Medical-Grade Liquid Silicone Rubber

The Value of DFM (Design for Manufacturing)

Design for Manufacturing, or DFM, is the process of designing products for ease of manufacturing as well as creating a better, more cost-effective product. DFM is a vital product-development step that looks to simplify and optimize the design to ensure high quality and efficiency during production.

Successful silicone molded parts must be designed from the beginning to be manufacturable. The DFM process should occur early in the design phase of any injection molding project and should engage key parties including designers, tool fabricators, raw material suppliers, manufacturers, and other stakeholders. The goal is to tap into the experience of each of these experts. The team will scrutinize the current design from many angles with the goal of identifying a more cost-effective solution that maintains quality!

Part design should be focused on the ease of manufacturing because it can help reduce cost and lead to a robust and reliable process. Several aspects of the design will be considered during the DFM process: part geometry, location and shape of critical surfaces, size, and among others. Additionally, the DFM process should consider material selection, dimensioning/tolerancing, and the selection of critical dimensions as all of these factors impact manufacturability. By making the right material, color, durometer, dimension, and tolerance choices, OEMs can develop molded devices and components that can be reliably manufactured in large volume—while minimizing scrap rates and losses.

The Value of DFM

OEMs need to ensure the part is as easy to manufacture as possible! This will result in more efficient production, better quality, and lower cycle times. Below are some ways OEMs gain value from the Design for Manufacturing process.

  • Save Significant Cost and Time: OEMs are often in a rush to get a new product to market so it is tempting to shorten – or even skip – the DFM process. However, it is important to keep in mind that changes to the design become exponentially more expensive and timely to implement as the product advances through the life-cycle. A thorough DFM upfront will allow any optimizations to be made or issues to be resolved before the changes significantly impact the project timeline or budget! When it comes to DFM, the old adage “an ounce of prevention is worth a pound of cure” is very true!
  • Optimize Functionality and Aesthetics: tooling for injection molds is often expensive to fabricate and costly to modify; thus, it is imperative to get the tool design right the first time! If the design is off even by a small margin, the product aesthetics and functionality will be altered. The DFM process typically includes computer simulations of the design so the team can fully visualize the product. Oftentimes, this step yields additional insights and optimizations that would have been lost if the DFM process was not performed – resulting in a more functional and aesthetically-pleasing product.
  • Confirm Manufacturability: last but certainly not least, the DFM process ensures the part can be manufactured! This may seem obvious but there are more instances of products reaching production only to realize the product cannot actually be manufactured per its current design – what a nightmare! To avoid this situation, OEMS should partner with an experienced injection molder, like ProMed, that has DFM expertise. ProMed’s design and manufacturing teams are integrated to allow manufacturability issues to be identified and addressed during the design process instead of after the tooling is fabricated – saving customers significant development time and cost as well as innumerable headaches! ProMed works with customers throughout the product life-cycle, providing a cost-effective solution that meets the customer’s needs!

ProMed’s DFM Approach

Over the years, ProMed has evolved into a full-service provider of molded parts and assembled products, including molded silicone components, biomaterial grade plastic components, combination components (pharmaceuticals into silicone) and value-added assemblies. 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. Through multiple media platforms, ProMed’s collaborative DFM meetings include a diverse group of engineering experience that work to provide you with the best path that will meet your requirements, budget and timeline.

Our innovative processes range from simply molding components to automated assembly to providing complete devices. 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. Let our team of experts take you all the way from concept to completion – or jump in anywhere in between. We offer complete in-house production and technical services such as:

  • Design, tooling, molding and assembly
  • Transfer, liquid injection, RTV, insert and compression molding capabilities
  • Standardized tooling platforms
  • IQ/OQ/PQ activities

Contact ProMed today at 763-331-3800 to discuss how we can help with your next silicone injection molding project!


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!


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.


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.


Pharmaceutical Combination Products: Why Silicone is the Perfect Match

What is a Combination Product?

“Combination product” is a term used in the medical industry that refers to a product composed of two or more of the following: drug, device, and biological product. For over a decade there has been an increasing convergence between devices and drug therapies, leading to combination devices that more effectively deliver drugs and treatments to patients. Implantable medical devices are a common pharmaceutical combination product that provide a variety of functions from vascular stents that preserve blood flow to electrostimulation devices that regulate heart rhythm or block spurious signals in the brain, to orthopedic devices that mechanically reinforce the spine or restore range of motion of hips and knees. Other examples of combination products include inhalers and insulin pumps.

Pharmaceutical combination products, in particular implantables, provide a great benefit to patients over conventional dosage methods. For example, implantable devices provide site specific drug administration where the drug is most needed – this targeted treatment often allows for lower doses, reducing side effects. Additionally, this form of drug dosage is less burdensome to the patient. For these reasons, the trend toward combination products is expected to continue as demand grows for patient-centric drug delivery and self-administration of healthcare.

Silicone – the Perfect Match for Combination Products

Silicone has long been a popular material for medical device manufacturers due to its durability, ease of molding by many methods, wide useful temperature range, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, and compatibility with many sterilization methods. But the key characteristic that makes silicone the perfect match for combination products is its biocompatibility. Silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth. Additionally, medical-grade silicones have undergone stringent purity and biocompatibility testing that make them suitable for use in long-term implants.

LSR is a specific type of silicone used in combination products. The low viscosity of LSR makes it a great silicone material for making medical devices via injection molding, since the LSR can easily flow into and completely fill molds with relatively low injection pressures, even those with intricate and small features. Furthermore, the temperatures needed to vulcanize LSR are usually low enough that significant degradation of compounded substances like Active Pharmaceutical Ingredients (APIs) can be avoided.

One application where medical-grade silicones, such as LSR, really shine is drug-eluting implantable devices. Before molding, silicones can be compounded with APIs such as cancer drugs or hormones which can then be steadily released into a targeted area of the patient’s body over time once that molded implant is inserted. Drug-eluting implants are able to maintain the desired level of the API in the patient much more consistently and over a longer period of time than both pills and injections. Also, since the implant can usually be inserted near the targeted organ or tissue, lower total amounts of API are needed because that API doesn’t need to spread throughout the entire body before reaching the targeted area. As a result, the level of the API in the patient’s body remains inside the therapeutic window for a much longer duration.

ProMed’s Combination Product Capabilities

At ProMed, we combine industry-leading medical-grade LSR expertise with the latest developments in silicone materials and technology. From helping OEMs incorporate the latest medical-grade LSR 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 medical molding project.


Why Consistency Matters Most in Medical Silicone Injection Molding

Consistency is defined as the achievement of a level of performance that does not vary greatly in quality over time. While there are many factors that OEMs should consider when partnering with a silicone injection molder – consistency is certainly at the top of the list! This is especially true for OEMs that supply medical parts and devices to the healthcare industry – you simply cannot afford to cut corners when it comes to consistency and quality as these products are often critical to the health of the individual using them.

Due to its chemical inertness, durability, stability, and low toxicity, medical grade silicone is an excellent material for implantable and other medical devices and its use throughout the healthcare sector continues to grow. The healthcare industry has high expectations for its devices – requiring compliance with tight tolerances and cleanliness requirements that offer little room for error. A molder that has a high level of quality and repeatability in its medical device production is able to deliver consistent products to customers – becoming a trusted partner! Meeting an OEM’s specifications and requirements for a given device must be the top priority for every injection molder. From both the supplier and OEM perspectives, inconsistency and poor quality can result in various negative outcomes such as slower time to market, customer complaints, tainted reputation, strained supplier-OEM relationship – and worst of all, customer loss or harm! For these reasons, consistency and quality matter most in medical silicone injection molding!

Before partnering with an injection molder, OEMs should have a firm understanding of their quality program – this is an area where excellent injection molders stand out from their competition. A silicone injection molder’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 of their injection molded parts. A sound quality program demonstrates that the molder monitors the effectiveness of their supply chain and demonstrates traceability related to regulations of materials and finished goods – enabling the production of medical products with consistency and repeatability.

ProMed’s Commitment to Quality

Partnering with an experienced injection molder like ProMed allows for the necessary production planning needed to meet all of the necessary regulatory, quality, and commercial standards. ProMed understands the importance of quality to your success. That is why quality is embraced every step of the way to create a product that will assure confidence in your products. Our work force is highly specialized in the manufacturing and quality requirements of medical products, much of which go into the long-term implantable market space. Every employee at ProMed is trained with the idea that quality is their most important responsibility.

Our equipment utilizes cost-effective, high-end molding technology to keep operating expenses down while producing parts with an extremely high level of precision and repeatability. Our tools are designed and manufactured to exacting tolerances. Expert toolmakers use high-tech design software and machining centers to produce molds that are durable and dimensionally repeatable from cavity-to-cavity, part-to-part!

We are an approved, certified supplier to many of the top medical device manufacturers in the world. All ProMed facilities go through routine audits by our ISO registrars and customers. Below is a sample of the standards we meet.

 

·      ISO:13485 – 2016 certified ·      ISO Class 7 Clean Room
·      ISO:17025 certified ·      REACH and ROHS compliant
·      FDA 21 CFR 820, 210/211 and part 4 compliant

ProMed’s 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.