Medical Product Development

We support you in the implementation of usability for medical devices in accordance with DIN EN 62366-1 as required by the standard. We create use specifications, user interface operating concepts, carry out the use-related risk analysis, plan and carry out formative and summative tests, evaluate these and design your medical device.

Thanks to our many years of expertise in many other sectors, we are also able to incorporate the user experience increasingly demanded by users into medical devices. Products developed by us are not only fit for purpose, they also offer a high degree of positive user experience through modern, customized but characteristic design and gamification.

We also support your project plans in hardware-side product development.

• Product ergonomics & usability
• Product & UX design style guides
• Usability engineering
• Usability testing: formative/summative
• User Experience
• User Interface Design

We look at the development of your products from both a hardware and a software perspective. That is why we have taken the Human Centered Design Process a step further and literally go 2x around a product during development: with the user-oriented view of a UI / UX designer and from the three-dimensional-functional view of the industrial designer and engineer. In this way, an optimal operating and ergonomic concept go hand in hand and not only well thought-out and operable products are created, but also products that leave a positive, brand-defining experience through professional design. Usability and optimum operability and process reliability are therefore a central component. A normative requirement for medical devices.

Case Study Medical Usability 720°

• Definition / preparation of the specific critical areas to be tested
• Definition of the menu sequences/operating scenarios to be tested
• Coordination of the required target groups/subjects
• Organize test persons (min. 3 / user group, ideally 5-10)
• Organize premises
• Draw up a schedule
• Create questionnaires
• Create tasks for test persons
• Set up interview questions and questionnaires
• Create accompanying documentation
• Declaration of consent for video recordings
• Privacy policy

• Recording / simulation of a real room situation
• Principle sketches
• Lego functional models
• Cardboard models
• Prototyping / model making

• Pure simulation of an operating concept - without intelligence
• Integration of hardware buttons and input fields - intelligent click dummy
• Hardware is usually provided by the customer, standard hardware (various smartphones, tablets and touchmonitors) can be provided
• Further equipment available: Video camera + tripod, memo recording via app, photo camera

• Moderation of the testing by BUSSE
• Welcoming the test subjects
• Explanation of the procedure
• Handing out the data protection sheet
• Handing out the tasks
• Silent observation of the respondent, documentation of the time and clicks required, assistance, documentation of the respondent's statements and feelings, etc.
• Actively asking the respondent questions
• After the test: conducting the interview
• After the test: handing out the questionnaire

• Evaluation and documentation according to DIN EN 62366-1
• Summary of the questionnaires
• Summary of the interviews
• Derive conclusions for the tested system
• Initiate change management if necessary