Zimmer Biomet's spine offerings have grown since the company acquired LDR, with the Mobi-C® Cervical Disc, and Medtech, with the ROSA® Robotic Surgical Assistant, in 2016.
At the 2018 North American Spine Society Annual Meeting, Zimmer Biomet Spine Director of Strategic Communications Mark Richards discussed the company's current projects and what to expect in the future.
Question: What are you excited about in 2018 headed into 2019?
Mark Richards: Mobi-C is still a key driver for us. We recently announced the FDA approval of extended labeling to include seven-year results, which demonstrate clinical superiority of Mobi-C two-level cervical total disc replacement procedures compared to anterior cervical discectomy and fusion. Mobi-C remains the leader in a relatively untapped market, and we believe perhaps a third of patients receiving an ACDF [Anterior Cervical Discectomy and Fusion] would be candidates for cervical arthroplasty instead. In addition to educating those patients and surgeons about disc replacement, we believe it is important to foster continuing discussion with trained surgeons who may be searching for the perfect patient. Through Mobi-DISCourse events where these surgeons can consult with their peers who have been using the device longer and with more patients, they often conclude that the indications for disc replacement are broader than they may have originally thought. Zimmer Biomet is excited to continue to grow and develop the market and help surgeons serve well-indicated patients with cervical arthroplasty.
Q: Are surgeons reaching out to you about learning more? How do you connect with patients who are on the cusp with interest but not doing it today?
MR: The long-term clinical data for Mobi-C is great asset in reaching surgeons. Two podium talks at this year’s NASS meeting represent the latest presentations on the long-term data. We are now at 10 years of collected and reported data, and we have an excellent track record with Mobi-C. In addition to presentations at the spine societies, review of our clinical data is an important part of our ongoing surgeon training and education efforts.
Patient education has also been a focus since the beginning. We desire to reach patients who may have believe that cervical fusion is their only option, and let them know that there is an alternative treatment available. Our cervicaldisc.com website features a surgeon locator to connect potential patients with surgeons who have been trained to do disc replacement in their community. We are committed to educating patients and pointing them in the right direction, as well as to making sure surgeons have the right training to achieve good clinical results.
While insurance reimbursement was an early hurdle for two-level cervical disc, we appreciate that the clinical data has proven meaningful to payers, and the vast majority of lives in America are now covered for cervical disc replacement. With insurance coverage no longer an obstacle, we have found that little stands between a well-informed, well-indicated arthroplasty patient and the help they need.
Q: Are you seeing responsiveness from the patients? Does that drive adoption?
MR: Our success in patient education for Mobi-C speaks to the developing nature of healthcare consumerism. Prospective spine patients, as healthcare consumers, are much more informed than they were in years past. They are more likely to seek information about the benefits and risks of the procedure their surgeon has told them about, and are also more proactive in investigating alternatives. While we know that patient inquiry alone may not drive surgeons to perform arthroplasty rather than fusion, those market dynamics are real and influential. Many surgeons are now branding their practices based on the technology they offer, and appeal to those patients who are diligently seeking the best treatment.
We've also seen surgeons who embrace cervical arthroplasty refashion their practices as disc replacement centers. In addition to the expected increase in arthroplasty volume, many of those surgeons have seen growth in their ACDF volume, as well. So while education about disc replacement can drive adoption, each patient is likely getting the procedure for which they are best indicated. That’s a win-win.
Q: Considering the healthcare environment moving to value-based care, what is the value proposition around Zimmer Biomet's spine technologies?
MR: Historically and conventionally, medical device manufacturers have acutely engaged surgeon customers in the operating room to deliver instruments and implants during the surgical procedure. It has become clear that there is greater opportunity to serve surgeons and patients than that. There is a place for medical device manufacturers to serve as clinical partners and support surgeons and patients before, during, and after the operation with education about proper patient selection, tools for preoperative planning, and plans for postoperative care and clinical follow-up. Additionally, there are other decision makers and stake holders. It's not exclusively about the surgeon and the patient, because there are hospital administrators and payers to consider as well. Outcomes-based medicine is no longer just about the clinical outcome; there is concern for the total cost of care and the economic impact beyond the patient.
For Mobi-C, specifically, we have found success in demonstrating not just the clinical legitimacy of cervical disc replacement, but also the healthcare economics that suggest two-level arthroplasty is a better value than two-level fusion.
Across the portfolio we are focused on delivering procedural solutions, rather than just implants. In the lateral lumbar fusion space, we will leverage best-in-class implants along with an innovative retractor, and surgical assist arms. Similarly, when a surgeon plans a TLIF, we will bring everything required to do the procedure in a minimally-invasive fashion: innovative implants (expandable or 3D-printed cages with large graft area), biologics, and robotic surgical assistance for navigation.
Many medical device manufacturers are stuck in the paradigm of simply ‘delivering the implant.’ While surgeons and nurses appreciate the support in the operating room, companies that can bring products, technology, and services bundled together will not only meet the needs of their surgeon customers but also those of the extended customers throughout the healthcare delivery system who are looking for true partnership with industry. Zimmer Biomet seeks to be a health solution partner, rather than just a product provider.
Q: In 2016, Zimmer Biomet acquired Medtech with the ROSA Brain and ROSA Spine robotic technology. How is the company planning to develop that technology in the future?
MR: Instead of developing independent robots for brain and spine procedures, we are pursuing ROSA® One, a platform where one piece of capital equipment can be utilized for brain and spine surgeries based on different on-board application software. While it is not yet commercially available, we have submitted a 510(k) application with the FDA to market ROSA One for use in spine. With preoperative planning, navigation, and guidance, the technology shows real potential for use in an MIS TLIF procedure where the surgeon is working through a small portal and may benefit from assistance to gain optimal placement of the graft. That capability may prove to be as important as the design of the implants.
Q: Is Zimmer Biomet in the outpatient space?
MR: The success of Ambulatory Surgery Centers (ASCs) is an important development for outpatient spine treatment. While there are clearly some procedures that are well-suited for the ASC, an important factor for any surgery is the optimized design, delivery, and processing of instrumentation. As such, Mobi-C, with its straight-forward instrument set, has been well-received by surgeons working in ASCs. That is also true of our new Vital™ Spinal Fixation System, with just two instrument trays and color-coded instrumentation optimized for one- and two-level degenerative spine cases. While optimization like this may appeal to all healthcare providers, it seems to especially resonate with those working in an ASC, who value the delivery of quality healthcare in an optimized and cost-conscious environment.
Q: In the next two to three years, what is the best-case scenario in terms of what you'd like to be if everything falls into place?
MR: What everyone hopes is that they're reading the tea leaves correctly. Where a company is investing should be a good indication of their priorities.
For Zimmer Biomet Spine, we continuing to invest in Mobi-C, to do the very best we can to own and cultivate that market, and to ensure that as we expand the base of surgeon users we maintain the great clinical success we’ve enjoyed both throughout the study and since commercialization. The company’s investment in cervical disc, both organizationally and financially, demonstrates our enduring commitment to this segment as a fundamental part of our strategy for the future.
The development of a new business platform for Surgery Assisting Technology (SAT) at Zimmer Biomet also confirms our confidence in this exciting direction in the marketplace. While the initial foray for us has been surgical robotics, SAT will encompass far more, including software/analytics, advanced technologies, and program development services. How organizations care for patients is very different today than it was just a few years ago. Pressure to improve efficiency, effectiveness, and outcomes is changing the way care is delivered. SAT is a platform of collaborative technologies and services that help surgeons and staff streamline the delivery of care. In the end, that will define success. It is not enough to have a robot; we must provide robotics as part of a well-developed strategy that provides benefits to the healthcare system, including integrated contracting, account management, customer service, and product support, as well as improving the way surgeons treat their patients.