On June 22, 2011, the FDA released a new draft guidance, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design.” This guidance has implications for all medical device manufacturers. Once this draft is finalized it will set a new standard for integrating HF practices within the development process, and provide a more transparent understanding of what HF considerations the FDA will be looking for when evaluating a device submission. 

As product developers, we have long understood the criticality of integrating sound human factors practices within the development process. This new guidance, along with the FDA’s recent endorsement of AAMI’s HE75, means that now is the time to work with human factors experts to ensure your products will comply with the FDA, and that time and money are not wasted on failed submissions.

This guidance represents the FDA’s current thinking on how to integrate HF/E into the development process – this is important as it can be interpreted to represent the level of process integration and activities that the FDA reviewers may be evaluating against during a 510k submission.

This standard does not deviate significantly from industry best practices. However, there are elements of human factors that are not commonly known, especially to those who do not practice human factors engineering.  We will discuss four of these lesser-known practices to clarify how proper human factors can be implemented to satisfy the FDA.

1. Device Users, Use Environments and User Interfaces

This framework (which has been used in other standards) is positioned as an aid in the identification of human factors analyses that should be conducted for a specific device. The premise is that careful evaluation of the intended users and stakeholders of the device, the intended device, and the method of how a user interacts with that device will provide the development team with a preliminary understanding of potential risk and the analytical efforts that must be undertaken to better understand them.

At Insight we use a number of tools to evaluate a program and the design intent to identify research efforts that must be undertaken. One such tool is a human factors evaluation matrix that is used for human factors and ergonomic benchmarking of a system against existing alternatives and potential new concepts. This evaluation matrix is adapted from the “MED-AUDIT Black Box System (BBS) Taxonomy;” it maps accessibility, impairment and tasks required when interacting with a system. Our version allows our human factors experts to identify potential system and user errors through a thorough, task-based heuristic evaluation.

2. Analytical Methods for Identifying, Evaluating and Understanding Use-Related Hazards

This guidance makes a clear distinction between formative usability evaluations (which is a way to evaluate a concept) and analytical approaches that should be included earlier in the design process. It states that these approaches are interdependent and should be employed in complementary ways.

These analytical methods are something Insight has specialized in for years – we typically include these activities as part of a generational or discovery research effort. The FDA recognizes these approaches as ways to identify potential risks that occur as a part of task or scenarios of use, which is a strong justification for upfront user research to guide development activities.

The guidance discusses five categories of different analytical approaches, including contextual inquiry, interviews and focus groups, function and task analysis, heuristic review and expert reviews. We know a lot of companies are familiar with these methods and probably use them on occasion. But the trick with these tools is knowing how to apply them in a meaningful way – and realizing that in many cases there is a real distinction between these analytical approaches and existing VOC. No project is exactly alike, and because of this research plans must be tailored to each project’s specific needs.

Although there is no magic approach that works for every situation, our research and human factors experts are strong advocates of contextual approaches. Contextual inquiry is a powerful tool for design as it provides a rich data set that serves as a foundation for development activities and a point of reference when making development and business tradeoffs.

3. Mitigation and Control of Use-Related Hazards

Included in the guidance is a section related to approaches for addressing use-related hazards that are defined through human factors evaluation. Within the guidance is a prioritized list of mitigation strategies:
1.    Modify the device design to remove a hazard or reduce its consequences
2.    Make the user interface, including its operating logic, error tolerant
3.    Alert users to the hazard
4.    Develop written procedures and training for safe operation

This is a simple list, but it thoroughly encapsulates the different strategies for redesigning the device and modifying the user interactions that lead to hazardous situations. It provides a strong framework for making design decisions and evaluating the impact of potential tradeoffs.

This prioritized list of mitigation strategies is a helpful tool as it allows us to categorize design modifications within a framework that is relevant to the FDA, and allows our clients to understand where their device may stand when their submission is evaluated from a human factors perspective. Insight believes the best approach for addressing user-related hazards is to eliminate potential errors, but also is aware of the business implications related to redesigning components late in the development cycle. Our trained human factors staff is able to evaluate the potential impact of different mitigation strategies, and works with our design team and clients to help make an informed choice that considers all of the relevant tradeoffs associated with each.

4. Human Factors and Risk Management Processes

This guidance stresses integration of use-related hazards within the overall risk management element of a program, more so than existing standards. The guidance provides methods for assessing use-related hazards, which then need to be effectively managed within an overall QMS. The challenge for developers is learning to manage these risks in a way that does not stifle the design process, while serving as a robust process that aligns with the FDA’s expectations.

Insight has developed a successful QMS that is flexible yet rigorous; it fully integrates the management of use-related hazards and device failure hazards as recommended by this new guidance.  Our QMS has been carefully designed to be scalable across different phases of development, fostering creativity while still monitoring and mitigating hazards at thorough and detailed level.

This guidance provides a more transparent understanding of what HF considerations the FDA will be looking for when evaluating a device submission and when finalized will represent a new standard for HF practices for medical device development. While it is important for developers to understand what is included in this guidance, it is not a how-to manual. Working with a trained human factors team that can determine which HF activities need to be included is the only way to ensure that your devices comply with these standards. For a more detailed version of how Insight’s human factors plan is compliant with this new FDA guidance, or to discuss how our team can help your human factors efforts, please contact us.