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Case Study: Intellijoint KNEE, Fine Adjustment Cutting Guide

13 January 2023

A leader in joint replacement solutions

Intellijoint Surgical has fast built a reputation for providing truly innovative and easy-to-use solutions to orthopaedic surgeons. Since commercializing in 2016 this Canadian success story has supported over 40,000 joint replacements in Canada, the US, Australia, New Zealand and Japan.

The Intellijoint team describe themselves as problem solvers. Working directly with the surgeons who use their products, the company hears about challenges first-hand, then tasks itself with developing solutions.

One such challenge would eventually lead to the development of Intellijoint KNEE, a surgeon-controlled navigation system that provides real-time measurements of surgical cutting guides during total knee arthroplasty. But in order to develop a truly comprehensive solution, Intellijoint would find itself leaning on the expertise of our team at Enztec.

The need for a more precise cutting guide

Two simple cutting guides were created for the first iteration of the Intellijoint KNEE product. While surgeons were impressed with the solution, an opportunity for enhancement was quickly identified.

“Surgeons began asking for a cutting guide that would let them dial in slope, varus and resection depth after it was pinned,” says Samantha McCabe, Intellijoint’s Product Development Manager.

The challenges of developing such a guide were immediately obvious. “It was important for this new cutting guide to have a high degree of precision and control so surgeons could quickly achieve their desired cut,” McCabe explains. “We knew we needed to design a mechanical part with a complex mechanism that was also easy to clean and sterilize.”

Wanting to act on the feedback as quickly as possible, Intellijoint’s first thought was to attempt to develop the solution in-house. But it quickly became obvious that it would be a long, complicated and resource-heavy exercise. So they turned to Enztec.

“We had an introductory meeting with Enztec to discuss the project requirements and share some early prototypes we had created,” says McCabe. “They immediately understood what we were trying to accomplish. In our first meeting we could tell that they had been in operating rooms and understood our market and customers.”

A pre-developed solution made bespoke

Historically Intellijoint’s design process with contract manufacturers had involved a lot of iterating to get their designs manufacturable. “Because we only manufacture orthopaedic instruments, we know how they should feel and function. It’s up to us to ensure that they are perfect before they leave the facility,” says McCabe.

But working with Enztec was different. Intellijoint soon found out that every design had already been considered from a manufacturing point of view.

What’s more, Enztec had already identified the market need for an adjustable cutting guide and had begun developing a solution in their back offices, ready for the day that the Intellijoint KNEE request came to their door.

“To our surprise, they already had a design developed that met most of our requirements.” McCabe and her team were impressed. With 80% of the work already done, the focus shifted to the final 20%, the bespoke modifications that would ensure the new product met every one of Intellijoint’s needs.

Having never worked with a company like Enztec before, Intellijoint’s Operations, Quality Assurance and Regulatory departments weren’t short of questions. “They patiently answered every one,” says McCabe, “and ensured all departments were comfortable and confident in the partnership, the design and the go-to-market strategy”.

“They held their design to a high standard and identified and fixed issues before we even became aware of them. The first component they manufactured, for example, met all our specifications, but the Enztec design team didn’t like the way it felt. They immediately adjusted the design to improve the performance for our next order.”

“The attention to detail and desire to deliver a part that functioned the way they intended sets them apart as design partners."

From meeting room to theatre in six months

Looking back on her and her team’s experience with Enztec, McCabe is glowing.

“Working with Enztec we were able to quickly develop a cutting guide that met our requirements, and without needing to re-perform costly and time-consuming cleaning and sterilisation validations. The process was also surprisingly efficient: our initial meeting with Enztec was at the end of September 2020, and we had parts in operating rooms by March 2021.”

“We received very positive feedback on the final design and had many surgeons requesting it immediately. Nevertheless, we actively solicited feedback, and Enztec were very receptive to the minor modifications that were requested, such as more shift holes. This further demonstrated to us that they are a great partner for this component.”

Since its full release in April 2021, 180 Intellijoint KNEE units have been sold in the US alone, and 120 more units are currently on order, facilitating hundreds of successful total knee arthroplasties.

All in all, McCabe and her team couldn’t have been more pleased with their experience.

“Working with Enztec was extremely easy. The team was thoughtful, thorough and a pleasure to meet with every week. They were quick to respond to emails and always showed up to meetings prepared. And while the development of this component is complete, they continue to be a great partner.”

Keen to learn more about our Bespoke pathway, come see us at AAOS 2023.

 

“Enztec's attention to detail and desire to deliver a part that functioned the way they intended, sets them apart as design partners.” - Intellijoint Product Development Manager

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