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Human Factors

Human Factors Engineering intends to design save and effective medical devices. To do so a number of standards and guidelines need to be taken into account:

  • IEC 62366 in general describes the necessitiy of a HF engineering process
  • FDA‘s guidance “Applying Human Factors and Usability Engineering to Optimize Medical Devices” as the gold standard on how to perform research for medical devices
  • AMII HE 75, Human Factors Engineering-Design of Medical Devices as an encyclopedia for device design
  • EU guidance…

Please reach out to us, we are happy to talk you through this!

The Human Factors Engineering process

Designing a medical device is always an interative process. It starts with finding out…
… Who will use the device and what skills do these users have?
… And what potential risks could occur while using the device.
The iterative process aims at mitigating theses risks as far as possible to make the device safe and effective to use.

Types of Studies

There are noumerous research approaches for medical device design (and we are happy to help with all of them), but the below are the most important ones:

Formative HF Testing
Basically this summarizes everything you do to improve the device design and to mitigate risks. It can reach from very small, fast and informal studies up to highly standardized approaches, i.e. to test if the device would pass a validation study.

Human factors validation testing
This type of study is also called summative testing and its only purpose is to provide evidence to FDA or EU notified bodies, that the device is save and effective to use and thus can be marketed. These studies are usually quite big, take a long time and follow clear, pre-defined procedures.

Instructions for Use

Medical devices come with instructions for use. These are (at least) part of the validation testing and shall support the users in using the device. Our team of designers is happy to support you in creating them, from first drafts to ready-to-print final versions.

Want to know more?

Then get in touch with our experienced Human Factors consultants today!

Responsiveness is important to us so we promise to get back to you immediately.

Wolfgang Waxenberger
E:   wolfgang@uintent.net
T:   +49 40 8821566 62

Tabea Hermann
E:   tabea@uintent.net
T:   +49 40 8821566 63