Summative Usability Studies

1 Our expertise

THAY Medical have been performing Summative Usability Studies for over ten years. In this time we have performed over sixty successful Summative Usability 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.

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 ensures timely delivery and human factors data that is meaningful. Success is frequently based upon understanding, knowledge, experience, budget, management and close teamwork.

60+

Summative Usability Studies performed to date

2 Our process

Our current best practice is to de-risk the Summative Usability Studies by performing a smaller Pre-Summative 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 based upon our experience in meeting the regulatory requirements. The process is exactly the same, just fewer study participants are evaluated and is classed as a verification of the medical 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 for performing Summative Usability Studies is a 12-step sequence:

Our process is based upon a combination of IEC 62366-1, UK MHRA and many ISO standards to ensure 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 the US FDA. Compliance is the basis, with the aim to produce high-quality test data to prove use safety and effectiveness.

We can test anywhere in the world but prefer to go where science tells us to go - dependent upon the user population and where they live.

In these locations we simulate all clinical and home use environments and even perform testing in actual-use environments. We use a range of hospitals, universities, clinics, simulation centres and research facilities.

3 Our study locations

4 Participant Recruitment

For every Summative Usability Study we recruit participants to take part, to test each device to evaluate its usability and human factors performance. We have a 100% success in recruiting the required sample size of participants into the Summative Usability Studies we conduct. We have spent years honing our recruitment methods with our internal recruitment team. Coupled with a 100% success in gaining ethical approvals from Ethics Committees for patient involvement - it is a process that works. It is essential to the success we have had so far and is essential to our future success. Our Quality Management System aids us in this.

100%

Participant Recruitment

5 Our recent Summative Usability Studies

Whilst we would love to tell you about the excellent work we have completed, we cannot - at least not in any way that breaches any client trust and agreement. We can however detail the following:

  • Summative Usability Study: [Pharmaceutical] Hormone Treatment, evaluated in London, UK, 2026.

  • Summative Usability Study: [Pharmaceutical] Facial Filler injection, evaluated in London, UK, 2026.

  • Summative Usability Study: [Medical Device] Contact Lenses, evaluated in Dorset, UK, 2025.

We currently have more Summative Usability Studies in progress which increases our competance in this evaluation method.

6 Frequently Asked Questions on Summative Usability Studies

Q1: How long does a Summative Usability Study take to complete?

A Summative Usability Study takes between 3-5 months to complete depending on the complexity, size and amount of data.

Q2: Who is involved from THAY Medical in performing a high-quality Summative Usability Study?

THAY Medical assign at minimum of two or four Human Factors Engineers, the support of a Project Manager, a Quality Manager and our internal Recruitment Team to any Summative Usability Study to ensure the method, communicaton and data is optimal and the test performed smoothly and meeting all requirements including the sample size of participants required.

Q3: How much does a Summative Usability Study cost to outsource?

Typcially, for a one user group Summative Usability Study, it can start from £40k (€50k/$55k), most cost around twice this amount for a Summative Usability Study with 2-3 user groups.

Q4. What do I need to supply to THAY Medical to perform a Summative Usability Study?

The first thing we would need is finished product - production ready or first batch product or equivalent. Included in this are final design instructional materials (PILs, IFUs, Manuals, Websites, Apps, Quick Guides etc) and ideally with placebo medicines for drug delivery devices.

Q5. Can the data from a Summative Usability Study be used elsewhere?

Yes, the data and Test Reports from a Summative Usability Study are frequently used to support CA/CE Marking, submissions to Notified Bodies and Regulators around the world. It is a validation of your product and as such is valid to show it is safe and effective to use.