Medical Technology

USE-Ing. Case Studies

Usability Engineering for Medical Devices

Our Usability Labs for Medical Devices

Your medical engineering contact

Benedikt Janny

Dr.-Ing. Benedikt Janny

Usability Engineer

Certified Medical Devices Usability Expert (TÜV)

UXQB® Certified Professional for Usability and User Experience (CPUX-F)

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Certified Human Factors & Usability Engineer Medizinprodukte (Online)

The interactive online training for professionals, with a focus on the Regulatory Human Factors & Usability Engineering process for medical devices. Option to acquire the…

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Regulatory Compliance in Practice

Understanding Context of Use through
User Research

User Research

A context of use analysis, also known as User Research, marks the beginning of the user-centered development process. The goal is to thoroughly understand the future users, their workflows, and work environments. Within the requirements analysis, our experts derive relevant User Requirements & User Needs from this context of use. In accordance with normative requirements, we offer our customers the use of observing, interviewing, and testing techniques. The method spectrum includes basic techniques such as protocols, audio and video recordings, as well as the use of advanced technologies such as eye tracking & motion tracking. Through observation and interviews, we collect both qualitative and quantitative data for our customers, such as context interviews, user surveys, or focus group interviews.

Do you want to truly understand your users to create real added value?
We support you in achieving this.

Ensuring Safe Medical Devices through
Use-Related Risk Assessments

Use related Risk Analysis

Manufacturers of medical devices are required by ISO 14971 to analyze and minimize potential risks that may occur during product use. Therefore, within the scope of usability engineering, both interaction-related and usage-related risks, as well as hazardous situations, need to be considered in the development of medical devices. This leads to the creation of hazard-related use scenarios. Our experts support you in planning, conducting, and evaluating such use-related risk assessments, facilitate the integration with technical risk assessments, and provide the necessary regulatory documentation if required.

Do you want to ensure the safe use of your medical device?
Contact us to learn more.

Bundling Results through
Use Specification & User Interface Specification

User Interface Specification

The information collected during the analysis is systematically consolidated in the subsequent specification process. This process concludes in the regulatory-relevant use specification document and is the basis for deriving user requirements and user interface specifications. These requirement categories are then bundled and specified in the form of a functional and technical specification document. Workflow analyses make the workflow visible for the project team and help to optimize the medical device through intelligent product design. The derived task models, are transferred into regulatory-required use scenarios, that represent the basis to identify usability strengths and weaknesses of the medical device in later evaluation activities.

Wondering how to bridge the gap between qualitative research and technical specification?
Our experts will assist you in developing your requirement specification.

Testing Medical Devices with real Users through
User Interface Evaluations

User Evaluation

Both the FDA Guideline and IEC 62366-1 require the assurance of usability during development (formative) and at the end of development (summative), through the targeted use of usability evaluation methods. Our experts conduct expert-based inspection methods such as Cognitive Walkthroughs or Heuristic Evaluations, as well as usability tests (simulated use) with participants, or support you in conducting your own tests. The recruitment of representative test participants is an important regulatory requirement. With our pool of over 900 medical professionals, we are able to cover every medical discipline and recruit participants for tests. Standard-conforming evaluation and clear presentation of study results are also part of our expertise.

You want to test the usability of your medical devices with medical professionals before market launch?
We look forward to supporting you.

Insights into our medical engineering projects

BOWA - Arc Generator System

Intuitive HF-Generator HMI through Usability Engineering

How we conducted state of the art Usability Engineering in Electrosurgery..

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Summative User Interface Evaluation Medical Device

User-Centered development of an Exorobot for fatigue-free Operations

How we progressed from early user interviews to the actual operating room..

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User Interface via GO

Usability Tests of the Push Assist via GO

Innovative yet safe & user-friendly – User-centered mobility technology for physically disabled people.

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OrthoPilot Aesculap

Usability Evaluation of the Orthopedic Navigation System OrthoPilot®Elite

How we validate the usability of medical computer-based navigation systems used in surgical orthopaedics..

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