Pierre Jerome and Stephane Bette founded SpineGuard in 2009 to deliver the Dynamic Surgical Guidance technology to surgeons across the globe. The DSG technology guides surgeons during screw placement with less radiation exposure than less than standard modalities, which are in use today.
PediGuard probes are the first products which incorporate the DSG technology alerting surgeons in real time of potential vertebral cortical wall breaches. The PediGuard probes look and feel like standard probes currently used for drilling pedicles.
"The goal is to improve clinical outcome for patients by reducing the risk of complications related to misplaced implants and screws," says Mr. Bette. "Simultaneously it also reduces exposure to harmful ionizing radiation for operating room staff and surgeons who currently depend on radiation-based imaging to ensure accuracy of screw placement."
Peter Gabos, MD, a spine surgeon at Nemours/Alfred I. DuPont Hospital for Children in Wilmington, Del., has used the PediGuard with DSG technology for more than a year and has found increased accuracy in his pedicle screw placement. "PediGuard probes allow us to place screws perfectly within the pedicle and to avoid screw entry into areas where we don't want it to go," says Dr. Gabos. "It's important to keep the screw in the bone, and this technology allows us to place screws safely without image guidance."
Since he began using the technology, Dr. Gabos reports very few incidences where screw readjustment was necessary after verification with intraoperative CT scan(s). "This decreases the surgery time as well," he says.
Dr. Gabos uses the PediGuard probes while training new surgeons who are performing their first spine procedures. "It's an important layer of safety when a less experienced surgeon is placing screws under the guidance of a more experienced surgeon," says Dr. Gabos. "It gives the more experienced surgeon feedback on where the device is in the bone. We can then make fine adjustments to prevent a complication from a breach before it occurs."
The technology is also handy for surgeons performing charitable care in countries without access to sophisticated equipment, such as intraoperative CT scans. Dr. Gabos was recently in a third-world country performing spine surgery without any imaging technology and accurately placed multiple screws using PediGuard probes.
SpineGuard reported 43 percent revenue increase in 2015 over the previous year, and the company sold approximately 7,500 PediGuard units last year; almost 60 percent of those were sold in the United States.
But the company's strategic plan doesn't stop there. In the coming years, SpineGuard plans to embed the DSG technology in existing implants and instruments for spinal as well as orthopedic trauma surgery applications.
The new generation of SpineGuard's products reduces the number of necessary surgical steps while continuing to tackle screw placement accuracy while reducing exposure to harmful radiation for the surgeon, OR staff and the patient. Surgeons in Europe are beginning to perform surgeries with these next-generation products that include pedicle screws with a sensor in the tip. At the end of last year, the company also reported the successful completion of the first surgery with DSG "smart screws."
SpineGuard has entered into partnerships with implant manufacturers to incorporate the DSG technology in implants to further improve outcomes of spinal surgical procedures.
"What is really exciting with the new generation of products is they're truly differentiated in spine care because they are more efficient for surgeons," says Mr. Bette. "This more efficient technology lowers the overall cost of care. Technology is now a key part of the industry’s effort to provide more value to the healthcare system. We are showing hospitals and surgeons how much they can save with our DSG Technology."
The company could also potentially partner with navigation systems or robotic technology companies to embed the DSG technology and ultimately improve care. "Those technologies aren't always accurate today because they are not measuring the in situ information in real time," says Mr. Bette. "They are based on the virtual reconstruction of the patient's spinal anatomy from pre-op imaging and the position of the surgical instrument in the operating room. We can enhance these systems by sensing bone in real-time with the DSG Technology."
SpineGuard's focus is also switching toward a value-based solution for healthcare providers. While there is a cost associated with the PediGuard probes and DSG technology, providers should see the overall value as more significant. This technology can improve clinical outcomes and patient satisfaction metrics while making the procedure more efficient..
"Today we are challenged with providing a new technology that improves outcomes while reducing costs," says Mr. Bette. "The DSG technology is inexpensive when compared to navigation and intra-operative monitoring equipments. "
Bundled payments are one of the biggest ways healthcare providers are shifting from fee-for-service to pay-for-performance. Providers take on more risk with bundled payments and the shift reaches far beyond the hospital's board room.
Mr. Bette Says, "Today hospitals are making room for new technologies like ours by reducing the cost of commoditized products."
Device company executives are working with hospital committees as the strategy around providing value-based care evolves. When the hospital is tasked just with reducing costs, executives sometimes see the device and instrumentation as a cost but don't realize the investment in a better procedure upfront could cut complication and readmission costs down the road.
"We firmly believe we fit very well in the context of today's healthcare reform of improving outcomes while reducing costs," says Mr. Bette.
Going forward, the company's strategy is shifting from selling their products directly to hospitals to partnering with other companies and placing the DSG technology within existing systems.
"That's our way of adapting to the changes of healthcare," says Mr. Bette. "Rather than manufacture implants that are currently considered to be commodities for spinal care, we help others differentiate themselves with our value-adding technology. We will continue to develop this technology further and substantiate it with good clinical data."