Why a Great User Manual is the Best Medicine for Cost Overruns
Adding value and cost benefits through well-designed accompanying documentation
Reading time: approx. 1′ 31″
Importance and value
Accompanying documentation for medical devices plays a crucial role in their overall usability and value. Manufacturers must decide whether to meet the bare minimum requirements or to invest in high-quality documentation. Investing in well-designed documentation can provide significant value and cost benefits throughout the device's lifecycle.
Cost Considerations
Cost factors for medical devices include the device itself, single-use components, and training. Effective documentation can reduce these costs by improving usability, minimizing training time, and preventing use errors. The holistic view of costs, considering the entire service and application cycle, is essential for making informed purchasing decisions.
Business perspective
Modern business models should move beyond simple cost comparisons, integrating a comprehensive perspective on documentation's role in daily operations. Well-designed documentation is not just an add-on but a critical component of the device's ecosystem, enhancing overall user experience and efficiency.
Usability and Design Principles
Applying usability engineering and good design principles to documentation creates added value. Examples show that micro-learning units, which provide short, contextual training, can significantly reduce training costs. This approach is particularly effective in healthcare settings, where staff can benefit from quick, focused learning activities.
Good design encompasses more than standard usability criteria like effectiveness, efficiency, and satisfaction. It involves delivering relevant information at the right time, in the right context, using appropriate media. Factors such as readability, international understandability, and visualization are crucial.
Conclusion
In conclusion, truly effective medical devices are supported by excellent accompanying documentation. This facilitates the tasks of healthcare staff, enhancing efficiency and user satisfaction. Manufacturers should focus on both usability and good design, integrating design professionals early in the development process to maximize the value of their documentation.

Medical Devices: Usability Engineering of the Accompanying Documentation
2020
Oliver Gerstheimer