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
The Future of Spine Innovation: Q&A With Dr. Hyun Bae of Cedars-Sinai Medical Center FeaturedWritten by Heather Linder | Friday, 18 January 2013 15:32
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.Last modified on Friday, 18 January 2013 16:08
© Copyright ASC COMMUNICATIONS 2017. Interested in LINKING to or REPRINTING this content? View our policies here.
Most Read - Spine
- 10 most popular spine stories of 2016
- Physician-owned ASCs driving lumbar spine fusion market growth — 4 things to know
- Behind bars for fraud: Neurosurgeon Dr. Aria Sabit receives nearly 20-year prison sentence — 8 key insights
- 40 statistics on spine surgeon and neurosurgeon pay
- Dr. Allan Friedman to perform spine surgery on Duke's Mike Krzyzewski: 5 key notes
Top 40 Articles from the Past 6 Months
- 20 new MIS spine devices in 2016
- 44 MIS spine devices to know | 2016
- Police investigate death of American Spine Center's physician accused in federal kickback scheme: 6 things to know
- Suicide likely cause of Dr. Sandeep Sherlekar's death, police report shows: 6 things to know
- 12 statistics on social media's presence in the healthcare space
- 38 female spine surgeon leaders to know
- Dr. Gregory Sherr sues HealthEast, CentraCare & 6 neurosurgeons for allegedly ruining his reputation & career — 6 things to know
- 4 North Carolina orthopedic practices merge to create EmergeOrtho: 5 key notes
- Oregon spine surgeon implicated in $22M lawsuit for paralyzing patient with dropped instrument: 5 things to know
- US News & World Report: Top 10 hospitals for orthopedics
- 7 things to know about Mazor Robotics & Medtronic's plans to roll out Mazor X
- 11 highest-paying states for orthopedic surgeons: New Jersey tops the list at $494.5k
- UPMC to pay $2.5M+ to settle neurosurgery-related False Claims Act violation allegations: 7 things to know
- Beyond the implant — DePuy Synthes pushes innovation inside & out of the OR
- 21 statistics and facts for orthopedic surgeons — compensation, net worth and more
- The state of minimally invasive spine surgery: Dr. Frank Phillips on devices, payment & outpatient ASCs
- Are Stryker's hip implants about to be recalled?
- 19 more things to know about orthopedic bundled payments — September 2016
- Understanding the Impact of the CMS 2017 ASC Payment Rule on Spine Procedures
- Trump or Hillary? The physicians have voted
- 5 trends for orthopedic surgeons to watch in 2017
- 15 spine surgeons discuss techniques revolutionizing spine care
- FDA regulation, insurance coverage: Dr. Raj N. Sureja talks challenges in regenerative medicine
- Do you know what patients really care about when choosing a spine surgeon?
- Robotics is here to stay — Drs. Kornelis Poelstra & Dennis Devito on working with Mazor technology
- Medtronic, SeaSpine, Zimmer Biomet & more: 17 key notes
- 3 orthopedic clinics to pay $2.39M to settle False Claims Act allegations: 5 things to know
- 10 thoughts and statistics on medical malpractice claims against orthopedists
- 33 of the largest orthopedic groups in the US by number of physicians
- UCLA pays $8.5M to settle 2 lawsuits after undisclosed spine surgeon relationship with Medtronic: 5 key notes
- 4 of the most pressing challenges orthopedic surgeons face in 2017
- What not to wear — Physician's attire elicits mixed responses in outpatient orthopedic centers
- 5 largest orthopedic companies have 61% of market share
- 8 spine codes CMS proposes for ASC coverage in 2017
- 6 spine physicians ranked #1 on Google - 2016
- Dr. Robert Watkins performs spine surgery on Patriots' Rob Gronkowski
- 8 biggest stories in 2016's spine market — Acquisitions, lawsuits, bundled payments & more
- Orthopedic residency programs violate Match Code of Conduct: 6 things to know
- 7 trends in the spine surgical robot market
- The science of healthcare delivery: 10 thoughts on the future structure of healthcare organizations