What we do everyday is Human Factors and Usability Engineering.
We spend our time immersed in Human Factors and Usability Engineering for medical devices. This includes activities such as formative usability studies or summative Human Factors testing, user research with patients, carers and clinicians, and other activities that enable us to really understand a product’s intended users in depth. Our work is completely focused around compliance, and our ISO 13485 certified Quality Management System is the basis of all of this user-focused effort. We continuously improve and are passionate in what we do. This is why we are the Human Factors partner of choice for many organisations globally.
IEC 62366-1 Compliance
US FDA Compliance
UK MHRA Compliance
EU MDR Compliance
We frequently perform a full or partial Usability Engineering program for many types of medical devices to comply with IEC 62366-1. We are able to scale the amount based upon the risk level of the medical device to make the process optimal, yet ensure compliance to use in CE Marking.
For all types of US-based regulatory submissions, we are able to support you for compliance to this and other FDA guidelines – including ones for Drug-delivery Combination Products, Home-use medical devices and generic products where compliance to ANDA guidance is necessary.
For UK-based submissions to the MHRA, compliance to their own Human Factors and Usability Engineering guidance is required. We partner with many organisations to ensure compliance with this guidance to aid the submission and any subsequent economic assessments
The future regulation required in CE Marking a medical device in Europe is the Medical Device Regulation [2017/4/EC]. For many legacy devices the step is minimal, and for others more. We assist many organisations to make the jump to full MDR compliance for usability and Human Factors.
Types of Usability and Human Factors Testing
Remote Usability Testing is now a necessity in the current climate to perform Usability and Human Factors Testing where actual contact has to be eliminated. Using the internet, medical devices can be evaluated by users remotely, under the control of a strict Protocol and test method, with the Human Factors Test team located safely away from the participant.
Comparative Usability Testing is ideal at the start of the development process. It aims to compare new and existing designs as well as competitive designs of medical devices. If determining the benefits of improved tasks, sequences or operating methods, then comparing against known devices can determine how tangible the benefits really are.
Formative Usability Testing is where new designs of medical devices can be evaluated to determine whether they are going to be used safely. Since development is iterative, improving the design to be efficient, safe, effective and usable is key to ensuring the design meets the intended purposes and requirements. This testing is focused on reducing use-based risks.
Summative Human Factors Testing is the final evaluation performed prior to launch and is a design validation – ensuring the developed medical device meets its user needs. It is performed to quantify the amount of use-based risk the medical device has and to ensure that all elements of training, labelling, installation and instruction are adequate for the intended users.
Understanding people in depth
We are user researchers at our core. Investigating people, who at times will be users of medical devices. Understanding why they use devices in a particular manner. All so that we can predict future medical device use. After all, we are all predictable to some level!
To do this we use the techniques best suited to the research objectives required. This could be using ethnography, contextual inquiry, individual interviews through to the more quantifiable formative usability studies and summative Human Factors tests. We do this globally, especially in Europe, Australasia, Asia and North America.
We are able to recruit many types of clinician in many countries so that they can be interviewed, understood, and used in formative Usability Studies or in summative Human Factors tests. We abide by best industry practices, as well as our own ISO 13485 certified Quality Management System to do this ethically and responsibly.
In addition we focus on other medical device users – patients, caregivers, personal carers and supporting hospital staff such as Biomedical Engineers and Sterile Services staff. We are able to recruit many patient types with varying conditions, diseases and injuries in many countries to include in interviews, studies and tests.
Areas of Specialism
Drug Delivery Devices
In Vitro Diagnostic Kits
Clinical areas we really understand
Over the years we have gained deep insight into many clinical areas. By having the understanding of the users, their use environments and their behaviours, we can start to predict intended use and what likely issues may occur in the future that could be prevented. Clinical areas we have expertise in include:
- Parkinson’s Disease
- Alzheimer’s Disease
- Multiple Sclerosis
- Vital Signs Monitoring
- Negative Pressure Wound-care
- Medical Imaging
- 3D Surgical Printing
- Smoking Cessation
- Sexual Health