The OMTEC Surgeon Pod hosted future-focused presentations by orthopedic surgeons.
Materials, robotics and technology are constantly making the news, and many of the surgeons who spoke at OMTEC® 2019 are ready for the transformation that these enhancements can bring to the industry. But, based on their comments, the technologies themselves may not be ready for primetime.
Surgeons are excited about a wide array of potential innovations. Kornelis Poelstra, M.D., Ph.D., of The Robotic Spine Institute of Silicon Valley, is a vocal advocate for robotics as well as materials advancements that can usher in the next generation of spine products. To the latter point, he believes that the era of titanium products has reached the extent of its usefulness and that manufacturers should be looking at molybdenum-rhenium (MoRe) alloy as a replacement. (MiRus has developed medical devices with MoRe, and received the first FDA 510(k) clearance for the material to use it in its pedicle screw.) MoRe has superior biochemical and mechanical properties compared to metals currently used in spine, but as Dr. Poelstra noted, the orthopedic industry is typically slow to adopt any new technology.
That slow pace has also impacted the development of robotics within orthopedics. For all the focus that the industry puts on currently available robotics systems, Doug Unis, M.D., of Mount Sinai and Monogram Orthopaedics, said that these first-generation systems are too expensive, too slow and disruptive in the O.R. “Mako costs $1.2 million dollars and is an Atari. ROSA is a glorified saw guide. Same with Orthotaxy,” he said.
While he acknowledged the improvements being made in systems currently in development, Dr. Unis pointed to the “same old implants” that these robots will be implanting. During his presentation, he estimated that his practice maintained around $1,500 of inventory for every $100 of revenue they earned. He believes that the future of joint replacement lies in the synergy of robotics that are fast and cost-effective, along with patient-specific implants quickly created with additive manufacturing and delivered “just in time” for the procedure.
Despite the drawbacks of currently available robotics, these systems are generating a tremendous amount of data during procedures. However, providers have very few effective ways to utilize that data for their practices. Surgeon entrepreneurs like Kris Siemionow, M.D., Chief of Spine Surgery at the University of Illinois in Chicago and Founder of HoloSurgical, seek to solve those types of problems through artificial intelligence (AI).
The principle of Moore’s Law—that computing capacity doubles every two years—and the increasing affordability of data storage have opened the door for smaller companies to leverage big data. Part of HoloSurgical’s feature set is an AI-based tool that offers automatic color-coded spine anatomy identification, autonomous surgical planning and intraoperative guidance. However, the same properties that create value in such a tool, namely machine learning and evolution of the training network, are serious challenges to FDA’s approval process. The agency is working on a framework for devices that use adaptive AI algorithms but has not announced a timetable for draft guidance.
FDA has taken a stance on digital health and wearables, which has led to new product launches from industry and a consumer market overrun with healthcare-adjacent wearables. Unfortunately, as noted by Christopher Pelt, M.D., Medical Director of Orthopaedic and Trauma Unit at the University of Utah Department of Orthopaedics, consumer wearables have not been shown to improve patient outcomes. But he had an important caveat: They could.
Currently, wearables provide a scattered landscape of unvalidated data that the provider has no easy way to access or leverage. In his view, the current and upcoming generation of wearables could be of great value in rehabilitation, where they can offset the time and cost associated with an in-person physician or physical therapy visits. Those savings could further offset the higher cost of better-quality wearables that depart from the “gadget” market. Dr. Pelt’s patients are enrolled in Zimmer Biomet’s clinical study for mymobility, an Apple Watch app designed to facilitate the connection between hip and knee replacement patients and their surgical care teams.
The true potential of wearables will be unlocked when they can collect meaningful and actionable data in real-time that can be integrated with an electronic medical record. Artificial intelligence will be required to analyze the data, stratify risk and provide optimal advice. Under those circumstances, Dr. Pelt said, wearables could reduce low-value interventions, reduce overall costs and improve outcomes.
Some companies are using process innovation as a means to attack the inventory problem. The EcoSmart program by CrossRoads Extremity Systems seeks to reduce costs associated with instrument sterilization while adding efficiency to the workflow and storage requirements of the surgical team. After a procedure, the surgical team packages up the used instruments and returns them to CrossRoads, where they are cleaned and refurbished. For each returned instrument, the customer gets a rebate. Joe George, DPM, a podiatric surgeon at Illinois Orthopedic Institute, said that his practice saves around 5% to 7% through the rebates. As most companies struggle to streamline their inventory management approach, Dr. George feels that companies should consider processes that improve O.R. efficiency and turnover, as well as reduce waste and save money.
These surgeon voices are clear in that they are interested in leveraging new technology and platforms for the benefit of their patients and their practices, and they will look to the data to measure progress.
Mike Evers is ORTHOWORLD's Market Analyst.