Usability & User Centered Design
The "Usability & User-Centered Design" Division of the wwH-c GmbH
Usability of medical products is an important indicator of quality and a basic issue of patient safety. Safe, efficient, and intuitive use of medical products
will be achieved by suitable medical technologies. Recently, equipment manufacturers started to raise demands for the inclusion of a usability inspection in
obtaining CE certification conforming to the standards of DIN EN IEC 60601-1-6 and DIN EN IEC 62366. Medical equipment must now be designed with the help of a
usability engineering process.
The wwH-c GmbH offers support during the entire developing process - from the idea up to the released medical product. With us, you will develop
effective and safe medical products, which your customers can use intuitively (and enthusiastically).
Development of usable medical products
For the development of usable medical products, the
wwH-c GmbH has adopted the procedure of creating user-centered design schemes. Within the usability engineering approach, development focuses on the user’s
specific needs and requirements to create a more intuitive and usable device. From the very start of the development process, users will be included. Then,
by an iterative approach with repeating development and evaluation phases the usability of medical devices will be fully optimized and ensured.
The wwH-c GmbH assists you right from the drawing board to the final, ergonomic result. We promise to obtain for you the requirements, design concepts,
and prototypes and to evaluate these in collaboration with the many users from our global network.
Evaluation of the usability of medical products
For the usability evaluation of your medical device, we choose specific methods that are matched to your budget and specific phase of development.
For the evaluation of medical products by the standards DIN EN IEC 62366 and DIN EN IEC 60601-1-6, a standardized procedure has been developed in
cooperation with the University Hospital Tuebingen.
Furthermore, the wwH-c GmbH owns and runs the largest usability lab for medical devices in the world. Here, real users may evaluate medical products
or prototypes under real conditions (i.e. those corresponding to actual clinical tests and trials).
Assessment of the usability of medical products
The “UseProb” method has been developed especially for the assessment of the usability of medical products in cooperation with University Hospital Tuebingen. With this approach, the usability of medical devices may be analyzed and benchmarked accordingly in a completely safe environment. Thus, the results of UseProb evaluations may be used in the field of risk management, as well.
Services and offerings of the wwH-c GmbH
Among others, we offer the following services to companies and hospital operators:
- A standardized approach to usability tests including assessments by UseProb
- Usability evaluation (expert assessment, heuristic evaluation, focus groups, user interviews, user testing, etc.)
- Ergonomics documentation according to CE certification requirements
- User-centered development of interaction designs from concept to prototype
- Analysis of the user environment (user profile, environment and function analysis, system integration)
- Simulation of interaction concepts
- Specification of defined applications
- Workshops on creativity and innovation
- Market analysis
- Risk assessment
- Assistance with respect to MPG, authorization [or approval], DIN EN IEC 62366, DIN EN IEC 60601-1-6, DIN EN ISO 14971
- Usability as a prerequisite for the clinical trial and/or elements of the clinical assessment
- Training in usability evaluation, experience the Usability Workshop"