The Importance of Human Factors Validation Testing for New Medical Devices

Common complaints include lack of consistency in the makeup of the research team over the length of the engagement, lack of availability for consultation and communication with the team lead/senior researcher(s), and over complication of testing protocols and reports (making things harder than they need to be to meet regulatory requirements).

Because we are smalland experienced, we are able toput together a team that works with you and stays with you throughout the process with all team members being senior UX researchers. Together, We plan the study, create the test protocol, develop the screeners and recruit the participants for each of your identified user groups, design the scenarios and knowledge tasks based on your uFMEA/critical risk assessment, conduct the test sessions, perform a preliminary analysis for stakeholders, then write a draft report for review, and final report for inclusion in the FDA pre-submission package.

Depending on the stage of development of the product, UX Firm can conduct formative testing on prototype products to learn pitfalls for users and support an iterative design process that builds user experience into product development. This is ideal, but not always practical. In cases where the product is production-equivalent ready, we can conduct a small pre-summative study to catch what can be fixed before committing to a full summative study, thus providing the medical device manufacturer with the opportunity to improve the experience and results when the full human factors validation study is undertaken.

Support for your Team

Because we are small and experienced, we can support any part of the process that your team requires. If your team has created a test protocol or has documents or reports from prior research studies, we can use them as the basis for planning. No need to reinvent the wheel when the work is already done. If you have a template for documenting findings, we can apply it. If you don’t, we can design it.

After the research is completed, we can work with your implementation team to review changes you plan to make regarding any risk mitigation identified from the research. If you want us to participate in a call with FDA or review an FDA response to your Q-Sub, we can provide valuable input based on our experience.

No task is too small. We like to tell our clients, “We get in where we fit in.”

At the same time, we don’t try to be all things for all people. Effective research is our core strength. It allows us to stay razor-focused on what’s happening in user research as relates to FDA and MDR requirements.