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10 Tips For Designing Silicone Medical Components:

Liquid Silicone Rubbers (LSRs) are well suited to the unique needs of the medical product industry. Silicone materials are biocompatible, inert and stable, flexible, have a low compression set with a wide range of durometers, and offer superior heat resistance. High quality components with complex shapes can be repeated in high quantities in a cost effective manner. Designing medical device components for silicone requires up-front design considerations due to silicones unique properties. During early stages of the design process, partnering with a trusted partner can help smooth the process. Below is a top 10 tips list to help guide you through the process of Silicone parts for medical components. Tip #1: Optimize Product Design Tip #3: All Materials Are Not

#1

When designing silicone components for finished medical devices, review the components needed and how they function together in the finished device. Can

#3

Created Equal

Silicone material properties are ideal for medical applications due to their high heat, inert and flexibility and the wide range of

two or more components be combined? Can you combine a silicone and thermoplastics part together? To reduce part count, silicone can be overmolded to the following substrates: polycarbonates, Ultem, Radel and metals. This can help not only minimize part count but maximize assembly efficiencies. Working with your manufacturer can help to maximize the benefits of the LIM (liquid injection molding) process. Tip #2: Design For Robust

durometers. There are self-bonding options with silicone as well as surface treatments possible to aid in bonding. Your manufacturer should be able to help you. Note that although silicone flows like water, it is very abrasive. Proper mold maintenance will help longer tool life. Tip #4: High Quality Tooling

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Manufacturing When working with silicone components set expectations early. Work with a supplier that will review print specs and help work

#4

Key To Success

Just as in all molding, a component is only as good as the tool from which it is made. The key to successful silicone components

is precision tooling. Things you should ask your supplier: Where are your tools made? What experience does your supplier have with the tool maker (if they are not creating the tools themselves)? What experience do they have with complex parts? These answers are even more critical when it comes to complex geometric shapes as they require very high quality tooling. Engage with your toolmaker early on to ensure the best part design. With todays technologies precision European tooling is not the only option. Discuss alternatives with your manufacturer.

out any issues early in the process. Provide details of silicone components along with the full finished assembled device. Looking at designs early can help reduce or eliminate potential flash and partials that may be present at parting lines and vents. This allows you to evaluate any issues that may arise during manufacturing or even assembly. How will the silicone components be assembled? Your supplier should be able to help maximize the manufacturing process specific to your components and finished device.

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Tip #5: Involve A Silicone Expert Early

Tip #9: How Not To Be A Dust Collector

#5

Early Supplier Involvement (ESI) is critical for silicones components as many design features such as parting lines and wall thickness should be carefully considered.

#9

Silicones properties create challenges for cleanliness and packaging. Silicone should be molded in a controlled environment and operators should wear proper attire

Silicone components should allow for parting lines and vents to be designed around critical-to-function features of the part. Gate locations should also be selected away from critical-tofunction features. And thick-to-thin wall part designs should be carefully considered. Tip #6: Utilize Advanced Controls

including gloves. Will your components be further assembled? If so, how will they be shipped? When packing parts, if bulk packed, product should be double-poly bagged. For thin-wall silicone parts, vacuum-formed shells are an excellent shipping alternative. Tip #10: Simplify The Solution

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Successful silicone components and devices containing silicone are best molded in presses utilizing advanced process controls. Using cold decks with

#10

Sometimes simplifying the solution can make all the difference. With todays technology prototyping LSR is possible. Using prototype components to test product

multi-cavity tools will allow shot-to-shot consistency and a repeatable process. Parts prone to tearing can benefit from utilization of robotics to ensure consistent, repeatable part removal for complex silicone parts. And custom end-of arm tooling (EOAT) can save labor and provide higher quality by sorting by cavities. Tip #7: Creative Measurements

design using the same process as production parts, can help speed-to-market including Clinicals, V&V, and 510k. Samples of areas that can be simplified by LSR prototype parts include: overmolding vs. two-shot or cold deck vs. traditional gating.

SMC Ltd. Liquid Silicone Rubber (LSR) Passion for technology has driven SMC Ltd. to become the industry leader in Liquid Injection Molding (LIM) for the medical market. We have proven that complex silicone parts can be produced repeatedly in nearly half the lead-time as traditional silicone molding options. Our proprietary in-house silicone mold manufacturing process has allowed SMC to offer complex contoured geometries molded in combination with other materials. We continue to advance the science of mold making with tool building technology in our North American location. SMC has earned recognition as the leader in output-based validation methods, digital quality systems applications, and other cutting edge technologies that have provided a Tip #8: Program Planning Makes Perfect competitive advantage for our customers. With capabilities that range from up-front product development through the introduction of finished devices, to distribution, we can bring your product to market in the shortest time with the most predictable outcome.

#7

For Silicone The properties of silicone that make it desirable for medical components can also make it extremely difficult to mea-

sure. Outside features can be effectively measured with optical systems. Ask yourself if fit and function can be used? If not, holding fixtures may be required to achieve consistency. Gage R&R is critical during the new product development process so make sure that both you and your supplier are utilizing the same methods.

#8

Silicone tools typically require 40% more development time than thermoplastic tools and also have longer development leadtimes. When developing silicone compo-

nents as part of a finished device, program schedules should be adjusted accordingly. Multiple tool samplings are also required for venting and accurate steel shut-offs and should be included in the planning phase. Working with your supplier can help ensure timelines are met.
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