Here are five of Mr. Major and Mr. Neely's expectation for the minimally invasive spine market.
1. Number of cases will increase. Minimally invasive procedures are on the rise worldwide, Mr. Major says. Additionally, the aging patient population continues to grow, contributing to the global demand for spine surgeries. The demand for minimally invasive procedures will increase because patients like the promise of shorter hospital stays and faster recovery times.
"The aging patient population is demanding more products to treat spinal pathology," he says. "Because of the increase in volume across the board, we need more spinal technologies and a real commitment from top spine companies for outcomes based on research."
While minimally invasive spine has become a popular buzz word, the definition of minimally invasive remains up for debate. Mr. Major says researchers and surgeons alike should be able to agree that minimally invasive means less disruption of soft tissues and minimized blood loss, even if the margins are not definitive.
His company is largely focusing on developing minimally invasive tools, and he's confident the research will back up the investment many surgeons are making.
"I believe we'll be able to show through clinical research a good indication for minimally invasive procedures," he says. "We will see the trend of more and more pathologies treated through a minimally invasive approach."
2. More approaches will be enabled. More spine devices will be entering the market to give surgeons utmost flexibility in treating patients. K2M strives to give surgeons the broadest perspective in the operating room, something that has been a drawback for minimally invasive technology in the past.
The lateral approach to spine surgery has gained popularity, but Mr. Major says spine device producers will be developing devices for a myriad approaches and solutions to accommodate surgeons. He expects to see diagnoses driving procedures rather than devices.
"Each surgeon treats pathology differently, depending on the condition of the patient," he says. "Companies need to have a broad minimally invasive portfolio and need to provide an offering for multiple approaches. They need to give physicians enough options so that the pathology will drive the approach or technology they use."
However, expect lateral devices to stick around. Lateral procedures have reached a point in which surgeons can now know what patients and pathologies will work best for the technique.
3. More procedures will move to ASCs. Federal healthcare reform is putting pressure on healthcare systems to find less expensive ways of rendering services. Ambulatory surgery centers have proven to be more cost-effective atmospheres for certain surgical procedures, and more minimally invasive spine procedures will move into ASCs for both economical and clinical reasons, Mr. Neely says.
"In ASCs you have all the incentives correctly aligned," he says. "Surgeons are incented to use less invasive approaches and not over-instrument a patient for prospective reimbursements. The ASC model incentivizes surgeons to use the least invasive methods possible, while still achieving good long-term clinical results for the patient. This is economically beneficial to the patient, the payor and the surgeon."
Mr. Neely predicts lumbar fusions will move to ASCs in the near future, similar to the transition seen in total joint procedure migration to ASCs. His company has technology to make lumbar fusions feasible for surgery centers. Currently, lumbar fusions can be risky, invasive procedures with a great risk of complications, especially in an outpatient setting. While ASCs were quick to adopt simpler procedures such as discectomies or decompressions, surgeons in the past were skeptical of adopting fusion surgeries.
Minimally invasive biologics may also be moving into ASCs. New technologies are close to commercialization, Mr. Neely says, which will open up more types of outpatient procedures. These procedures include injectable non-instrumented intervention and disc injections, including stem cells and biologic products.
4. Standalone technology will become more prevalent. As technology and innovation in the minimally invasive spine market increase, more standalone devices will be become the standard for some procedures, including lumbar fusion.
Wenzel Spine received FDA clearance for a standalone, expandable, interbody device to give surgeons the ability to perform unilateral TLIF procedures with one device and zero impaction, Mr. Neely says. "We are eliminating the need for pedicle screws, rods and supplemental fixation," he says.
His company is waiting to gain clearance on a similar device for cervical procedures.
Eliminating supplemental supplies can reduce costs for ASCs and provide value to payors, but it can also help patients recover more quickly and eliminate complications. "One of the biggest post-operative complications in cervical procedures is swallowing problems caused by anterior plates and screws [which aren't necessary in standalone procedures]," he says.
5. Some reimbursement rates will increase. Spine became a popular specialty for its high reimbursement rates. Though reimbursement rates may drop as the frequency of procedures rises, both Mr. Neely and Mr. Major expect reimbursement rates for minimally invasive procedures to stay beneficial for healthcare systems.
This higher list price on minimally invasive procedures may drive reimbursements conditionally for some payors, Mr. Major says. New devices and techniques must be cost-effective and yield better outcomes in the short and long term.
"In some cases we will get higher reimbursement rates if we can continue to improve fast recovery time and faster operating room time," he says. Payors will likely share the savings from shorter hospital stays and operating expenses by initially providing higher reimbursement for physician fees to surgeons who perform minimally invasive procedures.
Mr. Neely also expects payors to see an added benefit of minimally invasive spinal procedures being performed in ASCs. "A spine surgeon in an ASC can perform a fusion procedure for 40 percent or less than the cost of an inpatient facility and deliver better clinical outcomes," he says. "When you have that much of a value proposition to deliver to payors, they are always going to stand up and look at that."
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5 Expectations for the Minimally Invasive Spine Market FeaturedWritten by Heather Linder | August 31, 2012
Thus far minimally invasive spinal procedures have promised better results for patients and healthcare providers. Two spine device industry experts take a look at the future of minimally invasive markets and technology. Eric Major is the president and CEO of K2M in Leesburg, Va., and Chad Neely is the CEO of Austin, Texas-based Wenzel Spine.
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