Simulated-use testing is a common usability evaluation method. But simulating use of surgical devices presents unique challenges. Common simulation techniques include “wet labs’ (live animals or animal tissue), cadaveric tissue, and manikins of varying fidelity. Each method has its own unique challenges. How do the differences between animal and human anatomy affect use if the device? How do you simulate using a device for its intended use when the animal or cadaveric model does not exhibit the pathology to be treated? How do the differences between live tissue and cadaveric tissue or a manikin affect use of the device? What are the costs and risks with each method, and how do you balance those trade-offs?
This poster will explore some of these unique challenges, using actual examples of situations we have encountered when planning and executing simulated use usability tests with surgical devices.