The Usability Engineering Process is used to help develop and design safe and effective medical devices that are also usable, ultimately reducing the overall risk of the medical device and improving the customer experience and satisfaction. When implemented early in the design process, it can help a medical device company save money and time by identifying potential use errors in the prototyping phase so design controls and mitigations can be implemented effectively. This blog post outlines the critical phases of the Usability Engineering Process and what they entail for a medical device.
What is Early Stage Human Factors Research?
Collect on-market safety data as an input to the medical device design
Find out what people are really thinking through observation at point of medical device use
Actions speak louder than words
Identify environmental, social, and motivational considerations for the design of the medical device
Use appropriate sample, representative of ALL user types
Ask the right questions
What is Use-Related Risk Analysis?
Methodically identify and record all use errors associated with the medical device
Use this information to improve the medical device design and maximize safety
A Use-Related Risk Analysis is required by regulatory agencies (e.g. FDA)
Ultimately answer the question, “Is this medical device usable enough to be used by and for my friends and family?”
[ITERATIVE PROTOTYPING AND USABILITY TESTING]
What is Iterative Prototyping?
Create prototypes that are minimally viable for evaluating usability
Run many low-cost usability studies to quickly identify and assess use-related risks
What is Usability Testing?
Behavioral testing to inform design and to identify use-related risks
Formally document prototype evaluations to support FDA submission and CE marking
Simulate realistic use, without having to release product first
“Predict the future” and eliminate surprises in the field
Comply with regulations to avoid FDA roadblocks
The Human Factors branch of the FDA has noted that it’s unlikely to have a successful PMA or 510(k) without performing early-stage usability testing with prototypes
What is Usability Validation?
Demonstrate the safety and usability of the medical device in simulated use
Usability Validation is currently required for CE Marking, and a key for successful submission to the FDA for many products
[HUMAN FACTORS SUBMISSION & COMPLIANCE]
What is a Usability Engineering Submission?
For most 510(k)s and ALL PMAs, a Usability Engineering Submission Report is required
Including a Usability Engineering Summary Report in a 510(k) can expedite submissions
What is Usability Engineering Compliance outside of the US?
Compliance to EN 62366:2008 is required in the E.U.
- IEC 62366 compliance includes the need for a Usability Engineering File