says it was an easy decision to start with acetabular reamers, because they’re “the instruments that surgeons complain about the most.” RAZOR says more than 80 orthopedic surgeons are now using the startup’s Single-Use Acetabular Reamer, which was introduced to the clinic in December 2020. In addition to cost savings, Khalili believes the single-use instrument puts a superior tool in surgeons’ hands. The hip is a ball and socket joint; the Acetabular Reamer is used to cut the hemispherical shape in the hip socket to accept the ball-shaped implant.
“So the instrument must be very accurate while being very sharp. Traditional reamers, however, get dull as they are used multiple times over several surgeries. All reamers, because they’re worn, lose their accuracy,” says Khalili. “RAZOR reamers are delivered sharp, accurate, clean and sterile for every surgery.”
The startup has developed a great amount of momentum in a short period of time. In addition to relocating its headquarters from New Hampshire to Indiana’s Orthopedic Capital of the World early this year, the company recently raised $2 million in a round of Series A funding, which included participation from Indiana-based Elevate Ventures. As part of the limited launch of the Acetabular Reamer, RAZOR says it’s already working with five original equipment manufacturers that comprise the majority of the U.S. market share, and the funding will help expand the commercial launch. Using the knowledge gained developing its first product, RAZOR plans to develop other single-use instruments for hip, knee and shoulder replacements.
Khalili says in the past decade, the manufacturing of single-use instrumentation has been mostly in Europe, but “RAZOR plans to bring those jobs to Indiana.”
“Over my career as an engineer, I have faced many a time when manufacturing was off-shored; I saw the pain and suffering this caused my friends and their families,” says Khalili. “RAZOR intends to perfect the art of single-use instrumentation and make Indiana the single-use surgical instrument capital of the world.”
Khalili says single-use instruments reduce the overall cost of care, because reusable instruments are one of the biggest expenses for hospitals, ASCs and original equipment manufacturers.
Khalili says single-use instruments help prevent infections by eliminating the potential of carrying contamination from one surgery to the next.