While experience has long guided surgeons through the delicate art of knee replacement, instinct alone can fall short. A Canberra-based startup, Viortec, is replacing feel with precision – developing a smart device that captures real-time surgical data to make joint replacement safer, smarter, and more consistent.
“Bones can be difficult to safely grip during surgery, making purchase unreliable,” said Dr Catherine Galvin FIEAust.
Engineering a device that can stabilise a potentially frail femur without damage – while simultaneously capturing data on the forces applied by the surgeon, has been a demanding engineering challenge.
In more than one million knee-replacements performed worldwide each year, orthopaedic surgeons have traditionally relied on feel to balance the knee’s ligaments. This means that during the surgery, the surgeon checks the knee’s ligament tension by applying pressure at the ankle.
Yet one in five patients report ongoing pain or instability after a knee replacement, heaping an increasing weight of cost and resources onto medical systems, providing a good argument for feel to be replaced by real, quantifiable data.
Engineers and surgeons working together
It’s this argument that guided the discussion, over a cup of coffee four years ago, between two colleagues from the Trauma and Orthopaedic Research Unit at the Canberra Hospital, Galvin, Chartered electrical engineer and Dr Tom Ward, a Rhodes scholar, orthopaedic surgeon and engineer.
The manual process of determination of soft-tissue stability during knee replacements, the pair decided, was too bespoke. It was a problem requiring a solution.
“We decided we could either keep doing research through the university system or build something ourselves,” Galvin, CEO of Viortec and lecturer at ANU’s School of Engineering, said.
“We chose the company path.”
Galvin believes it’s the combination of engineering nous and surgical experience that makes Viortec special. “It’s the dream team. The surgeon defines the problem and the engineer figures out how to solve it.”
It’s this insight into the workings of an operating theatre that makes SmartClamp so effective.
We agreed the first device to develop would focus on measuring the forces the surgeon applied to determine knee ligament stability during a total knee replacement. These forces have never been quantified, and this was a problem requiring a solution. That was the beginning of the SmartClamp.
“In operating theatres, we’ve got high-tech robots and then 19th-century methods for measuring ligament stability, it’s an odd mix of technologies.” said Galvin, who is no stranger to knee surgery – in 2016 she ended a 40-year love affair with Tae kwon do when she landed a jump badly, damaging almost all her knees soft tissue and breaking her tibial plat-eau.
Getting a grip: From conversation to clamp
Insights led to questions, such as: What if the femur could be held perfectly still during the knee replacement operation, Galvin asked. What if the ligament balancing forces being applied could be measured in real time? What if that force data could be recorded (in six-degrees of freedom) and used to under-stand the process, used for surgical training and to compare and improve future surgical results?
The result was the SmartClamp, a 3D printed, medical-grade stainless steel device that grips the distal femur, the lower end of the femur closest to the knee.
“It’s not an implant, and so it doesn’t have to be made from titanium,” Galvin said. “And it’s reuseable, not for single use. So it has to be capable of ongoing sterilisation.”
SmartClamp is a deceptively simple idea that hides the complex realities our team has had to confront, including the multitude of angles and forces involved.
“We had to consider the angle of the hip, the angle of the leg on the bed, the preferred angle for the surgeon to hold such a device and the various shapes and sizes of bodies and bones – every person’s femur is unique,” she said.
Then, there was the challenge of gripping the bone itself.
“Bones are incredibly slippery,” Galvin said. “We used the CT scans of hundreds of distal femurs to understand the shape of the distal femur and its variations.”
“We designed a very specific grip shape that would be secure without damaging the bone. We didn’t want to introduce micro-fractures, especially since most patients would be having the surgery as a result of osteoarthritis, which makes bones weaker.”
Over four years of prototype design and development, and extensive testing and evaluation, using simulations, desktop reconstructions and finally on cadaver knees, the device is now listed on the Australian Register of Therapeutic Goods (ARTG). SmartClamp is patent protected and is moving into the National stage of patent protection in Australia, United States and Europe. Shortly, a 40-patient clinical study will be commencing.
SmartClamp was nominated for Project of the Year in the Engineers Australia Excellence Awards 2025, a milestone Galvin celebrated while riding the Indian Pacific train between Sydney and Perth.
“We’d just been accepted onto the ARTG, which was huge,” she said. “That was a good reason to be involved with the Engineers Australia awards. It was a team effort and something to celebrate.”
Viortec boasts a heavy hitting engineering team including Chief Technical Officer and ANU academic Dr Nicolo Malagutti, Head of Mechanical Engineering Jim MacDougal, and engineers Hancheng Shao, Sean Leong, Shane Christensen, Andy Kim, Katherine Feng and Michael Crompton.
Harking back to the partnership between surgeon and engineer, the medical team has equally impressive credentials including Chief Medical Officer and orthopedic surgeon, Dr Tom Ward; orthopaedic surgeon Professor Paul Smith AM and clinical research specialist Dr Joe Lynch.
Trade secrets: Prototype to patient
Viortec is understandably careful about releasing precise details about SmartClamp.
“Much of what we’ve done has to remain a trade secret,” Galvin said. “But while the SmartClamp measures the forces surgeons apply to test ligament stability, surgeons are not using it to make decisions. The device is being used to better measure what the surgeon is doing, and to learn from that to inform surgical practice.”
Commercialisation in the high-stakes world of medical devices, however, remains a steep climb from here.
“Once we have the in-vivo [live patient] results, that’s when the real conversations can begin,” Galvin said.
“We have to go through ethics committees, which is something you don’t usually have to do in engineering, as we’re doing the in-vivo trials over the next six months.”
“People are most interested in what we will learn in-vivo. That will be a big learning period. We have to get everything right.”
If SmartClamp succeeds it will make surgery smarter, proving the collaboration between engineers and surgeons to be a transformative one for patients, clinicians and entire medical systems.
