MDDI_Medical Device & Diagnostic Industry

MDDI, June 2014

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Product Development Insight 22 | JUNE 2014 mddionline.com Image courtesy of RETROROCKET/iSTOCKPHOTO.COM Three Human Factors Failures to Avoid in Medical Device Design These human factors mistakes are all too common in medical device design. Here's how to steer clear of them. JAMIE HARTFORD M edtech has come a long way in incorporating human factors engineering into its designs, but there's still room for improvement. "The medical device industry is starting to understand human factors and the potential benefits it can provide," says Andy Schaudt, director of usability services at MedStar Health. "However, I think there's still a gap when it comes to providing designers with the human factors tools and methods they can use." As a result, mistakes are still made. Schaudt lays out the most common human factors failures medical device designers make and explains how to avoid them. Waiting Too Long to Incorporate Usability Testing One of the biggest failures designers make is waiting until too late in the product development cycle to incorporate usability testing. "With FDA now requiring summative testing, many device man- ufacturers say, 'Alright, we'll do what we need to pass,'" Schaudt says. "But unfortunately, they get to that stage and FDA wants a summary of how it was performed throughout the entire process, not just near the end." Usability testing can also uncover opportunities for design im- provements, and waiting until too late in the development pro- cess can mean expensive rework or missed opportunities to make products better. "Take the time to start bringing users in early during the concept stages by using basic methods such as focus groups," Schaudt says. "Get small handfuls of people going through some user testing with tasks and scenarios you set up for them, so you can determine use challenges." Not Distinguising Between Customers and Users Product development often begins with a customer needs assess- ment, in which the marketing team polls customers about what fea- tures they want a product to include. But Schaudt cautions that these assessments aren't always fo- cused on the right people. "Customers are not always end-users," he warns. For example, the customer for an infusion pump might be a healthcare system's procurement department, which decides which vendor to choose based on cost and infrastructure require- ments. But the people who actually end up using the devices— nurses—have different needs. "While the product might have a whole bunch of features, maybe the people who are actually programming these devices aren't using those features," Schaudt says. "Or maybe the device has alarms that are similar to other alarms in the environment, so they're getting masked. Or maybe the device's user interface has delays, so they're not getting feedback right away and that's result- ing in more user entry errors." To avoid such problems, he says it's important to get early feed- back from actual end users, not just the folks footing the bill. Ignoring Legacy Systems Even the most innovative device in the world is nothing if it doesn't fit in with the user's workflow. "You have to think about the system you're replacing," Schaudt says. Take the example of an infusion pump. "The nurse has been using that legacy pump for 10 or 15 years. They know how it works, they know how it fits into their workflow," he says. "If your new sys- tem changes their workflow, they could actually be prone to errors because they're used to the old method." Schaudt says studying legacy systems is vital when designing disruptive technologies. "If you design the new system with the system you're replacing in mind, you can make the new design seamlessly integrate into the new environment and improve safety in that regard," he says. Jamie Hartford is MD+DI's managing editor. Reach her at jamie. hartford@ubm.com. 2 ES451815_MD1406_022.pgs 06.05.2014 20:42 UBM black yellow magenta cyan

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