News Feature | February 4, 2016

FDA Clarifies Human Factor Studies For Medical Device And Combination Product Design

By Suzanne Hodsden

FDA Food-Facility Inspection Processes

The U.S. Food and Drug Administration (FDA) has released two new draft guidances and one final guidance related to human factors in product design. One draft guidance describes the agency’s recommendations regarding human factor studies in the design of combination products; the other lists which device types should include human factors (HF) data in their premarket submissions. The final guidance focuses on applying human factors and usability engineering to medical devices.

Currently, manufacturers of combination products — which comprise combinations of drugs, biologics and devices — have to submit applications through more than one center, a process fraught with confusion and delays, which is compounded by the complexity of the technology. In response to a report by the Combination Products Coalition (CPC), the FDA has held a series of focus groups to address inefficiencies in the regulatory process for combination products.

These focus groups identified key problems with recommended solutions, which were endorsed by Robert Califf, the President’s nominee for FDA commissioner and current deputy commissioner. One of their suggestions called for the FDA to issue more guidance, and in response, the agency has released a draft guidance that explains HF studies and special clinical recommended for combination products, specifically those that combine drugs or biologics with devices.

In order to achieve what the FDA refers to as “representativeness,” the agency has recommended that manufacturers and clinical researchers design human factor studies, which essentially “test drive” their products in real-life circumstances and require closer interaction with patients and consideration of their feedback. According to Chad Uy, project manager for Design Science, this process requires researchers to “infuse every step of the device-development process with as much realism as possible.”

In a 2011 draft guidance that was recently finalized, the FDA laid out the different types of human factor studies and their benefits to medical device manufacturers. Incorporating HF data early on and throughout the design process, the agency said, can reduce the need for costly modifications or updates further down the road.

In its most recent draft guidance, the FDA has redirected its attention from medical devices alone to combination products and other clinical studies, though many of its previous recommendations regarding HF data study design and data collection for devices overlap.

“For a combination product that includes drug and device constituent parts, both the device design control requirements and drug development expectations apply to the entire combination product,” wrote the FDA. “Therefore, when evaluating a combination product, the design of the product user interface should be assessed in HF studies if needed to ensure that use-related hazards associated with the product are eliminated or mitigated to reduce patient adverse events and medication errors to use-related errors.”

According to the FDA, HF studies of combination products are conducted as part of the product design controls process, and in most cases, before commencing major clinical trials. Because every combination product’s technology is unique, the agency encourages questions during development meetings.

In a separate guidance, the Center for Devices and Radiological Health (CDRH) reiterated that HF studies are essential for a “robust design control subsystem,” and identifies circumstances and high-risk devices for which HF data should be included in premarket submissions.

The guidance’s listed items include devices with “clear potential for serious harm resulting from human error,” such as artificial pancreas systems, robotic surgery devices, ventricular assist devices, and dialysis systems. The agency recommends HF Validation be submitted with these devices unless they contain no modifications to user population, user tasks or interfaces, or potential use environments.

The FDA will accept comments on the two draft guidances through May 2016.