Demand for outpatient spine surgery is increasing, driven by advancements in minimally invasive techniques that enable surgeons to perform complex procedures through small incisions while using specialized instruments and visualization tools.
Outpatient surgical volume increased by 18% in 2023, with lumbar/thoracic fusion procedures among the top procedures that shifted to same-day sites of care, according to the 2023 Impact of Change Forecast report published by SG2, a Vizient company and healthcare consulting group. The report noted that 17% of spinal decompression/laminectomy procedures will be performed in ASCs by 2033. Sg2 also projects a 20%-plus 10-year growth for motion preservation procedures such as artificial disc replacement.
The total number of outpatient spine procedures increased by approximately 193% from 2010 to 2021, with a compound annual growth rate per year of 15.7% for ASCs, according to research published in the North American Spine Society Journal.
Spine companies are responding to these trends by integrating navigation systems, robotics and intraoperative imaging into their product offerings. The goal is to enhance the precision, accuracy and efficiency of procedures performed in the outpatient setting.As the demand for same-day spine procedures continues to increase, companies are focused on producing solutions that allow surgeons who operate in ASCs to provide high-quality care for even complex cases.
Software Systems for Streamlined Workflows
Navigation technology is adapting to the unique demands of ASCs. PathKeeper Surgical’s 3D optical navigation system employs a preoperative CT scan of the patient’s anatomy, which is enhanced by machine learning and surgical planning software to create a 3D image for optimal visualization of the spine. During surgery, the system offers real-time, precise tracking and can segment the spine into individual vertebrae, tracking each independently.
“We start with the end in mind,” said Ryan LeBlanc, Chief Commercial Officer at PathKeeper Surgical. “Part of our business is supporting the shift of cases from the inpatient space to the outpatient setting.”
When it comes to making new technologies work in an ASC setting, LeBlanc noted that there are a few key challenges that spine companies must overcome — namely space and financial constraints. PathKeeper Surgical has found ways to adapt its product development strategies to address these needs.
The company’s preoperative CT scanning capability eliminates the need for cumbersome imaging equipment in the O.R., as well as radiation exposure to surgical team members from C-arms. PathKeeper also utilizes near-infrared (NIR) light, which does not disrupt the surgeon’s view of the surgical field.
Additionally, the system is instrument-agnostic, allowing surgeons to use their preferred tools. Each instrument is equipped with spatial markers and undergoes a quick calibration to ensure accurate tracking throughout surgery.
“We prioritize high accuracy, patient safety and proper implant placement while maintaining a small footprint,” LeBlanc said. “Our system is small enough to be stored in a closet and is highly cost-effective.”
Efficiency and ease of use are critical in the ASC setting, where time and resources are often limited.
LeBlanc emphasized the significance of providing surgeons with systems that not only fit within the limited space of an ASC but also operate effectively to save time and resources. “We understand that ASCs operate under tighter financial constraints than larger hospitals,” he said. “PathKeeper is compact and affordable, making it a viable option for ASCs looking to adopt advanced navigation technologies.”
Kevin McGann, President & CEO of Accelus, echoed these sentiments. “We are adapting our product development strategies to align with the unique requirements of ASCs,” he said. “This involves designing technologies and innovations that fit the ASC business model, which typically means smaller surgical footprints and fewer operating room personnel.”
His company’s FlareHawk interbody fusion system allows surgeons to perform procedures as minimally invasively as possible. The system can be implanted through a small incision thanks to its slim insertion profile. Once expanded, the conformable implant reduces subsidence, restores foraminal height and reestablishes sagittal balance from a posterior approach.
The articulating Orbit instrument from Spinal Elements allows for an efficient circumferential disctectomy.“The shift of cases to ASCs influences our approach to product design by prioritizing usability, efficiency and ease of use,” McGann said. “Our devices are designed with minimal insertion profiles and controlled expansion, aiming to simplify and expedite their use in the O.R. This focus on simplicity and efficiency seeks to reduce surgical times and enhance overall patient outcomes, critical factors in outpatient settings.”
Efforts to Enhancing Safety, Precision and Efficiency
Compared to traditional open surgery, minimally invasive techniques offer reduced recovery times, less postoperative pain and lower risk of complications. These benefits stem from the smaller incisions, reduced tissue disruption and more precise surgical interventions enabled by advanced navigation systems and digital tools.
One significant challenge in minimally invasive spine surgery is the need for precise bony anatomy visualization.
PathKeeper, LeBlanc said, has developed a standardized approach to address this hurdle and is working on a next-gen platform that features a miniature 3D camera. “The camera, which has a diameter smaller than a dime, can capture detailed images through a retractor, enabling precise navigation. In addition, we are exploring 2D and 3D registration to give surgeons ultimate workflow flexibility.”
McGann highlighted the strategies his company employs to ensure their products are cost-effective without sacrificing quality. In developing implants for ASCs, Accelus focuses on using high-quality materials that ensure durability and biocompatibility.
The company chooses sterilization methods to prioritize the safety of its products while maintaining their integrity. Implant packaging is designed to be user-friendly and protective, ensuring that implants remain sterile and in optimal condition until they are ready for use. These considerations help optimize product performance and shelf life, crucial factors for the ASC setting.
The integration of digital technologies plays a notable role in enhancing the safety, precision and efficiency of spine surgeries performed in ASCs. Advanced navigation systems, robotics and intraoperative imaging are transforming how surgeries are performed.
Spine companies are working to ensure that surgeons who are accustomed to using certain technologies in hospitals have access to similar tools in ASCs. For example, LeBlanc said the PathKeeper system is “fundamentally digital,” making it easy to use in an ASC setting. It also has unique features, such as motion tracking and anatomy-specific navigation alerts, to enhance the precision of surgery without the need for ionizing radiation.
“When surgeons are using a specific type of technology in hospitals, they don’t want to operate without it,” says LeBlanc. “They should work with platforms that are as good or better in their surgery centers.”
McGann highlighted similar advancements with FlareHawk, which leverages adaptive geometry technology to ensure optimal placement and expansion of spinal implants. This technology not only improves surgical outcomes but also enhances the overall patient experience by minimizing the invasiveness of the procedure. He noted that FlareHawk can improve surgical outcomes thanks in part to its minimal insertion profile that is designed to minimize neural retraction and tissue disruption during insertion.
The Orbit articulating discectomy system from Spinal Elements allows for a linear sweep of the whole disc space with a mechanical device during TLIF procedures. The Orbit system consists of articulating and rotating discectomy instrumentation that uses a minimal, posterior incision or MIS tubular approach to achieve efficient disruption and removal of disc tissue while preparing the endplates for fusion.
“Efficiency is important with cases moving to the ambulatory setting,” said Rick Simmons, Chief Marketing Officer at Spinal Elements. “There is a lot of whitespace in the ASC market. Our current products create an efficient TLIF operation and position us to participate in the endoscopic and navigated space.”
Teaming Up to Find Effective Solutions
Spine companies are emphasizing collaboration with ASCs and surgeons to gather feedback and insights that inform product development decisions.
“We actively seek their input through regular feedback sessions, clinical studies and pilot programs,” McGann said. “This collaboration allows us to gather valuable insights about the specific needs and challenges faced in ASC environments. By integrating this information into our product development process, we ensure our innovations are practical, effective and tailored to the real-world scenarios encountered by our customers.”
PathKeeper Surgical’s foundation in artificial intelligence and 3D camera technology allows the company to create customized software packages for different settings and patient populations, from degenerative spine cases to more complex procedures involving deformities or tumors.
“We leverage our position as a small startup to stay agile and innovative, constantly seeking feedback from ASCs and surgeons,” LeBlanc said. “This approach helps us maintain a competitive advantage by directly addressing their needs.”
Ongoing customer support is critical to the successful implementation of new technologies in ASCs. PathKeeper Surgical and Accelus prioritize comprehensive education programs tailored to the needs of ASC staff members.
“Our training sessions are designed to be concise and effective, ensuring that ASC personnel can quickly get up to speed with our system,” LeBlanc said. “We also provide virtual support to address any issues or questions that may arise.”
Accelus adapts its training programs to the unique needs of ASCs. “We tailor education and ongoing support to ensure seamless integration of our products into their workflows.”
Simmons believes there is a significant opportunity for spine companies that participate in the TLIF market to improve the education and training of surgical teams. “Specifically,” he said, “by making the sequential steps of the surgery less complicated and enhancing disc prep efficiency.”
Future Directions and Innovations
By prioritizing the efficiency, safety and precision of spine surgery through active collaboration with ASCs and surgeons, companies are helping to make complex procedures more accessible and improving patient outcomes in the outpatient setting. LeBlanc envisions efforts focusing on creating tools that bridge the gap between hospital and ASC settings.
“Our goal is to expand the use of optical navigation in spine and orthopedic surgeries,” he said. “Additionally, by utilizing AI to track and analyze surgical procedures in real time, we aim to continuously improve and innovate in computer-aided surgery.”
LeBlanc and McGann agree that spine companies need to continue to develop technologies that cater to ASCs, ensuring that these facilities provide high-quality care for complex spine cases. By tapping into AI and other advanced digital tools, companies can streamline surgical workflows and ultimately help surgeons deliver better outcomes for patients.
“The future of product development for outpatient spine surgery lies in further advancing minimally invasive techniques and integrating digital solutions,” McGann said. “We envision a continued shift toward technologies that enhance surgical precision, reduce recovery times and improve patient outcomes. Innovations such as enhanced surgical instruments, improved imaging techniques and advanced surgical planning tools will play a significant role in the future of spine care.”
Independent ASCs aren’t the only facilities that are emerging as primary sites of care for spine procedures. Simmons said the hospital-run ASC market is also ramping up.
“Hospitals have figured out the value of not fighting with the community-based surgery center and are embracing the segregation of their low-demand patient populations to the ASC setting,” he said. “The shift makes it attractive for a smaller company like ours because we have the laser focus to develop a suite of technology that takes up a smaller footprint. A lot of our competitors’ solutions rely on multiple trays of instruments. We’re trying to get everything we design into a singular tray or singular implant so that it doesn’t burden the facility with a lot of equipment.”
The future is clearly bright for product development in outpatient spine surgery, especially for companies that are positioned to capitalize on the opportunities the market presents.
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