Usability for MedTech – The Path to Safe Medical Devices

Why usability is the key to success

The development of medical devices comes with high demands: they must not only be safe, but also intuitive and efficient to use. IEC 62366, the international usability standard, defines clear requirements for the design of medical devices. But how can companies meet these requirements while developing user-friendly products that succeed in the market?
The answer: through a structured, user-centered development process.

The Ergonomen: your partner for usability in the MedTech industry

Our approach combines user empathy with methodological rigor.

1. User-centered processes, from idea to certification: We guide you through the entire development process—from requirements analysis and prototyping to validation and verification. Our methods are based on best practices designed to identify and minimize risks early on.
2. Expertise in IEC 62366: Compliance with IEC 62366 isn’t a hurdle—it’s an opportunity. It enables you to design safe, market-ready products. With our experience applying these standards, we ensure your documentation and testing meet regulatory demands with ease.
3. Empathy meets structure: We understand the perspectives of your users—from healthcare professionals to patients. Using creative methods like focus groups, interviews, and usability testing, we develop deep insights into your target audiences’ needs. At the same time, our structured processes ensure efficient implementation.
4. International experience and cross-industry expertise: Our projects range from MedTech start-ups to global corporations. We leverage this broad experience to create solutions that are both innovative and practical.
5. Flexibility and tailored solutions: Every client and every project is unique. Whether you need targeted support or a long-term partnership, we adapt to your needs.

A practical example: success through collaboration

A client in the MedTech industry set out to develop a new home dialysis device that would be both safe and easy to use. With our support, user interviews and prototype testing were conducted early in the project. The result: improvements that not only enhanced safety but also simplified use for patients. Thanks to clear documentation, the certification process went smoothly and the product became a market success.

Why usability is more than just a standard

IEC 62366 requires companies to put users at the center. But at Ergonomen, we see usability as more than just a regulatory step. It’s a chance to combine innovation and safety, build trust, and set your products apart from the competition.

Your next step: secure your market advantage

Get in touch and learn how we can help turn your vision into reality—safely, user-friendly, and efficiently.
+41 44 849 29 29