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The basis for the development of medical products according to IEC 62366 is the human-centred design process from DIN 9241, which has been an integral part of the development process at BUSSE for many years. For good usability, it is important that users can achieve their goals effectively, efficiently and satisfactorily while using a product. But user experience is often forgotten in the field of medical technology, which considers the areas before and after use. Application errors can be avoided by good design.
A medical device often has several different man-machine interfaces such as manipulation elements (control elements), display elements (e.g. displays) and sustentation elements (e.g. supports). These are operated by changing personnel with sometimes different tasks and objectives. They are intended to be sold and used internationally and are subject to strict legal requirements within the scope of approval.
We look at the development of your products from both hardware and software perspectives. That's why we have taken the Human Centered Design Process further and literally go twice around a product in development: with the user-oriented view of a UI / UX designer and from the three-dimensional and functional view of the industrial designer and engineer. Thus, optimal operating and ergonomic concepts go hand in hand and not only well thought-out and operable products are created, but products that leave a positive, brand-forming experience through professional design. Thus, usability and optimal operability and process reliability are a central component. A normative requirement for medical products.
Modern operating centre for eye surgery trimmed to a minimum footprint. A curved arm, which hovers above the patient, is mounted on a base geometric body with round corners and a high-gloss veneer. The treatment arm appears very slender and not very threatening due to atmospheric lighting effects and a play of penetrating attachments.
+ Product design
+ Mechanical construction
+ Model making
+ Prototypes
+ Product design
+ Mechanical construction
+ Model making
+ Prototype
+ Product design
+ Interface Design
+ Mechanical construction
+ Model making
+ Product design
+ Brand design
+ Colour design
+ Ergonomics
+ CAD reference surface design
You can find further examples of successful product developments in the automotive, machine, building and tool technology sectors, among others, on our website in the references.
From the summative to the formative test
1. Preparation for usability testing
+ Definition / preparation of the critical areas to be specifically queried
+ Definition of the menu sequences/operating scenarios to be queried
+ Coordination of the required target groups/test persons
+ Organize test persons (min. 1 / user group, optimal are 5-10)
+ Set up schedule
+ Creation of questionnaires
+ Create tasks for test persons
+ Set up interview questions and questionnaires
+ Create accompanying documentation
+ Declaration of consent for video recordings
+ Privacy policy
From the summative to the formative test
2a. Prototyping Hardware & Software
+ Recording of the entire room situation
+ Principle sketches
+ Lego functional models
+ Cardboard models
+ Prototype construction
From the summative to the formative test
2b. Creating Software Click-Dummies
+ Clickdummies in Axure / XD to test the usability of a concept - less intelligence, based on HTML
+ Clickdummy in Axure / XD to test the user experience of a finished design - pure stringing together of screens, no intelligence
+ Available hardware: 6 x 24" Touch monitors, 14" Convertible Touch Notebook, 10" & 12,9" Tablets, 5" Smartphones (iPhone & Android)
+ Additional equipment: video camera + tripod, memo recording via app, photo camera
From the summative to the formative test
3. Carrying out usability tests - moderation of the testing by BDE
+ Greeting of the test person
+ Explanation of the procedure
+ Delivery of the data protection form
+ Handing over the 1st task
+ Silent observation of the respondent, documentation of the required time and clicks, assistance, documentation of the respondent's statements and feelings, etc.
+ Active questioning of the respondent
+ After the test: conducting the interview
+ After the test: hand out the questionnaire
From the summative to the formative test
4. Evaluation Usability Test
+ Evaluation of the documentation according to test tasks, personal data, experiences
+ Summary of the questionnaires
+ Summary of the interviews
+ Draw conclusions and recommendations for the tested system
Through human-centered product development according to the Human Centered Design Process, costs during development for design and development can be reduced. After the market launch, support teams and service are relieved through self-explanatory products. Users can work more productively, fewer errors occur and they are significantly more satisfied. The positive experience, the good "user experience" is always the focus of a development phase.
In addition, the early focus on the use cases allows operating and risk potentials to be identified and reduced - an important factor for successful market approval!
Inspired by our visit to MEDICA 2019, which is always held in November, and by our many projects from the medical technology sector and many other industries, we have also summarised what we consider to be the current design trends in the medical industry for 2020. We analyse these trends holistically in terms of product design, user interface, function and technology. In doing so, we place the user in the foreground.
We are looking forward to your project and are eager to help you.
busse-design.com/kontakt
info@busse-design.com
+49 (0)7308 811 499 0