Tips to help device developers get paid from smart ortho implant maker Canary Medical

Canary Medical founder and CEO Dr. Bill Hunter said the smart ortho implant developer just passed a major milestone, logging a millennium’s worth of patient follow-up.

That’s 1,000 years of day-by-day follow-up on patients after they’ve had a joint replaced, he said, collecting data that helps Canary Medical’s remote patient monitoring system measure and analyze post-op recovery and implant performance.

The data also helped Canary Medical secure New Technology Add-On Payment (NTAP) reimbursement this month, which in turn helps sell the technology to orthopedic practices, Hunter said in a presentation at DeviceTalks West 2023 in Santa Clara, California.

“We’re starting to see a substantive inflection point,” he said. “What I think is really fascinating is… that if a practice adopts it, they tend to adopt it in its entirety.”

Sensors in the smart implant monitor from 7 a.m. to 10 p.m. daily in year one, the time period where the patient goes through the most physiologic changes. The device monitors less frequently in the years after to preserve battery life, since the battery can’t be replaced without removing the implant.

“That’s how we got 20 years of functionality out of single battery and a single implant,” Hunter said.

These sensors measure patient activity and range of motion to track how well the patient is recovering. They can also measure — at 800 observations per second — vibration of an implant to track the implant’s stability and osseointegration.

For five seconds at 2 a.m., the implant transmits data via Bluetooth to a base station in the patient’s bedroom. But patients need to keep that base station powered up and within transmission range for the data to sync, allowing the patient and physician to review the data that next day.

The data can tell a doctor how well the patient is doing compared to their pre-surgery performance, and also against where they would be expected to be based on other patients’ recoveries. Traditionally, most orthopedic patients recover without problems so follow-up declines unless there’s a serious problem. But remote monitoring helps to track all patients while identifying outliers who need more attention, allowing a doctor to identify patients who need to be seen.

Patient compliance hacks

“Human nature is [that] people are going to say, “I feel great. I don’t need this knee monitor anymore,'” Hunter said.

But Canary Medical has figured out a few “hacks” for ensuring compliance with its smart knee monitoring system.

Doctors can contact the patient and ask them to plug their at-home base station back in or whatever else it takes so the receiver can start pulling data from the implant again. An anniversary of the procedure might be a good excuse to reach out.

“The way I look at it is from a very clinical perspective. As long as they keep it on — honestly, for the first six months — but hopefully for the first year, that’s where most of your physiology happens,” Hunter said. “By year five and six. I’m really just looking for changes from baseline. I want to see how year six looks compared to the end of year one. And so if I get enough readings off of that it’s probably going to serve its clinical utility.”

Even if a patient isn’t using the base station that receives daily data from their knee implant, their doctor can download the last 30 days worth of data when the patient comes for an in-office visit. There are other factors that motivate doctors to make that contact — not just reimbursements for annual follow-ups, but also the potential that the patient may need another knee replaced at some time.

Reimbursement tips

Canary Medical won FDA breakthrough device status for its hip, knee and shoulder smart implants.  Hunter said the benefits of breakthrough status boosted its reimbursement efforts for the Persona IQ knee implant it made with Zimmer Biomet, which secured FDA de novo marketing authorization in 2021.

“It really did help. We [had] an interactive review, and now that we’re launched, it’s helped a lot because it’s accelerated our reimbursement,” Hunter said.

Beyond Canary Medical’s NTAP reimbursement, Hunter said he expects Transitional Pass-Through (TPT) payment for outpatient procedures as well.

“That’s a big head start that’s going to allow us to get paid while we go about the process of building long-term value proposition,” he said.

To help physicians get paid for using the technology, Canary Medical also created a fully integrated PDF for billing.

“This goes right into the billing system, and they’re able to get paid $110 per month for doing remote patient monitoring. … It’s probably about 10 times less expensive than doing this stuff in person. But for a doc, $1,000 per patient if you’re doing 400 knees a year, it’s absolutely worth doing right. And you’re used to being paid for that anyways, but that was for in-person office visits and X-rays and MRIs and a bunch of other things. Make the same amount of money — arguably more because you don’t lose patients to follow-up — but you’re actually not costing the system more at all.”