Usability Engineering in Medical Device Packaging Design

In an article on the meddeviceonline website, Sean Hägen of BlackHägen Design discusses the importance of Human Factors Engineering (HFE) or Usability Engineering (UE) in the design of medical devices, with a focus on packaging and labelling.

Here are the key points from this article:

  1. What is HFE or UE? HFE, also known as UE, involves understanding the human behaviour of medical device users to design user-friendly medical devices. It includes mechanical and software-driven user interfaces, systems, tasks, instructional documentation, packaging, labelling, and user training.
  2. When should HFE be utilised? HFE should be integrated into the product design process from the beginning and should continue throughout the development process to ensure an optimal user experience.
  3. Packaging Needs to Be Validated: Regulatory agencies like the FDA consider packaging and labeling as a significant part of the user interface. They require a validation process to demonstrate safe and effective use.
  4. Include Packaging early in the product development process: The healthcare industry emphasizes the early inclusion of packaging and labelling in the product development process to minimize risks, reduce costs, and improve user satisfaction and safety.
  5. Labelling must be included in QA: Quality assurance (QA) programs in medical device manufacturing must incorporate elements related to labelling to meet good manufacturing practice (GMP) requirements.
  6. Packaging and labelling are often interconnected, and both are considered parts of the medical device user interface. Labels contain critical information, and packaging design can significantly impact usability and user safety.
  7. Different usage scenarios require varying packaging requirements, especially as medical devices are used both in clinical settings and at home.
  8. HFE task analysis is essential in identifying opportunities to enhance workflow efficiency and user experience by designing packaging that aids device protection, organization, and accessibility.
  9. Prioritizing HFE principles in the early stages of the design process improves packaging and reduces timeline risks and unexpected costs.
  10. Future innovations in medical device packaging may include advanced security features like 2-D bar codes, UV identification codes, holograms, or hidden text to combat product counterfeiting.

You can read the full article here.