Technolution Usability and Human Factors Engineering
Usability Engineering is a vital aspect in obtaining 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.
We will help you integrate Usability Engineering in your device development and at the same time document the process to ensure compliance with authorities.
We work with all types of MedTech development, including devices, IVD, combination products and software. 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 ISO 13485:2016 certified and work according to recognized Human Factors and Usability Engineering standards and guidances (FDA guidance & IEC 62366-1:2015).
Why focus on Usability Engineering?
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.
Focusing on and prioritizing Usability Engineering activities will generate numerous benefits:
- Medical devices that can be used safely and effectively
- 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
- Minimized need for training and support
- Improved user satisfaction leading to improved sales
- Improved market life and customer loyalty
- Minimized risk of liability claims and product market withdrawals
Jens Thor HansenR&D Manager / Ambu
Technolution has been a key player in creating a product optimized for uses.
Ole JakobsenOwner / Axlab
Technolution’s broad know-how has meant that we have a well proven product ready for the market.
- User Research and Use specification
- Usability Engineering strategy and planning
- Integration with Design Control and Risk Management
- Task Analysis and Use error risk analysis
- User Interface specification and design (incl. Packaging, labelling and instructions for use)
- Heuristic evaluation and expert reviews
- Formative tests (planning, execution, analysis and reporting)
- Usability test protocol
- Summative evaluation (Human Factors Validation testing)
- Human Factors documentation and reporting
- Usability Engineering training and courses
At Technolution we have a team of Usability and Human Factors Engineering experts, who are skilled in – and experienced with – all Usability Engineering activities, including FDA interaction. This enable us to help you in an effective, efficient and flexible manner at a high professional level.
Our expert knowledge and extensive experience
Enable us to advice 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, Design 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.
” In January 2018, we conducted a user study in collaboration with Technolution in their new test facilities. Their large bright rooms worked very well for this purpose. The team and stakeholders from the company could sit and follow the live stream on a large monitor without disturbing the test. It is certainly a setup I will use again for future studies.” [Senior Usability Engineer, LEO Pharma]
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