Frequently Asked Questions (FAQ)
What is human-centered design in healthcare?
Human-centered design (HCD) is an approach to creating healthcare devices and software that prioritizes the needs, abilities, and limitations of end users—such as clinicians, patients, and caregivers. HCD involves iterative testing, user feedback, and multidisciplinary collaboration to ensure solutions are safe, effective, and easy to use in real-world healthcare environments.
Why is usability important for medical devices and health software?
Usability is critical in healthcare because poor design can lead to user errors, workflow inefficiencies, and even patient harm. High usability ensures that devices and software are intuitive, reduce cognitive load, and support clinicians in delivering safe, effective care.
What are some common usability challenges in healthcare technology?
Common challenges include complex interfaces, lack of interoperability, insufficient user training, alert fatigue, and workflows that do not match clinical practice. Addressing these requires user research, iterative prototyping, and ongoing usability testing.
How does human-centered design improve patient safety?
By involving end users throughout the design process, HCD helps identify and mitigate risks early. This leads to products that are less prone to user error, support correct decision-making, and ultimately improve patient outcomes.
What regulations or standards apply to usability in healthcare?
Key standards include IEC 62366 (usability engineering for medical devices), FDA human factors guidance, and ONC certification for EHR usability. Compliance ensures products meet safety, effectiveness, and accessibility requirements.
How can I get started with human-centered design for my healthcare product?
Start by engaging real users early, conducting contextual inquiry, and mapping user journeys. Use prototypes to gather feedback, iterate designs, and perform usability testing with representative users. Partnering with usability experts can accelerate the process and ensure regulatory compliance.
How does accessibility relate to usability in healthcare?
Accessibility ensures that healthcare technology can be used by people with disabilities, which is a core aspect of usability. Following accessibility standards (like WCAG) helps make products inclusive and legally compliant.
What are the benefits of ongoing usability testing?
Ongoing usability testing uncovers issues as products evolve, ensures continued alignment with user needs, and supports continuous improvement. It also helps maintain compliance with regulatory standards and enhances user satisfaction.