Beacon surgeon, Notre Dame engineer, collaborate on spinal fusion implant to help patients heal faster

Dr. Stephen Smith, Beacon Medical Group North Central Neurosurgery, and Dr. Ryan Roeder, University of Notre Dame engineer and professor.

After two decades of innovative, collaborative work by a Beacon Health System neurosurgeon and a Notre Dame engineer, patients suffering from chronic back pain will now have a promising new option in spinal surgery that leads to faster, more complete healing.

Dr. Stephen Smith, who practices at Beacon Medical Group North Central Neurosurgery, teamed up with University of Notre Dame engineer and professor Dr. Ryan Roeder to develop new technology that advances the science of spine fusion surgery to bring much-needed relief to patients in our community and beyond.

The first clinical case was recently completed by Dr. Smith at Beacon Health System.

Implanting their new FDA-approved medical device was a momentous milestone in the journey of these co-inventors and friends. Dr. Smith is eager to see this new device being used to help patients and proud of the attention this clinical breakthrough brings to an already highly respected neurosurgery program.

“The collaborative effort by Beacon and Notre Dame in generating new technology, more jobs and more growth in the city, that’s pretty cool for a hometown boy to be able to say, to say that I helped contribute a little bit to that and to improve patient care,” Dr. Smith said. “We’re just trying to make this better, and we think we have. If that results in faster healing and better success rates in surgeries, then we won. If it makes a difference in someone’s life, that’s what it’s all about.”

Spinal fusion + spacers = opportunity

When the bones of the spine move out of alignment or begin to break down, it can pinch the spinal cord, leading to pain, numbness or both that affect a person’s strength and ability to move. The source of the problem? Degenerative changes that simply add up as we go through life, and Dr. Smith said being affected is a matter of time, luck and genetics.

The resulting conditions – spinal stenosis, herniated disks and spondylosisthesis, to name a few – can be disabling. Spinal fusion has long been the go-to treatment when less invasive options fail to deliver relief. During this procedure, the surgeon “cleans out” the affected bones of the spine, then inserts a spacer to hold space open for the spinal cord and other nerves. The bones above and below the spacer grow into it to fuse into one solid bone. The faster this happens, the better for the patient.

But not all spacers are built the same. Spacers can be made from several different materials – none of which have been ideal from a surgical perspective.

• Donated bone – Donations are not always available. In addition, the body may absorb or reject the bone, or the donated bone could be fragile.
• Metal spacers – While strong, metal is not as flexible as bone or plastic. In addition, providers have difficulty seeing how well a person is healing after surgery, because the metal spacer blocks the view in X-rays.
• Plastic spacers – Designed to allow bone to grow in and around them, plastic spacers offer more flexibility than metal and more reliability than donated bone. However, the spacer itself is never really incorporated into the bone growth, and patients often get scar tissue around the site.

Dr. Smith, a South Bend native, remembers putting in his first spinal spacer during his first year of residency in 2001 and thinking, “How is this going to work?” He asked the question because the spacer was made of a plastic material that was very different from bone, and he started thinking about a way to make spacer implants better. Dr. Smith started conjuring up ways of making the spacer more porous and easier for the body to recognize as similar to bone.

But he lacked the technical expertise of an engineer to know how this could be done.

Around the same time, Dr. Roeder, an expert in both materials engineering and biomedical engineering who was born in Bremen, and his students, were investigating materials that could better interact with bone. They took a material called polyetheretherketone (PEEK) and experimented with how to make its surface act more like bone.

But Dr. Roeder lacked the clinical knowledge of a neurosurgeon to know how it could be used.

That they met in 2005 while both were in search of answers to the same problem almost seems like fate. The timing was perfect. They quickly began their collaboration, first as part of Notre Dame’s research program, and later independently with their Grand Rapids-based company called HAPPE Spine. They formed the company after not finding anyone interested in their idea at the time.

“We couldn’t find any bigger spine companies to support our research because the message was, ‘We think what we have is good enough,” Dr. Smith said. “Good enough is pretty good, but that’s an enemy of humanity – complacency and good enough. New ideas need to be ahead of their time. If they’re not, they’re not new ideas.”

Rethinking spinal implants

The answer they were both looking for turned out to be in a substance called hydroxyapatite (HA), which is found in natural bones but can also be created in a lab. By impregnating the PEEK plastic with HA, they created a surface that new bone growth could more easily hold onto. At the same time, they redesigned the spacers to be more porous overall.

With the support of a team of researchers, they developed the combined material into a spacer implant and figured out how to make it work in a human body.

“The spacer is still made of PEEK polymer but has porosity and HA, so it’s more biofriendly. So bone can actually grow into it, and the body recognizes it as more real,” Dr. Smith said. “We start getting a lot closer to healing bone.” The new technology means faster bone growth and fusion times – meaning faster and more complete healing for patients.

Fast forward to May 2023, when Dr. Smith and Dr. Roeder reached a major milestone: FDA approval of the implant, which is called the INTEGRATE-C ® Interbody Fusion System. “The FDA clearance represented all the technical challenges we had to overcome,” Dr. Roeder said. “What’s gratifying about working in this kind of area is that at the end of the day, you’re doing something to help people. We’re incredibly fortunate that this has gone where it has.”

After 20 years of research, Dr. Smith and Dr. Roeder have developed a material that can truly be integrated into the human body. “It’s a big win for our community that this all happened here,” Dr. Smith said. “Innovations in medical devices aren’t typically happening in South Bend.”

At Beacon, this groundbreaking technology for spinal fusion implants will be part of a comprehensive approach that includes an entire team, with neurologists, neurosurgeons, rehabilitative therapists, specially trained nurses and additional specialists working together to provide outstanding, innovative care. Beacon’s neurosurgery program offers the highest level of neurological care in the region, with advanced technologies for both the diagnosis and treatment of neurological disorders.

“For me as a doctor, my main concern is that my patients are getting as good care, if not better, as they would get anywhere else,” Dr. Smith said. “I feel it’s our obligation to them. This really is a big deal. This does something other implants don’t – it helps patients heal faster.”

And it was important, especially for Dr. Smith, to have the first patient, the first surgery and the first implant happen right here at Beacon Health System in South Bend.

“South Bend is as good as anywhere else,” he said. “Beacon is a great hospital and I’ve seen us do great work. It’s not second-rate care because you’re in a smaller town. Something like this happening right here in South Bend is very exciting. Even though we’re small in size, the ideas and the dedication are mighty and they have produced this. It’s a proud feeling.”