Mar 6, 2022

The HFE process and regulatory imperative

Applying human factors engineering (HFE) proves essential to the development of safe medical technology. Regardless of whether a manufacturer is designing a medical device, combination product, in-vitro diagnostic or software as a medical device, HFE plays a crucial role in ensuring that the final design will satisfy the needs of patients and healthcare professionals.

The imperative to focus on usability and reducing use-related risk is not new to the medical industry. Rather, regulators such as the US Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA), as well as China’s National Medical Products Administration (NMPA) have established requirements that manufacturers apply HFE rigorously throughout their product development efforts.

Specifically, HFE processes aim to improve device safety, effectiveness, and ease of use by minimizing the likelihood of use errors (aka mistakes). What constitutes an effective HFE and usability process in practice at a medical device manufacturer? Key components include the following:

  • Research helps manufacturers learn about a product’s users and the environments in which it will be used. User research findings are used to determine and prioritize user needs and inform user interface requirements.
  • Analysis focuses on analyzing user tasks and use-related risks, with the goal of identifying use errors that could occur when a user interacts with the product.
  • Design includes conceptualizing, specifying, and implementing all aspects of the user interface, e.g., hardware, software, labeling and training.
  • Evaluation includes formative evaluations, e.g., formative usability tests, that empowers a manufacturer to test drive, or complete samples of new products, to identify opportunities to improve user interface.
  • Validation is the pivotal usability test during which the manufacturer confirms that representative users can interact with the product in a safe and effective manner.
  • Submission is the final step in the HFE process; It involves consolidating all HFE documentation into a final report that tells a compelling story about how the manufacturer applied HFE throughout the product’s development.

Barriers to applying HFE effectively

Individuals who routinely lead HFE activities are undoubtedly familiar with each step of the HFE process described above. That said, they may still face significant challenges getting their project teams to execute HFE activities in a way that aligns with the latest regulatory expectations and industry best practices. Sometimes this is because the demand for HFE support exceeds the capacity of internal experts. Other times, HFE experts must first gain management buy-in on the value of HFE, i.e., they must “evangelize” HFE, before sufficient resources are allocated to get the work done.  

These challenges create an opportunity for manufacturers to consider new ways to develop and expand internal HFE capabilities as well as educate project teams and management on the HFE process.

A new digital platform for medical device HFE support

To help medical technology manufacturers establish the HFE expertise needed to meet regulatory and commercial imperatives, Emergo by UL’s Human Factors Research & Design team has created a new web-based platform, the Optimal Product Usability Suite (OPUS™).

OPUS provides efficient access to HFE training, templates, tools, and regulatory guidance. By leading manufacturers through the HFE process step-by-step, OPUS allows project teams, including those with limited previous HFE knowledge, to focus on producing high-quality HFE deliverables and making products that can be used safely and effectively.

Learn more about OPUS™ and HFE education resources from Emergo by UL Human Factors Research & Design:

Author

  • Erin Davis and Stewart Eisenhart

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