Quality Considerations for Medical Silicone Injection Molding

Simply put: quality matters most in silicone injection molding. Inconsistency and poor quality can lead to 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! OEMs that supply medical parts and devices to the healthcare industry simply cannot afford to cut corners when it comes to quality.

The key quality consideration for OEMs is your molding partner. Not all manufacturers produce quality products, and quality assurance and control are areas where excellent injection molders stand out from the competition! 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. An 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 silicone 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. When assessing a potential molding partner, OEMs should consider the following about their project and the supplier being evaluated:

  • What inspections and standards does my product have to meet?
  • What certifications and compliances such as ISO, FDA, and REACH does the supplier have?
  • Does the supplier have experience manufacturing products for my industry and have they been recognized?
  • Does the supplier utilize the latest quality software and automated machine technologies?
  • What is the supplier’s quality track record and the typical level of rework due to quality issues?
  • What is the supplier’s preventative maintenance plan for your injection mold?

Raw material selection is another quality consideration. Due to its chemical inertness, durability, stability, and low toxicity, medical grade silicone is an excellent raw material for implantable and other medical devices. Medical grade silicones are known for their quality and are often specified by OEMs.

Utilizing advanced technologies and cleanrooms are also quality considerations for medical silicone injection molding. Cleanrooms control contaminants and air quality, and are essential to manufacturing high quality medical products. Maintaining and operating a cleanroom environment to ISO standards requires excellent processes and procedures. Cleanroom processing includes raw material handling as well as packaging to avoid particulates and other forms of contamination during these steps. Use of advanced and automated technologies during processing can also enhance quality. For example, computer-controlled programs can automate various operations such as measuring, mixing, and sampling to improve batch consistency as well as repeatability from batch to batch.

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

About ProMed

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 how we can help with your next silicone injection molding project!


Why Value-Added Operations Make Sense

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

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

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

Why Value-Added Operations Make Sense

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

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

ProMed’s Value-Added Operations

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

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

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

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

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


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

What are Active Implantable Devices?

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

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

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

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

Recent Advances in Active Implantable Devices

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

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

Forecasting the AIMD Market into 2025 and Beyond

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

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

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

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

ProMed’s Capabilities

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

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

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

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


Best Practices for HCR Injection Molding

What is High-Consistency Rubber (HCR)?

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

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

Best Practices for HCR Injection Molding

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

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

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

ProMed’s HCR Processing Capabilities

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

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

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

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


Combining the Power of Medical Devices and Drug-Eluting Products

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

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

Benefits and Examples of Drug-Eluting Medical Devices

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

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

Recent Advances in Drug-Eluting Devices

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

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

ProMed Pharma’s Capabilities

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

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

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

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


ProMed pharma 2019

The Development of Novel Sustained Release Drug Implants

Medical implants are devices that are placed on the inside or surface of the body with the purpose of delivering medication, monitoring body conditions, or supporting organ health. When most people think of implantables, they think of drug pumps used to deliver insulin in the treatment of diabetics. This form of implantables are typically programmable “active” devices which require regular resupply of the medication through an access port.

Another type of implant is a drug delivery device that, when placed inside the body, releases drugs at a defined rate and for a defined period. These technologies enable the sustained release of drugs through a small non-mechanical subcutaneous implant device, and provide long-term, “passive” release without the need for replenishment. Typically found as thin flexible rods, these delivery systems are particularly effective for the delivery of highly potent drugs such as hormones. Commercial examples include implants for contraception and the treatment of prostate cancer. One significant advance in recent years is the addition of sustained release drug implants that dissolve over time and do not require removal of the implant – reducing the number of procedures required and the potential for complications such as infections.

Benefits of Sustained Release Drug Implants

For over a decade there has been an increasing convergence between implantable devices and drug therapies, including devices that deliver drugs. Sustained release drug implants offer several advantages over conventional drug delivery options. First, implantable devices allow targeted, localized therapy where the drug is most needed. This may also allow for significantly lower doses of a drug which can minimize potential side effects and reduce the impact on the kidneys and liver. Second, implantable devices allow for sustained release of a therapeutic agent. Both pills and injections produce Active Pharmaceuticals Ingredient (API) concentrations that rapidly rise and then exponentially decay as the body dilutes, metabolizes, and/or excretes the pharmaceutical compounds. By contrast, sustained release drug implants can slowly and steadily release the API at a controllable, optimal rate within the therapeutic window. The last and perhaps most important advantage is patient compliance, as the treatment regimen associated with an implantable device is generally less burdensome than pills or injections, and patients won’t forget to administer the medication. These implants offer prolonged delivery of treatment ranging from weeks to years.

Materials for Sustained Release Drug Implants

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.

As you would expect, there are key material considerations for products used in drug delivery such as biocompatibility, the ability of the material to control release of the API, stability, durability, and the ability to naturally degrade over time if necessary.

Medical grade silicones have long been a material of choice for drug delivery given their 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. Ethylene vinyl acetate (EVA), polyurethanes and acrylate hydrogels have also been utilized in select applications. Another option is to use a biodegradable material such as poly(lactic-co-glycolic acid), or PLGA, to controllable release the drug while essentially “dissolving away” by hydrolysis. While new material development for drug delivery remains an active field of research, injection molding is expected to continue to play a significant role in the manufacturing of drug delivery devices due to its ability to produce high volumes at low prices while meeting tight dimensional tolerances.

Recent Innovations in Sustained Release Drug Delivery Devices

The development of novel sustained release drug implants is an area of significant research and advances in recent years. Below are a few notable innovations that give a glimpse into the future of this exciting and relatively new field.

  • Contraception has long been an area where implantable devices have been utilized. Recently, a grant was awarded to Inflammasome Therapeutics for the development of a long-term bioerodible birth control implant. After being implanted under the skin, the device will provide a constant and consistent low plasma level of the hormone levonorgestrel for a period of up to 2 years at which point it will fully dissolve and require no removal. This is a huge step as current contraception implantables require removal. This form of treatment is expected to be extended to other disease treatments sch as HIV and arthritis.
  • A huge area for research and development is nanomedicine, which entails targeted drug delivery in which particles attracted to disease cells directly treat those cells. For example, scientists at Houston Methodist Research Institute recently successfully delivered long-term medications via a nanochannel delivery system (nDS) implanted under the skin. The implant is remotely controlled using Bluetooth technology. Researchers are hopeful that these devices can allow for remote patient care and lower healthcare costs. Additionally, this technology would allow for patient treatment during off hours, such as at night, when some treatments are proven to be more effective.
  • Researchers recently created a new type of coating for drug delivery that can be activated externally, specifically with infrared radiation (IR). The coating is considered a hybrid stimulus-responsive system that will allow for more on-demand, localized treatment of a given area with sustained release drugs.

ProMed’s Implant Molding Capabilities

ProMed understands the importance of quality to your success, especially when it comes to implants. We have a history of manufacturing drug delivery products, which means we have the experience as well as robust systems and processes in place to handle your specific project needs! Our work has historically focused on molding silicone drug delivery devices using injection and compression molding techniques. In some cases, co-extrusion or over molding of a thin, drug-free layer has been used to enable more uniform release of drug from the implant.

We have a well-established pallet of durable and biodegradable polymeric materials that provide options for delivery of potent compounds such as hormones, opioids, antibiotics, and oncology drugs. 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.


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.


Top 3 Qualities to Look for When Choosing a Contract Manufacturer

When OEMs are looking to outsource production to a contract manufacturer (CM), they need to accomplish several goals:

  • Ensure a smooth transfer of production operations, including documentation, raw material, parts, and fixtures.
  • Achieve a shorter time to market than can be achieved by keeping procurement, inventory management, assembly, testing, packaging, and distribution in-house.
  • Continue to provide the technical assistance needed to help resolve any production or supply chain issues.

To those ends, OEMs should focus on a few key aspects of any potential CM partner as they whittle down all the competing firms in their search. Just as there are many different types of OEMs and original device manufacturers (ODMs), there are plenty of CMs. . .but not all of them are a good fit for your product, size, or industry. We’ve compiled a short list of the most important qualities OEMs should look for in order to select the best CM for them.

Expertise in the Materials and Processes Most Applicable to Your Product and Industry

A CM’s expertise is valuable for more than design for manufacturing (DFM) reviews during prototyping and before high-volume production. Production execution also requires automation, materials, and process knowledge, even if the best fabrication method or material grade is chosen.

A prime example of this is the choice of materials in silicone molded medical devices. Liquid silicone rubber (LSR) has been displacing high consistency rubber (HCR) as the preferred material for years. HCR, however may still be an OEM’s best choice in some cases, as the cost and performance tradeoffs between the two materials vary depending on the specific requirements of the product design. OEMs must face similar choices when it comes to deciding between medical-grade silicone rubbers and thermoplastic resins.

A CM which specializes in silicone molding can provide both general guidance and specific recommendations—backed by engineering data and lessons learned from previous projects.

The value of a CM’s expertise extends beyond material selection. Manufacturing is about much more than “what” (i.e. the materials) is used to make a product. The processes that make that product—the “how” –is just as important.

For injection molding production lines which must pass process validation for regulatory approval and which must remain under control, the scientific injection molding process is vital for determining the optimal molding process parameters. Besides helping to satisfy regulatory requirements, scientific injection molding also increases production efficiency and thereby lowers the cost per part.

And now to “where”. Medical devices are also increasingly manufactured in cleanroom facilities. Medical device OEMs therefore need CMs with cleanroom manufacturing facilities and the associated gowning procedures, material control, and air handling infrastructure in place.

Finally, we cannot mention medical device manufacturing without discussing the training, documentation, testing, inspection, validation and other processes necessary to achieve regulatory approval. A medical device CM must have a quality management system (QMS) which is compliant with at least FDA medical device requirements (and usually also ISO 13485). Just as important as satisfying current regulations is keeping in step with new ones, given how the FDA is attempting to keep up with new advances in the industry.

Necessary Production Capacity

To avoid the inconvenience of selecting, qualifying, and investing in a CM only to have to repeat the process all over again when production requirements outgrow the CM’s capacity, OEMs need to have a realistic estimate of the expected demand for their product over its lifetime, and they also need to verify if a potential CM can match that expected demand before that CM is chosen.

Here are some questions OEMs should ask:

  • How much floor space does your manufacturing facility have?
  • How many facilities will be involved in this project?
  • What is the staffing level at your facility (i.e. how many employees)?
  • How much warehouse space do you have for parts and finished goods inventory?
  • Do you have the shop floor space available for another production line if necessary?
  • Does your proposed production line or automated workcell have any reserve capacity to accommodate drastically increased production requirements in the future?

By asking the right questions, OEMs can avoid the costly mistake of outgrowing their CM.

Location That Aligns with Your Logistics Needs

With the emergence of “full-service” CMs, logistical concerns are becoming almost as important as production ones. Take location, for instance: the central United States is good for linking domestic suppliers, production, and customers in a tight, responsive supply chain. As an added bonus, there are no delays at customs or tariffs to worry about. The same cannot be said for supposedly cheaper overseas factories.

Another location advantage that a given CM can bring to the table is proximity to multiple transportation hubs (e.g. shipping ports, rail lines, highways, and major airports). From expediting urgent shipments via next-day air to facilitating continent-wide distribution, location can be almost as vital in logistics as it is in real estate.

As a premier contract manufacturer of molded medical devices, ProMed’s focus, expertise and passion lies in silicone molding, particularly LSR injection molding. With our large manufacturing facilities based in Minnesota and a talented team who can take a new design from concept to completion, ProMed continues to win the business and accolades of medical device OEMs.

What can we mold for you?


Prototype Advancements for Innovative Medical Device Designs. ProMed Molding

Prototype Advancements for Innovative Medical Device Designs

Prototyping new product designs will always be necessary in the medical device industry.

Computer simulation of a device’s mechanical performance has come a long way, but simulation doesn’t reveal everything. For starters, users need a physical prototype in order to give feedback. They must physically hold or interact with device in order to provide the subjective (but nonetheless invaluable) insights which are useful for refining the appearance or even the function of a new medical device. Prototypes are also necessary for validating the manufacturing capabilities of a production line—a regulatory requirement. Lastly, making, testing, and examining prototypes can help an OEM identify unknown issues that weren’t caught in the digital model of the design.

Prototyping then plays a pivotal role in moving innovative medical device concepts from the idea stage to the marketplace. Those innovative concepts in turn require modernizations in prototyping technology and materials. Let’s explore a few of these innovations.

Smart polymers

One material advance that medical device prototypes are incorporating is smart polymers. What makes these polymers “smart” is their ability to change their shape, electrical conductivity, size, or other characteristic in response to stimuli like light, pH change, or temperature. Currently, the use of smart polymers is limited to targeted drug delivery, but future medical devices like wearables could leverage them as sensors for personalized and preventive healthcare.

Online Quotes and Ordering

Advances in CAD/CAM software are largely responsible for a recent process innovation when it comes to prototyping: rapid prototype price quoting and ordering. By uploading the digital files and material requirements of a new design, OEMs can hand off all the information that the CM engineer needs, to quickly review the requirements and estimate a price.

The speed and ease of this process for OEMs allows them to submit prototype designs for quote to many CMs, enabling them to “shop around” in a completely digital way. Besides helping them find the best price, the material, dimensional, and surface capabilities of multiple prototyping vendors can all be compared, helping the OEM make an informed decision quickly. In turn, the total turnaround time for an OEM to receive those prototype parts also drastically shortens, leading to faster design iterations and a better final design before high volume production begins.

Additive Manufacturing (3D Printing)

Additive manufacturing (better known as 3D printing) refers to a slew of different fabrication technologies well-suited for low-volume manufacturing, including producing prototypes. Due to the fact that the 3D printing of medical device prototypes is still relatively new, there is a lot of research and development activity in new materials, processes, and process improvements. Medical devices pile on their own challenges: biocompatibility, more stringent safety requirements, and in some cases the need to withstand repeated sterilization.

Despite these challenges and often conflicting requirements, the medical device 3D printing market’s value was estimated to be $750 million in 2016 and is expected to grow 17.5% from 2017 to 2025. As existing heavyweights in the general 3D printing industry continue to market their offerings even more into the medical device industry, the unique benefits of 3D printed prototypes will continue to unlock novel, innovative products and therapies. From 3D printed jawbones to titanium spinal implants, additive manufacturing already is a key enabler of medical device innovation.

The key 3D printing technologies to keep an eye on are:

  • FDM (Fused Deposition Modeling): A molten material (usually thermoplastic resin) is extruded into a very fine thread which is then laid down in successive layers, building up the part.
  • Stereolithography: Short wavelength (e.g. blue or UV) light selectively illuminates a pool of photopolymerizing resin from the bottom, causing each layer of the part to solidify as it is drawn up and out of tank.
  • Metal Laser Sintering: A very intense laser beam is directed at a bed of metal powder. The high power of the beam rapidly heats the powder, causing the metal grains to fuse. By fusing layers and layers of metal powder, a complete 3D object is fabricated.

One hurdle FDM, stereolithography, and other additive manufacturing technologies will have to clear is reliably making parts out of silicone rubber—a dominant material in medical devices, especially implantables. Current elastomeric materials commercially available for 3D printing don’t match true silicone rubber’s mechanical properties. This is a major reason why ProMed’s rapid prototyping service uses aluminum injection molds and real, production-grade liquid silicone rubber (LSR) –the close match between the performance of the prototypes and that of production parts adds tremendous value to engineers developing their next new design.

The materials and methods used to create prototypes of tomorrow’s medical devices are advancing rapidly and in many directions. These advances push medicine and healthcare forward by providing a steady stream of new solutions for the problems patients face.

By keeping up with the latest medical device prototyping and production innovations, ProMed is able to remain the leader in medical silicone molding.

Our rapid tooling capabilities and quick quote turnaround time save both the time and money of our customers, helping them launch new medical innovations into the marketplace faster. What breakthrough are you trying to bring to the market?