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Sep 22, 2021

Human-Centered Design: Human-centered to an intuitive and safe medical device

Many medical incidents are still due to operational errors. Not surprisingly, as medical technology is becoming increasingly complex: Products and processes are digitalized, automated and interconnected. Big Data and the latest technology such as robotics or augmented reality come into play. But the context of operation also changes: Due to the skills shortage, many employees utilize their capacities to the limit. Products that are no longer operated only by specialist personnel, but also by laypersons. To master this increasing complexity, safe and intuitive operating concepts are needed. They must be optimally tailored to the different target groups and usage contexts. Human-centered design definitely helps with this. In this article, you will learn about the advantages of this human-centered approach and exactly how you can implement it in the development of medical products.

In addition to functionality, usability plays an important role in the development of medical products or digital health services. Usability ensures that users can use a product or digital service safely and efficiently. The IEC 62366 standard therefore requires medical product manufacturers to implement usability measures and document them in compliance with the current standards. With a human-centered design, you therefore meet the requirements of IEC 62366. But this is not the only reason why human-centered design pays off for you.

Advantages of human-centered design

If you consistently involve users in the development process, you will develop products that precisely meet their requirements. This increases product acceptance and customer loyalty – even among increasingly heterogeneous target groups. With user-friendly products, you strengthen the market position of your company while positively distinguishing yourself from your competitors. Products with a high usability are optimally adapted to the target group and the usage environment. This enables users to operate them easily and safely – despite increasing complexity – even under time pressure and in critical situations. Intuitive operation also reduces the need for training courses and costly additional trainings.

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Human-centered design

A good usability and user experience does not come overnight, nor can it be written down as a task in the specifications. A good usability and user experience is created by consistently involving users in the entire development process, from the first idea to the final launch. The DIN EN ISO 9241-210 standard describes the human-centered design process in four phases. You iteratively go through them until you achieve an optimal result.

Analysis as a basis

Product ideas and concepts should always be based on the specific needs of the users. Therefore, human-centered design starts with analysis: In this phase, you collect and analyze facts about your target group and the usage context: What training and experience do users have? What tasks do they perform with the product? Is the product used in operating rooms, laboratories, ambulances or with patients at home?

For example, in our project with the test experts from QIAGEN (meanwhile DIALUNOX), both the usage context and the target groups were very heterogeneous: QIAGEN's rapid test reader can be used to test liquids for different properties – for example, by a lab technician in the laboratory, but also by a police officer on patrol. This required a stringent operating concept that also guides users without medical knowledge safely and efficiently through the test process.

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Translating requirements into concept and design

During the concept design phase, ideas and requirements are transformed into operating procedures and screen layouts: Based on typical usage scenarios, you will develop interaction and design concepts while laying the foundation for a simple, efficient and secure operation: How does the user navigate with the product? How can content and functions be structured? What are the screen types? How are they set up? These and many other questions need to be clarified in the process. In the following image gallery, we show you what a user-friendly concept can look like, using Swisstom as an example.

Making ideas tangible

Make ideas for your medical product or digital health service tangible as early as possible with through rapid prototyping. Depending on the development phase, prototypes can vary in detail and realism from low fidelity (paper prototypes) to high fidelity (HTML prototypes). Prototypes allow you to iteratively test and improve your ideas, concepts, and designs. Through early feedback from users, you can optimize your product and ensure that it offers added value and that users better understand.

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Gathering feedback

Continuously check if your ideas, concepts, and designs meet the defined requirements. For this purpose, the usability test has established itself as the gold standard. Users solve typical tasks with the product or service. This reveals strengths and weaknesses and shows where operation and design can still be improved. With questionnaires such as AttrakDiff, you can also find out how users subjectively perceive the product and its use.

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The sooner you gather feedback, the better: Because the sooner you uncover usability and design problems, the easier and cheaper it is to fix them. This not only secures your investment, but also the later acceptance by the target group. This is also demonstrated by our HoloMed project. In the project, we developed an AR application that supports physicians* during a neurosurgical operation. To put this to the test, we carried out several tests with a prototype under real conditions. Several physicians with different experience operated on a plastic skull using the app. Their feedback allowed us to identify and solve problems.

Human-centered despite Corona

Human-centered development focuses on people. However, this does not always have to take place in a direct face-to-face testing. Depending on the project phase and product, this also works perfectly well, remotely. If well-prepared, the remote setting also offers advantages: For example, there is less effort required of participants. Also, the familiar surroundings reduce nervousness. But remote testing reaches its limits at the latest during summative evaluation. However, an increasing vaccination rate, masks, tests etc. as well as a clean study planning make this increasingly possible again.

The first step to a user-friendly medical product

With the human-centered design process, you can optimally integrate users into the development of your medical products or digital health services. Human-centered design helps you better understand the needs of your target group and tailor your products and services accordingly. Has this aroused your interest, but you don't know how to get started? Then take the first step towards more usability, for example with our Medical UX review. Thanks to this, you will receive mission-critical impulses for the optimization of your medical product and the safety of your design in the shortest possible time.