Human factors engineering isn't just a mandate; it's good business.
Medtronic's Glucose Sensor Serter System features design elements to reduce patient anxiety associated with injecting a continuous glucose monitoring sensor.
It’s no coincidence that usability emerged as a trend among this year’s MDEA finalists.
“A lot of companies are doing human factors engineering because it’s a mandate,” says Michael E. Wiklund, a 2013 MDEA juror and general manager of UL’s human factors engineering practice (Concord, MA). FDA released a draft guidance on applying human factors to medical devices in June 2011, and its home-use draft guidance, released this past January, featured an entire section on human factors and usability.
But companies aren’t just focusing on usability because regulators are forcing them to; it’s also good business. “It’s not just about achieving device clearance,” Wiklund says. “With products where the functionality has been well established and is perhaps provided by many other products in the same space, making these improvements in ease of use can offer a competitive advantage.”
Dansac conducted an exhaustive user survey to help it decide which attributes would be most important to include in its NovaLife ostomy pouches.
In designing its Glucose Sensor Serter System, a finalist in the over-the-counter and self-care category, Medtronic (Minneapolis) took steps to improve the product’s usability. An ergonomic design, 90° insertion angle (the previous generation required a 45° insertion angle), fewer small parts, and simplified instructions have enabled a wider demographic range—from young children to the elderly—to use the product, according to the company. The Serter System also features a smaller needle to reduce pain and intimidation, leading 85% of users to say that insertion via the product was painless, according to Medtronic.
As patients increasingly become consumers, medical device makers are courting them by paying more attention to their needs. Dansac (Fredensborg, Denmark), a finalist in the general hospital and therapeutic products category for its NovaLife ostomy pouches, is one manufacturer that has committed to understanding the users of its products.
“What we and the rest of the industry have to do is focus on the holistic patient, not just on one particular spot on the abdomen and getting an appliance to fit there,” says Thom Nichols, senior principal clinical research statistician at Hollister Inc., Dansac’s parent company. “We have to consider the impact of our products on the individual in all the different aspects of their life.”
The NovaLife pouches were based on data gathered from more than 4000 ostomy users in North America, the UK, and Italy over nearly 10 years—the largest survey of its kind in the industry today, Nichols says. A 94-question assessment asked users what they want and need in ostomy products and gauged their opinions on different attributes Dansac was considering for its pouches. In the end, the data showed that the most important quality in an ostomy product from the users' perspective is that no one else notice they use it.
Dansac accommodated this by designing the NovaLife products with the starter hole close to the top of the pouch, so they sit lower on the abdomen and are less likely to be seen. The pouches also feature a filter system to minimize odors, a membrane to allow air flow in order to avoid ballooning, and a waterproof composition, so users can bathe, shower, and play sports.
Jamie Hartford is MD+DI's managing editor.