Not sure what the FDA wants? We know from experience and training.
- Usability study design, execution, subject recruiting, report writing - Clinical Input can do it all or just what is needed.
- Transform results into decisions and recommendations to ensure safe design and regulatory success.
Lower-Cost Usability Activities
Want success? Involve your end users early and often.
- Expert reviews/analyses of early or late prototypes often reveal shortcomings, risk, and gaps in product design.
- Field observation visits (sometimes referred to as ethnographic research or contextual inquiry) and user interviews, conducted appropriately, can shine insight into product design.
- Task analyses for a thorough and safer design.
Identify, mitigate, evaluate, repeat...
Using your risk management process to prioritize product design and features.
Evaluating potential patient harm from a clinical perspective, just like the regulators.