The future of smart implants: Surgeons await clinical evidence

calendar_today 24 August, 2022 person_outline Growth Plus Reports

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Introduction

Thanks to digital transformation, we have seen how people have adopted net banking, e-commerce, and online travel bookings as a part of their regular lives.

But does it stop here?

Of course not!

It is exciting to see the impact of digital transformation on the healthcare industry as well.

The most obvious effect of digital transformation is in how the combination of technology and healthcare is improving patient tracking and outcomes with the help of healthcare apps, sensors and wearable devices (like the hugely successful smartwatch) – however, these options extend beyond tracking and outcomes to provide simple and cost-effective ways for people to stay fit in this modern era.

The effect of digital transformation has been so powerful that many have wondered about expanding its reach to other areas. For example, what if the power of digital transformation is taken to the next level with smart implants?

What are Smart Implants?

Unlike wearable devices that are worn close to or on the skin’s surface for tracking vitals, smart implants can be installed in a person’s body, relying on bio/nano sensor technology to remotely monitor their condition for delivering improved outcomes.

The main objective of the biosensor or the nano sensor technology used in these implants is to enable personalized or patient-centric therapy.

Orthopaedics, cardiac resynchronization devices, pacemakers, dental implants, breast implants and neuromodulation represent some of the landmark use cases of smart implants.

Imagine a patient of knee replacement surgery receiving a smart implant to track outcomes and generate data across the patient’s journey, especially recovery. Now, the orthopaedic surgeon can monitor the data generated and make changes in the recovery process for better outcomes.

This is not fiction but a reality which recently came true at HSS (Hospital for Special Surgery) in New York in October 2021, opening a new frontier for both patients and doctors.

Currently, the knee (Persona IQ, Verasense) and spine (Loadpro) have benefitted from smart implants.

In August 2021, Persona IQ by Zimmer Biomet became the first smart knee implant to get De Novo approval by the USFDA for monitoring and remotely transmitting the data related to Biomechanics (the patient’s range of motion of the knee), Gait (walking steps and speed), so that the surgeon could intervene with a therapy plan at an early stage in case the patient was not progressing post-operation.

Verasense is another TKA (Total Knee Arthroplasty) device developed by Ortho Sensor Inc that wirelessly transmits data to the surgeons to help them make informed decisions regarding the positioning of the implant. In June 2018, it received 510(k) clearance by TGA Australia, and Bathrust Private Hospital was the first one to successfully use it.

For the spine, Intellirod Spine is a promising market player that developed Loadpro to track rod strains after spinal fusion for the surgeons to determine left vs right strain asymmetry during corrective surgery.

Many HCPs, especially surgeons are of the opinion that critical decisions made during all three phases of the surgery (pre-operative, operative and post-operative) must be accurate and in complete favour of the patients.

They believe that a lot of hard work is required by a patient in the initial weeks after the surgery because a catastrophe during recovery can lead to an incorrect treatment path.

Here, the availability of smart implants makes it easier to record and review crucial data points. By reviewing the recorded data, HCPs can monitor the progress of patients on their way to recovery, intervening in a timely manner whenever required.

Specifically, sensors in the implants provide granular patient data to the HCPs for a complete understanding of the patient’s progress that enables them to make informed decisions regarding the medication regime, physical therapy or to improve patient’s awareness.

Apart from guiding treatment in real-time, these smart implants also hold potential for massive cost savings by avoiding critical complications. This reduces chances of readmission, period of recovery, frequency of in-person visits, and the need for revision procedures.

Further, steady improvement in sensor technology is enhancing the accuracy of implants, favourably affecting both feasibility and reliability of use.

The Challenge: Presenting evidence (and a new experience) to clinicians

However, following the roll out of the first smart knee implant, clinicians must also learn how to read and review data. Thus, there is a need for the MedTech companies to make the data meaningful for the HCPs.

The data from smart implants are far from user-friendly, making it compulsory for HCPs to engage a full-time data analyst for interpreting the raw data. Even though these smart implants can measure several parameters, the physicians are still struggling to understand how to use the information as a part of their regular practise and help patients.

Another aspect that concerns HCPs is the (lack of prior) experience with smart implants. So, they want to understand and gain enough expertise on how to act on the implants and the generated data before using these implants on the patients.

Further, one must take into consideration the time it is going to take for HCPs to learn to interpret the information. Currently, looking at the patient influx, it is difficult for HCPs to make time from their busy schedule and review raw data. However, it is not surprising that several HCPs are of the opinion that if a sensor provides any new type of information, they need sufficient time to interpret and figure out how to utilise the same.

Besides, some surgeons also think that the size of the sensor can lead to the removal of more bone when performing the implantation providing the MedTech companies with clear challenges and questions that they must address before smart implants see wide acceptance.

Conclusion: What is the future of smart implants?

The domain of smart implants is nascent. However, HCPs are looking forward to more data regarding their use if that will allow for the improved monitoring of patients’ health and their overall treatment outcomes.

The idea behind combining technology with the implants is to build a digital ecosystem around the spectrum of care of the patient.

So, receiving FDA clearance only to track patient’s activity will not suffice the requirements of the HCPs, rather it is the support in clinical decision making that will make a huge difference to the patient care.

However, with more companies, including Stryker (that acquired Ortho Sensor Inc.), and Johnson & Johnson stepping into the area, a boom may be expected in future. Maybe after a few more years, when there will be enough data to clearly demonstrate how smart implants can improve health outcomes at a low cost, the market will take off!