In a session titled "New Developments in Orthopedic and Spine Devices and Implants" at the 10th Annual Orthopedic, Spine and Pain Management-Driven ASC Conference in Chicago, Chris Zorn, vice president of sales at Spine Surgical Innovation, and Kenneth A. Pettine, MD, founder of the Spine Institute and Loveland Surgery Center, discussed trends and developments in orthopedic and spine implants.
1. The focus is on developments that inspire innovation. Mr. Zorn said he has seen devices developed with an emphasis on making the healthcare system more efficient and less costly, particularly since reimbursement is under tremendous pressure. "What can we do to help make the procedures less traumatic for patients, easier for the surgeons and less expensive for the healthcare systems paying for all of this?" he said. "Delivering surgery in an ASC is obviously different from surgery in a hospital. You have to keep an eye on what you're doing and look for incremental changes that can help you or your patient in the OR, and changes that you can get paid for."
2. Innovative spine implants in the U.S. are hindered by a complicated regulatory process. A lengthy FDA approval process can delay many innovative implants in the U.S., said Dr. Pettine. "I am extremely optimistic about the future of spine surgery in ambulatory surgery centers, but I'm very pessimistic about the future of really innovative spine implants in the U.S.," he said, adding that the U.S. is behind in implant developments compared to other parts of the world. "Europe is at least three to five years ahead of us in terms of spinal implant technology. In the U.S., a study will take at least one year, then there is a two year wait for data, and then the FDA may sit on data for five years."
3. Venture capital money is declining. According to Dr. Pettine, venture capital money for new devices is draining, and the lengthy FDA device approval process is largely to blame. "When people invest in something, they're expecting a minimum five-year turnaround with that money," he said. "But in the U.S., we’re looking at seven to 10 years before a device gets approval, so this venture capital money is going elsewhere."
4. Reimbursements for disposables are low. Disposable supplies are not reimbursed well, said Dr. Pettine. "You can get reimbursed for an implant, but not disposables, in an ASC setting," he said. "So if a technique is associated with a lot of disposables, may not work for you at your surgery center."
5. Using more disposables can save money long-term. "Some countries want you to do everything disposable," said Mr. Zorn. "Since the pressure is on everybody to deliver more for less, switching your capital investment into a disposable method makes a lot of sense. The problem is that disposables are still outrageously priced in the U.S."
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1. The focus is on developments that inspire innovation. Mr. Zorn said he has seen devices developed with an emphasis on making the healthcare system more efficient and less costly, particularly since reimbursement is under tremendous pressure. "What can we do to help make the procedures less traumatic for patients, easier for the surgeons and less expensive for the healthcare systems paying for all of this?" he said. "Delivering surgery in an ASC is obviously different from surgery in a hospital. You have to keep an eye on what you're doing and look for incremental changes that can help you or your patient in the OR, and changes that you can get paid for."
2. Innovative spine implants in the U.S. are hindered by a complicated regulatory process. A lengthy FDA approval process can delay many innovative implants in the U.S., said Dr. Pettine. "I am extremely optimistic about the future of spine surgery in ambulatory surgery centers, but I'm very pessimistic about the future of really innovative spine implants in the U.S.," he said, adding that the U.S. is behind in implant developments compared to other parts of the world. "Europe is at least three to five years ahead of us in terms of spinal implant technology. In the U.S., a study will take at least one year, then there is a two year wait for data, and then the FDA may sit on data for five years."
3. Venture capital money is declining. According to Dr. Pettine, venture capital money for new devices is draining, and the lengthy FDA device approval process is largely to blame. "When people invest in something, they're expecting a minimum five-year turnaround with that money," he said. "But in the U.S., we’re looking at seven to 10 years before a device gets approval, so this venture capital money is going elsewhere."
4. Reimbursements for disposables are low. Disposable supplies are not reimbursed well, said Dr. Pettine. "You can get reimbursed for an implant, but not disposables, in an ASC setting," he said. "So if a technique is associated with a lot of disposables, may not work for you at your surgery center."
5. Using more disposables can save money long-term. "Some countries want you to do everything disposable," said Mr. Zorn. "Since the pressure is on everybody to deliver more for less, switching your capital investment into a disposable method makes a lot of sense. The problem is that disposables are still outrageously priced in the U.S."
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