Hyun Bae, MD, co-director of the spine fellowship program at Cedars-Sinai Spine Center in Los Angeles, gives eight predictions on how spine surgeons will interact with device companies and impact innovation in the future.
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1. There will be increased transparency on spine surgeon relationships with device companies. After high profile cases of potentially inappropriate relationships between device companies and spine surgeons, regulators, journals and professional societies are demanding more oversight on these relationships. While spine surgeons are still working closely with device companies, they are disclosing these influences and potential bias at a higher rate than in the past.
"I see the relationship between spine device companies and surgeons becoming more transparent," says Dr. Bae. "I don't think patients will look at that data, but we'll still disclose it publicly. However, that won't stop surgeons from participating with device companies."
2. Surgeons will still be involved in clinical trials. Since surgeons are on the forefront of delivering patient care, it's still incredibly beneficial for device companies to involve them in the innovation and clinical trial process.
"I think spine surgeons working with device companies is going to continue," says Dr. Bae. "It has been a rewarding and fruitful experience for spine surgeons to deliver better patient care. I still think we'll have a lot of surgeons involved in trials or testing, invention or consulting for device companies."
After the device is released, companies will need surgeons to provide feedback for future improvements. "They have to find out from users what is working and how to make it better," says Dr. Bae. "That's a powerful bond on both sides that will always move forward."
3. Innovation will be more difficult, but still possible. Innovation in the spine field has boomed over the past decade, but new regulatory updates and high cost of the pre-market approval process will likely slow innovation over the next decade.
"For novel inventions or breakthroughs in care — something that isn't just a new widget — will have a place because it's valuable and new," says Dr. Bae. "However, it will be more difficult to bring these things to the market because the more novel the device is, the more regulatory hurdles there are."
Most companies today are using the FDA 510(k) approach for improvements on current technologies and inventions, but the requirements for a truly novel device are more demanding. Investigational device exemption trials typically cost between $10 million and $60 million, and even after the device receives FDA approval there's no guarantee insurance companies will reimburse for it.
"The pressure from the FDA and payers on new devices will mean these types of innovations are few and far between," says Dr. Bae. "The device companies that have successfully completed their IDE already are in a good position."
4. Some new innovation will go overseas. More device companies are taking their new ideas overseas in response to the higher cost and regulatory burden in the United States. It's cheaper to move devices through regulatory bodies in other countries and some spine device companies now start there.
"The M6 artificial disc from Spinal Kinetics was going to undergo a clinical trial in the United States, but it was withdrawn because of the amount of money it takes to go through the FDA process," says Dr. Bae. "I think we'll go through a bit of a quite phase where we're going to see some improvements on the devices we utilize, but I don't think we'll see the innovation we saw in the early 2000s."
Instead, Dr. Bae says we're likely to see more incremental advancements in the United States, such as new styles of artificial, such as minor improvements to existing Class II implants or instruments discs.
5. More focus will be on the risk/benefit of minimally invasive techniques. More companies are now targeting less invasive solutions for spinal surgery as the new frontier in the field. However, the higher costs without a guarantee of payer coverage make investing in new technology risky.
"People are really looking at the risk/benefit ratio to see whether pursuing a new device idea would be worth it," says Dr. Bae. "Devices such as biologics to tackle low back pain and degenerative disc disease or something like stem cell injections, glue injections or radio-ablation therapy are now going through the studies. These are truly outpatient procedures that tackle the outpatient population. They have a wide applicability to many patients, so the risk is worth it."
Some of the recent IDE studies, such as the LDR one- and two-level IDE trial comparing cervical disc replacement to fusion, could have influential results on where the field is headed in the future. "I think the data on LDR's disc will raise some eyebrows and show disc replacements may be a better way to answer cervical disc disease," says Dr. Bae.
6. Device companies will see decreased utilization. Hospitals and surgeons are becoming more price-savvy when it comes to spine devices, and their new strategies could mean less device utilization. Companies are seeing volume slide and growth flatten for spine devices.
"At the end of the day, that means there is less money for research and development, and device companies are more worried about their bottom line," says Dr. Bae. "I think we've come a long way and have some great tools to really treat the spine, and mobility has increased dramatically. However, there are significant pressures to keep cost of care down."
7. More procedures are moving into the outpatient setting. As surgeons become more proficient with outpatient spine surgery they are moving cases into the ambulatory surgical center setting. Minimally invasive procedures are less painful for patients and can decrease recovery time.
"Device companies have enabled us to do minimally invasive spine surgery in the outpatient setting, and now it's been put to the surgeons to perform those cases," says Dr. Bae. "It's not as simple as doing open surgery, but surgeons have committed to it because they want the best procedure for their patients. I certainly think that most of the technology will be focused on spine procedures to create less trauma for the patient."
There are other outpatient spinal treatment opportunities in pain management and regenerative injections, such as Mesoblast, and surgeons will intermingle with interventionalists to treat patients early and prevent disc degeneration.
8. Multilevel care will become more prominent. As technology develops, there will be opportunity for growth in minimally invasive devices for multilevel procedures. Device companies currently focusing on the single-level procedures can begin developing solutions for larger multilevel cases.
"Disc replacement right now is showing an advantage in multilevel cases, and now we can start treating patients with hybrid procedures," says Dr. Bae. "There are four-level spondylotic cases where maybe not every level needs either a disc replacement or a fusion, so we can use a combination of both. In the future, as surgeons become more comfortable with these innovations, the case indications will expand."
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