Formative usability testing is a highly cost and time effective way to quickly surface shortcomings and areas for improvement in your product throughout the design process. The purpose of formative usability testing is to;
Formative testing is generally conducted;
Sento are experts in planning, executing and reporting formative testing to observe and record user feedback relating to your product. This will inform your product and the design decisions you make during the development process. We also highlight any new risks, design recommendations and risk mitigation steps.
Summative usability testing, also referred to as human factors validation, is a highly effective way to validate that your product meets its user’s needs. Product validation is a regulatory requirement for any medical device across all regions. Summative testing is generally conducted;
Sento are experts in planning, executing and reporting on summative studies. The results give you validation data on your product and prove your device is safe to use by its intended user(s) and meet regulatory requirements. We also have strategic partnerships with various test facilities and experienced recruitment agencies, in Australia and the US, to recruit suitable participants for the studies and manage all testing logistics.
Both formative and summative testing involve a planning, execution and reporting phase and generate key documentation for your Design History File (DHF) and regulatory (technical file) submission.
Think of formative testing as ‘informal’ testing of your product during the product development and design process. Formative assessments generally involve:
Summative testing is considered ‘formal’ testing of your product at the end of the product development and design process. Summative assessments generally involve: