Editor's note: Tom Donnelly is vice president, head of medtech at research firm Branding Science. Michael Gundrum is managing director, North and Latin America, at MTS the Wet Lab Company. Samantha Swanson is research manager at Branding Science.
When simulating procedures with medical devices it is important to keep as close to reality as possible, whether you are gathering insights for commercial teams or performing human factors studies for R&D teams. Reading a description of a device and seeing an image can be useful for some marketing research but it does not provide the same level of feedback as hands-on testing in the use environment by the intended end user.
How do you conduct such projects? This article will describe tips and tricks in conducting simulated medical device procedures by providing: an overview of human factors and the use of wet labs; guidance on logistics for global projects; and advice on data collection, analysis, reporting and deliverables.
Most readers are focused on helping commercial teams with marketing research, such as gathering market understanding, communications testing and brand-growth research. Such work is done for different types of industries, including consumer brands, finance, business-to-business and health care. When gathering insights for medical devices and technology (medtech), human factors (HF) studies may also be done to help guide their design for R&D teams.
Human factors focuses on the interactions between end-users and medical devices in the intended use environment. FDA guidance says that many use errors cannot be anticipated until the device is used in simulated and observed situations.1 While HF should be conducted in as close to the real procedures as possible, sometimes it is not ethical or possible to conduct device testing during the real procedure. In such cases, you might opt to do a simulated procedure instead.