The FDA's latest draft guidance document adds focus to Human Factors and Usability Engineering in Medical Device Design
Christina Mendat Ph.D
Director, Research and Human Factors
Radius Product Development
June 22, 2011, The FDA has once again called attention to the importance of Human Factors in Medical Product Design. In their most recently release draft guidance document: “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” the FDA highlights the critical role of user-centered risk analyses. The most important take-away from this is that a strong connection should be made between testing activities and risk analyses. Radius Product Development's own Christina Mendat PhD, Director - Research & Human Factors adds some perspective.
“As part of their design controls, manufacturers conduct a risk analysis that includes risks associated with device use. If the results of this analysis indicate that there is a moderate to high risk of use error, or if a manufacturer is modifying a marketed device due to problems associated with use, particularly as a corrective and preventive action (CAPA), then the manufacturer should perform appropriate human factors testing according to this guidance document.”
The important aspect of this is that many companies carry out very rigorous risk analyses which range from chemical to biological, to name a couple. Often missed, during these analyses, are those called “use-error” risks. The FDA lists a number of various use-errors that are identified in user-centered risks analyses. The document states:
Use-related hazards occur for one or more of the following reasons:
- Device use requires physical, perceptual, or cognitive abilities that exceed the abilities of the
user;
- The use environment affects operation of the device and this effect is not recognized or
understood by the user;
- The particular use environment impairs the user’s physical, perceptual, or cognitive
capabilities when using the device to an extent that negatively affects the user’s interactions
with the device;
- Device use is inconsistent with user’s expectations or intuition about device operation;
- Devices are used in ways that were not anticipated; or
- Devices are used in ways that were anticipated but inappropriate and for which adequate
controls were not applied.
As one might imagine, these types of errors may not be revealed in the traditional engineering risk analysis. These errors are identified, however, when approached using a different “lens.” This lens can take into account a number of factors such as existing behaviors, predicate devices, and knowledge of human factors and ergonomics to name a few. By conducting a user-centered risk analysis (also known as a human error safety risk assessment or U-FMEA), a number of project risks can be identified early on in the product design process. These can be conducted separately or as a joint effort with engineering. The key is to call out those errors that are user driven and to mitigate those accordingly. Important to the FDA is in knowing that a comprehensive approach was used during the product design process and that this approach was established earlier in the program (i.e. not later in the program or in an attempt to “retrofit” testing to product).
Although the FDA has highlighted the importance of these activities from a regulatory standpoint, this practice coupled with other human factors activities such as heuristic evaluations, formative testing and validation testing can highlight potential “showstoppers” resulting in earlier design modifications and a smoother design process overall. The core of this guidance document, as well as AAMI’s HE75 standard, is in understanding the users and their respective capabilities and limitations and how that can affect the usability of a product. Every manufacturer’s goal is to develop a compelling and safe medical solution. By integrating sound Human Factors engineering and research into the process, the product design process can be better informed, more proactive and result in products that are not only technically functional but intuitive and usable. This, in turn, can garner greater compliance, satisfaction and product loyalty overall.
We can help navigate the HF activities with a trained persective to ensure your device complies with these standards. For more detailed information on how Radius Product Development's Research and Human Factors capabilities complies with this new FDA guidance, contact us here.
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Christina is the Director of Research and Human Factors at Radius Product Development where her primary role is to provide technical expertise and mentorship to the research and HF teams and champion the integration of both in the product development process.Christina has contributed technical expertise to a number of projects ranging from large scale medical devices and systems to consumer goods. She is an expert at translating research findings such as user needs, requirements, product strengths and product weaknesses into compelling design directions and solutions.
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