4 Rules of Integrating Human Factors Into Medical Device Design

September 21, 2011

By Hope Hopkins, Research & Product Strategist

With the Food & Drug Administration’s (FDA) increased scrutiny on device usability, being able to understand and demonstrate the importance of human factors and intuitive use in device design has become a critical work tool.

Understanding the following 4 principles provides a fundamental knowledge base to be able to successfully design and engineer innovative medical products that incorporate the needs of multiple users and influencers, complex, existing workflows and the challenges of their sensory and physically demanding use environments while remaining FDA compliant.

#1: Understand usability requirements per the FDA

Simply stated, the FDA has put the onus on medical product companies to prove that adequate consideration of Human Factors Engineering (HFE) went into the design process. Applicable regulations pertaining to human factors worth familiarizing yourself with include:
FDA has also published numerous guidances on human factors engineering and usability evaluation, including its latest draft guidance published for public comment in June of this year. This proposed new guidance can be found at the following URL:

  • 21CFR§820.30(c) Design Inputs
  • 21CFR§820.30(g) Design Validation
  • 21CFR§820.100(a)(1) Corrective and Preventive Action

#2: Understand the roles and value of formative and summative testing

Usability testing is an integral part of risk management activities during medical product development and needs to be included throughout and at the end of the development process. As the product is being defined, formative testing is extremely valuable in order to glean insights on the design concept typically based on user evaluation of graphical representations, models or prototypes. Once the concept to be developed is decided upon and the product design continues along the design spectrum, iterative formative testing is used to assess the impact of design choices made and of the content and manner chosen for delivering information to users. Summative usability testing is performed on the final product design and its accompanying information to validate that the product can be used safely as intended in order to achieve its optimal effect.

#3: Understand that usability findings can (and should) lead to innovations

Enough said - user needs drive products.

#4: Understand how the GUI fits into usability

A device’s graphical user interface (GUI) is an important and complex component of usability assessment work. Intuitive task flow steps, clear display graphics, labels and icons, control button ergonomics, warning and error prompts all contribute to how well an individual is able to use a device without error or risk.

To learn more about these driving principles for success along with best practice strategies that support the inclusion of usability into the design process join David Copeland, Director of Industrial Design and Jessica Pichs, Principal, Research & Product Strategy on September 27th for a session sponsored by Life Science Alley.

Learn more about incorporating Human Factors and Usability into the design development process.