Liquid Silicone Rubber

2019 & Beyond - What the LSR Material Market is Predicting

What is LSR?

Liquid Silicone Rubber (LSR) is aplatinum-cured elastomer that can be injected into a mold cavity to manufacture a part. LSR starts out as a 2-part liquid that cures into a solid form when mixed together. LSR is a versatile rubber in the elastomer industry and has a wide range of end-uses 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, microwaves, seals, and grommets.

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.

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.

LSR MarketPredictions through 2026

The LSR market is forecasted to steadily grow over the next 5-10 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. (Note: CAGR is considered a good measure of an investment’s return over time compared to annual return figures that do not account for compounding).

This growth is attributed to several factors. First, enhancements to the physical properties of LSR is 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.

LSR growth 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.  The industries that are expected to demonstrate the highest demand for LSR are medical and automotive.

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. In addition, replacement of latex with LSR in impactable devices is expected to provide new opportunities for LSR applications.

The LSR market is segmented across five regions: Asia Pacific, North America, Europe, Latin America, and the Middle East & Africa (MEA). Among these, Asia Pacific is expected to continue as the largest marketplace for LSR, estimated at 35% of global market share, due to demand for the product in electrical & electronics and medical applications. Other factors contributing to the market growth are the easy access to raw material and favorable government policies. China and India are the strongest country-based markets in the Asia-Pacific region since distribution networks are well established and many LSR players have a strong presence in these countries.

The North America market, the United States in particular, is also forecasted to grow due to increasing usage of LSR in the electronics industry as well asincreased expenditures on, and technological advances of, medical devices. Europe is also forecasted to grow LSR demand due to growing demand for lightweight material in the automobile sector. Additionally, multinational companies are focusing on collaboration,and perhaps even joint ventures, with distributors to achieve sustainable growth. The Latin America and MEA regions are also expected to observe LSR market growth due to increasing demand for growing usage of LSR in consumer goods and healthcare industries.

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 moderate growth across all 5 regions as LSR usage expands to even more markets.

Contact ProMed today at 763-331-3800 to find a solution to your medical molding needs.

Medical-Grade Liquid Silicone Rubber

The Importance of Medical-Grade Liquid Silicone Rubber

Medical-grade Liquid Silicone Rubber (LSR) is becoming increasingly crucial to the medical device industry, as the combination of the general benefits of medical-grade silicones combine with LSR’s unique advantages for medical device OEMs. As new medical-grade LSR materials become commercially available, more reliable, better performing, and more affordable medical devices will be within reach of patients.

Medical-Grade Silicones

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, biocompatibility, and compatibility with many sterilization methods.

Medical-grade silicones add the benefits of stringent purity and biocompatibility testing, making them suitable for use in long-term implants.

One application where medical-grade silicones really shine is drug-eluting implantable devices. Before molding, silicones can be compounded with active pharmaceutical ingredients (APIs) such as cancer drugs or hormones which can 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 (the range of concentrations between too low to be effective and high enough to be toxic) for a much longer duration.

As we’ll see shortly, medical-grade LSR is a great material for making drug-eluting implants, due to its processing advantages.

The Advantages of LSR

LSR is a type of silicone material which starts out as two separate liquid components which are then precisely mixed together before injection into a heated mold, where the silicone elastomer becomes solid (i.e. vulcanizes).

The low viscosity of LSR makes it a great silicone material for making parts 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.

LSR’s inherent compatibility with injection molding results in the cost-effective, repeatable, and scalable manufacture of silicone parts—including medical devices and their components.

Furthermore, the temperatures needed to vulcanize LSR are usually low enough that significant degradation of compounded substances like APIs can be avoided. Thus, medical-grade LSR an excellent material for drug-eluting implants.

Implantables aren’t the only medical device application suitable for medical-grade LSR. Wearables (such as heart rate and activity monitors), respiratory products, linings for prosthetic limbs, and other devices which must stay in prolonged physical contact with a patient all benefit from medical-grade LSR’s outstanding biocompatibility and purity.

The Future of Medical-Grade LSRs

New and improved medical devices originate from innovations in both design and materials. As new medical-grade LSRs continue to be released on the market, the medical device industry as a whole will make steady advances and improve the length and quality of life of patients around the world.

Dow Corning’s release earlier this year of two new LSRs is a prime example. These new LSR materials cure quickly at low temperatures, don’t require a primer for binding to many substrates (including polyester), need low injection pressures, and boast broad process windows.

These are all significant features for the medical device industry for the following reasons:

  • Fast cure times at low vulcanizing temperatures enable silicone injection molders to shorten the total molding cycle time (which in turn can greatly reduce the cost per molded part), and consume less energy for each silicone part since the mold will not need to heated as much as other LSRs may require. Both of these result in reduce production costs for medical-grade LSR products, and consequently, lower costs for the patients and insurance companies to purchase these products.
  • The lower injection pressures of these LSRs will allow silicone medical device manufacturers to utilize more economical, lower tonnage injection presses. These LSRs’ broad process windows can enable lower defect and scrap rates, due to a more forgiving molding process.

New medical-grade LSRs, like these from Dow Corning, will help the whole medical device supply chain ramp up production capacity to meet global demand.

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. Contact us to find out how we can help you.

Thermoplastic & Silicone Use for Medical Molded Components

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.

Rubber & Plastics News Article “ProMed Succeeds with Rapid Prototyping”

Promed Prototypes

"ProMed has recently added rapid prototyping capabilities, fulfilling an industry need for fast turnaround of sample parts made from specified material." Read Article

Plastics Today Article "ProMed Prototypes Offer Fast Turnaround on Silicone Molded Parts"

ProMed Prototypes has been published in a national article which can be found at Plastics Today.

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