The spine industry has experienced a Renaissance period for the past few decades where innovation truly disrupted the old open spine surgeries of the past, making procedures less risky and painful. Advancement in fusion technology, motion preservation and less invasive procedures dominated recent advancements and additional biologic and regenerative solutions could be on the horizon.
But the healthcare environment is changing. Hospitals and insurance companies no longer give a blank check to purchase the latest technology at any price. The Food and Drug Administration updated the device approval process to make it more difficult and expensive to achieve clearance. Additional scrutiny and transparency into the relationships between physicians and device companies make collaboration more difficult. Consolidation in the medical device industry discourages truly disruptive technology development from the inside.
"I'm afraid we are going into the dark ages where we won't see much disruptive technology," says Hyun Bae, MD, Director of Spine Education at Cedars-Sinai Medical Center in Los Angeles. "Now with reimbursement pressures and implant companies not being able to get the premiums they once saw, research and development budgets have become restructured to maintain core business rather than focusing on disruptive and innovative technology. They have to show value to their shareholders, discouraging them from taking risks with large R and D budgets which may or may not produce results."
The mega-mergers in the orthopedic device space, including Zimmer's merger with Biomet and Medtronic's acquisition of Covidien, show how huge companies can become. There are big companies in the spine-focused market as well, including Globus, NuVasive and LDR, which succeed because of their laser focus on spine.
Here are 10 observations on the market:
1. Big orthopedic and spine device companies will spend their research and development money on refining technology they already have, not designing something disruptive. "They aren't start-up companies anymore," says Dr. Bae. "They would rather acquire innovation from a small company and pay the premium."
2. Spine-focused device companies within the specialty niche have a good chance of remaining independent and continuing to grow in their markets. "They have to sell their differentiation to play in these markets," says Dr. Bae. "This is where you will see the big companies innovate."
3. There will be a move away from plain PEEK. "It’s time for the differentiation of PEEK and interbody spacers," says Dr. Bae. "PEEK was sold to us by its modulus of elasticity, but in reality, it doesn't participate in the fusion, and aside from its load bearing capability, it may actually be slightly inhibitory. As this market differentiates we will see porous, HA-impregnated and titanium-coated PEEK devices. I also think we will see a resurgence of all titanium interbodies."
4. Most new innovation will be incremental. "You'll see innovations that are marginal instead of revolutionary," says Dr. Bae. "Big multi-specialty companies can tackle these changes because it doesn't deviate from their core business. Their marketing teams can justify the business easily with little risk so they'll invest their money there."
5. The innovations that will stick in the future won't only improve the quality, but also efficiency in the operating room. "These innovations will make the procedure easier, faster and less stressful for the surgeon to achieve what they want for the patient," says Dr. Bae. "Some people would say that image-guided surgery or bringing in the O-arm to improve precision leads to efficiency. However, the systems are not cost- and time-efficient. Although it has incredible benefits in terms safety, precision and decreased radiation exposure to the surgeon, it hasn't had the impact I'd imagine mainly because of the aforementioned cost, time, even effort."
6. Image guidance and robotic technology has potential to become more widely used in the future if it can become time- and cost-efficient. "If somehow we could mate the O-arm with a robotic-assisted device that could promptly put in the pedicle screws for you at the right price, this technology could improve spine surgery," says Dr. Bae. "In the future, this focus certainly will be the avenue for new technology."
7. Surgeons will adopt technologies that improve efficiency and make the procedure more predictable. "The technology will be focused on helping surgeons get their procedure done more easily," says Dr. Bae. "A good example of this is the spinous plate. We know that spinous process plates aren't as secure as pedicle screws, but they certainly have a market in the United States. One of the biggest reasons for that is the efficiency: the procedure is fast and easy, and the surgeon can do it without much risk to the neural structures. It's also coding-efficient to bill for the fusion and instrumentation. They get the same value, but the time and stress are less."
8. BMP use will stabilize. The BMP boom in the early 2000s demonstrated how disruptive technology could make an impact on spine surgeries. "When BMP came out, one would have thought the other biologic derivatives would have been knocked out of business," says Dr. Bae. "But the opposite happened. BMP built the business for every other biologic. I believe biologics is where we will see disruptive technology that will change the paradigm of how we treat patients.
9. There will be a new disruptive phase of biologics that includes stem cells. Right now stem cells are sold on hype — there isn't efficacy data — but companies are working on clinical trials to validate stem cells’ efficacy and reliability.
"There are multiple IDEs and INDs for stem cell therapies," says Dr. Bae. "Stem cells will be used more as a drug, a therapy that derives from the cells and demonstrates efficacy. The surgeon would know the dose going into the procedure, very similar to BMP. When a stem cell therapy succeeds in demonstrating efficacy in a FDA IDE or IND trial, a true inflection point will occur. Companies will invest resources to be a part of this new line of therapy, and patient as well as clinician demand will increase as the missing link (efficacy) is finally proven.
10. The deformity market will continue to grow. "Deformity is getting bigger and bigger, and the technology is more enabling," says Dr. Bae. "Fellows are training more on deformity and the aging population is huge. There are 10,000 people in the United States who turn 65-years-old every day. These are big cases, treating a growing market which means a tremendous amount of dollars."