As FDA works to ensure medical device safety and effectiveness, the agency is urging manufacturers to utilize human factors engineering during product design. After all, FDA’s Quality System Regulation on Design Controls “implies” the need for human factors, pointed out Molly Follette Story of FDA’s CDRH/ODE in a June 2012 Webinar with RAPS. And the agency remains focused on incorporating hundreds of comments on its 2011 draft guidance on “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” Ron Kaye, FDA’s Human Factors Premarket Review Team Leader, reported earlier this year at the “International Symposium on Human Factors and Ergonomics in Health Care.”
FDA expects manufacturers to “identify and mitigate risks, including all use-related risks,” Follette explained.
Paul van der Pol believes proper user training is essential to minimizing such risks, especially those faced during drug delivery.
As Director of Research and Development for Noble, van der Pol encourages manufacturers interested in human factors engineering to consider the role packaging and training devices can play in promoting proper use.
“One of the many challenges is patient education and training, so developing tools that ensure both patients and practitioners understand proper drug-delivery techniques can eliminate many user errors,” he says.
For instance, the most common error associated with the use of autoinjectors is that “patients prematurely take the device away from the body and administer an incomplete dose,” says van der Pol. “Doctors then don’t see an improvement in the patient’s condition. A training device for the patient would help.”
In addition, “physicians aren’t really trained to be educators, and doctors and nurses are pressed for time, so often there can be message erosion, and inconsistency seeps in,” says van der Pol. “Doctors and nurses like to have a tool for patient education. We believe the alternative is multisensory training.”
Noble has developed such multisensory training aids for autoinjectors and other drug delivery devices, including what van der Pol describes as the largest U.S. drug brands. “We researched how the brain learns and found that patients learn through visual and auditory stimulation as well as through touch,” he adds. “Multisensory learning can support spoken instructions as well as visuals. Our research shows that patients need certain messaging.” Recordings can be up to 6 minutes long, he adds.
Instructions for use (IFUs) are required under current regulations, but van der Pol sees a role for additional materials. “We can develop a quick reference card that can ‘speak’ to patients when they press certain buttons. And LEDs can highlight various steps. Patients could even be required to complete certain steps before moving on to next ones. The card can be built into packaging for a higher-quality experience, and it won’t get lost. And by giving packaging higher value, it will be kept and displayed by physicians and patients.”
Packaging can also deliver training devices and other collateral, so “patients can hear and see,” says van der Pol. “The touch will be in the training device, and what the patient hears can be synchronized with training. The benefits are safety and patient compliance.”
Reconstitution is one process that could benefit from such multisensory training aids. “Nurses can be trained with those, too,” he says.
And van der Pol says that one trend may encourage use of such aids. “We see a trend toward pharma companies seeking to minimize patient anxiety by trying to prolong the time between injections, such as every two weeks. The first injection might be given in the doctor’s office, and the next one two weeks later at home. As a result, education becomes even more important so patients understand how to inject themselves,” he says.
Spoken instructions can also be translated into various languages to support other regions, he adds. “Literacy in other regions may not be as high as it is in the United States, so spoken instructions could be the best way to accomplish training,” he says.
Sensors could be added to packaging to monitor product conditions, which could be a necessity for cold-chain products. “Sensors can also alert users to patient compliance,” he says.
Developing such aids could be a year-long project, so van der Pol urges companies to start as early as they can.