Formative/Summative Studies

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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. 

             Risk Evaluation

 

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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.


Quality is the best business plan.