Usability Engineering for Medical Devices 101

The 5 Parts of the Usability Engineering Process for a Medical Devices & Combination Products

1. User 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

2. 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?”

3. Iterative Prototyping & Usability Testing

• 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

4. 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

5. Human Factors Submission & Compliance

• 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

Next Steps