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Human Factors Engineering in the development of the TMINI® Miniature Robotic System: THINK Surgical

Our client asked:

As part of our work on the main development of the TMINI® Miniature Robotic System, Sagentia Medical was asked to provide the primary Human Factors (HF) expertise to ensure the TMINI® system was designed and developed for safe and effective use. We recognised that usability would be critical to the success of the product.

 

The project story:

  • Useability Engineering Plan
  • Use specification and user interface specifications
  • Ergonomic assessments with representative users using non-functioning form factor models
  • International user survey (quantitative primary research)
  • Contextual studies (day in the life studies) at US, UK and European hospitals
  • Task analysis (incl. perception, cognition, action analysis) and use-error risk analysis
  • Supported the design and development of the Graphical User Interface and Instructions for Use
  • Expert reviews with surgeons, OR staff and sterilisation technicians in the US & UK, using prototypes and mock-ups
  • Formative evaluations incorporating cognitive walkthroughs and simulated use scenarios with representative users (i.e., surgeons and OR staff). Formative studies included cadaver procedures at specialist facilities in the US
  • Maintained IEC62366-compliant UEF throughout
  • Supported the HF validation (summative) evaluations, including creation of the protocol and final report compilation

Results: deliverables and outcomes

Compilation of a well-structured and comprehensive Usability Engineering File (UEF) for the successful premarket submission of the TMINI® robotic system. The UEF contained extensive evidence pertaining to the system’s safe and effective use, including identification, evaluation, and final assessment of all potential use-related hazards.

In addition to applying a proficient usability engineering process, we supported the development of an intuitive system with a well-considered workflow and refined user interfaces. This led to a system that is believed to be simple to set up, easy to use and integrates well into the normal OR layout and surgeon workflow.