Applying the New FDA Human Factors Standards

The FDA recently started requiring manufacturers of medical devices to use human factor design techniques and usability testing in the design of their products. If you are a medical device manufacturer, some of these standards can be daunting if you have never used these techniques before.

The History

In 2000 the FDA issued the first such guidance in “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management”. Effectively, this document mandates that all medical devices undergo design for human factors, including usability testing at several points throughout the design process.

Updated guidance was issued in 2011, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design.” Although this guidance has not been approved yet, it will supersede the 2000 document when approved. It provides a likely course for the FDA and most device manufacturers should be following these standards today.

Other standards which have been subsequently developed and are recognized by the FDA are:

  • The ISO 14971-1:2007 standard Medical Devices - Application of Risk Management to Medical Devices
  • The AAMI / ANSI HE75:2009 standard Human Factors Engineering - Design of Medical Devices (General)
  • The ISO 62366 standard: Medical Devices - Application of Usability Engineering to Medical Devices

What You Need to Know

Ensuring that your devices meet the stringent requirements of the FDA may seem overwhelming, but through careful planning and good documentation, you should be able to sail through the FDA approval process.

As the design starts, you need to understand the target for your device. Specifically:

  • Who will the users be? (These might be doctors, nurses, patients, caregivers, or others.)
  • What is the use environment for the device? (Hospital, home, offices, cars, etc.)
  • What are key interactions that will happen between users and the device? (Data entry, displays, knobs, caps, wires, etc.)

Next, you need to define the hazards that may exist. This process is sometimes called Failure Mode and Effect Analysis (FMEA):

  • Failures by the user (e.g. leaving a cap off, or not pushing Enter)
  • Failures that the product could sustain (e.g. broken wire, unplugged, blank display)
  • Failures by lack of information (e.g. not knowing next steps, using for wrong purpose)

For each potential failure mode, estimate the likelihood of the failure and the consequences of the failure. This allows you to prioritize the risk. Then based on the priority, you can create a solution to avoid each of the most likely failures.

These hazards can be identified by sitting in a conference room, but usability testing is also a critical part of this process as it will expose failure modes that you didn't anticipate. Putting a mock-up (even in paper form) in front of actual users (doctors, patients, and caregivers) will provide valuable data that can save millions of dollars in liability issues later in the development and product life-cycle. Then, at each stage of development, additional user testing will reveal hidden issues before the product is on the market.

The FDA mandates such testing to ensure the safety of your users after the product is approved. But a huge side benefit is that products which are usability tested generally work better than those that don't. And usually the products which work best are the products which are most recommended and purchased. In other words, you can improve your profits through doing the required usability testing. When users identify enhancements to the product, it's worth listening to them. (That's why we always recommend that the product designers are involved in the usability testing - so they can see firsthand how their designs can be improved.)

Hildebrandt Associates can help you navigate the human factors and user testing requirements. Drop us a line for more information.