On February 3, 2016, the U.S. Food and Drug Administration (FDA) released two new draft guidances and one final guidance pertaining to human factors (HF) in medical device product design. The three documents include: Applying Human Factors and Usability Engineering to Medical Devices, List of Highest Priority Devices for Human Factors Review, and Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. Broadly, these documents represent FDA's current thinking on the incorporation of human factor testing into medical device design due to the potential for serious harm resulting from use error. Moreover, review of human factors data in premarket submissions such as premarket applications (PMAs), premarket notifications (510(k)s), and de novo submissions can help FDA evaluate the safety, effectiveness, and substantial equivalence of devices.
What Are Human Factors and Human Factors Engineering?
In short, FDA uses the term "human factors" (HF) to refer to the way in which users interface with a product (in this case, medical devices). The agency refers to human factors engineering (HFE), also known as usability engineering (UE), to mean "the application of knowledge about human behavior, abilities, limitations, and other characteristics of medical device users to the design of medical devices including mechanical and software driven user interfaces, systems, tasks, user documentation, and user training to enhance and demonstrate safe and effective use." In other words, it refers to incorporating knowledge about how users interact with a product to design a product that poses lower risk. HF studies are done to allow manufacturers and researchers to see how products will perform under real use conditions.
Applying Human Factors and Usability Engineering to Medical Devices—Final Guidance
This document finalizes a 2011 draft guidance on applying HFE and UE to medical devices, and it seeks to assist industry in following appropriate processes to maximize the likelihood that new medical devices will be safe and effective for intended users, uses, and use environments. This guidance recommends that manufacturers follow HFE or UE processes during the development of new medical devices, focusing specifically on the user interface. Indeed, according to FDA, the goal is to ensure that the device-user interface has been designed to eliminate or reduce use errors that could cause harm or degrade medical treatment.
FDA believes that for those devices for which an analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm, manufacturers should submit HF data in premarket submissions. The guidance also discusses how, during the device development process, manufacturers should take into account the device users (the intended users of the device), the environments in which the device can be used (hospital, surgical, etc.), the user interface (displays, alarms, alerts, etc.), and the interactions between them.
FDA discusses how HFE/UE analysis and evaluation methods can be used to identify problems known to exist with previous versions of the device or device type, while analytical and empirical methods can be useful for identifying use-related hazards. The results of these analyses and evaluations should then be used to help shape risk management efforts and development of the protocol for the human factors validation test. Importantly, FDA indicates the applicability of HF engineering not just in the development of new devices, but also when companies are modifying a marketed device to correct design deficiencies associated with use, particularly as a corrective and preventive action (CAPA).
Finally, and of great interest to manufacturers, FDA points out that in addition to improving safety, the use of HFE and UE during the development of products can save manufacturers money through reductions in redesign costs and updates after market introduction.
The full version of the guidance can be found here.
List of Highest-Priority Devices for Human Factors Review—Draft Guidance
This draft guidance discusses the device types that should have HF data included in premarket submissions. FDA included these devices because of a clear potential for serious harm resulting from use error and based the decision on knowledge gleaned through Medical Device Reporting and recall information. This data should be included unless the submission does not involve any changes to users, user tasks, user interface, or use environments from those of the predicates. However, FDA also stresses that this list is not all inclusive; submissions for device types not listed in the draft guidance should still contain human factors data if analysis of risk indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm.
A complete list of the devices covered can be seen in the document, located here.
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development—Draft Guidance
This document discusses the use of HF studies during the development of combination products as defined in 21 C.F.R. Part 3. The guidance focuses on combination drug/biological products and devices for review in an investigational or marketing application submitted to the respective center. Specifically, the application types contemplated by the draft guidance include an investigational device exemption application (IDE), an investigational new drug application (IND), a biologics license application (BLA), a new drug application (NDA), or PMAs. Importantly, however, the principles and recommendations may be applicable to combination products reviewed under other types of applications (e.g., 510(k)s or abbreviated new drug applications (ANDAs)), as appropriate. Essentially, FDA recommends the use of HF studies, which allow manufacturers and researchers to see how products will perform under real use conditions.
The full version of the guidance can be found here.