Surgical suite of instruments for total knee replacement
Stryker Orthopaedics
Triathlon - Total Knee Replacement
We began in the OR, recording multiple surgical procedures and interviewing everyone with a stake in the instrument set: surgeons, scrub techs, nurses, sales staff, etc. We deconstructed the surgical procedure, step by step. enabling us to analyze each instrument and determine its value: is there a need for redesign, alteration, refinement, combination, omission?
Weeks of intense sketch ideation followed. Concepts were debated, refined, then developed as semi-functional sketch models. Ergonomics and aesthetics took shape shape for design team and surgeon evaluation. Models were refined, then developed in CAD for semi-functional prototypes, providing a greater degree of feedback while also enabling detailed manufacturing discussions. Sawbone labs followed, and the more complex instruments were developed as cut-steel prototypes for cadaver lab testing. As feedback came in, CAD geometry was refined, FEA on critical components conducted, tolerance studies performed, and manufacturing drawings initiated. The new instrument set—Triathlon—has grown to become one of the most successful product lines in Stryker’s history.
Surgical Deconstruction
Mapping the surgical procedure required observing and recording multiple operations. We then deconstructed the procedure step by step, instrument by instrument, enabling the team to identify where there was opportunity for instrument refinement or replacement.
Engineering Ideation
Engineering the mechanisms that will enable these instruments to work in the most taxing environments - reliably, repeatedly, accurately. These are being hammered, submerged, caked with grit, and then autoclaved perhaps hundreds of times.
Industrial Design
With hundreds of controls across dozens of instruments, it’s imperative that the instrument set’s interface is simplified, unified, and intuitive. Whether it’s a bone-pin puller or a tibial alignment jig, new and seasoned surgeons alike must be able to pick up and operate any instrument with minimal instruction and maximum ease.
Rapid Prototyping
Semifunctional models were fabricated for various concepts. This is an extremely efficient method for failing quickly and cheaply… Ankle-clamp levers occluding their activation buttons? Swap them out for a revised contour. Modelling this way enables the development team to quickly identify successful design solutions.
Functional Prototyping
There’s no substitute for the real thing. Several instrument concepts required cut-steel, fully functional prototypes to enable surgeon evaluation during bone-saw testing and cadaver labs.
Production
Comprehensive design analysis - interviews with surgeons, scrub techs, sales people, etc. - yielded overwhelmingly positive feedback. The next phase included detailed tolerance studies, FEA on critical components, and dimensional drawings to ensure a smooth initial production run.