3 Ways to Reduce the Cost of Silicone Injection Molded Products

In today’s competitive environment, OEMs are looking for opportunities to reduce costs while maintaining product quality. While there are a number of factors that contribute to the cost of silicone injection molded products, we will focus on the top 3 ways to reduce cost: efficient part design, process automation, and consolidation of suppliers.

Efficient Design

In order to save cost on your silicone injection molded product, companies need to ensure the product is as easy to manufacture as possible! This will result in more efficient production, better quality, and lower cycle times. Below are some best practices that will help you reduce cost. Click here for additional tips on how to successfully Design For Manufacturability (DFM).

  • Minimize material: look for opportunities to reduce solid part sections and replace with more hollow sections. In the case of injection molding, use of gussets and ribs will often provide the required strength while using less material. It may seem like a small reduction in material but when multiplied over many production runs the result can be a large decrease in manufacturing costs! Additionally, devices that weigh less are cheaper to transport and store, further reducing costs.
  • Optimize Cycle Times: when it comes to production, time is money. Devices with easier ejection from the mold result in shorter cycle times and lower part cost – and this is accomplished with the appropriate draft. Draft is an essential element in part design and is simply the angling of walls to allow easier separation and removal of the product from the mold. A lack of draft makes it nearly impossible to remove the part. OEMs should ensure adequate draft in the part design to reduce cycle times and save cost.
  • Simplify the Product: several design features impact part cost such as tight tolerances and engraving. These all drive up cost and directionally reduce production efficiency. OEMs should work with their supplier to look at design alternatives and should ensure any complex features are “must-haves”!

Leveraging Automation

Automation, and the efficiency it brings, has become a vital component in the manufacturing of silicone injection molded products. Automation within the manufacturing process can occur during the design phase all the way through secondary operations. Companies should work with their manufacturing partner to design with automation in mind. For example, medical devices that are smooth are more suitable for automated assembly processes. Also, OEMs should be mindful of assembly order and ensure part orientation is consistent. These design consideration help ensure automated processes downstream are optimized and efficient.

Robotic work cells deliver speed and accuracy, resulting in lower cycle times and higher product quality. With an automated production line, personnel no longer have to execute the repetitive, time-consuming tasks – reducing the risk of human error and allowing personnel to focus on more value-added responsibilities. Additionally, in the case of injection molding, a highly-automated process can be controlled by as little as one operator, lowering labor and manufacturing costs.

Supplier Consolidation

The only constant in the manufacturing world is change. Over time, OEMs often find they have acquired a large supply chain that can be challenging and time-consuming to manage. One cost-cutting measure is to consolidate your supply base to one or two strategic partners. When partnering with a provider, like ProMed, customers receive a complete manufacturing solution that strengthens their supply chain. Additionally, since every step in the manufacturing process builds upon the next, it is cost-effective to partner with a supplier that can start and end the project with you – from the concept and design phase through production and secondary operations! There are many benefits to supplier consolidation including:

  • More purchasing power: by consolidating your supply chain, you will gain purchasing power. This can be in the form of negotiating lower manufacturing and transport rates due to higher annual spend, or lower raw material expenses due to more volume purchased.
  • Improved communications: by consolidating your suppliers, your points of contact are greatly reduced, possibly down to a single point of contact at your key supplier. This allows for a central, more customized level of support. This will also inevitably improve and simplify your supply chain communications, resulting in a better final product.
  • Easier to manage: a smaller supplier base is simply easier. There are less suppliers to setup and manage within internal systems, and the relationship is easier to manage.

About ProMed

ProMed has specialized in cleanroom manufacturing of components, assemblies in the medical industry since 1989. We’re now celebrating 30+ years! We utilize state-of-the art technology, draw from an experienced technical community, and take a creative systematic approach to provide you with a dependable, high-quality and overall cost-effective solution to your manufacturing needs. We are now a full-service provider of molded components and assembled products, including molded silicone components, combination components which incorporate pharmaceuticals, and value added assemblies.

ProMed was founded to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products. Additionally, our ProMed Caribe division specializes in the molding of silicone components, sub-assemblies, and assemblies, and is offered as a “lower cost” option for projects.

Contact ProMed today at 763-331-3800 to discuss how we can reduce the cost of your next molding project!


Choosing the Right Silicone Injection Molding Partner

There are many factors to consider when selecting a silicone injection molding partner and it is imperative that companies do their research to identify the right one! Price is, of course, a huge consideration, but there are many additional elements that must be considered when selecting a partner. Choosing the right silicone injection molding partner may seem like a daunting task since there are hundreds of options to choose from! Below are several tips to guide you through the selection process.

  • Proven History: companies must do their homework to better understand the background of each partner they are evaluating. For example, how long have they been in business, who were their previous clients, and have they won any awards or been recognized within the industry? You want an established partner with a proven history and repeat customers. Additionally, ensure potential partners has ample experience working with a company of your size and in your industry.
  • Range of Solutions: this may sound simple but not all injection molding partners offer the same solutions. You need to be clear on the requirements for your application and if a potential partner offers solutions that meet your needs. Keep in mind that partners with a broad range of material and equipment offerings are better positioned to provide support as your business grows over time.
  • Excellent Quality: OEMs need an experienced molding partner that is familiar with the necessary production planning needed to meet all of the necessary regulatory and quality standards. Additionally, OEMs need to ensure a molding partner is providing them with a reliable and dependable process. A supplier’s quality planning and assurance program is more than just meeting the requisite ISO and FDA requirements – it represents their proven way to ensure consistent quality silicone injection molded parts. When assessing a potential molding partner, OEMs should discuss the quality program at length and consider touring the facility to observe the conditions first hand and meet with the Quality Team.
  • Able to Meet Specifications: most OEMs have unique and specific product specifications and it is important that potential molders understand and be able to comply with those specifications. Simply put, there is an injection molding partner available that can manufacture your part without significant specification sacrifices! Partners should readily collaborate with OEMs, providing alternatives to specification challenges as well as design suggestions to save time and money. If this collaboration is not happening, you have not found the right partner!
  • Material Options: some injection molding partners specialize in the different material types, so it’s important to know what your potential supply base is capable of, and also what they specialize in. It is crucial that OEMs team up with an experienced partner, like ProMed, who offers a range of materials and will guide you through the selection process to ensure the right material is chosen to achieve the desired final product properties, such as strength, flexibility, and biocompatibility.
  • Offers Value-Added Operations: does the potential partner offer value-add services such as assembly, packaging, and other secondary operations to complete your project? These value-added operations offer significant value for OEMs such as streamlining production schedules, improving the consistency and reliability of the final product, and minimizing the number of vendors involved in the manufacturing process. All of these steps improve efficiency – saving OEMs time, resources, and money.
  • Strong Customer Service: look for any extra services and customer support that a potential silicone injection molding partner provides. For example, is it easy to contact the partner with technical support questions? You will want to discuss these topics to understand the level of customer support provided.
  • Solid Relationship: in the end, you are not simply looking for a supplier, you are looking for a trusted partner that can help your business grow! A true partner asks for input and listens to customers, offering solutions that ensure both parties are aligned and satisfied! Also, every supplier has its own unique company culture and relationships with its customers so ensure you mesh well with any potential partners. Good communication and a spirit of collaboration is needed from the start so do not ignore any red flags you note during the evaluation process – they will not go away after the partner is selected!

Additionally, OEMs need to have a direct discussion with potential vendors regarding risk tolerance. Risk and liability are a key element in most OEMs decision-making processes since the OEM is responsible for product issues and failures. This is why many OEMs, especially those in the medical industry, tend to be conservative and risk-averse. It is important for your injection molding vendor to understand – and deliver- when it comes to risk tolerance. Additionally, risk mitigation is another reason many OEMs strongly prefer to minimize the number of vendors involved in the manufacturing process, and select a partner that provides in-house design through production support, as well as secondary operations.

ProMed – Your Silicone Injection Molding Partner

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Click here to see why ProMed is your silicone injection molding partner. Contact ProMed today at 763-331-3800 to discuss your next silicone injection molding project!


The Basics of Medical Silicone Injection Molding

For companies seeking high-quality and cost-effective parts and devices for the medical sector, silicone injection molding is an ideal solution. Below are the basics of medical silicone injection molding including the process, materials, advantages, and how it differs from other silicone molding techniques.

Common Silicone Molding Methods

To better understand the basics of silicone injection molding it will be useful to understand how this process compares to other silicone molding techniques. Below are the most common methods used to manufacture silicone into a final product.

  • Compression Molding: silicone is compressed between two heated mold cavities to force the material to fill the desired mold shape.
  • Transfer Molding: silicone is pushed into the heated mold using a plunger, where it takes the shape of the cavity.
  • Extrusion: melted silicone is pushed out of a die to form the shape of the desired finished product.
  • Injection Molding: melted silicone is injected into a mold cavity to form the shape of the mold.

It is important to note that each of the primary molding techniques above may have variations of the basic process. For example, rotational molding is an extension of the techniques above where silicone is inserted into the mold at the desired temperature while the mold continuously rotates to form hollow parts with uniform wall thickness. Additionally, blow molding is another variation where heated silicone is blown into a mold along with air and as the silicone expands, it presses against the walls of the mold forming a thin-walled, hollow shape.

Materials Used in Medical Silicone Injection Molding

Silicone elastomers have long been a popular material for medical devices and components due to their durability, wide temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. Furthermore, silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth – making it a perfect option for medical implants!

Silicone elastomers are available in two commercial forms: Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). LSR and HCR are both used to manufacture medical device products. For companies already using HCR to manufacture medical device components, it may make sense to continue using this elastomer especially since the initial capital equipment costs have already been made. For new product development, LSR is often the best choice given the lower capital costs and labor associated with processing this elastomer. However, the decision to use LSR or HCR should be made on a case-by-case basis and OEMs should consult their molding partner.

Silicone Injection Molding Process and Equipment

There are also variations within medical silicone injection molding, however, the main equipment and process are generally the same. Below are examples of injection molding equipment. The process begins when silicone is fed into a heated barrel. In the picture below, solid raw material is stored in a hopper and then fed into the barrel. In the case of LSR manufacturing, the two liquids LSR components are stored in separate containers and then fed simultaneously into the barrel.

Next, a screw is used to mix, heat, and transport the silicone toward to the mold. The melted material is then injected through a nozzle into the mold and travels via a gate and runner system into the mold cavity; the proper design of the gate and runner system is essential to ensuring the mold is filled properly. As the silicone enters the mold, excess air can be released via vents. The pressure and temperature of the mold are maintained to allow the silicone to conform to the desired shape and harden quickly. Once the part is adequately cooled, the mold opens and the part is ejected, sometimes with the help of ejector pins. The mold is then ready to receive the next charge of silicone. The injection molding process is a continuous operation with minimal downtime, resulting in high output rates.

(photo credit: Wikipedia)

Advantages of Medical Silicone Injection Molding

Silicone injection molding has several benefits compared to other molding processes, and below are some of its key advantages.

  • High Quality & Very Reproducible: Silicone injection molding produces products that are virtually identical from part to part which provides excellent brand consistency and part reliability during high volume runs – this is especially crucial for parts and devices used in the medical industry! High reproducibility also allows for production to be scaled up to very large volumes, resulting in low costs per unit after the upfront equipment set-up costs are paid.
  • Excellent Versatility: silicone injection molding is a good choice for a wide range of part sizes, materials, and colors. Additionally, injection molding allows for the use of multiple materials simultaneously, allowing for a high degree of customization.
  • Able to Produce Complex Parts: silicone injection molding is typically performed at high pressure which forces the silicone into small crevices in the mold (that other molding processes are unable to reach), enabling the production of intricate and complex parts.
  • Efficient Production: silicone injection molding is a very fast process that generates high-output production compared to other molding methods, making injection molding a more efficient and cost-effective solution.
  • Automation Reduces Cost: silicone injection molding is highly automated via the use of machines and robotics, requiring less oversight by operations personnel. Automation reduces labor costs which decreases the manufacturing costs per unit.
  • Low Waste Generation: silicone injection molding manufactures smooth products that have minimal finishing requirements after removal from the mold – resulting in less waste generation compared to other molding techniques. Oftentimes, injection molding waste is able to be reused, resulting in a more environmentally-friendly and lower cost process.

ProMed’s Medical Silicone Injection Molding Capabilities

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.


Cost Effective Prototypes and Low Volume Production

ProMed’s Approach to Low Volume Production

Many silicone injection molding companies focus on high volume production runs, and often do not give enough attention to prototyping or low volume runs. In fact, some manufacturers avoid low volume production all together, requiring customers to commit to a minimum number of molded parts before agreeing to a new project. That is not ProMed’s approach! The ProMed team offers cost effective solutions for low volumes, and does not shy away from low volume production for silicone injection molding. Regardless of the volume, ProMed views each project as an opportunity to build a long-term relationship with a customer!

Cost-Effective Prototyping

When it comes to silicone injection molding, the initial tooling cost can be pricey! Thus, companies often utilize the prototyping phase to fine-tune the design and work out any potential manufacturability issues prior to investing in the tooling that will be utilized for high volume production. Prototyping lowers risk and costs for injection molding projects.

Experienced injection molders, like ProMed, offer different materials and methods for creating prototypes, as well as molds for low volume runs. Below are 4 of the most common techniques.

  • RTV Molding – Most companies are familiar with LSR and HCR but RTV (Room Temperature Vulcanization) may be lesser known. RTV is a silicone casting for prototyping, testing, and lower volume production. Making parts out of these materials requires a mold, which can be made of almost any metal or plastic material. This technique is actually an indirect molding process, or casting, where the molds are first created and then the actual parts are made. A cost-effective way to produce small volumes of parts, RTV casting reproduces surface textures and other fine details. Furthermore, since silicones feature great chemical and heat resistance, RTV molds can be used to cast materials like low melting point metals, epoxies, waxes, and gypsum—all without needing a mold release agent.
    • Pros: The use of RTV is attractive because of the low capital equipment requirements and the availability of raw materials. Once the mold is made, making parts is a simple fill-and-wait process, and a skilled technician can make the first part within a day.
    • Cons: RTV molding is a slow process with cure times extending from 20 minutes to hours, and ovens are often used to accelerate the curing process. Production rates and cost per piece are both largely determined by the processing time.
  • 3D printing – 3D printing in silicone is now an option for prototypes, thanks to new elastomeric materials specially formulated for 3D printing. As additive manufacturing technologies continue to advance, part fabrication speed and resolution continue to improve while capital equipment costs quickly drop.
    • Pros: 3D printing doesn’t require machining a mold and runs unattended. Very small batches of parts can be manufactured in hours.
    • Cons: The elastomeric material options are not true silicone rubber. The mechanical properties and method of manufacture do not approximate production LSR. Precision can be a challenge for fine featured parts and thin-walled part designs. Large batches of parts (>100) are not practical due to high unit cost.
  • HCR – Transfer molding is used to make parts out of HCR, and is a simple manufacturing process. HCR (“gum stock”) material is placed in a heated cavity to cure and form a part. HCR is a natural fit for transfer molding since gum stock is much more viscous than LSR.
    • Pros: Simple tools with little or no process development.
    • Cons: Complex geometries may not be possible and cycle times are longer than LSR.
  • LSR – Production equivalent injection molding press and production grade materials are molded in soft metal tooling.
    • Pros: Tooling can be made quickly and the production of parts is fast. The resulting prototypes are very close approximations of production parts.
    • Cons: Can result in a higher cost per part for small runs of parts, since the initial tool cost can’t be amortized over a large number of parts.

ProMed Prototyping Expertise

ProMed Prototypes fills a market void by offering customers real molded parts, made from a wide variety of materials. Our team of prototyping experts offers complete in-house mold design, mold build, and prototype component manufacturing. Allowing ProMed to serve its customers throughout a product’s lifecycle decreases production development time, development cost, and production piece part price due to critical manufacturing information learned through prototyping. Click here for a comparison of the speed, cost, and likeness to production for different prototype materials.

ProMed Prototypes offers quick turn prototypes that include tool design, tool manufacturing, prototype manufacturing, cleaning, packaging, and shipment. ProMed provides customers a distinct advantage because, in the world of product development, time is money, and getting a product to market before the competition is a key to the success of the long-term business strategy. When your device is ready for full scale production, ProMed Prototypes’ manufacturing knowledge will be transferred to the New Product Development department of ProMed Molded Products for pre-production runs, validation, and ongoing production runs. We focus on prototypes for the following industries:

  • Medical: Dedicated quality system, facilities and personnel support the activities necessary to develop and manufacture these drug eluting components. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for the controlled release of drugs from a variety of materials. Our medical prototypes are offered in a variety of materials including LSR, HCR, and RTV.
  • Aerospace and Defense: ProMed also has more than ten years of experience in serving the aerospace and defense markets. We offer quick turn silicone molded prototypes of nearly any geometry and material type, along with complex assembly and over-molding prototypes for the aerospace market. ProMed Prototypes has leveraged its experience to become a leader in providing precision quick turn silicone prototypes to the aerospace and defense markets, along with ProMed Molded Products taking many aerospace and defense products into full production.
  • Pharmaceuticals: ProMed Pharma, offers quick turn pharmaceutical prototypes for drug eluting and drug delivery components, among other pharmaceutical, medical device, and combination products. ProMed Pharma focuses on silicone and plastic pharmaceutical prototypes but has extensive experience in final product assembly and packaging as well.

Contact ProMed today at 763-331-3800 to discuss your next prototype or low volume project or click here to request a quote.


Why Value-Added Operations Make Sense

The term “value-added operations”, or secondary operations as they are often called, refers to services performed after the primary injection molding operation is completed. Value-added operations are common and nearly every medical product requires some of these services. Examples include operations like etching, cutting, assembly, testing, and packaging. Specific to the medical industry, an example of a value-added operation is the implanting of sensors on a catheter or parts assembly that turns a set of components into a functional medical device.

Value-added operations are sometimes viewed as an after-thought – additional steps that companies don’t have time to optimize. Secondary operations that are not well-planned result in inefficiencies, delays, and higher costs. When considered individually, value-added operations may not seem costly or timely, but when evaluated collectively, these services are often very time-consuming and expensive – so it is well worth the effort to optimize them!

When partnering with a single-source provider, such as ProMed, value-added operations become an extension of the injection molding process. This provides customers with a complete manufacturing solution, providing value by minimizing the number of vendors involved and enhancing product quality. Single-source providers that offer value-added services streamline manufacturing with continuous production line flow that reduces disruptions and improves efficiency – saving OEMs time and money!

Why Value-Added Operations Make Sense

There are many advantages to value-added operations. Each of the benefits below results in manufacturing efficiencies, saving OEMs money, resources, and time! Over time, OEMs often find they have acquired a large supply base that can be challenging and time-consuming to manage. One way to streamline and strengthen the supply chain is to consolidate the supply base. Additionally, since every step in the injection molding process builds upon the next, it is cost-effective to partner with a supplier that can start and end the project with you – from the concept and design phase through production and secondary operations!

  • Enhanced Quality and Speed to Market: value-added operations offer OEMs a greater degree of control and minimize the risk of supply chain or process disruptions. Delays are avoided since OEMs no longer need to manage production and logistics schedules across multiple vendors. These services streamline the production line, especially when combined with automation, allowing manufacturing to run seamlessly from injection molding through assembly, testing, and packaging. These services add efficiencies that result in decreased lead times and allow for faster speed to market. Regarding quality, value-added operations performed by the injection molder results in higher consistency and reliability of the end product. Fewer vendors handling the product also eliminates the potential for a quality dispute between vendors! Lastly, since product flow is continuous and there is minimal “down-time” in between molding and the various value-added services, less inventory is required. For all of these reasons, as well as those noted below, value-added operations save time and money – and make good business sense!
  • Improved communications: by consolidating your production and value-added operations into a single supplier, your points of contact decreases from several to one! This allows for a central, more customized level of support. This will also inevitably improve and simplify your supplier communications, resulting in a better final product.
  • More purchasing power: by consolidating your supplier base and incorporating value-added operations, OEMs gain purchasing power. This can be in the form of negotiating lower manufacturing and transport rates due to higher annual spend and more services being performed.

ProMed’s Value-Added Operations

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed elevates plastic injection molding to the next level with its suite of value-added operations. The extensive expertise of our production and engineering personnel has made our Value-Added Operations the fastest growing portion of our business today. We leverage life experiences and training within our robust New Product Development Processes coupled with our ISO-quality system. The result is high-quality, value added components that are delivered on time, utilizing all our extensive capabilities. Below are some of our value-added offerings.

  • Priming
  • Plasma etching
  • Laser etching
  • Welding
  • Marking
  • RTV inking
  • Bonding with UV cure or RTV adhesives
  • Assembly
  • Slitting

  • Cutting
  • Crimping
  • Annealing
  • Post-cure
  • Punching
  • Custom packaging
  • Insert over-molding
  • Functionality testing
  • Supply chain management

Contact ProMed today at 763-331-3800 to discuss how our value-added operations can save you time and money!


The Latest on Active Implantable Devices – Forecasting Into 2025 and Beyond

What are Active Implantable Devices?

Medical implants are devices that are placed on the inside or surface of the body with the purpose of delivering medication, monitoring body conditions, or supporting organ health. There are different types of implantable devices, but most generally fall into two categories: static or active. Static devices are the least complex and do not have moving parts; stents implanted in a patient’s artery are a common example of a static implant.

Active Implantable Medical Devices, commonly referred to as AIMDs, are more intricate in nature and often perform more complex functions than static devices. One of the key differences between active and static implantables is that AIMDs typically require an artificial power source, such as a battery or other electrical supply. Active implantable medical devices can be found in many healthcare applications including cardiac pacemakers, defibrillators, cochlear and other hearing aids, neuro stimulators, and infusion pumps.

As you would expect, there are key material considerations for AIMDs such as biocompatibility, stability, and durability. Medical grade silicones have long been a material of choice for implantables, including AIMDs, given their range of available durometers, extreme chemical inertness and biocompatibility, and excellent tear and heat resistance that make them ideal for parts that need to remain in the human body for extended periods of time. As this field continues to grow and expand in future years, medical grade silicones are expected to continue to play a significant role in the manufacturing of active implantable devices due to their ability to produce high volumes at low prices while meeting tight dimensional tolerances.

It is no surprise that active implantable devices have very strict and high standards that must be met in order to ensure patient safety. Compared to other medical devices, AIMDs can be more difficult to manufacture due to their intricacy and size, requiring additional considerations to achieve the necessary product specifications and tolerances. For these reasons, it is imperative that OEMs select a molding partner, like ProMed, that has both design expertise and manufacturing experience with active implantable devices, as well as an outstanding quality assurance program!

Recent Advances in Active Implantable Devices

The field of active implantable devices continues to rapidly expand and is an area of significant research and development. Below are three recent advances that give a glimpse into the not-so-distant future of AIMDs.

  • One of the issues of active implantable devices is that the electronic components are typically rigid and not biocompatible. A team of engineers are taking on this challenge by developing flexible, bioelectronic devices. Once successful, these devices will allow active implantables to expand into new treatments!
  • Another current limitation of AIMDs is battery life. Once a battery dies, the patient must undergo a procedure to replace the battery. One study currently underway is looking at methods to recharge a battery in-situ via a technology called “active photonic power transfer”. This program has tremendous implications for AIMDs as many surgeries could be avoided if batteries could be recharged remotely and did not need to be replaced!
  • Lastly, even though implants have come a long way, their size is still a challenge. The housing necessary to enclose the electronics is still larger than desired. Fortunately, a team is developing an ultra-thin coating that will allow for further size reduction of implants. The coating will encapsulate the electronics to protect them from the body’s environment and reduce the need for the traditional, bulky housing. This is an exciting time in the AIMD sector, with rapid R&D advancements!

Forecasting the AIMD Market into 2025 and Beyond

A recent report by Data Bridge Market Research projected the worldwide AIMD market will reach nearly $39 billion by 2027 with a CAGR (Compound Annual Growth Rate) of 7.8% during the period. This is an excellent growth rate, forecasting continued demand for active implantable devices in the coming years.

There are several drivers for the projected market growth. One of the main factors is the aging population worldwide. The number of people 65 years or older is expected to be nearly 1.5 billion by 2050, making up over 15% of the global population! As patients age, their need for active implantable devices grows in order to maintain a good quality of life. Additionally, cardiovascular disease and neurological disorders are becoming more prevalent, especially in developed countries, resulting in more demand for AIMDs that treat these conditions. Lastly, as the medical community continues to research and develop AIMDs, the field continues to advance, resulting in opportunities for AIMDs to expand into new areas of the medical sector.

As previously noted, the rise in cardiovascular disease is one of the factors responsible for the continued demand for active implantables, so it is no surprise that cardio products, such as cardioverter defibrillators, are forecasted to hold the largest AIMD market share. In terms of geography, North America is expected to continue to lead other regions in the demand for AIMDs in the foreseeable future.

The AIMD market does have some challenges to growth. For example, one of the key hurdles that must be addressed are the many regulatory standards that must be met by AIMDs in order to ensure patient safety; these standards can be daunting and may prevent some manufacturers from entering the AIMD market or expanding their product line.

ProMed’s Capabilities

At ProMed, we combine industry-leading medical-grade expertise with the latest developments in silicone materials and technology. From helping OEMs incorporate the latest medical-grade formulations into their designs to delivering rapid silicone prototypes, we serve as a premier silicone molding contract manufacturer for medical device OEMs.

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components. Working with both established and early-stage medical device and pharmaceutical companies, ProMed develops robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next active implantable device project.


Best Practices for HCR Injection Molding

What is High-Consistency Rubber (HCR)?

Silicone elastomers have long been a popular material for medical parts and devices due to their highly desirable mechanical and physical properties. One of the most common elastomers for manufacturing is High-Consistency Rubber, or HCR. It should be noted that the terms HCR and HTV, which stands for High Temperature Vulcanization, are often used interchangeably and refer to the same silicone material; for the purpose of this article, we will use the acronym HCR.

HCR is a type of silicone elastomer comprised of long polymer chains with a very high molecular weight. It is cured at high temperatures with a platinum catalyst or peroxides. HCR is known for its gummy consistency that is similar to peanut butter. Due to its higher viscosity compared to other elastomers, HCR is typically processed using compression and transfer molding methods, but can also be utilized for injection molding projects. HCR has many desirable properties such as excellent aging resistance, thermal stability, electrical properties, mechanical strength, elongation, and hardness. For these reasons, HCR is a good material for a broad range of applications and HCR products are found across many industries including medical, automotive, consumer goods, aerospace, and electrical uses.

Best Practices for HCR Injection Molding

Injection molding offers many benefits over other production methods, making it a very attractive manufacturing option. At a high level, the injection molding process for HCR is the same as with other elastomers: the silicone rubber is fed into a heated barrel and injected under pressure into a mold where the material completely vulcanizes into the desired part shape. However, due to its properties HCR processing presents some challenges when compared to other elastomers. But do not be alarmed – high quality parts are achievable with HCR when attention to detail is given during the part design phase as well as during manufacturing! Below are some best practices to consider when using HCR for injection molding projects.

  • High-consistency rubber takes longer to cure than many other molding materials. A longer cure time results in a longer injection molding cycle time. In order to make the project economics attractive, HCR molds often have a large number of cavities in order to accommodate the longer cycles and still achieve the desired production volume for each cycle – resulting in more attractive project economics!
  • One best practice that is especially important for HCR is preheating the material prior to injection into the mold. Preheating has a couple benefits. It reduces the viscosity and allows the HCR to more quickly fill the mold as well as more uniformly – reducing the cycle time and improving the quality of the final product.
  • HCR injection molded parts are susceptible to tearing when removed from the mold; this is referred to as hot tear. Hot tear is directly related to the mold temperature – the higher the temperature the more vulnerable the part is to hot tear; however, lower operating temperatures result in longer cure times – so manufacturers must adjust the temperature to optimize cure times while minimizing the potential for hot tear.
  • When compared to other silicone elastomers, HCR has higher part shrinkage rates. For this reason, it is crucial that OEMs work with their molding partner to design for manufacturing by selecting the right size and type of mold for their specific HCR project.
  • It is crucial to ensure the right size of shot for HCR projects to prevent over packing of the mold. When a shot size is too large for a given mold, HCR will seep from the mold resulting in flash. To avoid this situation, manufacturers must gradually increase the shot size until the mold completely fills without any mold leakage or flash on the final product.
  • To avoid air entrapment, the mold needs to have sufficient air flow and channeling when HCR is injected into the mold. Air that remains in the mold creates air bubble imperfections and inconsistencies in the final product. OEMs must ensure air flow is accounted for in the design and take steps to improve flow properties during production such as preheating and possibly a higher operating temperature.
  • Similar to other injection molding projects, selection of the right design for the mold, runners and gate, press, and other equipment are critical to the success of the project – and HCR injection molding is no exception. It is important to work with your design team to ensure the right equipment set-up during the design phase to set production up for success! Additionally, it is important to ensure the molding equipment are properly maintained over time.

The decision on which material is best for your injection molding project should be determined on a case-by-case basis and depend on a variety of factors including the requirements of the part and the OEM’s preferences. This is why it is important to team up with an experienced partner, such as ProMed, who will guide you through the selection process to ensure the right material is chosen for your project!

ProMed’s HCR Processing Capabilities

At ProMed, we combine industry-leading medical-grade expertise with the latest developments in silicone materials and technology – including HCR. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies. From helping OEMs incorporate the latest medical-grade silicone formulations into their designs to delivering rapid silicone prototypes, we serve as a premier silicone molding contract manufacturer for medical device OEMs.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. Our wide range of materials include: High-consistency Rubber (HCR): 20 to 80 Durometer, Liquid Silicone Rubber (LSR) 5 to 80 Durometer, Room Temperature Vulcanizing silicone (RTV). We will assist in your material selection to help ensure all design requirements are met.

Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical device project.


Growth in Liquid Silicone Rubber (LSR)

Why Is LSR So Popular?

Liquid Silicone Rubber (LSR) is a very pure, platinum-cured elastomer. LSR starts out as a 2-part liquid that is heated in order to accelerate the reaction of the two parts to form solid rubber. LSR has excellent properties, such as a low viscosity and low shrink rate, that make it a great choice for injection molding and the manufacturing of complex products and intricate parts. One of the benefits of LSR is that it cures faster than most other rubber materials; additionally, due to the highly automated nature of injection molding and the potential for 24/7 manufacturing, high volumes of LSR products can be produced in a short period of time – adding to its popularity!

There are several types of LSR that can be manufactured such as medical, self-lubricating, conductive, flame-retardant, and radio opaque. The type of LSR produced is determined by the additives incorporated during the manufacturing process. Additionally, LSR is available in different grades, namely medical, food, and industrial. As you can see, LSR is a very versatile material that is well suited for a wide range of industries – so it is not surprising that the worldwide demand for LSR continues to grow!

Growing Demand for Liquid Silicone Rubber

The LSR market has continued to steadily grow in recent years and some sources estimate the global market for LSR will reach a valuation of US$ 7.9 billion by 2026. Additionally, the global LSR market is forecasted to have a Compound Annual Growth Rate, or CAGR, of 4.5% through 2026 which is considered moderate growth.

This growth is attributed to several factors. First, enhancements to the physical properties of LSR are expected to allow LSR to continue to replace traditional rubber materials in various applications. Additionally, injection molding of LSR produces consistent parts, cycle to cycle, and is a low-cost option for part manufacturing. For these reasons, LSR injection molding continues to expand into new markets, driving the continued demand for LSR.

Demand for LSR is increasing in traditional rubber applications as well as applications where rubber materials have not historically been utilized. LSR has a broad range of applications from medical devices to consumer goods to electronics to automotive. For example, LSR can be found in catheters, stents, windshield wiper blades, LED headlights, adhesives, wearables, bakeware, microwaves, seals, and grommets. Below are some key sectors that are experiencing growth in the use of liquid silicone rubber.

  • Medical Devices: LSR has many attractive properties such as durability, low viscosity, chemical and temperature resistance, and flexibility, but its biocompatibility is outstanding. LSR has demonstrated superb compatibility with human tissue and body fluids, and is resistant to bacteria growth. Medical grades of LSR are temperature resistance and can easily sterilize, which makes them compatible with various medical devices and accessories such as implantable devices, liquid feeding bottles, dialysis filters, and oxygen mask instruments. Additionally, wearable medical devices are also gaining traction, leading to higher LSR demand.
  • Automotive Parts: Historically, automotive parts were made of metal or other materials. Due to their lighter weight, flexibility, longevity, and ease of manufacturers, elastomers such as LSR are increasingly being used by the automotive industry. For example, LSR is found in windshield wiper blades and LED headlights.
  • Wearables & Consumer Goods: Demand for wearable devices outside the medical sector also continues to grow, specifically products used to track fitness and health. LSR is ideal for wearables due to its resistance to moisture, ozone, and UV – resulting in a long product life! In addition to wearables, companies continue to seek LSR for other consumer goods applications. For example, many kitchen products such as bakeware and spatulas are made from LSR due to its ability to tolerate high temperatures and its excellent food safety ratings.

LSR’s growth in demand is also attributed to several societal factors such as growing demand for LSR in equipment and surgical tools necessary to treat the rising geriatric population and the growing awareness about health concerns, accelerated demand within the electronics industry due to continued innovation and technology advancements, as well as global urbanization and standard of living increases. Among the various grades of LSR, medical grade is expected to continue to hold the largest global market share. Moreover, stricter regulations and compliances of many specifications for use in medical products are further projected to drive the overall market growth.

The LSR market faces a couple key challenges including minimization of the carbon footprint associated with LSR production, and improvement of LSR’s reusability and disposability. But even with these challenges, the LSR market is forecasted to have continued growth globally as usage expands to even more markets.

ProMed’s LSR Molding Expertise

At ProMed, we combine industry-leading medical-grade LSR expertise with the latest developments in silicone materials and technology. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies. From helping OEMs incorporate the latest medical-grade silicone formulations into their designs to delivering rapid silicone prototypes, we serve as a premier silicone molding contract manufacturer for medical device OEMs.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. Our liquid silicone rubber offerings range from 5 to 80 durometer. We will assist in your material selection to help ensure all design requirements are met.

Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical device project.


Combining the Power of Medical Devices and Drug-Eluting Products

In the medical industry, a “combination product” is a term used to describe a product that is composed of two or more of the following: drug, device, and biological product. In recent years there continues to be increasing overlap between devices and drug therapies, leading to combination devices that more effectively deliver drugs and treatments to patients. This article will focus on the powerful combination of drug-eluting products and medical devices!

A drug-eluting device is a product that gradually releases a medicinal treatment over time. Generally, drug-eluting products are implanted into the body but there are some examples of external products such as drug-eluting wound dressings. For drug-eluting implantables, the exterior of the device can be coated with the drug, or the drug can be impregnated within the device during manufacturing.

Benefits and Examples of Drug-Eluting Medical Devices

Drug-eluting medical devices perform a variety of functions. One of the most common is vascular stents used to preserve and maintain blood flow in the heart. The stent is implanted in the patient’s artery and the device slowly releases the desired drug over time to target the care exactly where it is needed! Other examples of drug-eluting products include electrostimulation devices that regulate heart rhythm or block spurious signals in the brain, catheters with antimicrobial coating to prevent infections, and orthopedic devices that mechanically reinforce the spine or restore range of motion of hips and knees.

Drug-eluting medical products provide a great benefit to patients over conventional dosage methods. As noted above, these devices provide site specific drug administration where it is most needed – this targeted treatment often allows for lower doses since the drug does not have to spread throughout the entire body – resulting in fewer and less severe side effects. Drug-eluting implants are able to maintain the desired level of the drug, often referred to as the Active Pharmaceutical Ingredient (API), in the patient much more consistently and over a longer period of time than both pills and injections. For these reasons, the level of the API in the patient’s body remains inside the therapeutic window for a much longer duration. Additionally, drug-eluting medical devices are less burdensome to the patient and there is no risk of the patient forgetting to take a dose!

Recent Advances in Drug-Eluting Devices

Combining the power of medical devices and drug-eluting products is an exciting opportunity, and this field continues to be a focus area for research and development. One recent advancement is using a novel drug-eluting coating to reduce infections. Infection is often problematic with implants and it is estimated that up to 15% of hospital infections may be caused by internal medical devices! Bacteria often collect on the surface of an implant and form what is called a biofilm layer that makes it very difficult to fully remove the bacteria; in fact, in many cases, the implant must be removed, the bacteria treated via anti-biotics, and the device reimplanted – which is definitely not an ideal treatment plan! A cutting edge drug-eluting medical device in the form of a special coating was recently developed and will slowly release a drug that will combat the formation of a biofilm layer by the bacteria. The result is expected to yield fewer patient infections due to an implant as well as fewer procedures required to remove and reinstall implants when an infection does occur!

Traditionally, the field of medical devices has focused on palliative treatments, which try to manage a condition by improving quality of life and preventing the given problem from getting worse. But with the combination of medical devices and drug-eluting treatments, there is an opportunity to think broader than palliative treatments and shift toward treatments that potentially erase the damage from a prior medical event, such as a heart attack or stroke. And thinking even broader, these combination devices can potentially treat Alzheimer’s, Parkinson’s, or other diseases that are impacted by tissue or organ breakdowns – seeking to repair the tissue or organ and restore the patient to his/her original health. The sky is the limit when medical devices and drug-eluting products are combined!

ProMed Pharma’s Capabilities

ProMed Pharma is a leading contract manufacturer of polymer-based drug releasing molded dosage forms and combination device components, such as drug-eluting products. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for extended drug release from a variety of materials, including silicones and thermoplastics.

We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics – including Liquid Silicone Rubber (LSR) that is an excellent option for drug-eluting medical products! We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.


Liquid Silicone Rubber vs High Consistency Rubber for Medical Device Components

Silicone elastomers have long been a popular material for medical devices and medical device components due to their durability, ease of molding by many methods, wide temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. Furthermore, silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth – making it a perfect option for implants due to its excellent biocompatibility.

Silicone elastomers are available in two commercial forms: Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). HCR is known for its gummy consistency and mostly comes in partially vulcanized sheets. LSR is a newer technology and starts out as a 2-part liquid that cures into a solid form when mixed. LSR generally comes in buckets and has a longer shelf life than HCR.

Medical device OEMs often face a tough decision: should we use HCR or LSR for our medical device component manufacturing? LSR and HCR are both used to manufacture medical device products; however, there are some key differences. The following compares LSR and HCR to shed some light on their differences and when each should be utilized.

Viscosity Difference Leads to Different LSR and HCR Manufacturing Techniques

The performance characteristics of HCR and LSR are relatively similar; however, viscosity is a key differentiator between LSR and HCR, and has a significant impact on the equipment and processes used to manufacture each of these elastomers.

Simply put, viscosity is a measure of a material’s ability to flow. A low viscosity indicates a material is less viscous and more readily flows where a high viscosity indicates a material is more viscous and less apt to flow well. For reference, water has a relatively low viscosity and easily flows whereas molasses has a higher viscosity and is more resistant to flow.

LSR has a lower viscosity than HCR. Due to the lower viscosity, LSR is most often processed via injection molding. LSR’s desirable handling properties and lower shrink rate make it an excellent choice for manufacturing highly complex geometries and intricate products. Additionally, due to the automated nature of injection molding, LSR can produce high volumes of components in a short period of time. For this reason, deciding whether HCR or LSR injection molding is the better choice for your project largely depends on the production volume required.

A lower viscosity makes it easier for manufacturers to mix additives into LSR. Additives that can readily be incorporated into a batch of LSR include colorants, desiccants, barium, and pharmaceuticals such as hormones or steroids. For these reasons, LSR is a great option for medical devices such as combination products. The low viscosity of LSR and the temperatures needed to vulcanize LSR are usually low enough that significant degradation of compounded substances, like Active Pharmaceutical Ingredients (APIs) that are used in combination products, can be avoided.

Due to its higher viscosity and more challenging handling properties, HCR is typically processed using compression and transfer molding methods, which are more labor-intensive. In some cases, HCR is used in injection molding projects.

OEMs Often Prefer LSR

For companies already using HCR to manufacture medical device components, it may make sense to continue using this elastomer especially since the initial capital equipment costs have already been made. For new product development, however, LSR is often the best choice given the lower capital costs and labor associated with processing this elastomer. Due to its lower manufacturing cost and versatility with formulations, companies often prefer LSR over HCR – but the decision is on a case-by-case basis.

ProMed’s Silicone Manufacturing Capabilities

At ProMed, we combine industry-leading medical-grade LSR and HCR expertise with the latest developments in silicone materials and technology. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies. From helping OEMs incorporate the latest medical-grade silicone formulations into their designs to delivering rapid silicone prototypes, we serve as a premier silicone molding contract manufacturer for medical device OEMs.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. Our wide range of materials include: Liquid Silicone Rubber (LSR) 5 to 80 Durometer, High-consistency Rubber (HCR): 20 to 80 Durometer, Room Temperature Vulcanizing silicone (RTV). We will assist in your material selection to help ensure all design requirements are met.

Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

Contact ProMed today at 763-331-3800 to discuss your next medical device project.