What are smart implants?
Osteoarthritis is a common disease that impacts millions of people in the U.S. Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are two very common procedures that typically use traditional orthopedic implants to relieve pain and improve function for those living with the disease. Smart implants are a type of medical device that use smart technology to not only treat various conditions but to also detect and diagnose them. In addition to THA and TKA, smart orthopedic implants have been identified for use in spine fusion, fracture fixation, and others as well. The devices are designed to integrate with the body and provide real-time data to both the patient and their healthcare provider. They have been used to measure pressure, force, strain, stress, displacement, proximity, and temperature from inside the body. This technology allows providers to monitor the health and function of the implant, enabling them to make more informed decisions about the care and treatment of their patients. This blog will discuss how incorporating smart implants into clinical practice has the potential to benefit patients and providers as well as the challenges that need to be overcome first.
What is the history of smart implants and devices?
Orthopedic smart implants are a relatively new development in medicine. Some of the first devices were developed in the early 2000s. In the years since the technology has continued to evolve, and today’s smart implants are even more sophisticated and capable of providing a wide range of functions.
There are a number of companies that have developed smart orthopedic devices and implants that are currently being used. One example is VeraSense, a single-use instrument that transmits data wirelessly in real-time to allow surgeons to perform soft-tissue balancing and implant positioning during TKA. OrthoSensor originally received FDA approval for VeraSense in 2013 and then Stryker acquired the company and its products in 2021. Another example is Persona IQ, a smart knee implant that measures range of motion, step count, walking speed, and other gait metrics. Known as the first smart knee, it received FDA approval in 2021 and combines Zimmer Biomet’s knee implant, Persona, with Canary Medical’s implantable sensor.
Smart orthopedic implants and devices are a rapidly growing field that will likely continue to be developed and become increasingly sophisticated and effective with time.
How can smart implants benefit patients and providers?
Smart implants can lead to improved patient outcomes after surgery with real-time monitoring, personalized care, more engaged patients, and quality data.
Real-time monitoring
These devices are equipped with sensors, microprocessors, and other electronic components that allow them to perform a variety of functions. After orthopedic surgery, these devices can be used to continually monitor the patient’s condition and optimize the healing process. The ongoing tracking may also help to decrease or even eliminate the need for some hospital visits. The data can also be used for the detection of the loosening of implants, implant failure, and more.
Personalized care
Smart implants provide ongoing feedback on a patient’s condition after surgery. They can be used to monitor a patient’s range of motion, muscle strength, and other metrics that are important for recovery after orthopedic surgery. This information can be used by providers to make any necessary adjustments to their treatment plan and it can also guide physical therapy and other rehabilitation efforts. This personalized care can help to ensure that the patient is recovering as quickly and effectively as possible.
Patient engagement
Smart implants may also help patients become more involved in their care. With their implant data readily available, patients can manage their own recovery by monitoring their progress. It could also help them with setting, tracking, and achieving their goals.
Quality data
The adoption of smart implants in clinical practice would lead to a vast amount of data. Clinical studies could greatly benefit from the devices providing data collection occurring in real-time. This would not only reduce the burden on patients to comply, but it would also lead to high quality and quantity of data.
What are the challenges associated with smart implants?
Despite decades of research, smart implants are still not widely used as there are a number of limitations and challenges associated with the devices.
Safety and reliability
Smart implants are designed to be used inside the human body, so it is important that they are safe and reliable. This can be challenging to achieve, as there are many factors that can affect the safety and reliability of these devices, such as the materials used, the design of the device, and the manufacturing process.
Regulatory challenges
Smart implants are subject to a number of regulatory requirements, and meeting these requirements can be a challenge for manufacturers. This includes obtaining approval from the US Food and Drug Administration (FDA).
Cost
Smart implants can also be expensive to develop and manufacture, which can make them cost-prohibitive for some patients. This can be a challenge for both manufacturers and healthcare providers and should be considered.
Privacy Concerns
Ensuring patients’ privacy is crucial for any hospital or private practice. With cybersecurity threats being on the rise in healthcare and other sectors, manufacturers and providers will need to take the necessary precautions to protect patients’ data received from these devices.
Summary
Overall, smart implants can be an effective tool for improving patient outcomes after orthopedic surgery by providing continuous monitoring and helping patients to manage their own recovery. Further, smart orthopedic implants have the potential to facilitate a transition toward more personalized medical care. However, the development and use of these devices presents a number of technical, safety, regulatory, cost, and privacy challenges that need to be addressed in order for these devices to be widely adopted.
Resources
Smart implants in orthopedic surgery, improving patient outcomes: a review | Implantable sensor technology: from research to clinical practice | Concept, design and fabrication of smart orthopedic implants | FDA public workshop: Orthopaedic sensing, measuring, and advanced reporting technology (SMART) devices |
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