Medical device manufactures have often looked at usability engineering as a mere additional sheet of paper necessary for market access. So for a long time, only the minimum required by IEC 62366-1 was implemented, i.e. the focus was placed on analyzing use-related risks. 

Excellent usability engineering offers the opportunity to focus intensively on actual user needs and greatly improves the product application. Increased user experience is a key differentiating factor to out-smart the competition. 

What many companies also overlook: Knowledge gained from usability engineering not only drives risk management, but – when used smartly – is direct input for requirements engineering. In addition, information from the clinical evaluation process and later post-market surveillance also provide important information about usability and should therefore be systematically used as input for usability engineering. 

In this digital_Blink we have Michael Engler as guest who is involved in standardization for usability engineering. He also has many years of experience in requirements engineering and usability engineering in the medtech industry and knows the secrets of how lean but efficient usability engineering can be realized. 

We will talk about: 

• Usability Engineering as product lifecycle processes within the quality management system
• The hidden potential: Commonly unseen usability activities and their benefits
• The important role of the task analysis
• User Interface Specification: Direct link from usability to requirements vs. link to risk analysis
• Integration of clinical evaluation and post-market surveillance data