Human Factors & Usability

Human Factors
Human factors is not a stage in our process - it is a fundamental foundation that runs throughout the course of every project, from desk-based research through to post-market surveillance.

Usability Engineering
The concept of Usability Engineering (UE) brings together Human Factors, Risk Management and User Experience design to understand and optimise how users interact with medical devices. UE is a regulatory requirement and PDD can fully integrate UE throughout the medical device design and development process or support stand-alone usability testing for your own development projects.

Regulatory Landscape
PDD has a comprehensive understanding of IEC62366 and ISO14971 which are both harmonised under the Medical Device Directive. PDD operates in compliance with the FDA and design guidance documents such as HE75.

Process
In-line with regulatory requirements to develop a UE file for pre-market submissions, we can provide you with a full suite of regulatory documentation to suit the needs of your project.

On-Site Facilities
There are two usability testing rooms at our London studio.

The private rooms can be used for formative or summative evaluations and are equipped with twin ceiling mounted cameras and microphones for recording and remote client viewing.

A wide range of use-scenarios can be simulated such as the home, outdoors or hospital environments. Furthermore, our flexible spaces can facilitate focus groups, training sessions, workshops and interviews.

Services
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For more information on PDD's usability engineering process click here.

 

News & Insights

14/02/2017

‘Insight Driven Innovation’, PDD features in New Design Year Book 2017

Vassilios Kanellopoulos talks to New Design magazine about PDD enjoying another successful year creating innovative products, services and experiences for clients the world over.

6/04/2017

The role of a moderator in Human Factors studies...

It may sound strange to say it but the role of a moderator, in my opinion, is to be a bit of a Chameleon. And a few acting skills don’t go amiss either! Let me explain…