Summative Usability Studies

THAY Medical have been performing Summative Usability Studies for over ten years. In this time we have performed over fifty successful studies, all exceeding expectations. We know what is needed to make the process as easy as possible, to meet budgets and to meet deadlines as well as to be compliant 100% of the time. What drives this? Our in-house expertise of Human Factors Engineers, working to our ISO 13485 Quality Management System (certified for Human Factors Engineering) together with a tight collaboration with the manufacturer or developer. Success is frequently based upon understanding, knowledge, experience, budget, management and close teamwork.

Our current best practice is to de-risk the Summative Usability Study by performing a smaller Pre-Summative Usability Study beforehand if a final Formative Usability Study has not been performed. What this does is to ensure the product (system) design is as complete as possible from a use-risk perspective and to ensure everything is working as intended. This is only if a final Formative Usability Study has not been performed. The process is exactly the same, just fewer study participants are evaluated and is classed as a verification of the product (system) design or design change and is generally only performed when there are unknowns in the user performance or use-based risk levels.

Our Process:

Our process for performing Summative Usability Studies is a 12-step sequence:

Our process is based upon a combination of all standards and guidance to ensure total compliance, but also best industry practices. Our process is driven by our customers and reflected in our Quality Management System to ensure we continuously improve our service and exceed the expectations of customers and regulators.

Our capabilities:

We have performed Summative Usability Studies for over 50 customers and offer the following flexibility in location, use environment and participants for any study:

THAY Medical have performed Summative Usability Studies around the world, in many languages, with a variety of medical products. We are confident we can perform a Summative Usability Study for you to exceed your expectations and meet time schedules and budgets!

Testimonials from our customers

  • “Spoke to several HF vendors, THAY Medical were the only one who could accommodate and execute this study. Pulled off a face to face study under very difficult circumstances. Excellent report too. Very pleased.”

    – Design Engineering Consultant, Small Design Company.

  • “THAY Medical were knowledgeable on usability and human factors. Their passion and understanding of the subject was very clear from the start of the project. Very keen to stay in touch!”

    – Senior Marketing Executive, Medical Device Manufacturer.

  • “Great planning, organisation and performance. One of the best we have ever used. THAY Medical is a symbol for high quality work and is our preferred partner for usability testing.”

    – Regulatory Affairs Specialist, Medical Device Manufacturer.

  • “Very collaborative approach. High competency and efficiency. Everything was flawless. I’ll call on THAY Medical again in the future!”

    – Director of Research and Development, Medical Software Developer.

Get in touch

If you would like to find out more about how we can help make a difference for your medical products, please don’t hesitate to reach out and we’d be happy to chat.