usability engineering - in short
Usability Engineering is critical in developing safe and effective medical devices
Usability Engineering is a vital aspect in developing safe and effective medical devices and fulfilling requirements from authorities. FDA and Notified Bodies have increased their focus on Usability Engineering and they expect that you validate that the intended users can use your product as intended in the intended use environment.
Usability engineering
Our capabilities
Whether your organization needs a single of our competences or the entire range, we are here to help you.
User Research and Use Specification
Strategy and Planning
Integration with Design Control and Risk Management
Task Analysis and Use Error Risk Analysis
User Interface Specification and Design
Heuristic Evaluation and Expert Reviews
Formative Tests
Usability Test Protocol
Design Change Impact Assessment
Human Factors Documentation and Reporting
Usability Engineering Training and Courses
Summative Evaluation
usability engineering - the long read
We work with all types of MedTech development, including devices, IVD, combination products and software
It is not enough that your medical device has the right features if the users are not able to use them correctly. In the interaction between the user and the device, it is critical to account for human capabilities and limitations. Hence, evaluating the User Interface should get as much attention as designing the device.
What we offer
We will help you integrate Usability Engineering in your device development and at the same time document the process to ensure compliance with authorities.
Our services range from Early Stage user insights and formative User Interface evaluations to late stage summative evaluation, HFE reporting and authority dialogue. We often assist in existing product updates and design changes.
Technolution is working in compliance with recognized Human Factors and Usability Engineering standards and guidances (FDA guidance & IEC 62366-1:2015).
Expert knowledge and extensive experience
Our expert knowledge and extensive experience enable us to advise our clients on both the strategic and operational level. When working with Usability Engineering, we make sure to integrate the activities with Design Control and Risk Management. We utilize input from Risk Management to scope the Usability Engineering activities and make sure that the output from these activities provide valuable input for both the User Interface Specification and Risk Analysis. Our inhouse product development capabilities furthermore enable us to provide redesign suggestions to improve the usability of your device.
For user testing, Technolution can also provide test facilities and test recruitment assistance both in Denmark and through our network within the EU and in the US.
We also offer Usability Engineering courses, tailor made to suit your company needs and product category.
Focusing on and prioritizing Usability Engineering activities will generate numerous benefits:
- Minimized need for training and support
- Fewer late stage changes in the development, ultimately leading to faster time-to-market
- Regulatory compliance: Even though it is not always required to submit Usability Engineering documentation to authorities, documentation is still mandatory and can be requested by authorities during e.g. inspections and audits
- Simpler and more intuitive product user interfaces
- Improved user satisfaction leading to improved sales
- Improved market life and customer loyalty
- Minimized risk of liability claims and product market withdrawals
Want to know more?
Get in touch
Do you want to know more or didn’t you find what you were looking for?
As Head of Usability Engineering, Jon is prepared to receive your enquiry.
What we do
We have ten areas of expertise that take you from A-Z
Whether you need a single competence or any combination of skills, our experts are ready to assist you through the entire development process. Based on the specific needs of the project, we assemble the ideal team of specialists.
related cases
Cases you might be interested in:
Principles for Combination Products: Questions and Answers Guidance for Industry and FDA Staff
news from fda Application of Human Factors Engineering Principles for Combination Products — Questions and
When is a new summative evaluation needed?
This article will introduce you to assessing the usability impact of your design change and thereby plan for any needed summative evaluation.
Using task analysis to identify potential use errors and get valuable design input
Find out how you can identify use errors and their sources and get valuable design input with PCA analysis.
