Based in Cambridge UK, we work globally with pharmaceutical and medical device companies. We provide usability insight to support the development of safe and effective medical devices, and to bring them to market quickly.

We perform formative evaluations and HF validation studies in Europe and the United States. Our clients include some of the world’s leading pharmaceutical and Medtech companies. We also provide HF consultancy and can assist you with embedding HF into your product development processes.

Our team of Ergonomists and Human Factors specialists have developed a deep insight into what makes medical devices usable. Our successful track record with FDA gives us valuable insight into the requirements of regulators, and we advise our clients on the likely most effective human factors strategy.

We perform:

Gap analysis – we review your HF activities and identify gaps in your program. You get a plan to close the gap and ensure compliance with international usability engineering standards

Risk analysis – we review (or write) a use-related risk analysis to identify possible use errors, design mitigation, and integrate it into your formative evaluation plans

Design analysis – we provide expert review of your product design and identify the strengths and weaknesses from a usability perspective

 

 

 

Types of studies we perform

Characterising the physical capabilities of your intended users can give your product designers insights into the ‘capability window’ in which they need to work. We can help you to characterise your users’ sensory, cognitive and physical capabilities quickly and inexpensively.

Formative evaluations are a vital part of the design verification process. Our deep experience enables us to guide your product development around the key usability requirements for your device. Focusing on usability goals and testable requirements, we can provide the user insight which shortens development time.

When you have verified that the user interface of your device has been optimised and is ready for validation, this is when we provide the complete package of testing support, from initial briefing right through to production of the study report and all steps in between. We recruit, find the right venue, design the protocol, get IRB approval if required, provide the testing staff, analyse the data and finally produce the study report.

Post market surveillance is an essential requirement. We can help you to gather, analyse and report usability data from users of your devices. Post-market data is an important source of insight into how devices can be improved. So don’t think that usability data is limited to product development; it can prove valuable once your product is on the market too.

Global Testing Capabilities

map North America South America Australasia Europe Africa Middle East Asia South Asia
Title
Content
Speak to the medical device usability specialists