Harnessing Connected Med Device Data for Improved Patient Outcomes

Lorraine Chapman | April 6, 2017 | 8 Min Read

Lorraine Chapman, Sr. Director of Healthcare at Macadamian sat down with Ivan Delevic, President and CEO of OrthoSensor to discuss connected medical devices and how OrthoSensor is using data analytics to improve patient outcomes in Orthopedics.

Harnessing analytics for improved outcomes is becoming table stakes in Healthcare today. With the convergence of sensors and other data-generating devices, analytics can support quantified decision making in many different areas including Orthopedics.

At a recent Medical Technologies Frost & Sullivan event (in San Diego, March 19-21st), I sat down with Ivan Delevic, President and CEO of Orthosensor, to explore how we can improve the care of patients and economic performance of orthopedic services with decision support resulting from efficient integration of sensor outputs with clinical, patient, hospital and other device data. Sensors and data analytics enable every orthopedic patient to benefit from information gathered from all prior patients.

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Lorraine Chapman: First of all Ivan, I should note for everyone that Macadamian had the pleasure of working with OrthoSensor in 2015. We were brought in to enhance and improve the overall user experience of the existing VERASENSE iQ application, as well as designing a new tablet application to facilitate the collection of pre-and post-operative patient information. Early on, OrthoSensor recognized the user experience needed to be optimized to better support input of the patient data, the association of that data with the pre- and post-operative data, as well as sensor data to provide better analytics and metrics to show improved outcomes for patients.

Can you tell us more about Orthosensor and how the company is currently utilizing sensors to improve surgical outcomes?

Ivan Delevic: OrthoSensor is a Florida-based company, founded by Dr. Martin Roche who is a visionary orthopedic surgeon at the Holy Cross Hospital in Fort Lauderdale.

As a bit of background, orthopedic surgery is focused on realigning bones and recreating joint function by replacing the joint surfaces with metal and plastic implants. Most of us will have knee joint problems in our lifetime. During a joint replacement procedure, the surgeon will resect the bone and replace it with implants and align the joint to where it needs to be to function better. Outcomes are based on a small margin of error of aligning the joint to make sure it functions the way it used to function before arthritis impacted the knee. Implant designs have not changed much over the last 25 years, but the materials technology has evolved quite a bit to support longer lasting plastics and metals. Orthopedic implants now last much longer and are very successful in their performance. However, 20-25% of people will complain about the implant not feeling very good after the 9-12 month recovery period. We at OrthoSensor believe that this lack of patient satisfaction significantly relates to the soft tissue forces and the joint balance. Today, surgeons use a very subjective feel to assess balance during surgery. Dr. Roche came up with the novel idea of using pressure sensors to quantify changes in the soft tissue balance to improve patient outcomes. Through OrthoSensor, he brought in sensor-based data into soft tissue evaluation in orthopedics.

LC: So the sensor provides real-time feedback about the placement and “feel” of the implant at the time of implant?

ID: Yes and we want to extend the roadmap to integrate sensors into the implant itself in the future, so data can be collected post-operatively as well. We have over 50 patents and another 70 in filing. OrthoSensor didn’t just develop a new product – we created a completely new field of data-driven balancing that did not exist before! Our ultimate vision is to become a data services company, not only a sensor-based device company. The sensors are really just a vehicle – the value is in the data.

LC: And it is ultimately the data that will help improve outcomes?

ID: Yes. Patients who leave the hospital with a balanced knee will likely recover faster, have less pain and reduce the risk of needing a revision in the mid-term.

LC: How did you overcome the barriers to adopting your technology?

ID: Orthopedic surgeons initially adopted our product on its clinical merits. This IS changing since the bundled payment started, to include more of a barrier on the economic side. Even with growing clinical evidence through peer-reviewed journals, our products are considered increasingly on their economic merits. Purchase decisions are driven through the VAC (Value Added Committee) and being decided on in large part by hospital administrators.

From a perspective of reimbursement, orthopedic joint surgery gets a lump sum payment. Medicare, through the bundled payment, is now looking at the 90-day period of care, not just the cost of the surgery itself. What was an average of $13-14K payment before became a threshold of around $25K for the cost of care over the 90 day period. This number shows that about half of the primary total joint procedure costs happen after the surgery, in the initial recovery period.

Like so many other companies, we encountered the economic pushback from administrators looking to understand the ROI of implementing the new technology. We collected a lot of economic data of the 90-day bundle, then did the analytics related to outcomes of patients that were balanced with VeraSense to prove that the additional sensor cost during surgery will save the system more than the amount the hospital pays for the product. This proof is now helping us get accepted at more accounts.

LC: Which naturally leads to my next question, what is the current state of healthcare and payers in terms of paying and appreciating these types of offerings? What does that mean for reimbursement and bundled payment models?

ID: A lot of systems that are not vertically integrated need to resolve an issue in that hospitals do not have all of the economic information and controls about the processes that happen outside the hospital. Under the bundled payment program the original hospital that performed the surgery will be largely responsible for follow-up costs relating to a surgery over the 90 days, even if it is provided at a different hospital.

OrthoSensor wants to ensure that data is collected systemically during the surgery and post-operatively to correlate the patient outcomes with surgical decisions in a quantified way. Using the sensors, we can take a “digital signature” during surgery and put it in a cloud-based repository to be able to access it post operatively. Most of the private insurers are starting to demand that hospitals collect registry data to track quality. We bring the ability to automate this process more.

In addition, the cost of wearables has dropped significantly. As a result, OrthoSensor intends to work on creating simple wearables to provide an objective baseline ahead of the surgery and post surgically to monitor the performance over the 90 days after surgery. Effort of motion, range of motion and activity are some of the important diagnostic data that could be collected through wearables.

As an example, early evolution and increase of the range of motion in the knee is a significant indicator of recovery. This information can provide reassuring feedback to the patient if their range of motion is improving according to a schedule. Alternatively, the surgeon could receive an alert if the patient halts their progress in that regard during rehabilitation and intervene appropriately.

LC: Could the sensor now be integrated into the joint itself?

ID: Yes, but there is still sizeable work to make this a reality. For example, we don’t want batteries in the joint, so we’ll need to have some sort of energy harvesting solution. OrthoSensor is working on solutions to address issues like this. The technologies are getting there to enable a smart implant and we hope to be one of the first to offer it. We have mastered the data processing and algorithms, including our own ASIC, and are ready to move towards developing sensors integrated into the joint.

LC: Are you going to be monetizing the data you collect?

ID: We are building the infrastructure in order to collect and eventually monetize the data, but are early in our work to fit the business model around data services into the current funding realities. The concept of monetizing clinical data in this way is fairly new and the business models are still evolving. We could sell to the orthopedic community data about what decisions are best predictors of positive outcomes. Everyone is looking to show the economic return on investment (ROI) and the data has to demonstrate real returns to be valuable.

LC: Are you looking at integrating predictive data models?

ID: To answer that question, we need to recognize the diverse nature of the data itself and its path of collection, analysis, and reporting. OrthoSensor intends, at an aggregate and analytics level, to collect as much of the data as it can. However, there will be dynamics between OrthoSensor, the hospitals and the implant manufacturers related to who owns what aspect of the comprehensive data. The data aggregation path between various contributors will require some time to really evolve.

Some countries, like Australia, have a patient joint registry. This registry provides wonderful tools for driving consequential improvements in the orthopedic process and quality. We are working on introducing a flag in these registries to be able to track differences in outcomes as a result of using the OrthoSensor tools.

LC: How do the business models need to innovate to support these new technologies and new treatment paradigms?

ID: We are experimenting with different business models. Our primary current business model is to sell disposable sensors for around $500 on average between US and Internationally. We have a tablet-based user interface device that we provide through a monthly subscription model so we avoid a capital equipment purchase process. By not fully transferring this asset, the technical data of the tablets stays more within OrthoSensor. We also have the benefit of the ability to manage and upgrade the tablet devices remotely. Our products are currently used in over a 100 hospitals in the US.

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