Macadamian Blog

Human factors in medical devices

The FDA  requires that if you are developing a medical device that you pay attention to human factors and usability in the design. I recently attended a BayBio event where a panel of medical device firms talked about how they meet the FDA's human factors requirement and what impact it has on their product development process. The great news is that, at least for the companies on the panel, they already see usability and human factors as critical to the success of their product. For the FDA, human factors is a patient safety issue, and they are right. Poorly designed devices lead to operator error, which can put the patient at risk or result in misdiagnosis. The panel agreed, but they also use design to differentiate - they know that if they can design a product that offers the best user experience in their segment, then chances are they will dominate their field. This is especially true of new devices and startups looking to displace an established competitor.

One of the most encouraging stories was from Greg Kapust, CEO of Breathe Technologies. Breathe develops a ventilation device, and they require their staff to actually spend time living with a ventiation device. What an amazing way to develop empathy for your customer. We all know that one of the barriers to adopting user-centered design principles is that designers and developers think they know what's best for the customer. Walk a mile in your customers shoes sometime.