Several hundred pain clinicians, neurosurgeons, and neuromodulation industry professionals assembled in Orlando, Florida, July 15-17 for the 2021 Mid-Year meeting of NANS, the North American Neuromodulation Society. The event, which augmented the society’s January 2021 web conference, was the first in-person neuromodulation meeting for many attendees since the onset of the coronavirus pandemic.
The meeting featured a pre-conference commercial session called i3 (invention, investment, and invigoration), which was devoted to “Innovation in a Hyper-Connected World.” Course director Ash Sharan from Thomas Jefferson University kicked off the session with a discussion of technology tools used in the delivery of healthcare including chatbots, telehealth, and networking tools.
Erika Ross from Abbott gave an overview of the company’s efforts to integrate neuromodulation therapies with digital health tools. Abbott’s digitally enabled patient-centricity incorporates artificial intelligence, virtual reality, telehealth, and wearable components. In one study, patients wore Apple watches to help map parameters like heart rate and steps climbed with pain scores. Her team created a “random forest” model that mapped those metrics to the perception of pain. “We could actually predict with a high degree of accuracy what patient’s pain scores would be,” she said.
Abhi Kulkarni from Medtronic described his company’s efforts at data-enabled neuromodulation. Historically, neuromodulation devices were “data-poor,” he said. But advances in biosignals have promised to change that situation. In particular, he mentioned evoked potentials, local field potentials, and EMG signals as examples. “The combination of biosensing and data acquisition is going to bend the curve of neuromodulation in the future,” he said. Kulkarni predicted that the amount of data collected per session would increase and the amount energy consumed would decrease in the years to come. “Data that comes through the therapy will have as much value as the therapy itself,” he said.
Other presenters in the morning session included Yelana Yesha, the director of the NSF Center for Accelerated Real Time Analytics and professor of computer science at the University of Miami. She spoke about the role of blockchain and AI/machine learning concepts in the healthcare ecosystem.
Danica Marinac-Dabic, the associate director of the Office of Clinical Evidence and Analysis at FDA/CDRH, addressed regulatory issues confronting device firms.
Mark Domyahn from JD Lymon spoke of the challenges confronting neuromodulation vendors when it comes to reimbursement pathways. “Getting value out of the reimbursement system is a journey that each technology has to figure out,” he said. “And figuring it out early is really important.” Domyahn said that the gap between what the FDA wants and what CMS wants was very narrow 15 years ago. Now it’s getting to be a chasm the size of the Grand Canyon, he said. “Payers write checks—the FDA does not. Payers are built to say no—never forget that,” he exhorted. “Come at them with something meaningful.” Domyahn advised attendees to make sure they understand that CMS’ concept of “medically reasonable and necessary” is not the same as the FDA’s “safe and effective” metric. He stressed the three most important factors in reimbursement: coverage, coding, and payment. Of the three the most important is coverage.
Neuromodulation device vendors seeking reimbursement coverage need to answer several questions early on in the commercialization process. These include: What’s the unmet need? How does your product address it? What are the value propositions, both clinical and economic, and for whom do they apply? Domyahn advised attendees to avoid the thinking that their product will save society money. “Society doesn’t write a check,” he quipped. Instead, it’s important to know your specific target population and how your product will benefit that population. It’s also important to consider whether your product is novel or a “me-too” product. Either route could work, but being first to market changes the reimbursement landscape dramatically, he said.
The i3 morning session concluded with a panel discussion with executives from the big four firms in SCS: Abbott, Medtronic, Boston Scientific, and Nevro. Dave Anderson from Medtronic mentioned the company’s new Vanta primary cell SCS system. Brad Maruca from Abbott shared his perspective on innovation. “Our approach to every problem starts with the patient,” he said.
Nevro CEO Keith Grossman said that innovation is part of the company’s DNA. “We consider innovation in the form of evidence,” he said. He also mentioned service and support as key elements of innovation. He also highlighted his firm’s impending foray into painful diabetic neuropathy. “This is an enormous group of patients who are not being treated effectively,” he said.
Boston Scientific Neuromodulation president Maulik Nanavaty mentioned that compared to five years ago, patients are more informed and have more knowledge when they walk into a physicians’ office. “At the end of the day, the physician, the patient, and the device all have to work together,” he said.
The executives seemed to agree that there could be room in the SCS market for one or two new players if they had unique technology, in response to a question about the impending entry of Saluda and Biotronik. But they cautioned that entering this market was not for the faint of heart and that it could take several years for a new player to achieve a foothold.
In an interview with NBR, Boston Scientific vice president of medical affairs Nilesh Patel described some of the competitive advantage of the firms’ new fast-acting sub-perception (FAST) and Contour therapies. Patel said that FAST provides profound paresthesia-free pain relief in minutes, while Contour delivers stimulation in a more efficient manner than traditional SCS.