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Identify user needs for medical devices – these are your options

Author: Marvin Kolb

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Feb 2024

The development of medical devices is a complex task that requires not only technical knowledge, but also a deep understanding of the needs and requirements of users. Whether doctors, nursing staff or patients – their perspectives are crucial to the success of a medical device. This detailed article presents various methods for identifying user needs that developers and designers can use to ensure that their products are not only effective but also user-friendly.

Enjoy the read!


User surveys and interviews

The basis for identifying user needs is direct dialog with potential users. Structured or unstructured interviews offer a unique opportunity to gain valuable insights from healthcare professionals and patients. This direct communication makes it possible to understand both functional and emotional needs and integrate them into the development process.


On-site visits

Theoretical knowledge alone is often not enough to grasp the reality on site. Direct observation of work processes and challenges in hospitals or clinics enables developers to gain authentic insights into the use of their products. This personal insight can reveal potential weaknesses that might be overlooked in an office.


Analysis of studies and literature

Scientific studies and specialist literature provide a solid basis for identifying user needs. Access to existing knowledge enables developers to fall back on proven methods and findings. This systematic literature research is crucial in order to understand the context and the existing challenges.


Expert interviews

Consultation with experts in relevant fields is essential. Doctors, nurses and medical technology engineers can share their experience and offer unique insights. These discussions are crucial to understand not only the needs but also the technical requirements and ensure that the product meets the highest quality standards.



The usability of a medical device is at the heart of its effectiveness (you must also meet the usability requirements of the regulations for the approval of your medical device). Usability tests with prototypes allow direct feedback from users to identify weaknesses and optimize the design, and to remove unacceptable risks of use from the entire product. These tests should be carried out at various stages of the development process to ensure continuous improvement.


Analysis of complaints and feedback

In order to learn from the mistakes of others, the evaluation of complaints, error reports and feedback on existing products is crucial. This systematic analysis helps to identify and avoid potential problems at an early stage. It also offers the opportunity to adopt best practices from other manufacturers and integrate them into your own development process.


Workshops and focus groups

Collaboration in workshops and focus groups enables an interactive discussion. The direct exchange of ideas promotes a deeper understanding of needs and requirements. This participatory approach also offers users the opportunity to actively participate in the development process and thus contribute their perspectives.


Analysis of competitive products

Analyzing existing products on the market provides insights into preferred functions and features. This market analysis enables developers to identify trends and strategically position their products. These insights serve as a source of inspiration to differentiate their own product and gain a competitive advantage.


Continuous feedback

Incorporating user feedback throughout the development process is crucial. An iterative approach ensures that the final product not only meets user expectations but also has a positive impact on healthcare. Creating a structured feedback mechanism allows developers to respond quickly to changes and ensure that the product is continuously improved.



Identifying user needs is not just one step in the development process of medical devices, but a continuous process. The combination of different methods, from direct surveys to usability tests, enables you to develop a comprehensive understanding of your users’ requirements.

An iterative process that incorporates continuous feedback ensures that the final product not only meets user expectations, but also has a positive impact on healthcare.

Only by carefully considering user needs can a medical device deliver its full benefits and make a significant contribution to patient care.

Do you need help with usability research for your medical device? What is your specific case? Comment on this article or get in touch using our contact form. We look forward to hearing from you.


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