Orthopedic device industry watchers think so, and Zimmer Biomet appears set to be the first out of the gate this year through a partnership with the startup Canary Medical.What do drug-eluting stents and “smart” implantable medical devices have in common? It turns out it’s a lot, at least according to Dr. Bill Hunter.
The founder and CEO of Angiotech Pharmaceuticals from 1992 to 2011, Hunter saw that medical device companies had cardiovascular stents that could save lives but also caused inflammation problems, while pharmaceutical companies had drugs that could stop the inflammation. He helped bring the technologies together, playing a role in the invention and development of the Taxus drug-eluting coronary stent from Boston Scientific and the Zilver PTX peripheral drug-eluting stent from Cook Medical.
Hunter started Canary Medical (Vancouver, British Columbia) in 2012 because he thought that micro-electromechanical systems (MEMS), sensors, batteries and wireless communications had advanced enough — especially when it came to pacemakers — that one could package sensors with implantable medical devices.
The company’s name came from the idea that the resulting data stream could do for healthcare what canaries did for coal miners: Provide an early warning.
“I used to say, ‘We live in a world where your refrigerator’s connected to the internet. Why are lifesaving medical devices not?’ There’s some pretty valuable information we’d like to know,” Hunter said in a recent interview with Medical Design & Outsourcing and MassDevice.
“We were all from a cardiology background,” Hunter said of the Canary team in the early days. “We thought, ‘Hey, we could do this almost by making a pacemaker.’ We take a battery, we take telemetry, substitute sensors for the leads.”
The execution of the idea was still hard, according to Hunter. “You got to have consumer electronics to get it there. You got to do cloud storage and data analytics and user interfaces on the other end. None of the components is rocket science, but putting them all together is actually a bit bigger task than meets the eye. And so it’s pretty exciting.”
The result was the Canary Health Implantable Reporting Processor (CHIRP). It’s the size of triple-A battery and modular enough that Zimmer Biomet officials in recent years saw the potential of embedding the sensor inside the tibial extension segment of a commercial knee prosthesis.
The birth of smart knee implants
Zimmer Biomet this year plans to launch the Persona-IQ, a next-gen version of its successful, personalized Persona Revision knee implants that will incorporate the CHIRP sensor.
The Persona-IQ received breakthrough device designation from the FDA in October 2019. Zimmer Biomet and Canary Health are in the final stages of a De Novo 510(k) clearance process with the agency — as well as reimbursement decisions from CMS that could enable doctors to receive extra payments for monitoring CHIRP data.
During a March earnings call, Zimmer Biomet CEO Bryan Hanson described Persona-IQ as an important piece of the puzzle to create a digital ecosystem around ZB’s implants.
“We’ve had a significant shift in our research and development dollars toward robotic storage, data informatics to build that ecosystem that’s going to be meaningful for patients and for our customers alike. And I got to say, there’s a lot of excitement around that in our organization, a lot of excitement from our customer base as well,” Hanson said.
Competitors are already working to catch up. Stryker, for example, announced in January that it had bought privately held OrthoSensor and its Verasense intraoperative sensor tech that could further enhance the ortho giant’s Mako robots.
“Smart devices and implants will play an important role in the future of orthopedics, and the addition of OrthoSensor will allow us to continue to innovate and advance smart sensor technologies, including intraoperative sensors, wearables and ultimately, smart implants,” Stryker investor relations VP Preston Wells said during a January earnings call.
Zimmer Biomet appears to be at the forefront of smart implants, and the Persona-IQ should start driving revenue growth in late 2021 and early 2022, SVB Leerink managing director Rich Newitter said during a DeviceTalks Weekly podcast in February.
Information from sensors such as the CHIRP could decrease the number of times a patient needs to come back to a doctor’s office — and could even one day identify problems with an implant before they happen, according to Newitter.
“I think that it is a pretty exciting time for what I think will be an important first-generation of sensor-based technology in orthopedics,” Newitter said.
Smart implants appear to answer the ortho device makers’ question of how to further innovate and make procedures better, said Truist Securities managing director Kaila Krum. “Ultimately, I do think that that smart implants will play a role.”
Creating a ‘knee-CG’
The CHIRP sensor in its tiny package includes gyroscopes, accelerometers and a pedometer, enabling it to measure and passively broadcast data on step count, range of motion and gait. A Home Base Station that’s the size of a modem plugs into a home outlet and uploads the data to cloud infrastructure powered by Microsoft Azure. Health providers can use the data to track how well the knee implant performs and spot potential infections or failures.
The battery technology is sufficiently long-lasting that a CHIRP implant could broadcast for up to 20 years. Its data could make it easier for doctors to do more knee patient checkups remotely — something they’ve been struggling to do amid the COVID-19 pandemic.
“We can monitor a patient, see if they’re active, do their range of motion, see how they’re progressing,” Hunter said. “That’s a good product.”
Hunter thinks CHIRP could accomplish even more in the future, though, as artificial intelligence helps spot patterns that could provide early warnings of problems. One of the Canary team members even coined the term “knee-CG,” a comparison to how an ECG measures the heart’s electrical activity but tells so much more based on its data patterns.
Imagine, for example, a stoplight chart in which most postoperative patients have green lights because the CHIRP data suggests that they are doing fine with their knee implants and probably only need reassurance. Meanwhile, a fifth have yellow and red lights, signifying they need to get back into the office for further work.
“If we can identify problems early, then it really becomes a ‘why not’ therapy at that point in time,” Hunter said.
For now, Canary Medical remains focused on Zimmer Biomet’s Persona-IQ launch. But Hunter sees the potential in coming years to package CHIRP sensors inside hip and shoulder implants. “It really is a modification of existing technology,” he said.
Looking farther into the future, Hunter envisions smart ortho screws that could run currents through bones to measure healing — and even tiny ring-shaped sensors in the cardiovascular space.
“The sensor technology is so good that we have a sensor power source and transmitter that we can fit onto a 1-by-1.5-mm chip,” he said. “So we’re going to start to be able to get into smaller and smaller and more intricate devices as we go forward.”