Skip to content

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.

 

Medical markets

Discover our breadth of expertise across the MedTech market and how we collaborate to drive the advancement of medical technology.

Medical services

Find out how our specialist MedTech Ru0026D consulting services can help you transform patient outcomes through innovative medical device development.

Contact us

We’d be delighted to discuss your challenges and explore how innovative thinking could help solve them. If you’d like us to get in touch, please complete the contact us form.