Manufacturing for medical devices usually starts with the design phase. This is where the design and the requirements are put into a detailed plan before going into production to create a life-saving product.

While there are several manufacturing techniques to use for producing healthcare products, the silicone molding process is the most preferred. The reason why this is possible is that the process has a low cost per item, can produce in a high volume, and is compatible with FDA-approved raw material. It can also sustain tight tolerances and the process can produce uniform results.

Silicone molding is a flexible process. However, there could be few drawbacks that you should consider when designing any parts for this technique. In molding medical parts, there are five design considerations on top of our list. Read this article to know more about them.

Design Consideration for Silicone Molding Success

The design considerations for molding medical devices are interrelated. However, you should bear in mind that the main consideration should be the intended use of the silicone molded part.

1. Function of the device

Of all the factors you should consider when designing a part, you need to plan your design around its supposed function. Whether the part will be implanted in a patient for the long-term or as a piece of life-supporting equipment.

The function of the medical device requires specific temperature, applied stresses, and chemical exposure. This will impact the material choice, the shape of the parts, and other requirements.

2. Disposable or Sterilized

Medical devices can be sterilized or incinerated depending on their use. In this case, the concern is more on the material choice that could withstand the repeated sterilization. This is where liquid silicone rubber fits well in the medical industry. This material has a high melting temperature and is resistant to heat and/or hydrolysis.

3. Material Choice

Silicone molding has to lean towards a specific material, liquid silicone rubber. However, there are other types of materials that can be used to manufacture medical products. Whatever the material choice is, it should have certain properties like biocompatibility, opacity, resistance to heat and cold, radiation, chemicals, and wear.

Over-molding is not an issue because designers are not restricted to only one material. For example, a stiff thermoplastic can be over-molded with a soft silicone as a grip.

4. Ease of Production

Another consideration when designing silicone molded parts intended for medical use is how easy for this part to mold. In this case, you need to incorporate features like consistent thickness on its walls, adequate draft angles, generous radius for perpendicular features like walls, ribs, and bosses. The design should be uncomplicated to make without expensive iterations.

5. Price of the Molded Part

The last consideration in designing medical devices is the price of the finished product. The market for healthcare products is highly competitive and the product must be affordable to provide value to its users.

Aside from the price of the individual part, designers should also consider the quantity for tooling. As you all know, tooling for injection molding can be expensive. Even more so for multi-cavity tools. With high volume production, manufacturers can save time and cost of materials.

Nice Rapid is happy to accept any requirement for silicone molded medical devices. Our design team can help avoid pitfalls, improve your products, and make sure that you have high-quality results.