Around a month ago, our team conducted a remote Summative Human Factors Test on an in vitro medical device required for this pandemic in six weeks, start to finish. Looking back in hindsight, we all have the same response: “How on earth did we manage to deliver it on time?” A lot of effort was…
Global Human Factors and Usability Engineering for Medical Devices
THAY Medical are a specialist Human Factors and Usability Engineering consultancy who partner with clients to focus on medical device users. We are based in the UK and Sweden and focus only on the world-class delivery of our services. We lead and are passionate on what we do to ensure that all users can safely and effectively use medical devices.
< Continuity of Service >
In this time of pandemic with the Coronavirus, we would like to assure all customers that our services continue. We have however implemented certain precautions to ensure the safety of our staff and the people we interact with. We are implementing remote-testing services for specific users who we need to evaluate medical devices with due to local restrictions in the countries they reside in. For all other aspects of Human Factors and Usability Engineering, our services remain optimal and efficient. Please contact us if you require any further information.
Remote Usability Testing
Remote Usability Testing is now a necessity during the pandemic to ensure rapidly developed medical devices can be evaluated with intended users prior to registration and use. THAY Medical have adapted to perform all Usability and Human Factors Testing remotely until it is safe to interact with people directly again.
We have adapted our ISO 13485 certified Quality System to cope with the extra demands remote testing requires including converting our R&D laboratory into a Decontamination Room where we are able to distribute and receive test devices safely to avoid exposure to contaminants.
Usability and Human Factors Engineering
We are specialists at performing Usability Engineering and Human Factors Tests on medical devices. We perform Usability and Human Factors tests in many countries globally. Our work exceeds the requirements of all the world-wide Usability and Human Factors Engineering regulations, including the FDA Human Factors guidances, IEC 62366-1 and the UK’s MHRA guidance. We also perform tests to meet ISO 11607 for sterile packaging and the FDA’s ANDA guidance for drug delivery devices. We are passionate on ensuring medical devices can be used safely and effectively.
Understanding clinicians, caregivers and patients and all users of medical devices is vital when developing new medical technologies and when modifiying existing products. THAY Medical are specialists at performing front-end user research into how users interact with new clinical practices and use tasks through performing Ethnography, Heuristic Evaluations, Expert Reviews, Structured Interviews and user-focused research. We listen. We observe. We record. Combined, these form high-quality user needs, user requirements and ultimately – safe and usable medical devices.
We are able to perform research, studies and tests in many countries globally – especially in Europe, Asia, Australasia and the USA.
We recruit and manage participants in our research, studies and test ethically to ensure their safe participation. Their safety is paramount.
We research, study and test in all types of use environments that medical devices and technologies are used within from hospitals to homes.
We have the capability to recreate and simulate intended use environments for research, studies and tests to realistic levels for all medical devices.
Latest News & Blog Posts
- Ready! Set! Conduct a Human Factors Study in six weeks!
- How THAY Medical adapted to COVID-19
In the beginning was normality. Or so we all thought. Now normality has changed. It adapted, it progressed, it enveloped us all and we have all had to adapt to a new normal. One that challenges our perceptions of personal and family safety, and for employers, the safety of our employees and their families, their…
- Not Another User Manual!
An exhausting, though a very vital, part of the whole medical device manufacturing process is the development of the Instructions for Use (IFU). Why exhausting, you may ask? Well, I am sure that any medical device manufacturer who has had the pleasure to generate an IFU would definitely back me up on this. So, what…