Using Aligned Elements in Medical Devices Human Factors Education - University of Furtwangen leading the way
Within recent years, Human Factors and Usability Engineering in Medical Devices have evolved to become a mandatory design input requirement for the development from medical products worldwide.
As patient care evolves and is transferred to private homes or public environments, less skilled or even unskilled users including patients and caretakers must be enabled to safely use these complex devices. The academic field of Human Factors Engineering is represented at many institutions. University of Furtwangen is one of them, offering a master's degree in Human Factors, focusing on all aspects that lead to human-centered technology and optimal human-machine interaction.
Humans at the center, Experts in the making
To prepare the students for the future, the University of Furtwangen has decided to incorporate digital tools in their education and uses Aligned Elements to create, trace and manage Usability and Human Factors related Design Control as well as embedding these in the overall traceability and medical device development documentation.
"Performing and documenting the intertwined domains of usability engineering, risk management and requirements management according to Medical Device regulations and standards, such as the IEC 62366, is required in medical device development and poses particular challenges to engineers and manufacturers. Aligned Elements has proved to be the ideal software for us to convey this aspect of medical device development to our students."
"In order to work through the regulatory requirements for the development process, using a holistic example, we include a practical exercise entitled Design Control alongside the lectures", says Prof. Dr.-Ing. Stefan Pfeffer, Dean of this Human Factors course.
Hands-on work with real-world examples
The students work with Aligned Elements and think through the process using the example of a blood pressure monitor. 
The great thing about this is that, by developing the content in Aligned Elements, the students will also experience how the three processes are interconnected and how synergies between them are created.
"We believe that this approach is the optimal way to prepare our students for the challenges and realities in modern medical device development.", concludes Prof. Dr.-Ing. Pfeffer.
How Aligned supports Furtwangen University
"The increased focus on Human Factors Engineering is one of the most patient-relevant shifts in our industry in recent years. It is an aspect that has been treated as an afterthought far too long. That "anyone with a bit of taste" can conduct meaningful and value-creating usability engineering is simply not true. Experts are dearly needed and we are happy to support the University of Furtwangen in this endeavour, to equip the next generation of experts with the skills they need to successfully develop the next generation of medical devices.", adds Karl Larsson, Managing Director, Aligned AG
Find out more at: Human Factors - Become a human-machine interpreter (hs-furtwangen.de)
