Even if your mobile medical app isn't subject to regulation, you should still consider a human-centric approach to design.
The release of the official FDA guidance on mobile medical apps provides a much-needed framework for medical software innovators. Included in the guidance is a solid requirement to include human factors activities throughout the app development process.
|Don't miss the conference session on "Clarifying Plans for the Mobile Health App Regulation," presented by Bradley Merrill Thompson, partner at Epstein Becker & Green, at MD&M Minneapolis on October 28, 2013.|
Those of us who advocate for a human-centric design approach to medical device development were delighted that FDA kept its human factors expectations consistent with previous guidance given to the medical software and device industries. FDA knows a human-centric design approach is the best way to minimize the risk of harm to your patients and customers.
This approach includes the weaving of human factors engineering into the entire design and development process. This is nothing new to established medical device manufacturers, who have had a head start in adjusting to these requirements. However, it may be news to those who are unfamiliar with using human factors activities during design and development.
Large medical device manufacturers, like those in big pharma, have been navigating these waters for years. They sail the regulatory ocean like freighters, with established methods, routes, and the resources to employ specialized personnel. Conversely, the countless new entrants that will be filling the app stores are like smaller, more nimble vessels, with multidisciplinary personnel and tighter budgets.
Yet both will have to equally comply with human factors requirements regarding mobile medical app development. Appendix E of the FDA guidance on mobile medical apps states:
Mobile medical app manufacturers are required to comply with the QS regulation [21 CFR 820.30]. Furthermore, mobile medical app manufacturers are required… to appropriately verify and validate their mobile medical apps along with the mobile platform to ensure safe and effective operation of the mobile medical app."
That guidance conveys a solemn responsibility to medical app developers: FDA expects you to have the same attention and dedication to your users’ safety as is typically expected of medical device manufacturers. That means you have to perform certain activities and/or research to show that your app won’t cause an unreasonable risk of harm when used or misused.
To comply with these regulations, typical human factors activities that you might be expected to engage in include:
If any items in that list seem unfamiliar, or if you find yourself navigating these waters without experience, you’ll need guidance. This means hiring or partnering with individuals or institutions with expertise conducting human factors activities in the FDA environment. FDA expects these activities to be executed by qualified human factors experts and that all usability testing include participants from the intended user population(s).
As regards this testing, beware of falling into the trap of using your market research folks and some employees with free time as “representative users.” From a regulatory perspective, such an approach might not cut it. The higher the risks of your product, the more rigorous your efforts should be.
But what if your mobile medical app isn’t subject to regulation? Should you still consider adhering to the human-centric design process?
Absolutely. The FDA guidance recommends that app manufacturers follow the human factors guidelines even when their products are not subject to regulation. In addition to being the best way to mitigate the risk of harm to your users, it is also the best way to encourage product use and adoption, while avoiding the high costs associated with unnecessary redesigns and product recalls.
We live in an exciting time. Mobile and healthcare technology have been advancing on parallel paths for decades, and we are witnessing a rare event: the merging of the two as an intertwined entity. Progress will occur at a pace limited only by the imaginations of the innovators. As the pace quickens, we should remember that humans are the center of what we do, and it’s our obligation to ensure the new mobile tools that fill the app stores will be as safe, effective, and usable as possible for the people who download them.
|Learn more about FDA's guidance on mobile medical apps at the MD&M Minneapolis conference.|
T. Grant Leffingwell is a principal research scientist at Battelle.
[image courtesy of KROMKRATHOG/FREEDIGITALPHOTOS.NET]