human-factors-testing

About Human Factors Testing

THAY Medical specialise in conducting human factors testing on medical devices and drug delivery devices.

– Formative (Verification) Human factors Testing;

– Summative (Validation) Human factors Testing;

– Comparison Device Human factors Testing;

THAY Medical have the expertise to fully perform human factors studies to ensure the optimum outcomes are achieved. We as a minimum achieve compliance to the current regulations and best industry standards such as IEC/ISO 62366, FDA UCM259760 and ISO14971.

  • User Research
  • Contextual Enquiry
  • Task Analysis
  • Heuristic Analysis
  • Human Factors Risk Management
  • User Interfaces Research and Specification
  • Concept Design Human Factors Assessments
  • Formative Human Factors Studies
  • Summative Human Factors Studies
  • Human Factors Reporting

Want to know more information?

Do you want to find out more information?

Have you got a question for THAY Medical?

Please contact us! We would love to hear from you.

Send message

More on Human Factors Testing

Where can we test?   Everywhere that currently trades with the UK including Europe, USA, Brazil, Israel and Australia.

Who can we test?   Clinicians, patients, carers, pharmacists, healthcare system users and the general public.

What can we test?   Medical devices, drug delivery devices, healthcare systems, apps and consumer healthcare devices.

Where can we test?   In a simulated and real use environments – hospitals, ambulances, in-house or viewing facilities.

More on Where We Test

THAY Medical are able to run human factors studies almost anywhere in most use environments.

Typically we run studies using viewing facilities, clinics, ambulances, operating theatres, hospital rooms, wards and clinician offices. We always aim to replicate the intended use environment as far as practicably possible.

We can perform studies in Europe, USA, Brazil, Israel and Australia at present since this is where they are most often required. In some countries, we use partners to perform the studies and in others we do it ourselves. Local knowledge is key to a successful study since you have to meet local ethical requirements, be able to recruit the right participants and perform the study in a timely and cost effective manner.

More on People We Test

THAY Medical are focused on reflecting the intended users of the device and can recruit nearly all user groups.

For medical devices this is often consultants, registrars, MD’s, specialists, nurses, biomedical engineers, junior level staff and patients. For pharmaceutical products, this is more often patients, carers, specialists and nurses. We can recruit patients with most conditions – Diabetes, Rheumatoid arthritis, Dementia, Parkinson’s disease, Crohn’s disease, COPD, asthma and many more, where injections, infusions, inhalation or ingestion is required to be evaluated with a drug delivery device. We also ensure that the correct medical professionals are recruited since the prescriber’s and decision makers, alongside the users are often part of the product life-cycle.

More on How We Test

THAY Medical use the latest test methods to ensure that the data collected is of the highest quality.

Key to this is to map out the study to focus on use safety, predicting use errors (and where they are likely to occur), reflect typical and worst case use scenarios and to use the highest fidelity simulated environments. The process used is that of the one reflected in many guidance documents – IEC/ISO 62366, AAMI He-75, UCM 259760 etc., so that the processes used are as a minimum industry level, and at a maximum, better. Everything is recorded, both electronically and in hard copy form. All recordings are in high definition (HD), all paperwork created, stored and managed to the requirements for Data Protection and confidentiality.

In addition, THAY Medical staff work to the latest guidances from the BHBIA, ABPI (PMCPA), MRS, EphMRA, NIH, FDA and many more organisations; and follow the requirements for confidentiality, data protection, ethics and professional conduct to the level found in globally accepted legislation and regulations, such as the Declaration of Helsinki (1964). All human factors studies are classed as “research involving human subjects” and as such we check that country specific ethical requirements are met with every study.

More on Documentation

All human factors studies require high fidelity, usable documentation.

It is the documentation that collates evidence of the test data and the safe methods used to collect the test data. THAY Medical are able to fully write or review study documentation such as the Test Plans, Study Protocols, Data Collections; design input documents such as Application and Usability specifications, Usability / Human factors risk assessments, labelling, Instructions for Use, User Manuals, Patient Information Leaflets, user documents and Human Factors Reports (including specialist ones to the FDA formats). In addition THAY Medical are able to write all documentation required for full ethical reviews and clinical or external notified body reviews.

More on Products We Can Test

We can test all types of medical devices.

THAY Medical test many medical devices. Our expertise is only derived from testing a range of medical devices. We focus heavily on drug delivery devices – infusion pumps, pen injectors and accessories, but also test hospital-based medical devices. Recently we have evaluated consumer healthcare devices, needles and software applications. As long as the product is a medical device – we can test it.

Creating a Positive User Experiance

Evidence of use safety and proof that the medical device creates a positive user experience.

When you perform a human factors study, data is obtained that can determine the inherent level of use safety the device possesses. Alongside determining predictable use errors, human factors testing can determine new use errors where the study participant (user), for example, performs differently to that expected or intended. This is often due to misunderstanding human emotions, cognitive processes and the logical reactions of the intended user under the conditions subjected to in the use environment. “Know thy user, for he is not thee” is David S. Platt’s law of user experience design and means that you have to understand the predictable and to some level, the unpredictable. With medical devices, this is key since they all carry a level of use based risk.

intern nurse holding a clipboard

Recruitment

Southampton, Hampshire, UK – January 23, 2006: Medical patient simulator and dummy for education and training purposes

Formative Level

Close-up Of Hand With Mobile And Smartwatch Showing Heartbeat Rate

Summative Level

humanity-254788_1920

Global Test Locations

progress-1807541_1920

Test Environments We Use

services_0003_medical-device-testing

Medical Devices We Specialise In