Hyun Bae, MD, is the Director of Education at Cedars-Sinai Medical Center and the Medical Director of the Spine Institute in Santa Monica. He has researched stem cell repair for degenerative disc disease and the use of growth factors to treat spinal cord injuries. He was among the first to use growth factor tissue engineering for intervertebral discs and chaired the "Spine Across the Sea" meeting in 2012 for the North American Spine Society. Here are Dr. Bae's expectations for the future of spine innovation and devices.
Question: Where do you see spine implant innovation heading?
Dr. Hyun Bae: We are going to see very little innovation because the pathway is very difficult. It's arduous to get a novel device through the FDA. I've seen many devices go through the FDA process that never got approval. Companies are getting very cautious about spending the amount of money that is takes to complete the trial with the risk of eventual denial.
A recent example is [Spinal Kinetics] M6, a great cervical disc used in Europe for a long time. Recently, they've withheld their trial in the U.S., thinking it may be too costly and risky. I think that in the U.S., implant-related innovation that requires an [Investigational Device Exemption] is going to be pretty rare.
Q: What type of innovation do you expect to become more prevalent?
HB: The clinical trials we are going to see for new devices and procedures will not target minimally invasive surgery but minimally invasive procedures. They will be targeting early intervention in the spinal disease cascade for interventional spine specialist and less so for spinal surgeons. Before, most of the trials were for spinal surgeons. The new clinical trials will be before both.
There is a tremendous amount of interest in clinical trials looking at degenerative disc disease and treatment of low back pain. Recent device trials were centered on disc replacement but now treatments are centered on regenerative therapies which can be performed at surgery centers, such as injecting discs with fibrin glue or stem cells and early cartilage cell growth factors. All of these clinical trials that involve the injection of discs can be done by both surgeons and interventionalists.
Q: Why will these regenerative techniques gain traction?
HB: There is a huge demand from patients that don't want surgery. I also think as the procedural morbidity cost is decreased. Patients' ultimate expectations are decreased as well. Meaning that patients will be extremely satisfied even if the treatment helps partially or only for a limited period of time.
Patients want a cure. They have been stuck in the paradigm where the cure was surgery, even though good results are sometimes difficult to guarantee. Other solutions on the pain management side are not that great either. Patients are really stuck and looking for a better alternative. The industry will follow what the consumer demands. A great interest exists in non-surgical alternatives to treating back pain. Can we regenerate discs or try to maintain them if we can intervene earlier? Also will that lead to pain relief? These questions still have to be answered but the demand and need is great.
Q: Will limited spine treatment reimbursements continue to plague the industry?
HB: There is no question that reimbursements will continue to be a problem. All clinical trials are going to have to show efficacy to get reimbursement. However these treatments have the advantage of being less costly than spinal surgery. That also has to be balanced with the fact that since the procedure is relatively easy that overuse and abuse is going to be an issue. Also a population of patients exists that will pay cash for novel procedures that are alternatives to surgery especially if you can demonstrate some efficacy. Currently there is a thriving industry on delivering stem cell therapy on a cash basis with little or no demonstration of true efficacy.
Q: Should we expect to see robotic surgeries become more common?
HB: I think truly robotic spine surgery is not going to happen. Certainly centers may use some type of mechanized aid for surgery or image guidance. But as far as a true robot, it's not going to become a must-have for spine center soon. We are nowhere close to the innovation that the da Vinci surgical system provides for urology. The technology may get there at some point, but I don't see it in the near future.
Q: How will the economy impact innovation?
HB: We are going to see consolidation between implant companies. Most spine companies will go to a direct model to pay sales reps and keep profits. Maintaining high implant costs will be difficult as hospitals are hiring more surgeons. This in effect allows hospitals to dictate pricing and implant usage. The decreased margin and the Obama device tax will hurt the bottom line and mean less innovation, less educational grants and probably less company sponsored meetings. On the sales side, this means that salaries will be lower and possibly capped. It probably means that the quality of the sales representative and service will suffer.
Q: Do you except to see an increase in stem cell usage?
HB: I think we will start seeing some stem cell technology in the operating room. Bone marrow aspirate filtration or centrifugation is already being done. With the scrutiny on BMP currently, viable alternatives are in great demand. I think stem cell technology is an attractive idea. However, the greatest barrier will again be the FDA.
More Articles on Spine:
How Large Scale Patient Education Efforts Improve Orthopedic Practices: Q&A With Steven Siwek of Medical Marketing Solutions
Tri-City Medical Center Purchases Second Renaissance Spine System
21 Spine Devices Receive FDA 510(k) Clearance in December
Question: Where do you see spine implant innovation heading?
Dr. Hyun Bae: We are going to see very little innovation because the pathway is very difficult. It's arduous to get a novel device through the FDA. I've seen many devices go through the FDA process that never got approval. Companies are getting very cautious about spending the amount of money that is takes to complete the trial with the risk of eventual denial.
A recent example is [Spinal Kinetics] M6, a great cervical disc used in Europe for a long time. Recently, they've withheld their trial in the U.S., thinking it may be too costly and risky. I think that in the U.S., implant-related innovation that requires an [Investigational Device Exemption] is going to be pretty rare.
Q: What type of innovation do you expect to become more prevalent?
HB: The clinical trials we are going to see for new devices and procedures will not target minimally invasive surgery but minimally invasive procedures. They will be targeting early intervention in the spinal disease cascade for interventional spine specialist and less so for spinal surgeons. Before, most of the trials were for spinal surgeons. The new clinical trials will be before both.
There is a tremendous amount of interest in clinical trials looking at degenerative disc disease and treatment of low back pain. Recent device trials were centered on disc replacement but now treatments are centered on regenerative therapies which can be performed at surgery centers, such as injecting discs with fibrin glue or stem cells and early cartilage cell growth factors. All of these clinical trials that involve the injection of discs can be done by both surgeons and interventionalists.
Q: Why will these regenerative techniques gain traction?
HB: There is a huge demand from patients that don't want surgery. I also think as the procedural morbidity cost is decreased. Patients' ultimate expectations are decreased as well. Meaning that patients will be extremely satisfied even if the treatment helps partially or only for a limited period of time.
Patients want a cure. They have been stuck in the paradigm where the cure was surgery, even though good results are sometimes difficult to guarantee. Other solutions on the pain management side are not that great either. Patients are really stuck and looking for a better alternative. The industry will follow what the consumer demands. A great interest exists in non-surgical alternatives to treating back pain. Can we regenerate discs or try to maintain them if we can intervene earlier? Also will that lead to pain relief? These questions still have to be answered but the demand and need is great.
Q: Will limited spine treatment reimbursements continue to plague the industry?
HB: There is no question that reimbursements will continue to be a problem. All clinical trials are going to have to show efficacy to get reimbursement. However these treatments have the advantage of being less costly than spinal surgery. That also has to be balanced with the fact that since the procedure is relatively easy that overuse and abuse is going to be an issue. Also a population of patients exists that will pay cash for novel procedures that are alternatives to surgery especially if you can demonstrate some efficacy. Currently there is a thriving industry on delivering stem cell therapy on a cash basis with little or no demonstration of true efficacy.
Q: Should we expect to see robotic surgeries become more common?
HB: I think truly robotic spine surgery is not going to happen. Certainly centers may use some type of mechanized aid for surgery or image guidance. But as far as a true robot, it's not going to become a must-have for spine center soon. We are nowhere close to the innovation that the da Vinci surgical system provides for urology. The technology may get there at some point, but I don't see it in the near future.
Q: How will the economy impact innovation?
HB: We are going to see consolidation between implant companies. Most spine companies will go to a direct model to pay sales reps and keep profits. Maintaining high implant costs will be difficult as hospitals are hiring more surgeons. This in effect allows hospitals to dictate pricing and implant usage. The decreased margin and the Obama device tax will hurt the bottom line and mean less innovation, less educational grants and probably less company sponsored meetings. On the sales side, this means that salaries will be lower and possibly capped. It probably means that the quality of the sales representative and service will suffer.
Q: Do you except to see an increase in stem cell usage?
HB: I think we will start seeing some stem cell technology in the operating room. Bone marrow aspirate filtration or centrifugation is already being done. With the scrutiny on BMP currently, viable alternatives are in great demand. I think stem cell technology is an attractive idea. However, the greatest barrier will again be the FDA.
More Articles on Spine:
How Large Scale Patient Education Efforts Improve Orthopedic Practices: Q&A With Steven Siwek of Medical Marketing Solutions
Tri-City Medical Center Purchases Second Renaissance Spine System
21 Spine Devices Receive FDA 510(k) Clearance in December