Commonly Overlooked Factors in Medical Device Design

Developing medical devices is a complex and demanding process. From conceptualization to prototyping, trial production, and final commercialization, strict regulations and safety standards must be adhered to. However, compliance alone is not sufficient. To launch a successful medical device without enduring lengthy and costly delays and revisions, it is essential to navigate the regulatory landscape and understand the procedures and details involved in product development. Here, we discuss four often overlooked considerations in medical device design to help optimize your product and ensure a smooth and rapid development process.

1. How to protect the sensitive components?

Overmolding is a technique that integrates two or more materials to form a cohesive product. In medical devices, this process typically involves thermoplastics or elastomers covering a substrate, resulting in ergonomic and durable exteriors. Overmolding offers several advantages, such as protecting the substrate from abrasion and corrosion and enhancing user experience with flexible and hygienic surfaces. Additionally, overmolding can lead to efficient production, safeguarding sensitive components during use, and preventing intellectual property theft.

2. Surface treatment should be considered along with color selection?

The same color can appear differently depending on the surface treatment applied. Medical devices offer a variety of finishing options to achieve diverse appearances and functionalities. Surface treatment and color perception are closely linked, so it's essential to consider them together. During the development stage, you can request your manufacturing supplier to produce parts in the same color but with different surface treatments, such as anodizing, plating, transparency, and translucency. These samples will help you see how the same color varies with different finishes, aiding in the selection of the optimal combination.

Furthermore, the degree of surface finish significantly impacts color perception. Using a single color with different finishes, like matte and glossy, can highlight the surface variations. It's important to note that shiny surfaces on medical equipment can easily show fingerprints and smudges, while overly rough textures can harbor contaminants. Finding the right balance between these factors is crucial.

3. Are your medical parts fool-proofing?

If a product design allows for incorrect assembly, mistakes are likely to occur, reducing efficiency and increasing costs and time. Similarly, if medical products can be misused, end users may use them incorrectly, leading to serious consequences, including threats to life and health. Therefore, fool-proofing design is crucial. It minimizes errors, eliminates the need for rework during assembly, optimizes the user experience, and avoids unnecessary costs. As illustrated by the Fool-Proofing Pyramid, as the pyramid's level rises, so does the degree of error prevention.

4. Do not forget the nameplates.

Nameplates on medical devices must be durable enough to withstand frequent and rigorous sanitary procedures in their intended environments. Common materials used in the medical industry for nameplates include metalized polyester, polycarbonate, anodized aluminum, and stainless steel. Both polyester and polycarbonate are suitable for both external and internal medical equipment; polyester provides a shiny appearance, while polycarbonate is flame-resistant. Anodized aluminum and stainless steel are often used for nameplates on medical equipment, enduring regular cleaning and sterilization. Anodized aluminum, in particular, offers superior resistance to abrasion and chemicals, making it ideal for sterilizing and cleaning environments.

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The examples mentioned above are common aspects that might be overlooked in medical device design. Zonze provides expert technical advice and design support to assist customers in developing their medical devices.