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 summative studies in Europe and the United States. Our clients include some of the world’s leading pharmaceutical and Medtech companies. We also perform ergonomic and anthropometric research.

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.

Over the past 24 months we have performed 30 human factors studies, approximately 40% of which were in the United States to FDA guidance. Our HF work supports successful product approvals in the US and EU.

Because we are independent of any design house we can work with your chosen product design specialists. And our independence gives you confidence that we will give you unbiased, objective advice with no suspicion that we are ‘testing our own product’.

 

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.

One or two of our clients have started to ask us for post-market usability data, either to answer questions from regulators or to provide supporting evidence for marketing claims. Not only that, but usability data has been used (successfully) to support pricing and reimbursement strategies. 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

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Speak to the medical device usability specialists