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Author Archives: Krista Reske

1. Common Materials for Silicone Injection Molding

   March 23, 2022 8:33 am Leave a Comment

   MediSilicone injection molding is a cost-effective manufacturing solution that many OEMs rely on for high-quality, efficient production. This method of manufacturing is very common within the medical sector and has several benefits compared to other molding processes. For example, silicone injection molding is a good choice for a wide range of part sizes, materials, and colors – including highly intricate and complex parts. This method produces products that are virtually identical from part to part which provides excellent brand consistency and part reliability during high volume runs, which is especially crucial for products used in the medical industry. The high reproducibility of silicone injection molding also allows for production to be scaled up to very large volumes, resulting in low costs per unit.

   Common Silicones for Injection Molding: LSR and HCR

   Silicone elastomers have long been a popular material for silicone injection molding due to their highly desirable mechanical and physical properties. Silicones have excellent durability, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, a wide temperature range, 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 primarily available in two forms for medical manufacturing: Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). LSR and HCR are both used in medical manufacturing. While HCR and LSR have several similarities, viscosity is a key differentiator and often impacts the decision on which material is utilized for a given silicone injection molding project. The following provides an overview of both elastomers and when each should be utilized.

   What is Liquid Silicone Rubber (LSR)?

   Liquid Silicone Rubber (LSR) is a platinum-cured elastomer. LSR is a newer silicone 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.

   LSR is a versatile silicone that has a wide range of end-uses from medical devices to consumer goods to electronics to automotive. 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. Given its versatility, it is not surprising that the worldwide demand for LSR continues to grow.

   LSR has excellent properties, such as a low viscosity and low shrink rate, that make it a great choice for silicone 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 silicone 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.

   A key benefit of LSR’s lower viscosity is that it is easier to mix additives into. 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.

   While LSR has many attractive properties, 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.

   Looking for a proven and reliable medical manufacturing partner for your next silicone injection molding project?

   Contact the professionals at ProMed to learn more about our range of medical manufacturing solutions and the various silicone materials we utilize.

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   What is High-Consistency Rubber (HCR)?

   Another common elastomer for silicone injection molding 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, and mostly comes in partially vulcanized sheets.

   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 within medical manufacturing. Due to its higher viscosity compared to other elastomers such as LSR, HCR is typically processed using compression and transfer molding methods, but is also utilized for silicone injection molding projects.

   HCR takes longer to cure than many other molding materials. A longer cure time results in a longer silicone injection molding cycle time. To improve project economics, 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 a more cost-effective solution on a per unit basis.

   Which Silicone is Best for My Injection Molding Project?

   Medical device OEMs often face a tough decision: should we use HCR or LSR for our silicone injection molding project? For companies already using HCR to manufacture medical 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 silicone. Due to its lower cost and versatility with formulations, companies often prefer LSR over HCR – but the decision should be made on a case-by-case basis. 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 silicone injection molding project.

   About ProMed

   ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. Over time, we broadened our product offerings to include assembly, micro-molding of highly engineered plastics, and combination products. 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 Silicone 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.

2. 5 Benefits of Complete Prototyping Services in Medical Manufacturing

   January 26, 2022 8:34 am Leave a Comment

   When it comes to molding, the initial tooling cost can be pricey and time-consuming. Thus, companies often utilize rapid prototyping to fine-tune the design and work out any potential manufacturability issues prior to investing in the tooling that will be utilized for final production. The advantages of prototyping are extensive, and below are 5 benefits of rapid prototyping services in medical manufacturing.

   It should be noted that some injection molding manufacturers focus on high volume production runs, and often do not give much attention to prototyping. That is not ProMed’s approach. The ProMed team offers cost effective solutions for rapid prototyping, and does not shy away from low volume production for medical manufacturing. Regardless of the volume, ProMed views each project as an opportunity to build a long-term relationship with a customer. Watch our short video to learn more about our complete prototyping services.

   1. Optimizes Design: rapid prototyping enables the design to be optimized by early identification of design flaws or manufacturing issues. Simply put, this step ensures products can be manufactured cost-effectively and at high quality well before final production. During rapid prototyping, the team has the opportunity to address unforeseen design challenges and test product features and manufacturing methods before initiating full-scale production.
   2. Enables Quick Reiterations: rapid prototyping is an iterative process that allows designers to incorporate valuable feedback from customers and end-users into the final design. This step improves the design as well as creating a higher level of customer satisfaction in the final product. With each iteration, confidence in the final design and the product’s marketability grows.
   3. Ensures Quicker Speed to Market: any time saved during product development directly corresponds to faster speed to market. OEMs are often in a rush to get a new product to market so it is tempting to shorten – or even skip – the prototyping step. 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.

    

   Looking for a proven and reliable partner to start and end the project with you?

   CONTACT PROMED

   Contact ProMed to learn more about our prototyping services and our range of silicone molding solutions.

    

   1. Lowers Manufacturing Risk: there is some degree of risk associated with every manufacturing project and rapid prototyping lowers the risk level. Prototypes enable designers to quickly discard ideas that will not result in a successful manufacturing project – and focus on the designs that will. A thorough Design for Manufacturing process (DFM) upfront allows optimizations to be made or issues to be resolved before the changes significantly impact the project timeline and budget – reducing the project risk.
   2. Reduces Cost: 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. Rapid prototyping gets the tool design right and ensures product manufacturability. These steps result in higher quality production, less rework, and lower waste generation – leading to significantly lower costs.

   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 rapid 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 rapid 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 rapid 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 rapid 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 rapid 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.

3. Medical Manufacturing Explained: What Happens in a Class 10,000 Clean Room?

   December 8, 2021 8:34 am Leave a Comment

   Medical devices and components for the healthcare industry often come in contact with human skin and tissues, and are even implanted in some cases. For this reason, medical manufacturing typically requires a cleaner, more sterile environment to avoid the potential for contamination that could result in diminished functionality of the product, or lead to infection or other risks for the patient. There are various technologies that medical manufacturers can employ to ensure cleanliness, and one of the most common and effective is a clean room, or cleanroom. ProMed’s manufacturing facilities, for example, are equipped with certified class 10,000 / ISO Class 7 clean rooms, demonstrating a strong commitment to quality.

   What is a Clean Room in Medical Manufacturing?

   Medical grade silicones are often processed in a very controlled and special facility known as a clean room. These rooms reduce the potential for contamination from dust and airborne microbes such as bacteria or viruses. Clean rooms control contaminants and air quality, and are essential to manufacturing high quality medical products. Clean rooms vary in size from large open spaces to small laboratory rooms. In addition to controlling cleanliness and contaminants, some clean rooms further control conditions such as humidity, air flow, air pressure, temperature, and electrostatic discharge.

   The International Organization for Standardization (ISO) establishes the requirements for medical device manufacturing. Maintaining and operating a clean room environment to ISO standards requires excellent processes and procedures. In addition to production, clean room processing includes raw material handling as well as packaging to avoid particulates and other forms of contamination during these steps. Medical manufacturers, like ProMed, that are ISO 13485 certified have demonstrated the capability and know-how to manufacture medical devices under the requisite cleanliness and contamination controls.

   Have a medical manufacturing project that requires a class 10,000 clean room?
   Contact ProMed to learn more about our advanced facilities and range of silicone injection molding solutions.

   Contact Us

   What is a Class 10,000 Clean Room?

   There are different levels of ISO requirements for medical manufacturing, ranging from ISO 5 to ISO 8. Most medical device manufacturing is categorized as ISO 7. Each ISO level of a clean room has a corresponding class. Clean rooms are categorized by class ranging from 100 to 100,000. The class is based on the number and size of particles permitted per volume of air. For example, an ISO 7 clean room is equivalent to a class 10,000 clean room, which means the facility must have less than 10,000 particles per cubic foot. Special filtration systems within the clean room use HEPA filters, air flow, and other measures to manage the purity of the air to ensure the necessary ISO requirements are met.

   In addition to using air filtration to control cleanliness, class 10,000 clean rooms typically require personnel to wear protective equipment ranging from full bunny suits to partial coverings such as shoe covers, laboratory coats, hair nets, safety glasses, and gloves. These measures prevent human contaminants like hair, sweat, or skin from coming in contact with the manufacturing process. Clean rooms are often designed with specific wall and floor materials that are readily cleaned, as well as stainless-steel work tops and sinks. Lastly, some clean room designs include an air shower at the room entrance to reduce the level of contaminants entering the manufacturing space.

   At ProMed, 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 clean rooms. Our facilities support silicone injection molding of various medical devices and components including:

   • Surgical instruments
   • Connector boots
   • Grommets
   • Tines

   • Inner/outer seals
   • Suture sleeves
   • Balloons

   About ProMed Pharma

   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 have multiple manufacturing sites, all are certified class 10,000 / ISO Class 7 cleanrooms.

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

4. 4 Surprising QMS Statistics about Medical Manufacturing Companies

   December 1, 2021 8:35 am Leave a Comment

   Most medical manufacturing companies know that quality is key. At ProMed, quality is our main driver and is an integral part of every process we undertake. Our quality professionals work hand-in-hand with our manufacturing teams to ensure quality is part of every decision we make. We provide OEMs a reliable and dependable process that yields consistent results. Consistent quality is hard work and requires rigorous, on-going monitoring of every process from purchasing to manufacturing to distribution. But the effort and focus on quality is well worth the reward. Our robust quality control and quality assurance programs ensure uniform, high-quality medical devices, and are one of the reasons ProMed stands out from the competition. Click here to watch a short video about our Quality Management System.

   What is a QMS for Medical Manufacturing Companies?

   Medical manufacturing companies utilize a Quality Management System, QMS, to manage their quality program. A QMS is a formal system that documents processes, procedures, and responsibilities that pertain to quality. This system addresses the design, production, labeling, distribution, storage, and other aspects related to medical component manufacturing. Medical manufacturing companies utilize the QMS to demonstrate compliance with customer requirements and regulatory regulations from the U.S. FDA as well as standards like ISO 13485.

   There are many benefits of a robust QMS program. In addition to meeting the customer and regulatory specifications, a strong QMS often leads to more efficient operations, less waste, and fewer errors – resulting in a lower cost medical component.

   Most highly-regulated sectors, like healthcare, require a QMS as part of the product development and registration process. The complexity of the QMS may vary depending on the classification and risk of the medical component. For example, an implantable medical device will typically have more stringent QMS requirements than a single-use medical instrument.

   Looking for a medical manufacturing company that consistently delivers high-quality products?

   Contact the ProMed team today to discuss our liquid injection molding solutions and our unwavering commitment to quality.

   Contact Us

   QMS Statistics about Medical Manufacturing Companies

   An industry benchmark was recently conducted to test the health of quality management across the medical device industry. Below are 4 surprising QMS statistics about medical manufacturing companies. Based on these statistics and findings, it is clearly important that OEMs partner with a medical manufacturing company, like ProMed, that is truly committed to quality and embeds quality in every aspect of medical manufacturing.

   1. Over two-thirds of medical manufacturing companies surveyed indicated quality is woven into the company culture. The majority of medical manufacturing companies no longer view QMS programs as a “tick the box” activity but as an opportunity to distinguish themselves from the competition.
   2. Responsiveness is a key aspect of any robust QMS program. However, 71% of professionals surveyed indicate the data collected by their quality system is not easily accessible in real-time. It is important that medical manufacturing companies take advantage of new technologies, such as the Internet of Things (IoT) and Industry 4.0, to improve connectivity and enable real-time access to information.
   3. Most QMS programs are managed electronically with tools ranging from Excel to purpose-built QMS tools. About half of the survey respondents indicate they use general-purpose tools and over 80 percent noted they are asked to “make do” with legacy QMS tools and solutions.
   4. Most days, 3 medical manufacturing companies receive a letter indicating their medical device or component did not meet the requisite QMS standards. It is crucial that OEMs understand the QMS requirements for their specific medical component in order to remain in compliance with FDA and other standards.

   ProMed’s Commitment to Quality

   At ProMed, quality is not just a department, it is a cultural commitment. We understand 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.

   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. 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. Additionally, our products are wholly synthetic, not animal derived, and do not contain substances of very high concern or materials sourced from conflict regions.

   • ISO:13485 – 2016 certified
   • ISO:17025 certified
   • FDA 21 CFR 820, 210/211 and part 4 compliant

   • ISO Class 7 Clean Room
   • REACH and ROHS compliant

   Contact ProMed today at 763-331-3800 to discuss how we can help design your next molded project for success.

5. The Future of Liquid Silicone Rubber in Medical Manufacturing

   October 6, 2021 8:35 am Leave a Comment

   Medical manufacturing continues to face more challenging requirements for medical products as well as stringent regulations and end-user expectations for devices such as wearables. Manufacturers are tasked with meeting these demands while keeping costs low without sacrificing quality. One technology that manufacturers are turning to, and that stands out from the competition, is Liquid Silicone Rubber (LSR) molding. As demand continues to grow, the future of LSR in medical manufacturing looks very promising.

   What is LSR?

   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 that can be injected into a mold cavity to manufacture a part. 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 advantages 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. LSR is a versatile rubber in the elastomer industry and has a wide range of end-uses including medical devices such as stents and catheters. Click here to learn why the medical industry uses silicones.

   Benefits of LSR in Medical Manufacturing

   In medical manufacturing, 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 resistant 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, demand continues to grow for wearable medical devices, leading to even higher LSR demand.

   Medical manufacturing typically requires a higher level of cleanliness to avoid contamination during processing. In fact, many manufacturers, like ProMed, employ cleanrooms to minimize risk of contamination and achieve the necessary cleanliness during manufacturing. One of the benefits of LSR is that it can be injection molded, which is a highly automated process, further reducing the risk of contamination from operators, equipment, or the environment.

   Have a medical manufacturing project that demands biocompatibility?
   Contact the team at ProMed team to learn more about our broad range of LSR molding solutions.

   Contact Us

   Continued LSR Market Growth

   The LSR market has experienced continuous growth and expansion in recent years, and this trend is projected to continue over the next 5-10 years. Some sources forecast the global LSR market will grow at a rate of 7.1% in terms of value, from USD 2.4 Billion in 2020 to USD 4.2 Billion by 2028. The healthcare sector is one of the primary drivers for LSR demand increases world-wide as medical manufacturing is experiencing significant growth.

   The growth of LSR for the medical sector is attributed to a few key factors. First, due to its excellent biocompatibility, the demand for implantables continues to grow, driving the need for liquid silicone rubber. Second, there is growing demand for LSR in equipment and surgical tools necessary to treat the rising geriatric population. Lastly, LSR has hypo-allergenic characteristics that make it an excellent material for medical products that come in contact with human skin, such as wearables and medical products for babies.

   For these reasons, the future of liquid silicone rubber in medical manufacturing is forecasted to be strong. It should be noted that, similar to most sectors, the COVID-19 pandemic has disrupted the global LSR supply chain. However, the supply chains are expected to fully recover and not impact the short- or long-term demand for liquid silicone rubber in medical manufacturing.

   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 have multiple manufacturing sites, all are certified class 10,000 / ISO Class 7 cleanrooms.

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

6. 5 Advantages of Additive Manufacturing

   August 18, 2021 8:35 am Leave a Comment

   Many conventional manufacturing methods, such as CNC machining, use tools to cut and carve material into the desired shape and size. These traditional techniques are subtractive in nature since they start from a block of raw material, and material is removed as necessary to reach the final product. On the other hand, as the name implies, additive manufacturing technologies start from nothing and add layer by layer of material to create the final product. AM employs CAD software to control the deposit of material, layer upon the previous layer, to fabricate the desired 3-dimensional product. As the product cools, the layers are bonded together to form a strong, durable product. Additive manufacturing methods can be used with a range of raw materials including plastics, ceramics, and metals.

   There are various AM processes on the market such as material extrusion, powder bed fusion, and jetting, but 3D printing is the most widely known method. In fact, the terms additive manufacturing and 3D printing are often used interchangeably but there is a key distinction: 3D printing is one of several fabrication technologies under the umbrella of additive manufacturing.

   AM is part of the digitalization of manufacturing that is often referred to as Industry 4.0. AM technologies have advanced significantly in recent years and are transforming the way many manufacturers operate. AM, specifically 3D printing, is one of the fastest growing industries in the U.S. today and conditions are ripe for innovation. The true potential for AM and 3D printing lies in the new opportunities for creativity that it provides – and not what forms of manufacturing it will replace.

   5 Advantages of Additive Manufacturing

   Additive manufacturing offers many advantages over traditional manufacturing techniques, and many manufacturers are turning to this method to reap the benefits. Below are 5 key advantages of additive manufacturing.

   1. Faster Cycle Times: additive manufacturing methods are known for their speed. 3D printing only needs a new CAD input in order to manufacture a new product and does not require retooling or machine changes – resulting in significant time savings. Additionally, 3D printed parts are one single piece and do not require secondary operations, further reducing lead times. For these reasons, 3D printing is a cost-effective option that allows designers to rapidly prototype and test new ideas.
   2. Less Waste: traditional, subtractive manufacturing naturally generates waste since manufacturers start with a large block of raw material and remove material to reach the desired shape and size. For example, during CNC machining the metal waste must be collected, cleaned and recycled, costing OEMs both time and money. Conversely, additive manufacturing methods, such as 3D printing, generate significantly less waste than traditional manufacturing, and in some cases, waste can be entirely eliminated.
   3. More Nimble Production: traditional manufacturing, such as CNC machining or injection molding, requires tooling that is difficult to modify once production is initiated. However, additive manufacturing is able to innovate and tweak designs during the production phase by simply changing the CAD input to accommodate customer feedback or other design improvements – with no tooling changes required. 3D printing also saves OEMs time and money as tooling is typically time-consuming and costly to fabricate.
   4. More Design Flexibility: AM products are 100% customizable. Additive manufacturing provides designers with more creativity and flexibility in part designs in order to experiment with different shapes and weights to address market demands. For example, AM is proving itself an excellent solution for parts used in tight spaces such as airplane cabins that require unique shapes and lighter weights. Additionally, 3D printing is becoming the go-to fabrication method for prosthetics due to its ease of customization and ability to create intricate and complex parts.
   5. Optimized Inventory: additive manufacturing techniques, like 3D printing, allow manufacturers to fabricate parts on-demand rather than stock piling spares in a warehouse – resulting in lower storage, inventory, and transportation costs.

   About ProMed

   For over 30 years, ProMed has specialized in producing small, intricately designed silicone and plastic components, combined with value-added services and subassembly capabilities to support both life-saving and life enhancing devices. In alignment with these focused services, ProMed Pharma provides complete manufacturing, assembly, and testing support for drug delivery and combination devices.

   We work together with our customers from concept to completion by providing design for manufacturability input, material selection, tooling/fixturing, process development, manufacturing and value-added services that result in cost-effective solutions and superior quality.

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

7. Why the Medical Industry Uses Silicones

   August 4, 2021 10:34 am Leave a Comment

   When it comes to material selection, the medical industry is one of the most demanding sectors. Materials employed within healthcare must be durable enough to withstand harsh conditions, resistant to degradation, and, of course, compatible with the human body. Most materials are unable to tolerate medical environments; fortunately, the medical industry can rely on silicones for essential, life-saving devices and products.

    

   Why the Medical Industry Uses Silicones

   Silicones 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. Additionally, medical-grade silicones, such as Liquid Silicone Rubber (LSR), have undergone stringent purity and biocompatibility testing that make them suitable for short and long-term usage.

   Silicone has a unique molecular structure, namely its silicon-oxygen backbone, that results in several excellent properties. The following is a deeper dive into some of these properties, and why the medical industry uses silicones.

   • Superior Biocompatibility: medical devices and products often come in contact with the human body – either externally on a patient’s skin or internally as an implant that contacts tissue and fluids. Materials utilized in these applications are subject to rigorous and extensive biocompatibility testing and must comply with stringent regulations. Simply put, medical grade silicones are unmatched in their biocompatibility, making silicones an excellent option for the medical industry.
   • Withstands Sterilization: medical grade material must be able to withstand sterilization in order to minimize contaminants and the risk of infections. Devices and products made of medical grade silicone are easily sterilized and resist bacteria growth. In fact, medical grade silicones are often processed in special facilities called cleanrooms that reduce the potential for contamination. For example, all of ProMed’s manufacturing facilities are equipped with certified class 10,000 / ISO Class 7 cleanrooms, demonstrating a strong commitment to quality.
   • Chemical Resistance: silicones are resistant to water and many other chemicals. For example, LSR is chemically inert and its biocompatibility is unparalleled, making LSR a great option for medical devices, implantables, and other healthcare applications.
   • Ease of Processing: silicones utilized by the medical industry are easily processed via a variety of manufacturing methods. The 3 most common molding techniques are injection molding, transfer molding, and compression molding. Due to the high volumes required for many medical devices and products, injection molding is often the most cost-effective solution.
   • Conductivity: many materials degrade when exposed to electrical and other environmental stresses over time, however, this is not the case for silicones. Silicones are naturally nonconductive, and are often used in high-voltage and electrical equipment due to its electrical resistance and ability to act as an insulator. However, some medical applications require conductive silicone, which allows electric current to flow through the silicone product. Silicones are able to be formulated as necessary to meet the requisite conductivity demands.
   • Superb Stability: silicone is known for its resistance to UV, weather, and other environmental conditions that tend to age materials, leading to a high level of stability and long-life span for silicone products. These characteristics are critical for a number of medical devices such as implantables.
   • Wide Temperature Range: compared to other materials, silicones, such as LSR, have excellent thermal stability. These blends are able to withstand high temperatures without deforming or melting. As for low temperatures, LSR maintains its flexibility and does not become brittle and vulnerable to breaking like thermoplastic elastomers.

    

   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 have certified class 10,000 / ISO Class 7 cleanrooms.

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

8. The Value of DFM (Design for Manufacturing)

   March 17, 2021 11:52 am Leave a Comment

   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!

9. Top 5 Design Considerations for Medical Injection Molded Parts

   April 11, 2018 8:00 am Leave a Comment

   For medical device OEMs, the design phase is when a general concept and a list of requirements becomes a detailed plan for creating a potentially life-saving product. While there are several fabrication methods available for making medical devices, injection molding continues to be the dominant method. Its advantages of low price per part, high production volumes, compatibility with many different FDA-approved materials, and its ability to maintain tight tolerances, produces consistent results.

   Injection molding is a supremely flexible process, but there are a few constraints and requirements that need to be incorporated into the design of any parts made by that process. For medical injection molded parts in particular, we’ve identified the five most important of these design considerations, which we’ve listed below along with our advice for part design success.

    

   Part Function: What is it Supposed to Do?

   All five of these design considerations are interrelated—design choices in one area constrain your options in the other four—but the primary driver of the part design process is ultimately the intended end-use of the medical injection molded part.

   Are you designing a device meant to remain implanted in a patient for several years, or is the part a knob or button on a monitoring device or life-supporting equipment? Perhaps it’s a patient connected device that is disposable? Each of those uses implies specific operating temperatures, chemical exposure, and applied stresses over the lifetime of a product. Everything from material choice to the shape of the part is determined by this, so having a well-defined list of requirements at the beginning of the design process will not only help your team, but also assist your medical injection molding contract manufacturer with their DFM review and subsequent mold design.

    

   Will the Part Need to be Repeatedly Sterilized or will it be Disposable?

   Single-use products meant to be incinerated give you more leeway with material choice than those that will need to repeatedly withstand the abuse from the sterilization method(s) chosen. Devices that will be steam sterilized will need to be made out of materials that not only have a high melting temperature, but are also highly resistant to both heat and hydrolysis. On the other hand, ethylene oxide (EtO) sterilization requires excellent chemical resistance. UV, gamma, and e-beam methods limit your choices to other materials. Finally, only a handful of niche materials are suitable for devices which could potentially be sterilized by multiple methods over their lifetime.

    

   What will it be Made of?

   From liquid silicone rubber (LSR) and thermoplastic elastomers (TPEs) to polysulfone and PEEK, the choices of rubbers and resins are almost endless. With that wide selection of materials come wide ranges of durometers, opacities, biocompatibilities, lubricities, and resistances to heat, steam, radiation, chemicals, tearing, and wear.

   With overmolding, design engineers aren’t restricted to just one material. A stiff thermoplastic component can be overmolded with soft silicone rubber grip, a popular combination for the product to be mechanically strong yet comfortable to hold.

    

   How Easy is the Part to Actually Mold?

   In order to consistently make high quality parts without exorbitantly expensive revisions, your part design needs to incorporate features such as adequate draft angles, consistent wall thicknesses, and generous radii for perpendicular features such as walls, bosses, and ribs.

   Furthermore, for parts made with thermoplastics, really thick walls should be eliminated via core-outs. This not only helps prevent sink marks and warping, but also reduces the cost per part since less cycle time is required to fill and cool large volumes, not to mention the material cost savings from the reduction in resin used to pack the mold.

    

   Price of the Finished Part

   Ultimately, medical injection molded parts must be price competitive with competing products already on the market, and affordable enough to provide compelling value over the lifetime of the product.

   Closely tied to the price per part, is the production volume expected for the tooling. If you are making millions of parts with a single mold, it’s easier to justify more expensive mold materials (like hardened steel) and features like hot runners for thermoplastic molds and cold decks for LSR.  Multi-cavity molds may require a larger upfront investment, but also pay for themselves in the long run due to time and material savings.

   Having processed many medical injection molded parts from initial concept to finished product, ProMed’s medical device design expertise can help your engineering team avoid common pitfalls, improve your product, and ensure consistent, high quality results.

10. 5 Molding Processes From ProMed Molded Products

    March 28, 2018 10:26 am Leave a Comment

    From surgical instrument handles and catheters, to drug-eluting implants and stents, different jobs require different devices to be made. Different devices in turn, require different fabrication processes. In this article, we’ll discuss five different molding processes within our expertise here at ProMed, and explain the niches that each of them fill.

     

    Silicone Injection Molding

    Liquid Injection Molding (LIM) is a process in which liquid silicone rubber (LSR) is injected into a heated mold under pressure, completely filling the cavity before curing into a solid part which is then ejected from the mold. This process is virtually identical to the injection molding of thermoplastic polymers, except for the fact that LSR is a thermoset polymer. This means that the mold must be heated (not cooled as with thermoplastic resins) so that the mold permanently cures the silicone in a process called vulcanization. Once cured, the part will not melt back into a liquid. This flipping of temperature zones also means that LIM utilizes “cold decks”, not “hot runners” in order to conserve material and reduce cycle times.

    Injection molding is a natural fit for making medical devices out of silicone because LSR’s low viscosity allows the mold cavities to be filled quicker and at lower pressures. LIM’s short molding cycles produce cost-effective parts in medium- or high-volume production runs, making it a popular choice for our OEM customers.

     

    Transfer molding

    Transfer molding is a process that’s similar to injection molding, and uses many of the same elements: a heated mold cavity, sprue channels, and an external actuator that pushes the molten material into the mold. In transfer molding, an open chamber (called the pot) is filled with the material to be molded (which can start as either a solid or liquid). Then, a plunger pushes on this material and squeezes it into the mold, which is connected to the pot via channels.

    Transfer molding typically uses higher pressures than injection molding does to fill the mold. Another difference is the fact that the mold casting material may begin the process as a solid, in contrast to both LIM and thermoplastic injection molding.

    Whereas LIM is the preferred process for LSR, transfer molding (along with compression molding, explained below) is commonly used for a different type of silicone called high consistency rubber (HCR). HCR’s higher viscosity makes that particular silicone unsuitable for injection molding.

     

    Compression molding

    If the pot in the transfer molding process were removed, and the top half of the heated mold took the place of the plunger, the result would be compression molding. Unlike both injection molding and transfer molding where the molded material is forced into the cavity, compression molding forces the heated cavity onto the material.

    Like transfer molding and LIM, thermoset elastomers like silicone are used as the molding material. The heat for the vulcanization is provided by the mold and usually a preheating of the material as well.

    Suitable for high-volume production, compression molding excels at fabricating large parts at low cost and with less waste compared to other methods (as there is no runner system or gates to trim off). One disadvantage of compression molding is that the process doesn’t accommodate undercuts in the parts, as any undercuts make ejecting the cured part very difficult.

     

    Insert Molding & Overmolding

    Parts made by the three molding processes described above need not be a single material all the way through. It’s often very desirable to make a composite product which has a plastic or silicone layer molded over some or all of a piece of a different material. Silicone gripping surfaces on steel surgical instruments are just one example of such overmolding.

    Creating overmolded parts is typically a two-shot (or more) process—essentially a separate molding process for each layer. OEMs must carefully check the material compatibility of the materials they wish to combine because not all combinations of elastomers, thermoplastics, and metals are possible. On the whole, though there are few obstacles, leaving the OEM’s design team’s creativity as the limiting factor.

    Insert molding also involves combining premade parts with molded rubber or plastics, but is a one-shot process. This is because the inserts are usually metal parts like threaded studs, which are machined rather than molded.

    Both overmolding and insert molding are great for joining parts to moldable materials without using adhesives or mechanical fasteners.

     

    RTV Casting

    The last molding process on our list is actually an indirect molding (i.e. casting) process, since it’s a method to make molds that then make the actual parts. With that aside, room temperature vulcanizing (RTV) silicone casting definitely deserves to be on any list of processes applicable to silicone molded medical devices.

    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 (e.g. zinc and pewter), epoxies, waxes, and gypsum—all without needing a mold release agent.

    The team at ProMed specializes in molding medical devices, including the five methods we touched on here. Whether you’re in the market for micro-molded implantable devices, or an RTV casting for new design concept, the professionals at ProMed have you covered.

11. Injection Molding and Its Application to Drug Delivery

    February 28, 2018 7:02 am Leave a Comment

    Injection molding, a manufacturing method used for making everything from car parts to kids’ toys, is also utilized to make life-saving medical devices, including those inserted or implanted into patients’ bodies. Catheters, balloons, and feeding tubes are all made possible and affordable when biocompatible materials combine with injection molding.

    As we have discussed before in an earlier article, the material of choice for implantable medical devices is often medical grade silicone. Its range of available durometers, extreme chemical inertness and biocompatibility, excellent tear and heat resistance make it ideal for parts that need to remain in the human body for extended periods of time.

    Furthermore, the low viscosity of liquid silicone rubber (LSR) make that elastomer ideal for injection molding (and therefore mass producing) implantable medical devices, making life-saving advances in medical technology more affordable for patients.

    Polymers Delivering Doses: Drug-Eluting Implantable Devices

    But those advances don’t stop with opening up arteries or providing ports into and out of the body. Increasingly, injection molded implantable medical devices are being used to deliver steady, long-term doses of hormones, cancer drugs and other active pharmaceutical agents (APIs). Injection molding of medical devices is extending its impact into drug delivery.

    Drug-eluting medical implants offer several advantages over both pills and injections when it comes to drug delivery. Perhaps the most important clinical benefit is the larger amount of time the API dose is within therapeutic window—the range of concentrations within the body low enough not to be toxic, but high enough to be effective. Both pills and injections produce API concentrations that rapidly rise and then exponentially decay as the body dilutes, metabolizes, and/or excretes the pharmaceutical compounds. By contrast, drug-eluting implants can slowly and steadily release the API at a controllable, optimal rate within the therapeutic window.

    These implants are able to do so because the matrix of the device is loaded with the API before they are molded. Silicones, because of the relatively low temperatures at which they can be injection molded and vulcanized and their ability to be compounded with various APIs, are optimal for this application because the injection molding process is less likely to degrade the drug.

    Molded medical implants can also provide site specific administration of a drug, and therefore achieve local concentrations of an API that would be above the therapeutic window if present systematically. This enables lower total doses, reduces side effects, and has a greater therapeutic effect.

    A third benefit of drug delivery via an implantable device is much greater patient compliance. Since the implant can continually release the drug within the body for several months, there are no daily doses for the patient to forget.

    Peering Beyond Silicone

    Even as medical grade silicone finds wide use in drug-eluting implantable devices, an exciting new frontier is opening up: expanding beyond silicone into synthetic biodegradable polymers. Such polymers open the door to drug-eluting implants which slowly and safely dissolve away inside the patient’s body, releasing the loaded therapeutic as they do so. These implants don’t need to be removed at the end of the treatment period. Another benefit is the potential to slowly release difficult to deliver API’s, because the therapeutic is released as the polymer encasing the API particles dissolves away, much like an oral pill. This results in steady release rate over time even for these difficult molecules.

    Although this new breed of drug-eluting implants won’t be made with silicone, they in all likelihood will still be made via injection molding. Although technical questions still remain—like which polymers in this class have low enough melting points to be molded without significantly degrading any compounded API—injection molding’s ability to produce high volumes at low price per part while at the same time maintaining tight dimensional tolerances, will surely play a key role in this new drug delivery technology.

12. Thermoplastic & Silicone Use for Medical Molded Components

    February 5, 2018 7:36 am Leave a Comment

    High quality medical components—whether for implants, instruments, or IV bags—must be safe and durable, because lives literally depend on them. Low toxicity, high biocompatibility, chemical inertness, and the ability to repeatedly withstand sterilization environments (like gamma rays, steam, or EtO) are all requirements of the materials that long-life medical components are made of. The ability to safely reuse the same medical devices reduces the cost of medical care, while re-use procedures put in place protect not only the healthcare professional, but also the patient’s health and safety.

    For disposable, single-use medical parts where repeated sterilization isn’t a requirement, the toxicity and biocompatibility requirements, however, still apply. In addition, those single-use parts must be cost-effective for the manufacturer and affordable for the consumer.

    For both categories of medical components, plastics and elastomers (rubbers) are the materials of choice. Since medical grade thermoplastics (which harden when cooled down to near ambient temperature) and silicones (like LSR which permanently sets when heated) have a lot to offer designers of new molded medical components, we’ll be discussing them in this post.

     

    Silicone: Safe and Versatile

    Let’s begin with silicone, which has many chemical and mechanical properties well suited for medical molded components:

    Very chemically inert: Medical grade silicone resists attack from disinfecting chemicals and biochemical interaction. Medical grade silicones have excellent biocompatibility.

    Strong, flexible, and durable: Silicones have high tear and tensile strength, great elongation, and low compression set, even over a wide temperature range. They’re high elasticity and flexibility is a great match for applications such as feeding tubes and seals for peristaltic IV drug delivery pumps.

    Sticky when it needs to be: Although silicone has a low surface energy (and is thus used in applications that need to repel liquids), there are formulations of Liquid Silicone Rubber (LSR) that are self-adhesive and can stick to other plastics without priming. Overmolding silicone to specific thermoplastics is a common occurrence for durable medical devices that need extra grip capabilities for the doctor/nurse.

    Silicone is permeable and thus makes a great matrix for pharmaceutical delivery in drug-eluting implants.

    Wide range of available durometers: from 0 Shore A to 80 Shore A. This customizability makes it great for applications like clinical and surgical instrument grips, gaskets and o-ring seals.

     

    There’s a Great (Medical) Future in Plastics

    All of these features are why medical grade silicones have been widely used for decades, and will continue to be considered, in spite of LSR’s higher cost compared to some other resins.

    But they are not the only game in town when it comes to molded medical components. Thermoplastics are also popular choices, especially for niche use. With so many different polymers (and varying molecular weights of each polymer), this family of plastics exhibits a wide gamut of thermal, chemical, and mechanical properties. A few of these are worth mentioning here:

    Polysulfone (PS): This thermoplastic elastomer (TPE) has excellent resistance to both hydrolysis and heat, and thus can be sterilized by steam and autoclaving. PS has great biocompatibility, and can be thermoformed by injection molding and extruding.

    Polyether ether ketone (PEEK): PEEK maintains its excellent chemical resistance and mechanical stability at high temperatures (and thus can be sterilized by heat and disinfected by chemical agents). Like both silicone and PS, PEEK can be molded, albeit at very high temperatures (PEEK melts at about 343°C). Since PEEK resists biodegradation, it’s a good candidate for implantable medical devices.

    Medical device OEM’s can choose from many polymers for their next innovative, life-saving product. Although silicones continue to dominate (particularly in implantable devices), some thermoplastics have long been chosen for use in healthcare.

    ProMed’s extensive LSR and thermoplastic expertise and manufacturing capabilities can take your molded medical product from concept to completion, just as we have for so many other global OEMs.