In 2017, Consensus Orthopedics launched TracPatch, a wearable device that monitors patients pre- and post-op in an effort to engage them in tracking their own recovery. TracPatch represents an example of a smaller company developing technology—outside of implantables and hardware—that responds to the evidence-based medicine movement in the healthcare industry.
Consensus launched TracPatch in the U.S. and Australia for total knee reconstruction in 2017, and will launch TracPatch ACL and a demo of TracPatch Hip at the 2018 AAOS meeting. The company’s pipeline includes applications in multiple orthopaedic specialties, including shoulder and elbow.
Spotlight on Sensors
The ability to collect and transmit data through sensors to make smarter decisions—on the manufacturing floor, in the OR, during home recovery and in the design of next-generation devices—is one of the great technological advancements upon which orthopaedic companies can capitalize in coming years. Companies like Apple and Google see digital health as the future and are firmly seated in the healthcare space.
FDA sees this too, and continues to roll out guidance on medical device approaches to apps, cybersecurity, interoperability, software and telemedicine.
BONEZONE author Deborah Munro, D.Eng, of Munro Medical, penned an article on ways that companies can design micro electro mechanical systems, referred to as MEMS devices or sensors, for your next device.
To provide perspective along with the how-to, we interviewed two additional companies using or developing uses for sensors in orthopaedics:
Douglas McCollum, Marketing & Communications Manager for Consensus Orthopedics, answered our questions about the technology:
BONEZONE: How does TracPatch work?
Mr. McCollum: The TracPatch device is a rechargeable unit attached to an adhesive disposable patch that is applied directly to the patient’s skin. The device continuously collects data, 24/7. It syncs wirelessly by Bluetooth to a smartphone with data uploads to the TracPatch cloud server. The patient and healthcare provider both have apps on their smartphones, which guide and empower the patient with exercises, videos and direct-to healthcare-provider contact. TracPatch provides the healthcare provider with anytime, anywhere insight into a patient’s recovery, allowing for immediate care adjustments and the ability to get ahead of recovery issues, empowering patients and healthcare providers with real-time recovery efficiency.
BONEZONE: What are you tracking?
Mr. McCollum: TracPatch will monitor:
- Range of motion
- Exercise recognition/compliance
- Notable events
- Temperature trends
- Advanced analytics
Focused on reducing episode-of-care spending, TracPatch could help cut healthcare system costs by reducing readmissions, at-home physical therapy, manipulations under anesthesia and unnecessary office visits.
BONEZONE: Do you know of competitors developing such a technology?
Mr. McCollum: No one is developing what we have created. We have seen some technology used in bracing, but none offer the capabilities or analytics when adhering the TracPatch sensors directly to the patient.
BONEZONE: What was the FDA process like? What about reimbursement?
Mr. McCollum: TracPatch is a Class I device, and the regulatory process has been straightforward. We are evaluating other regulatory pathways for future devices. As well, multiple reimbursement strategies are available and we have created a reimbursement plan that we feel is competitive and opportunistic.
BONEZONE: How far is orthopaedics from incorporating sensors into the actual implant?
Mr. McCollum: The problem with an implantable device is that it is specific to the implant. Our product is agnostic; it can be used with any implant and can be placed pre-operatively to create a baseline for post-operative recovery. The TracPatch wearable minimizes regulatory concerns that you would have with an implantable device, such as potential ill effects from batteries and electronics inside the patient. There is no limit on the use of TracPatch as a wearable device.
Carolyn LaWell is ORTHOWORLD’s Chief Content Officer. She can be reached by email.