When it comes to medical innovation, perhaps the most elusive evidence for any researcher to capture are the potential patient outcomes for a new device or surgical technique. For many innovations, only time will tell. For others, simulation opens the door for discovery. When it comes to orthopaedics, Cleveland Clinic is fortunate to have a team dedicated to simulating the complex motions and loads of the human body to test a wide variety of implants and surgical techniques. The Clinic’s biomechanical testing platform, also known as simVITRO, is now helping fellow institutions answer clinical questions all over the world.
In the case of orthopaedics, there are a multitude of test systems focused on the wear and fatigue life of potential implants. However, these systems are not able to answer other difficult scientific questions, such as: What is the best way to reconstruct an ACL? If a tumor is removed from the spine, does the patient need a fusion surgery or do enough of the natural structures remain intact and allow for a less invasive surgery? What hip implant provides the best stability? How big does a shoulder bone defect need to be before requiring surgical intervention? What knee implant allows for the closest knee joint motions to that of the native knee? simVITRO was built in-house in the BioRobotics Core of the Department of Biomedical Engineering to answer these questions and many more.
“If you’ve ever seen or heard of the robots that test furniture by replicating a seating motion over-and-over to ensure durability, that’s kind of what simVITRO does,” says Robb Colbrunn, simVITRO Team Lead. “As you can imagine, the human body is more complex than a chair, and replicating these complex motion and loading profiles require unique configurations of hardware and software systems which can be difficult to create.”
This difficulty is well known in research centers. Typically, when a research center wants to perform this type of orthopaedic biomechanics testing, a student is charged with obtaining a robot and the associated hardware, designing and coding up the software, integrating all the various components, and performing the experiments. This can take years and a lot of funding just to get started. The know-how generated in the set-up process is also harbored by a few individuals, making it difficult to replicate the process for the next project after that student graduates. In addition, students are more focused on doing the work required to graduate, not building a long term sustainable testing platform. Aware of these pitfalls, Cleveland Clinic recruited Colbrunn to the Lerner Research Institute 12 years ago and laid out a vision of creating a laboratory that would set the world standard for in vitro orthopaedic biomechanics research.
“It was an exciting and daunting vision,” says Colbrunn. “Project by project we developed the tools for robotic testing of each new joint. First knee, then foot, followed by shoulder, hip, and spine. We didn’t end up with simVITRO on the first try. Nor did we ever consider the possibility of making a product out of our software.”
After several projects, the team realized in 2011 that they had an unsustainable software base. Several different versions of the software existed. While everything was largely similar, the different joints and robots resulted in slightly different code. One little change in the code would need to be changed in several places.
“That is when we reimagined the software, and the concept of simVITRO was born,” says Colbrunn. “The new system would need to be fully customizable, without needing to reinvent the wheel with each question. The principle was that we could test any joint, use any robot, apply any load, and measure anything.”
Colbrunn and his colleague, Tara Nagle, took up the challenge, and within 6 months, the first concept of simVITRO was up and running.
“We focused on building the right foundation with immense amounts of flexibility such that all the required hardware components out there in the world could be plugged in, if needed,” adds Colbrunn. “In addition to making sure it was open for new hardware components as they became available, we also wanted to make it flexible for users to adapt simVITRO to their particular application. It’s not an easy thing to conceptualize, but we built something that’s proven to be very robust, which is a credit to my team.”
After being approached by a university in Australia about purchasing simVITRO, the team approached Cleveland Clinic Innovations about commercializing the new platform in 2012. CCI and simVITRO worked together to validate the unmet need, and subsequently began marketing the system as a fully customizable robotic platform that could be fully implemented within weeks at any research center. A testament to the demand, simVITRO had 3 takers in the first year.
Today, there are 12 simVITRO systems worldwide, as well as a partnership with a European distributor. The team grew in size with the recruitment of Callan Gillespie, and also just launched a website to field a growing amount of inquiries. With each new client, simVITRO capabilities continue to grow, as does its commercial viability. simVITRO has begun receiving calls outside of orthopaedics, and outside of the healthcare market in general. While the prospects are exciting, Colbrunn is particularly energized by the growing number of researchers who have been enabled by simVITRO to make new discoveries that can improve patient care.
“I’m proud of the way we went about building simVITRO. We wanted a system that would not only solve our problem, but it turns out the flexible robotics framework also serves a broader research industry problem,” says Colbrunn. “The concept of ‘use any robot, apply any load, and measure anything’ has ramifications for improving patient outcomes as well as mechanical testing of…well…anything.”
To learn more about simVITRO, visit its website, or contact Sonja O’Malley.