Bram van de Lagemaat

What is an IP rating, really?

An IP rating is a standardized code defined under IEC 60529 that describes how well a device is protected against solid particles (like dust) and liquids (like water). The code consists of two digits:

• The first digit reflects dust protection (0 = no protection, 6 = dust-tight).
• The second digit reflects water protection (0 = no protection, 8 = full immersion).

For example, IP54 ensures that an enclosure is protected against limited dust ingress and water splashes from any direction.

• The “5” for dust allows small amounts of dust in, but operation remains unaffected.
• The “4” for water protects against splashes from all directions.
• Per IEC 60529, water is sprayed at ~10 liters per minute from all directions, typically from a distance of 3 meters.

In practice, IP54 means protection against rain, accidental splashes, or cleaning with a damp cloth, important for medical equipment, EV chargers, and other devices exposed to occasional dust or moisture.

Why IP-aware design matters

While an IP label may seem like a simple sticker on a datasheet, achieving it in reality is a detailed engineering challenge. It requires careful consideration of every potential ingress point, from seams and gaskets to buttons and cable entries. In many products, connectors and seals are the most common failure points unless carefully integrated into the design.

IP-aware design is not just about meeting a test; it’s about ensuring a product continues to perform out in the real world, with temperature changes, pressure differences, vibration, and repeated use factored into its everyday life.

Core principles of IP-compatible design

Building IP-rated products requires seamless collaboration between design and engineering at every stage. Key considerations include:

1. Think system-wide
   Effective protection isn’t just a gasket, it’s engineered interfaces, smart material choices, and manufacturing quality, built to perform consistently under temperature swings, pressure changes, vibration, and everyday use.
2. Choose the right seals and materials
   Selecting gaskets, adhesives, and sealing materials carefully is essential. Silicone gaskets, compression seals, and high-bond adhesives all contribute to long-term protection, ensuring the product stays reliable throughout its life.
3. Manage airflow and pressure
   Products can fail IP testing not because of water, but because pressure changes (e.g., due to temperature swings) stress seals. Integrating hydrophobic vents can help manage internal pressure without compromising protection.
4. Pay attention to connectors and user interfaces
   Buttons, USB ports, and cable glands are classic weak points. Using IP-rated connectors and custom-designed covers or membranes ensures these elements don’t become ingress paths.
5. Prototype early and test often
   Testing early prototypes with the actual materials and seals helps catch issues before production. Test them in the environment where the product will actually be used to ensure reliable performance.

What is medical design, really?

In simple terms, medical design involves creating medical devices and tools with a strong focus on user needs, safety, and functionality. It is a careful process where every aspect of use, performance, and production is considered.

Some of the key elements of medical design include:

• Ergonomics: Products must be easy and comfortable to use for both healthcare professionals and patients.
• Hygiene: Materials and shapes need to be easy to clean to prevent infection and contamination.
• Safety: Clear instructions and intuitive visual or tactile signals help ensure the product is used correctly.
• Appearance: A friendly and intuitive design helps build trust with users.
• Regulatory compliance: Products must meet international standards and legal requirements.

The role of industrial design in medical innovation

When developing a new medical application, it is essential to bring together technical performance and user experience. The product must work flawlessly, and users must be able to operate it safely and intuitively. Design also plays a major role in product acceptance. If a product looks reliable and user-friendly, it gives people confidence, which is key to its success. Industrial designers focus on exactly these factors and play an important part in turning innovation into reality.

Case study: Vitestro

One example where all these aspects came into play is Vitestro’s blood collection robot. This machine allows patients to draw their own blood under the supervision of a healthcare professional. Helder was involved in designing and engineering a suitable housing for the product.

By using full-size mock-ups, we were able to study the actions of both patients and medical staff. Based on these insights, we created a housing that meets requirements for ergonomics, safety, and cleanability. The product also has a friendly and reliable appearance, which supports its acceptance in medical environments.

You can find more information and visuals from this project on the project page.

From idea to certified product

Developing a medical product is a structured and highly detailed process. Strict requirements and international standards must be followed, and the entire process needs to be traceable. Risk analysis is a critical step to ensure safe use. At Helder, we support our clients every step of the way, combining a strong attention to detail with expertise in materials and processes. We also guide clients through the path to CE certification, so that their product is not only innovative, but also safe and compliant.

Beyond design: Full-scope support in medical product development

While this article highlights the importance of product design, our involvement often extends well beyond that stage. Through Helder Products, we assist clients with the sourcing and production of molds, parts, and components, collaborating with our trusted network of certified manufacturing partners. This ensures that medical products are not only thoughtfully designed, but also ready for reliable and scalable production. In an upcoming blog post, we’ll take a closer look at these capabilities and how they contribute to successful medical innovations.