Injection molding is a versatile manufacturing technique used in the silicone industry for over a century. In particular, liquid injection molding (LIM) is a medical device manufacturing process with several advantages over other methods. For instance, it allows for increased product strength and weight. It also produces a final product within the parameters set by the device and regulatory bodies while remaining more economically efficient than other alternatives.
The underlying principle of the process is to create medical equipment and devices from specially formulated silicone materials that are strong, dependable, and FDA-compliant. This article will examine the benefits of medical device injection molding and the factors to consider when selecting materials.
Benefits of Medical Device Injection Molding
Liquid injection molding offers numerous advantages to medical device manufacturers, making it one of the most effective methods for producing rubber components. Some of the benefits that medical injection molding companies provide include the following:
Silicone liquid injection molding works well with moving parts devices. It extends the life of complex features that rely on buffers and materials to keep parts running without imposing undue wear and tear. Furthermore, silicone rubber is a safer and less allergenic alternative to other medical device materials due to its biocompatibility.
Flexible Design Options
Manufacturers have a wide range of design options with medical injection molding. It enables the integration of multiple components into a single fully bonded solution, which is ideal for medical applications. A single piece is also more substantial than an assembly of individual parts and thus lighter.
Silicone molding components are strong and flexible and can be stretched up to six times before breaking. This increases durability while also broadening the potential medical applications. Moreover, the parts perform as expected because the liquid injection molding process is so precise.
The design of the medical silicone injection process aids in the reduction of unnecessary costs. As a result, when a large volume of medical injection parts is produced, the manufacturing method can reduce the expenditure per part. This makes medical injection molding more cost-effective than transfer molding and compression molding.
Decreased Burden of Sterilization
The materials commonly used in this manufacturing process are contaminant-resistant; they do not require a lot of sterilization to stay bacteria-free. Because of this feature, the material easily fulfills FDA standards and other prerequisites.
Considerations in Choosing Silicone Materials for Medical Injection Molding
Several silicone grades are suitable for medical device injection molding. Each material has characteristics that influence how it performs in the application and operating environment for which it was designed. When deciding on the best medical-grade silicone material for your application, keep the following factors in mind:
Tubing, medical instruments, and other external applications have different requirements than implanted medical devices. Thus, examining your application’s FDA requirements is critical before deciding on the material.
Strength and Resistance
Silicone resins have varying degrees of strength, so make sure the medical-grade silicone material you choose has the strength properties required for your application. Moreover, chemical and heat resistance are crucial when selecting a medical-grade material, especially if your finished components must be sterilized through autoclave, gamma ray, or chemical methods.
Operating conditions influence strength, temperature resistance, chemical resistance, corrosion resistance, radiation exposure, and other factors. Hence, it is vital to ensure that the medical-grade silicone you choose can withstand the demands of your working environment.
Although medical injection molding and medical insert molding are both viable methods for prototyping medical devices, not all silicone grades are compatible with both. Therefore, you must determine what approach to take before deciding on medical-grade silicone material.
A manufacturing company’s ISO certifications reflect its dedication to quality control and proven capacity to meet and surpass client expectations. Albeit a quick and easy procedure, examining your provider’s certification is essential to ensuring that you are getting the standard you require.
Choosing the best manufacturing company is undoubtedly the key to success in terms of best solutions, extended life, hygienic design, meeting standards, and cost-effectiveness over the entire product life. However, analysis and expert opinions are equally important in the medical industry before the manufacturing process, as not all machine capabilities can work on specific requirements.
ETI Is Your ISO-Certified Expert In Liquid Injection Molding
Elastomer Technologies Inc. is an ISO 13845:2016 certified company for comprehensive quality assurance management in medical device manufacturing.
At ETI, we ensure the safety and affordability of some of the most critical medical equipment in cardiology, general surgery, oncology, neurosurgery, orthopedics, and other fields. We employ a wide range of high-quality materials to ensure product durability, strength, and resistance to the inherent stressors of the healthcare industry — such as chemicals, bacteria, and extreme temperatures.
Due to a combination of the effects of the pandemic and geopolitical tension globally, there is a strong trend for reshoring manufacturing, especially with medical device components. Medical devices can be critical and having a predictable supply chain may outweigh the savings of producing offshore, at least in the current environment.
An article by MDO Contributors Network described 3 things to consider when deciding to re-shore medical device production to ensure a smooth process.
Three considerations for reshoring your medical device components and assemblies
October 4, 2022 By MDO Contributors Network
1: Your existing tools can’t always be salvaged.
While the ideal transition would be to take existing tools overseas, ship them to an onshore facility and flip the switch to begin production in the U.S., things rarely go that smoothly. The article mentions several of those reasons including the possibilities that the tools were either inefficient or not well-maintained. They may have been customized for overseas production, but specifications may be different here in the U.S. In addition, there may be a need for updated drawings, design mechanics or other quality control issues.
ETI has the ability to evaluate your tool and customize or repair to ensure smooth production. If needed, a new tool will be recommended to improve efficiency and quality of the parts. Our team will work with you to provide the best solution for your needs.
As the article mentions, it is important to manage expectations and consider this an opportunity to improve the tooling efficiency. ETI can evaluate and provide flexible tooling options to consider.
2: Preparation for the validation process can expose potential risks.
The team at ETI will ensure that all of the quality control measures are in place. We are ISO 9001 and ISO 13485 certified with a separate clean room for production of silicone parts for medical devices. Our quality control team will ensure that all procedures and documents are done properly to fulfill any quality validation requirements supporting the ISO 13485 certification.
3: You may need to say goodbye to part of your current supply chain.
The Covid-19 pandemic exposed the risks of utilizing just-in-time manufacturing with multiple supply chain vendors collaborating overseas. In fact, any portion of the production supply chain currently being utilized offshore may have to be evaluated for replacement. This exchange will bring all of the materials onshore and ensure access to materials and vendors that would not be feasible if any more lockdowns commence in the near future.
With the wealth of experience and connections available, ETI can help to source new vendors and assist with everything from tooling to accessing materials for your silicone and rubber parts.
ETI can become your onshore partner to bring your medical device production back to the U.S. Doing so will ensure quality production of your silicone parts and offers a more reliable supply chain in this uncertain global business environment. While ETI focuses on small to medium-sized parts of up to 12 inches, we can evaluate your project of any size or make a referral as needed.