THAY Medical specialise in conducting usability and human factors testing on all types of medical devices – including in vitro diagnostic devices and drug delivery devices. We most frequently perform the following types of evaluations: 

  • Design concepts Human Factors Testing – comparing two ore more design concepts against each other.
  • Comparison Device Human Factors Testing – comparing two or more existing devices against each other.
  • Formative Human Factors Testing – Verifying design and use safety.
  • Summative Human Factors Testing – Validating design and use safety.
  • Post-market Human Factors Testing – evaluating design changes.
  • Clinical Feedback Human Factors Testing – ensuring medical devices are being used as intended.

THAY Medical have the expertise to fully perform human factors testing to ensure the optimum outcomes are achieved. We are good at what we do!

Locations we test in

We perform Human Factors Testing in many countries to meet regulatory requirements and customer preferences. We perform testing in Western Europe – UK, Ireland, France, Germany, Spain and Portugal; in Oceania – Australia and New Zealand, and in Northern America – Canada and the USA. We most frequently perform Human Factors Testing in Western Europe and the USA since most devices require CE Marking or evidence to support a pre-market authorisation in the USA. We are expanding our global reach, so please contact us if you require testing elsewhere.

Use environments we test in

THAY Medical are able to perform Human Factors Testing in many clinical and non-clinical use environments. We have particular expertise in testing devices in home-use environments, in hospitals and clinics, as well as in ambulances and helicopters. Generally, we perform testing in simulated use environments or real use environments, in all the countries listed above. Most medical devices are hospital focused, but increasingly more are integrated into consumer technologies, and as such are home-use devices.

People we recruit for testing

Any medical device should be tested with the correct users. THAY Medical have in-house capability to recruit users (participants) for Human Factors Testing in the countries listed above. We have an exceptional track record of always fulfilling the recruitment sample sizes, and since this is performed and managed in-house, we are able to recruit the most types of user:

  • Healthcare professionals such as Nurses, Doctors, Physicians, Clinical Specialists, Engineers and Consultants
  • Members of the public (lay users)
  • Patients such as those with long-term conditions, injuries, disabilities or specific diseases
  • Pharmacists and Healthcare payers

Global compliance to regulations and laws

THAY Medical operate ethically in all countries and we abide by the laws of each country tested in. These include Anti-bribery, Non-clinical research, Accounting, Data Protection and Ethical service Acts and Regulations. In addition, we comply with market research, pharmaceutical and clinical regulations that involve the testing of human users (subjects).As a minimum, we achieve compliance to the current regulations and best industry standards in human factors, usability, design control, such as IEC 62366-1:2015, ISO 9241, IEC 60601-1-6:2010, FDA UCM 259760, UK MHRA Guidance and ISO 14971.

Costs and Durations

Human Factors Testing is a critical method of gaining evidence of use safety of a device – essential in proving the product has acceptable or minimal use-based risk. It is not as expensive to perform as a clinical study or clinical trial, and is often a fraction of the cost. Typically our Human Factors Tests start at £4,000 / €4,500 / $5,000, but for more complex devices, that involve many user types, the cost increases. If a specific test environment is required, the cost of performing the test can be higher since it costs to hire or simulate a specific use of the device. Typical durations for performing human factors tests from start to finish are:

  • Comparison Device Human Factors Testing – 6 weeks
  • Design Concepts Human Factors Testing – 6 weeks
  • Formative Human Factors Testing – 6 weeks
  • Summative Human Factors Testing – 8-12 weeks
  • Post-market Human Factors Testing – 6 weeks
  • Clinical Feedback Human Factors Testing – 5 weeks

If you have a device that requires testing for its Human Factors and usability, please contact us.

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