Copy to clipboard 
Zorica Buser, Ph.D., started her talk at the Annual Meeting of the North American Spine Society (NASS) with an important disclosure: “I believe that orthobiologics matter.” Perhaps the comment shouldn’t have been surprising coming from a researcher focused on osteobiologics and regenerative orthobiologics. However, it was still an interesting statement, considering the title of her talk was “Advanced Technology Obviates the Need for Biologics.”
Dr. Buser is Director of Research and Director of Regenerative Medicine (Spine Restoration) at Gerling Institute and a Research Assistant in the Department of Orthopedic Surgery at New York University. She’s an active member of multiple societies and serves as co-chair of the NASS Section on Biologics and & Basic Research.
There has long been debate about the role biologics play in a successful spinal fusion. The challenging reimbursement landscape and the advent of additive manufacturing have placed a greater emphasis on spine implants in recent years. But the conversation should not be one of cages versus biologics, Dr. Buser said. Both are needed, and both require further research to advance technology and decisions around their use.
“Bone is a living tissue. It’s not enough to put in a static implant that doesn’t respond to bone remodeling,” she said. “I agree that implants are needed for mechanical support. We’ve made changes to the implant topography and pore size, and that’s helping, but we still need a biological stimulus. That’s why I believe it’s not one versus the other.”
I took away from your talk that while we need advancements in implants and biologics, there is a lack of understanding of the entire product landscape. Was that your message?
Dr. Buser: Yes. We need advancements, but we also need simplification. The spine market has an extensive portfolio of implants and biologics — so much so that it’s confusing. We need to simplify products into groups so that if a particular patient is in a specific risk group, we know that a certain type of product is likely to work for them. Within the AOSpine Knowledge Forum Degenerative, we are working on initiatives to champion that type of work.
While we need advancements, we also need education for the different stakeholders, including patients, clinical team members, researchers, regulators and even hospital administration. When they get bombarded with seven different cages that look the same but have different names, it’s hard to justify the need.
There are hundreds of spine and biologics companies selling products today. How are surgeons and hospitals making sense of the growing number of options? What role should industry play in educating these stakeholders?
Dr. Buser: Evidence is the top priority. We must find a way to communicate evidence in a simple, universal language so that hospital administrators, first-year residents, spine fellows, scientists, surgeons and regulators understand the science behind a product. That effort calls for more collaboration between industry and academia.
Products currently on the market address a fundamental problem in spine care. Low back pain is a leading cause of disability worldwide, and we need to solve it. When a new osteobiologic for spine fusion is introduced, though, we don’t necessarily understand how it fits within the current market and regulatory space, or how it will move the needle. The reason that we have so many spine companies is that everyone is trying to improve upon something that already exists.
We sometimes lack innovation because we’re emphasizing quantity over quality. We need to ask the right questions to identify the clinical need and cost-benefit of new products.
What additional technology focus would you like to see moving forward?
Dr. Buser: I believe that biologics are the first step toward a successful fusion. We need good biologics, preferably patient-specific ones. We need to adjust our advancements to head in the direction of personalized medicine to be successful.
What type of technology would be an absolute game changer for the spine space?
Dr. Buser: There are a lot of good candidates. Two areas excite me.
Disc degeneration is an untapped market. We know that not every patient needs spine fusion. I don’t know if we can regenerate the disc, but I do think we can help restore or pause degeneration.
I also believe imaging tools are important and will advance with the integration of artificial intelligence. Our institute is starting to use tools that help standardize imaging parameters which can help us optimize pre-surgical patient treatment instead of leaning on manual assessment of imaging.
We need to engage patients and help them understand their journey of care. Patients read a lot. However, they can be misguided by the many products on the spine market that are written about in white papers and touted with great marketing language, but lack enough clinical evidence.
You mentioned smart implants during your talk. What role will they play in the future of spine care?
Dr. Buser: Innovation in the spine device space is ready for the next step: personalized medicine. A smart spine implant can sense changes in bone stiffness or stages of bone remodeling and, hopefully, help the surrounding tissue to adjust and promote successful fusion in real time.
Robust timelines are set to review patients’ fusions at six months and one year. It’s somewhat theoretical, because each patient’s body responds differently to an implant. The fusion response is different based on the patient’s comorbidities. An implant that can stimulate the surrounding cells and hold graft materials, could offer excellent synchronization.
I understand that NASS is focused on working with industry on innovation. What does that work entail?
Dr. Buser: The society has started a new section on innovation and technology. We hope to bring together different stakeholders in the spine and orthopedic field to sit down, look at trends, understand where innovation is headed and come up with ideas on ways we can excel. The section has just launched — we will be forming faculty and organizing sessions soon.
NASS is a diverse community with a lot of stakeholder voices. We need a section that brings everyone together to focus on the problems and collaborate to find solutions.
