Human Factors…. it is increasingly becoming a part of product development these days, but what does it really mean? Furthermore, how does it apply to the life sciences industry? If these questions are important to you, you are in the right place.
The Human Factors and Ergonomic Society (HFES) has a succinct description. “Human Factors is concerned with the application of what we know about people, their abilities, characteristics, and limitations to the design of equipment they use, environments in which they function, and jobs they perform.” It is not specific to life sciences but clearly has implications for medical devices and combination products.
The US FDA has a perspective worth noting as well: “Human factors/usability engineering focuses on the interactions between people and devices. Figure 1 presents a model of the interactions
between a user and a device, the processes performed by each, and the user interface between them. The critical element in these interactions is the device user interface, depicted as the red zone.”
“For medical devices and combination products (products that are comprised of either a device and a drug or a device and a biologic), the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful, and users can use the device safely and effectively.” Doing this right requires a Human Factors Plan that lays out your strategy and documents its execution.
A Human Factors (HF) Plan describes the systematic plan for developing the user interface design for a medical device or combination product. The plan incorporates human factors/usability engineering principles to minimize use errors and outlines the necessary processes and evaluations in order to ensure your product’s user interface is safe and effective for its intended users, uses, and use environments. A Human Factors Plan is a “living document” intended to be updated, reviewed, and approved as information becomes available throughout the product’s lifecycle.
The plan defines the process to analyze, specify, develop, and evaluate the usability of the product as it relates to safety. Typically, the following Human Factors Engineering / Usability Engineering (HFE/UE) activities are within the scope of this plan:
Development of User Needs and Usability Requirements
Identification of the user interface characteristics related to safety and effectiveness and the assessment of risk associated with use-related hazards and hazardous situations
Formative and Summative evaluations of the user interface including User Interface Design Validation
Keep in mind that third party vendors are often part of the team since they bring specialized expertise, strategic direction, and skills that many companies do not have on staff.
Once you have your team and your plan in place, and you’re ready to execute that plan on time and on budget, there is also an important report to keep in mind. The Human Factors Engineering / Usability Engineering (HFE/UE) Report will document that the Human Factors Plan has been appropriately implemented and shall summarize all human factors activities and results as described in this plan. The HFE/UE Report is organized according to one of two different FDA guidance documents depending on the type of product. If you are working on a medical device you’ll need to follow the FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices. For drug, biologic, or combination product submissions, you’ll need the FDA draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications. The HFE/UE Report provides an overall summary of the human factors program in accordance with FDA Guidance. The report will also serve as final evidence of overall Human Factors validation. Trust us, this isn’t a step you want to leave out unless you like having lengthy discussions with the FDA while your product development and commercialization plans grind to a halt.
Make sure your Human Factors in Medical Devices Plan includes all the necessary Human Factors Engineering / Usability Engineering deliverables
Download the Checklist Here.
As a final note, remember that a Human Factors in Medical Devices Plan is intended to be refined throughout the product’s lifecycle. So even when you’re done, you’re never truly “done,” and that’s because the FDA and other regulatory agencies want to ensure users can use the device safely and effectively throughout its lifecycle, even after the product is on the market.
If all of this sounds a bit daunting, contact us and we’ll be happy to help. We have a library of templates and standard operating procedures to help you out. Most importantly, our experts at Kymanox have regulatory experience with over 900 medical reviews and evaluations of medical devices and combination products and have a track record of developing products from invention through commercialization using Human Factors as the foundation.