Insight on how engineers can gain an understanding of how the process works and how they can participate productively.
Medical device manufacturers and designers must overcome various challenges to succeed in an expanding global marketplace, challenged along the way by aspects of design, research, validation, and bringing their devices to a competitive market in a cost-effective manner.
How do you design a usability test that mimics the panicked, stressful situation that a user may be in when he or she is using your medical device in the real world?
Because the validation test is required human factors testing, it can be tempting to skip over preliminary human factors activities during the development process. However, this approach is problematic from both a device usability and a safety standpoint.
The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016) provided and established the relationship between risk and sample size. This article will demonstrate the use of reliability-based life testing for process validation.
In some cases, the rotary speeds from dental drills can cause dangerously high temperatures, which can permanently damage bone tissue as they increase the denaturation of hard tissue proteins. This article discusses research on drilling techniques in a lab setting.
When studies are successful, human factors (HF) validation can be as straightforward as checking off the boxes on a study protocol. If all the pieces of testing don’t come together as planned, however, HF validation can be a complicated endeavor. At the recent HFES Symposium on Human Factors and Ergonomics in Health Care, we shared our thoughts on how to know whether or not you’ve cleared that last hurdle.
More and more medical devices have some sort of software component to them. The teams responsible for testing this software often rely on scripted testing, both manual and automated, to decrease the risk of defects in a product under development. The problem with this approach is that scripted testing is not meant to identify error conditions in scenarios that significantly deviate from the design or requirements, even if a comprehensive risk management plan is followed. To find these hidden or divergent risks, you need to go off script, and that’s where adding exploratory testing can help.