Initial situation & project
Healthyfy is an innovative telemedicine software invented by Case Study that enables users to carry out medical check-ups conveniently via video call. The software provides doctors with access to important patient health data, such as from sensors that patients wear on their bodies. As a result, Healthyfy enables effective remote monitoring and immediate intervention in the event of worrying health data. The application includes several features that make it a medical device. For example, for a doctor can use Healthyfy to remotely adjust a diabetic patient’s insulin pump.
Our approach
01
Project Planning and Kick-off
At the kick-off meeting, we start with an introduction and the objectives. We then plan usability tests and create a detailed project plan with milestones. Finally, we summarize the results and conduct a feedback session. Detailed documentation of the meeting ensures that all discussed points and decisions are recorded.
02
Elicitation of requirements
When gathering requirements for the Healthyfy application, we start by identifying key stakeholders, including patients, doctors and caregivers. We conduct in-depth interviews and workshops to understand their specific needs and expectations. We create personas and user journeys to visualize the usage scenarios of the different target groups. Through interviews, surveys, and observations, we gather comprehensive data that helps us define the functional and non-functional requirements of the software.
03
The right users
To identify the right users for user testing, we start by defining the core characteristics of our target groups, including patients, doctors and nursing staff. We create detailed profiles that include typical demographic characteristics, behaviors, needs and goals of these user groups. Based on these profiles, we develop recruitment criteria to ensure that the test participants represent the actual users of the Healthyfy software. Through targeted recruitment, we ensure that the user tests deliver meaningful and relevant results that help to optimize the user experience and, most importantly, ensure safe use.
04
Wireframes
We create initial wireframes to visualize the basic structure and layout of the Healthyfy software. This process starts with sketching the main screens and user flows based on the previously collected requirements and usage scenarios. Wireframes serve as visual blueprints that help us plan the arrangement of elements and interactions within the software. This step allows us to test and optimize design ideas at an early stage before moving on to detailed design and development. Wireframes allow us to identify potential usability issues and ensure that the software is intuitive and easy to use, allowing us to gather valuable feedback from stakeholders and users..
05
Prototyping
After wireframing, we continue with prototyping to transform the previously developed concepts and designs (at interaction level) into interactive models. We create prototypes that simulate the most important functions and user flows of the Healthyfy software. These prototypes are refined in several iterations (typically we need two here) based on continuous feedback from stakeholders and users (see next step). Prototyping allows us to identify and fix potential usability issues early on before investing significant resources in development.
06
Formative Evaluationen
After we have created the first prototypes, we continue our work with formative evaluations to continuously test and improve the usability of the Healthyfy software. In these evaluations, we carry out user tests with real users to test the software in realistic scenarios and identify critical operating errors. We collect detailed feedback on the user experience, analyze the results and make targeted adjustments to the design and functions of the software. This iterative process is repeated until the software no longer has any critical operating errors and smooth, intuitive use is guaranteed (as mentioned in the previous step: this typically takes place over the course of two evaluations). Through this methodical approach, we ensure that Healthyfy meets the highest usability standards and optimally meets the needs of users, but above all that the application passes the subsequent summative evaluation, which is essential for approval.
07
UX and UI design
Based on the results of the formative evaluations, we design the user interface (UI) of the Healthyfy application so that it can be used without unacceptable risks for all user groups and is optimally tailored to the needs and preferences of the users. The collected data and user feedback help us to make the navigation more intuitive and to optimize the user flow. We simplify complex interactions and ensure that important functions are easily accessible. Color palettes, typography, and icons are chosen to be both visually appealing and functional, and we include clear, understandable cues and prompts to enhance usability. Through this data-driven and user-centered UI design, we ensure that Healthyfy is not only safe, efficient, and effective to use, but also provides a positive and satisfying user experience.
08
Front-end development
For the front-end development of Healthyfy, we rely on a structured and agile development process that transforms the previously validated designs and prototypes into a robust and user-friendly application. We start by selecting the appropriate technologies and frameworks to ensure optimal performance and scalability. Our development team works closely with our designers to implement the UI/UX design with pixel-perfect accuracy. Through regular code reviews and continuous integration, we ensure that Healthyfy’s front-end is both functional and high quality. Throughout the development process, we take great care to adhere to quality standards and ensure seamless integration with the software’s backend to ensure a consistent and performant user experience.
09
Summative Evaluation
For the summative evaluation of Healthyfy, we conduct tests to assess the overall performance of the software and ensure that it meets all the defined safety requirements of the regulations, objectives and quality standards. We use usability tests with representative users, quantitative analysis of user metrics and feedback surveys. You can find more detailed insights and results on our approach and evaluation method in our white paper on the summative evaluation of Healthyfy: Simply click on this link to download the white paper.
10
The right documentation
For the proper documentation of Healthyfy, we rely on a structured approach that meets all regulatory requirements for approval as a medical device. We document the entire development process including requirements specifications, design documentation, risk analysis, test protocols and summative evaluation results. Our documentation is complete and transparent to ensure traceability of all development phases and compliance with applicable standards and regulations. Through clear and precise documentation, we prepare Healthyfy optimally for the approval process as a medical device so that nothing stands in the way of meeting the necessary regulatory requirements.
11
PMS
Following successful approval as a medical device, we continue to support the Healthyfy team in the regular preparation of documentation for post-market surveillance. We ensure that all necessary processes and documents are implemented to continuously monitor the performance and safety of the software in accordance with regulatory requirements. This includes the evaluation of various data sources, the regular updating of risk management plans and the preparation of reports on adverse events or product changes. Our aim is to support the Healthyfy team in maintaining compliance and ensuring that the software continuously meets the highest quality and safety standards.
12
The result
Healthyfy was successfully approved without any regulatory issues and the team is already working on the next version of the software. The success of Healthyfy is due to the fact that the product is perfectly tailored to the needs and requirements of users. The application offers an intuitive user experience that allows patients and doctors to collaborate efficiently and perform medical check-ups via the telemedicine platform. Through continuous feedback and iterative improvements, Healthyfy has met user expectations by enabling seamless and secure remote monitoring and personalized medical care.
Get to know us
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