How Consensus Orthopedics added smarts to orthopedic devices

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Consensus Orthopedics TracPatch DeviceLab

TracPatch enables caregivers to monitor total knee patients for range of motion and other key metrics in a post-surgical home setting. [Image courtesy of Consensus Orthopedics]

Consensus Orthopedics made headlines with its TracPatch this year. So how did an ortho company get a digital product to market?

Let’s face it, orthopedic devices are dumb. That is to say, they are mute. Silent. And in today’s healthcare environment, the silent kind of dumb is dangerous.

Consensus Orthopedics (El Dorado Hills, Calif.) wanted to change that – and DeviceLab (Tustin, Calif.) played an important role. The growing orthopedic company makes high precision hip and knee products for the U.S. and global market and has seen 50% growth over the last five years.

(See the best minds in medtech live at DeviceTalks Boston on Oct. 2.)

Consensus is a growing orthopedic company that makes high-precision hip and knee products for the U.S. and global market and has seen 50% growth over the last five years.

But as president Curt Wiedenhoefer put it, ortho devices mostly remain “non-intelligent devices.” At DeviceTalks Minnesota in June, Wiedenhoefer said that lack of intelligence is costly and out of sync with today’s healthcare needs.

“[The orthopedic] industry is going through a transformation in a few ways,” Wiedenhoefer said.

First, about 1.2 million total joints are performed in the United States each year, and that number is going to climb to about 4 million per year by 2030. Second, patients are being asked to leave hospitals the same day of surgery, which means they are outside of a controlled setting far sooner than they used to be. These patients may live in rural areas, making in-person follow up care difficult.  And finally, the average age of a total joint replacement patient is 66, which means they are more likely to be in the Medicare program. CMS’s Comprehensive Care for Joint Replacement (CJR), requires hospitals and post-acute providers to partner and coordinate for a patient’s entire 90-day episode of care.

In 2016, Wiedenhoefer estimated about 700,000 total knees were performed in the U.S., “and we had very little data collected on those knees.” In short, the only data the healthcare system has on such patients is objective (e.g., what they fill out on forms).

Consensus decided it needed to combat the lack of data immediately. “We eventually want microelectronics embedded in orthopedic devices, but that is going to be a long regulatory process, and we need information more quickly,” Wiedenhoefer said. “Our goal in 2017 was to have the first wearable product for the total joint replacement patient.”

Creating such a device, however, would have taken Consensus out of its core business technology. “We know metal and plastic, not electronics.”

In lieu of a lengthy product redesign and to ensure the wearable was done right, Consensus partnered with DeviceLab. DeviceLab is an engineering consulting firm with a proprietary build platform called Apollo. Henry Bryson, director of business development at DeviceLab and the moderator of the DeviceTalks panel discussion, noted that Apollo is platform agnostic, meaning it can use any sensor and any operating system to gather and identify alert conditions.

Apollo seamlessly integrates multiple complementary technologies. It is designed to reduce costs and development time to get medical IoT device to market quickly. It can accommodate patient monitoring, imaging, POC diagnostics and therapies through wireless medical design technologies.

The result of this partnership is a wearable device called TracPatch, which was launched in March this year. TracPatch remotely monitors a patient’s post-surgical activities by sending activity data to healthcare providers during the first six weeks of at home recovery. It provides range of motion (ROM), ambulation, exercise compliance and wound site temperature trends to healthcare providers.

DeviceLab helped Consensus create the wearable component, which is placed on the lower leg just below the joint line. It uses Bluetooth Low Energy to transmit key post-surgical data points from the wearable to a patient’s phone and then directly to a secure cloud-based platform.

The wearable device is also a tool for pre-surgical data capture because it allows surgical teams to monitor activity levels and range of motion before the surgery.

TracPatch ticks all the boxes: it offers an inexpensive method for patient monitoring to improve patient compliance and to track to post-surgical events. Those tasks allow healthcare teams treat patients who need help, keep healthy patients out of the hospital and keep costs down while enabling access to recovery metrics for improvement in surgical procedures.

Wiedenhoefer anticipates that the TracPatch will be rolled out to other joint replacement areas, as well as other knee procedures such as ACL.

(See the best minds in medtech live at DeviceTalks Boston on Oct. 2.)

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