FDA and UI Development
July 1, 2007
PRODUCT DEVELOPMENT INSIGHT
According to Robert North, PhD, “FDA is less interested in how aesthetic a product is, or whether it has superior competitive features, than in how use-related hazards have been identified and controlled.” North is chief scientist of Human Centered Strategies (Colorado Springs, CO). He is currently sitting on the AAMI committee that is updating the human interaction standards that are expected to be published in the next year.1 “FDA views errors during human interaction with a device as seriously as any mechanical, electrical, software, or chemical errors that may make a device cause patient harm.” Certainly FDA's guidelines seem focused on usability's effect on errors, but North does acknowledge FDA's interest in improving the user experience. “FDA certainly appreciates that the more usable the interface, the more likely the user is to be error free.”
So how should a development team plan the early design-research and concept-testing phases to make sure they do not fall foul of FDA scrutiny?
To understand the effect of regulation on the design-research and early concept-testing phases, the overall process that FDA requires must first be understood. This process is succinctly described on FDA's Web site.2 It cites AAMI/ANSI HE74-2001, “Human Factors Design Process for Medical Devices.” It further states the following:
This standard serves as a guideline for integrating human factors engineering into the product design and development process necessary to satisfy the FDA Quality Systems—Design Control requirement to ensure that the needs of the user are appropriately defined, verified and validated. Any declaration of conformance to this standard with respect to establishing a manufacturer's standard design and development process adequate to meet the needs of the user should be accompanied by the following documentation at a minimum:
Description of the process to be followed in defining the user needs to establish the device-user interface design input.
Description of the process to be followed in verifying that the user needs as defined by the design input is addressed by the design output.
Description of the process to be followed in validating that the final design functions in a way as to met the intended users needs.
Description of the risk analysis process to be followed in identifying and assessing reasonably foreseeable risks associated with intended use.
All of these FDA requirements affect how a medical manufacturer would structure and document design research and early concept work.
At first glance, these requirements might seem daunting to apply to this early process. But as with many regulations, the key is to apply them early and appropriately, when they can actually help the whole process run smoothly. Done right, they can enable product developers to catch errors and mitigate risk effectively.
The design-research approach outlined throughout this article primarily covers the first two items on the FDA list. The user needs, which are defined using the first item in FDA's list, become the design inputs in this process. The second step is to verify that the design inputs are addressed by the final concept, or the design output, that is chosen. However, it is worthwhile to start a simplified risk analysis at the beginning. In addition, build enough time and resources into the plan for appropriate validation along the way.
Reference
1. AAMI HE-75, “Human Factors Engineering—Design of Medical Devices,” in progress, expected to be published in late 2007.
2. FDA, “FDA's Human Factors Program” [online] (Rockville, MD: FDA); available from Internet: www.fda/gov/cdrh/humanfactors/index.html.
Copyright ©2007 Medical Device & Diagnostic Industry
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