Medical Device Usability
BERGO is one of Europe's leading consultancies and training providers in the area of medical device usability. We help manufacturers conform with essential requirements related to usability through compliance with ISO/IEC 62366:2007.
For premarket approval in the United States, we also assist manufacturers with key National Standards, such as ANSI/AAMI HE75: 2009, as well as guidance documents in human factors engineering.
Our project experience covers various areas of the medical device industry including drug delivery, diagnostic, respiratory, surgical and advanced laboratory instruments.
User Research
We are able to collect information on the intended user population of a medical device, and identify the characteristics that are critical to human performance.
We conduct research methods, such as interviews, contextual enquiries, and literature reviews to gather information on the level of technical knowledge, experience, education and training of intended users.
User-interface Design
We are skilled in the use of task analysis techniques for identifying and analysing frequent and/or safety-critical user interactions with both hardware and software attributes of the user interface.
Depending on the type of device, we analyse users in context or collect information in workshops to explore the safety, efficiency and effectiveness of primary operating functions.
Usability Testing and Evaluation
For every $1 invested in usability testing, the return is between $10 to $100.
IBM
As required in IEC 62366, we are able to assist with usability verification and validation activities.
We support/run formative and summative usability tests, and evaluate user interface designs using techniques such as cognitive walkthrough and heuristic evaluation.
Use-error Analysis
For medical devices that have safety-critical features, we are able to perform risk analyses of use-errors as required in ISO 14971: 2007.
We conduct techniques, such as Human FMEA, PHEA and FTA, to analyse human failures, consequences and factors affecting performance. We are able to propose modes of control to reduce or eliminate risks of use-errors.
Usability Integration
Implementing a usability engineering process, as described in IEC 62366, often presents a number of challenges that require usability expertise.
We can map usability techniques to different stages of product design and development, set up usability programmes and processes, and form usability teams.
Cross-Cultural Design
Designing products for culturally diverse markets is a challenging activity faced by all international product manufacturers.
We are able to define key differences between cross-cultural users, particularly those linked to human performance, and can run/support usability tests in different regions of the world. Read more