Roundtables

Innovation in Spine: Can Anything Stem the Flow? 5 46 Another problem is the tendency among spine surgeons to focus on instru- mentation and fusion surgery. They are so focused on implants and that makes it difficult to open them up to other treatment options such as mini- mally invasive spine surgeries or biologics that can help avoid fusions. Dr. Perez-Cruet: One of the biggest roadblocks is finding good partners to work with to develop these technologies. Also, it takes money and resources. Currently, there is a concern amongst the companies about making large investments in healthcare when they are not sure if they are going to be re- imbursed for developing these technologies. Whether the current changes in healthcare will foster reimbursement for these technologies remains to be seen. Dr. Cho: I think it would be the cost. In order to run an investigational device exemption trial, companies need to spend millions of dollars. I don't know how this problem can be overcome. Medical research is expensive and we don't want to cut corners either. Dr. Schuler: The biggest roadblock is insurance companies, governmental payers and third-party payers denying physicians and patients the ability to undergo contemporary treatments and denying physicians the ability to per- form these modern surgical advances. We are seeing an enormous rise in denials for patients to certain types of care and an increase length of time for approvals for all procedures. To overcome this negative process, physicians need to continue producing data showing which techniques work most effectively. This needs to be financed through patient-centered funding programs and nonprofits, not corporate funding. The insurers and the third-party payers are discrediting research funded by corporations and are claiming that there is a conflict of interest. Payers are choosing the studies that support their reimbursement policies and are deny- ing any studies that counter their financially motivated coverage decisions. This is unethical, and it is wrong. Q: How can surgeons overcome some of the regulatory burdens on innovation? Dr. Perez-Cruet: We need to be able to foster innovation from a regulatory and governmental standpoint. We need to think about how we can make bringing products to the marketplace easier and in ways that are not cost- prohibitive. There are ways in which it could be more streamlined. Also, there needs to be legislation that protects innovation. There should not be a huge liability burden for bringing new technologies to the marketplace. Q: Beyond strictly technology, how are surgeons evolving their approach to provide better care for patients? Dr. Carlson: We are always looking for patient-specific improvements in our procedures. With advancing technology, some of the more complex procedures can now be done as outpatient. Patients don't really want to stay in a hospital overnight. The patients understand the need for the operating room but the po- tential risks in staying in the hospital environment frightens most patients. From wrong medications and wrong dosing to risks of hospital-acquired infections, patients don't want to add to the potential complications of their procedures. Another development is the advances in anesthesia. Anesthetics are obviously necessary for the performance of surgery. With influence from patient de- mand, drug companies are making medications that can be used to decrease or prevent pain. These new medications will also have fewer side effects that have the potential to make patients uncomfortable and require a hospital stay. Patients are able to [procure] medications in real time to provide pain control and directly relate the need for treatment to activity levels. Q: Will the current healthcare environment bring spine surgery innovation to a standstill? Dr. Carlson: Advances in spinal care will continue although it maybe slowed by changes in the healthcare system. As patients demand improvements in their care, it will be the healthcare system that may not be able to respond quickly enough to the demand. There will always be a demand for the inno- vative care that provides the best outcome, but the system is slow and bulky and will lag behind the desires of the patients. I believe over the next few years, healthcare delivery will change drastically. Unfortunately, I see the current system as a hindrance to advancement. This means that patients will seek care outside of the system anytime they have a chance. This will slow the ability of the best and brightest among us to make the improvements that will be demanded in the future. I see most surgeries trending toward outpatient environments and hospitals becoming less rel- evant to the healthcare systems as a whole. Dr. Perez-Cruet: I don't think it will bring innovation to a standstill. Compa- nies will have to foster innovations that provide cost-effective care. There will always be value in products that improve healthcare for patients. Q: What do you hope to see in terms of spine surgery innovation in the next five to 10 years? Dr. Perez-Cruet: I think we can do a better job understanding the patho- physiology of some of the disorders that we treat, so that we can enable more focused treatments, which can provide patients with really improved quality of life. A more focused approach addressing the underlying cause of the pa- tient's symptoms is what we need. Additionally, I feel that biologic restora- tion of the spinal column — that is, intervertebral disc via stem cells — may become a reality. Dr. Schuler: Regenerative techniques, which will obviate the need for many surgeries. The more we can heal through regenerative treatments, the more the patient can avoid or procrastinate the need for surgery. Dr. Cho: I would like to see long-term follow-up studies on cervical artificial discs. Hopefully, they will answer whether this technology can decrease the incidence of adjacent segment disease and also stay functional over time. If there is a way to decrease radiation exposure during minimally invasive surgery, I think that would be a huge step forward. I would like to see more data on biologics such as stem cell technology before they are applied in hu- mans. n through patient-centered funding programs and nonprofits, not corpo- rate funding. e insurers and the third-party pay- ers are discrediting research funded by corporations and are claiming that there is a conflict of interest. Payers are choosing the studies that support their reimbursement policies and are deny- ing any studies that counter their financially motivated coverage decisions. is is unethical, and it is wrong. Q: How can surgeons overcome some of the regulatory burdens on innovation? Dr. Perez-Cruet: We need to be able to foster innovation from a regulatory and governmental standpoint. We need to think about how we can make bringing products to the marketplace easier and in ways that are not cost- prohibitive. ere are ways in which it could be more streamlined. Also, there needs to be legislation that protects innovation. ere should not be a huge liability burden for bringing new technologies to the marketplace. Q: Beyond strictly technology, how are surgeons evolving their approach to provide better care for patients? Dr. Carlson: We are always looking for patient-specific improvements in our procedures. With advancing technology, some of the more com- plex procedures can now be done as outpatient. Patients don't really want to stay in a hospital overnight. e patients understand the need for the operating room but the po- tential risks in staying in the hospital en- vironment frightens most patients. From wrong medications and wrong dosing to risks of hospital-acquired infections, patients don't want to add to the potential complications of their procedures. Another development is the advances in anesthesia. Anesthetics are obvi- ously necessary for the performance of surgery. With influence from patient de- mand, drug companies are making medications that can be used to decrease or prevent pain. ese new medications will also have fewer side effects that have the poten- tial to make patients uncomfortable and require a hospital stay. Patients are able to [procure] medications in real time to provide pain control and directly relate the need for treatment to activity levels. Q: Will the current healthcare envi- ronment bring spine surgery innova- tion to a standstill? Dr. Carlson: Advances in spinal care will continue although it maybe slowed by changes in the healthcare system. As patients demand improve- ments in their care, it will be the healthcare system that may not be able to respond quickly enough to the de- mand. ere will always be a demand for the inno- vative care that provides the best outcome, but the system is slow and bulky and will lag behind the desires of the patients. I believe over the next few years, healthcare delivery will change drastically. Unfortunately, I see the current sys- tem as a hindrance to advancement. is means that patients will seek care outside of the system anytime they have a chance. is will slow the ability of the best and brightest among us to make the improvements that will be demanded in the future. I see most surgeries trending toward outpatient environments and hospitals becom- ing less rel- evant to the healthcare systems as a whole. Dr. Perez-Cruet: I don't think it will bring innovation to a standstill. Com- pa- nies will have to foster innovations that provide cost-effective care. ere will always be value in products that improve healthcare for patients. Q: What do you hope to see in terms of spine surgery innovation in the next five to 10 years? Dr. Perez-Cruet: I think we can do a better job understanding the patho- physiology of some of the disorders that we treat, so that we can enable more focused treatments, which can provide patients with really improved quality of life. A more focused ap- proach addressing the underlying cause of the pa- tient's symptoms is what we need. Additionally, I feel that biologic restora- tion of the spinal col- umn — that is, intervertebral disc via stem cells — may become a reality. Dr. Schuler: Regenerative techniques, which will obviate the need for many surgeries. e more we can heal through regenerative treatments, the more the patient can avoid or procras- tinate the need for surgery. Dr. Cho: I would like to see long-term follow-up studies on cervical artifi- cial discs. Hopefully, they will answer whether this technology can decrease the incidence of adjacent segment disease and also stay functional over time. If there is a way to decrease radiation exposure during minimally invasive surgery, I think that would be a huge step forward. I would like to see more data on biologics such as stem cell technology before they are applied in humans. n

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