usability testing of medical devices
One unique area we specialize in at Drop Gear Design is conducting usability testing for new medical devices coming to market. Broken down into two tiers by the FDA known as formative and summative testing, usability testing is a means to determine if a medical device will meet its intended users’ needs and preferences. It is also critical to expose any potential vulnerabilities that could lead to dangerous use errors that might result in injury or death.
Usability testing is a crucial step on the course to approval for any new medical device and can occur early, mid, and late-stage in the development cycle. It can also be an expensive endeavor, which calls for a strict process in order to maximize value of the effort. At Drop Gear Design, we have perfected that process and can help you streamline your formative or summative usability testing to help your product reach its highest potential and get to market faster. Our usability testing services include but are not limited to:
- Creating a detailed test protocol to ensure your goals are met and the testing runs efficiently and consistently.
- Develop technical documentation such as the Information for Use (IFU) or package labeling.
- Identify risks and potential problems with a Failure Mode and Effects Analysis (FMEA).
- Source anatomical models and simulators to be used for the testing, or design and build one from scratch if a scholastic option doesn’t exist.
- Facilitate with selecting the venue(s) and scheduling representative participants.
When it comes time to conduct the study, we use a dedicated two-person team that includes one of our senior engineers and our resident research scientist. We intentionally provide moderators with differing technical backgrounds, giving us the professional diversity to gather a broader set of observations, which increases the value of your research study. Once testing is completed, we organize our notes, photos, videos, and data into a comprehensive report containing an analysis of the data and summary of the executive findings and conclusions, including tangible recommendations on how the results of the study should affect your product’s development moving forward.
What sets us apart from other usability testing consultants is that we are also a full-service design firm. Being present at the initial trials of your device puts us in the best possible position to bridge the gap between end-user and design team.
We know first-hand what it takes to make a successful product, and we can follow up these studies with the guidance to not only get you through the approval process, but to make your device an industry game-changer.
Ready to get started?