Medical device designers should consider including packaging in their human factors studies.
Human factors studies are now commonplace during medical device development, thanks to FDA's guidance "Applying Human Factors and Usability Engineering to Medical Devices." But what about during packaging development?
Human factors principles are nearly always applied to medical devices, "and often the packaging," reported Stephen Wilcox, principal and founder of Design Science. Wilcox spoke at HealthPack in March to a room filled with packaging engineers and designers.
However, human factors studies are required by the above-mentioned FDA's guidance and outside the United States by the standard that covers usability and safety of medical devices, ISO/IEC 62366, Wilcox said. "Any auxiliary part of a device including packaging that could cause harm if a mistake is made has to be subjected to usability testing," he said at HealthPack.
Wilcox later told MD&DI that "in fact, FDA and the relevant medical device standards require packaging to be subjected to human factors efforts if defects of the packaging present a potential risk of patient harm."
There could be interesting lessons to learn from packaging users during human factors studies. "Issues that apply to device development also apply to packaging," Wilcox said at HealthPack. He explained that human factors experts do three things: Help define user-related design goals, provide technical information about humans, and perform usability testing.
These aspects could help medical device companies develop better packaging, which is often critical for safe and effective device use, aseptic presentation, and appropriate storage and handling.
"One might learn where opportunities lie throughout the life of a package," Wilcox said. "Follow your package as it moves through use."
For instance, human factors studies could help reveal "how kits are actually used," Wilcox said at the conference, thereby demonstrating "how they should be configured."
One of Design Science's projects entailed evaluating a kit with eight components. "We did a quantitative analysis in terms of how often each device is used and in what order," he explained. "Any time you have multiple items being used, you can graph the time they're used."
"You can look for ways to reduce complexity," he added.
User stress could have an impact on safe and effective product use, so human factors studies could be used to gauge user comfort with both products and packages. "When someone is using something, measure the stress level," he said. "We wire people up and measure heart rates and respiration."
Device designers could also use human factors studies to learn how to make text readable, design warnings, and differentiate similar products, he said. They can learn how to "integrate text and graphics and how to place an IFU within the package," he said as well as how to "organize components intuitively and efficiently."
Observation is a critical part of human factors studies. "What users say is only half accurate," he said. "People don't always tell the truth. You have to go out and see it."
The key to usability testing is to focus on errors, he said. "Recruit users and ask them to use your product/package and see what happens."
Usability testing studies can also be divided in two types: formative and summative. Formative is used to learn about what to fix, whereas summative is used at the very end of studies with real products so that FDA can gauge that a product is ready for market, he explained.
For either one, Wilcox outlined the methodology as follows:
1. Choose a sample
2. Create the testing environment, including replicating the sound level, lighting, and/or other typical distractions
3. Design the protocol. "You don't want mistakes because of information you provided," he emphasized.
4. Test, observe, ask questions.
5. Analyze data.
6. Report the results.
"Is there more opportunity to reduce the possibility of error? If yes, then regulators will send you back," he said.
Wilcox will be speaking next at the upcoming MD&M East 2017 conference June 13 in the panel discussion "What Does Usability Mean Today for Medical Device Engineers?" and then presenting the talk "New Tools for Obtaining Better Data from Contextual Inquiry." While he said he probably won't specifically talk about medical device packaging or labeling, he said what he'll be discussing "will apply to packaging as well as devices."
Daphne Allen is executive editor of Pharmaceutical & Medical Packaging News and a contributor to MD&DI and Qmed. Reach her at [email protected] and on Twitter at @daphneallen