The Affordable Care Act set quality and cost transparency initiatives in motion, forcing healthcare providers to pay more attention to their outcomes and spending than ever before. The transition is a sharp turn from the past, but ultimately could lead to better care in the future.
The value equation now reaches beyond providers to the rest of the industry, including medical device companies. Orthopedic and spine device companies are now partnering with physicians to develop the clinically significant advances that can also lead the charge in lowering the cost of care.
"When I look at influencing a spinal fusion, the most valuable and important aspect of the spinal fusion is the interbody device," says Paul Slosar, MD, Titan Spine's chief medical officer. "The healthcare environment is pushing doctors to examine their patient outcomes, which are measured both in the short and long term, as well as total cost of care. If this device assists surgeons to move the needle forward, then Titan Spine can help us take the necessary step toward providing more value-based care."
There are some surgeons moving cases to ambulatory surgery centers as a high-quality, low-cost site of care. "There is a shift toward less invasive procedures and pain improvement, with value-based care driving that shift," says Jeff Dunkel, Titan Spine Vice President, Strategic Partnering. "When patients have gone through the normal conservative treatment protocol and are still in debilitating pain, they often choose to undergo surgery, to allow them to return to an improved quality of life as quickly as possible."
A study presented at the International Society for the Advancement of Spine Surgery (ISASS) Annual Meeting in 2015 examined 77 patients who underwent anterior lumbar interbody fusion procedures with the Titan Spine Endoskeleton device. There were 138 spinal segment levels treated and a 100 percent fusion rate between six and 12 months. There was no appreciable subsidence and the radiology interobserver reliability rate was 95 percent.
"We see a clinical benefit earlier than with other implants, and there are fewer downstream spend events in the long term," says Dr. Slosar. "Fewer patients need failed surgery repairs. We don't see costly failed fusion like we do with other implants."
Innovation in medical devices and treatments allow patients to recover more quickly. Minimally invasive procedures, outpatient surgery and higher fusion rates can return patients to work or their daily activities, lowering the overall episode of care. Titan
Spine's proprietary surface technology using nanotechnology is the only spine device with the FDA's nanotechnology designation.
"When you get down to the cellular level, the implant interacts with the cells so you can drive behavior," says Dr. Slosar. "The implant promotes bone formation faster and more directly. Insurance companies and Medicare can identify performance measures objectively, including shorter hospital stays and returning to activity sooner."
The technology is at the forefront of regenerative medicine, promoting the patient’s body to heal itself through bone growth at the fusion site without the risk of debris generation during impaction. The Spine Journal published a study earlier this year comparing titanium-coated PEEK and Titan's implants that were subjected to simulated biomechanical impaction. The researchers found 26 percent of the teeth on the titanium-coated PEEK implants lost coating material — from one to 191 microns — and more than half the particles were less than 10 microns, the size that can lead to phagocytosis.
"Our industry historically has been focused on how fusion occurs on a mechanical basis, but we now know things initially heal on a cellular basis," says Peter Ullrich, MD, CEO of Titan Spine. "If you can increase regeneration at the cellular level immediately following surgery, it can help the patient heal faster. And if the interbody fusion device upregulates the patient’s natural bone growth regenerative mechanisms, you'll achieve faster bone growth and fusion."
Titan is so confident in the technology that they offer a guarantee.
"We put our guarantee in place to share risk with the hospital," says Dr. Ullrich. "We say these devices will fuse the patient's spine, and we stand by that. Hospitals, insurance companies and patients like the guarantee that their implant will work as expected. That's what we should be doing as an industry."
The guarantee promises to replace any implant that needs a revision for free. The guarantee is appealing to hospitals and physicians because it shows the company backs up their product.
Insurance companies are now taking another look at spine technology, including Titan's outcomes. In one dataset examined, patients who had the Titan Spine implants underwent physical therapy 55 days postoperative, compared with 112 days for demographically matched patients that received other spinal implants. Titan patients were also discharged one day sooner following surgery.
"I have seen significant and reliable improvement in my fusion patients in the early post-op timeframe as compared to when I was using different interbody devices,” says Dr. Slosar. “I've been able to achieve a higher percentage of my working patients returning to light duty faster than before and that ultimately benefits the system."
Titan Spine is a small, nimble company with the ability to focus on research and innovation. They aren't responsible to shareholders and are focused on improving patient outcomes. "What we have seen with Titan is the investment in personnel and policy," says Mr. Dunkel. "Other companies are larger and delays are eating away at their R&D budget whereas we invest in the science and the product. If we do that correctly, the finances work out."