injection molded products, silicone manufacturing, molded products

Applications of Biomaterial Grade Injection Molded Products

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. One category of materials that continues to gain traction in silicone manufacturing is biomaterials.

At ProMed, we have extensive experience with biomaterial grade injection molded products. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and biomaterial 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. Our ProMed Molded Products division specializes in the molding of silicone and biomaterial grade plastic components , sub-assemblies, and assemblies.

What Are Biomaterials?

Biomaterials are an area of great innovation within the medical industry, and this sector continues to evolve over time. Initially, molded products made of biomaterials were focused on doing no harm to the patient, and thus, caused no injuries or toxic effects to the patient. As biomaterials advanced, the focus shifted to being a material that is responsive and interactive with local biological conditions. Biomaterials are now defined as “material intended to interface with biological systems to evaluate, treat, augment, or replace any tissue, organ, or function of the body”. For example, if we consider implantable devices, traditional implantables were designed with inert biomaterials that “did no harm” when placed inside the body. However, implantables of today are often focused on interacting and integrating with the biological environment inside the body – and in some cases even biodegrading, or bioabsorbing, over time.

Have a medical project that would benefit from a biomaterial grade injection molded product?

Contact the team at ProMed to learn more about our advanced facilities and range of silicone manufacturing solutions.

Applications of Biomaterial Grade Injection Molded Products

In the early days of biomaterials in silicone manufacturing, it was challenging to find many applications of injection molded products. However, as innovations were made and companies gained more experience with these materials, biomaterial grade injection molded products are finding a broader range of uses and play a crucial part in biomedical applications. Today’s biomaterials are easily incorporated into existing injection molding processes as no additional equipment is needed to manufacture these materials. Biomaterials include polymers, natural rubbers, polyurethanes, and silicone rubbers. Silicones are a common biomaterial used for injection molded products for the medical sector due to its attractive properties. Silicone offers excellent biocompatibility, chemical resistance, and stability. Silicones also offer a wide range of operating temperatures, are easily sterilized, and are a great choice for injection molding.

Biomaterials serve an important role in biomedical applications. Below are some applications of biomaterial grade injection molded products.

  • Cardiovascular devices: biomaterials are used in a wide range of cardiovascular products including vascular grafts, heart valves, pacemaker leads, artificial heart and ventricular assist device components, stents, balloons, and blood substitutes.
  • Orthopedics: biomaterials are used in various applications to treat musculoskeletal issues including joint replacements, bone defect fillers, fracture fixation plates, and artificial tendons and ligaments.
  • Ophthalmic: biomaterials are integrated into existing treatments for the eyes such as contact lenses, corneal implants and artificial corneas, and intraocular lenses.
  • Drug delivery: biomaterials are used in controlled and targeted drug-delivery systems, and have revolutionized this form of treatment.
  • Spinal implants: biomaterials are becoming an alternative to traditional spinal implants made of titanium, stainless steel or cobalt-chromium. For example, biomaterials are used to fill in the disc space in the spine to treat disc degeneration issues.
  • Soft tissue repair/replacement: biodegradable biomaterials are being considered for tissue engineering and soft tissue repair, such as burn and wound dressings and artificial skin. Researchers on focused on controlling the rate of degrading within the boy as well as the mechanical properties of the material. Bone repairs with biomaterials is also being studied.
  • Gene therapy: there is a great deal of potential in using biomaterials for gene therapy and thus, research is on-going in this area. Biomaterials would be used to carry and target treatment for certain genes within a patient.
  • Miscellaneous: there are several other applications for biomaterial grade injection molded products including dental implants, cochlear implants, urologic implants, and sutures.

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 biomaterial grade injection molding project.


Why A Skilled Injection Molding Partner Matters

There are many factors to consider when choosing an injection molding partner. One area to examine is the skill of the molding partner. This may seem like an obvious consideration but it is crucial that OEMs consider the breadth and depth of capabilities of any molding partner being considered.

Simply put, the skill and capabilities of an injection molding partner matters as not all manufacturers are equipped to offer the same solutions. For this reason, OEMs must partner with a manufacturer, like ProMed, that has the proven experience, facilities, and know-how to safely and successfully complete injection molding projects. Below are some of the benefits of working with a skilled injection molding partner, and why skill matters. It should be noted that all of the advantages below lead to more cost-effective solutions and higher levels of customer satisfaction.

  • Broad Material Options: some injection molders specialize in specific material types, so it’s important to know what your potential partner is capable of, and also what they specialize in. It is crucial that OEMs team up with a proven partner, like ProMed, who has experience with a diverse range of materials and will guide you through the selection process to ensure the right material is chosen to achieve the desired final product properties, such as strength, flexibility, and biocompatibility.
  • Able to Achieve Specifications: most OEMs have unique and specific product specifications and it is important that molding partners understand and are able to comply with those specifications. In nearly every case, a skilled injection molding partner can manufacture your part without significant specification sacrifices. Partners should readily collaborate with OEMs, providing alternatives to specification challenges as well as design suggestions to save time and money. If this collaboration is not happening, you have not found the right molding partner.
  • Superb Quality: partnering with a skilled injection molder ensures the necessary production planning occurs in order to meet the requisite regulatory, quality, and commercial standards. The ProMed work force is highly specialized in the manufacturing and quality requirements of medical products. We are an approved, certified supplier to many of the top medical device manufacturers in the world. Click here to learn more about our commitment to quality as well as our ISO clean rooms and various certifications.

Looking for a skilled molding partner that consistently delivers high-quality products?
Contact the ProMed team today to discuss our injection molding solutions.

  • Advanced Molding Technologies: a skilled injection molding partner not only has a proven team of professionals, but also employs state-of-the-art technologies. At ProMed, we utilize 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.
  • Future Growth Opportunities: as noted, not all injection molding partners offer the same solutions – and what you need today may not be what you need tomorrow. Skilled injection molding companies with a broad range of capabilities and offerings are better positioned to provide support as your business evolves and grows over time.

ProMed 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 and have extensive experience in a wide range of 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 design your next molded project for success.


Why the Medical Industry Uses Silicones

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.


How Long Do Injection Molds Last?

One of the primary costs of an injection molding project is the tooling. Given the size of the initial investment in the injection mold, OEMs want the mold to last as long as possible and often wonder how long the mold will last. It is important to understand that the lifetime of injection molds is typically measured in production cycles as opposed to time. This approach allows OEMs to determine when the initial tooling cost will be paid off, and if the cost of the tooling is justified based on the number of parts the mold is expected to manufacture.

There are several factors that play a part in injection mold longevity. One key design criteria that predicts tooling life span is mold class, which is indicative of the life expectancy of the mold based on the number of cycles it is designed for.

What is Tooling Mold Class?

The tooling mold class as defined by the Plastics Industry Association sets standards on the physical tool construction and life expectancy. To determine which mold class to proceed with, designers often start with the desired life expectancy and the tool material. For example, if the project has a short life expectancy with a commodity grade material or an engineered grade that is not abrasive, designers can likely start at Class 105 or “prototyping” mold class. As expected, the more cycles required of tooling, the more robust the mold must be, thus, driving up the overall tooling cost. By selecting the appropriate mold class for your application, you can save a significant amount of costs by not over-engineering the tool. Below are descriptions of different mold classes. It should be noted that the following are only general guidelines and OEMs should consult with a trusted injection molding partner, like ProMed, to ensure the right design criteria, including mold class, are selected for your specific project.

  • Mold Class 101: this class is for high volumes and is rated for 1,000,000+ cycles. These molds typically operate with very fast cycle times. Due to the high-volume requirements, these molds are made with the highest quality materials and are the most expensive. These molds can tolerate harsh materials and operating conditions, and are able to achieve tight tolerances.
  • Mold Class 102: this class is rated for no more than one million cycles. This tool is for medium to high volume production and is usually a good option for abrasive materials as well as close tolerance products.
  • Mold Class 103: this mold class is rated for under 500,000 cycles. This is a common mold for low to medium volume production.
  • Mold Class 104: this mold class is rated for under 100,000 Cycles. This tooling is a good option for lower production volumes with non-abrasive materials.
  • Mold Class 105: this class is rated for no more than 500 cycles and is typically for prototype purposes. This tooling is the least expensive.

What Impacts Mold Longevity?

Although mold class is a good basis for designing tooling longevity, there is no method to determine exactly how many cycles a mold will last. However, the factors below each impact the life span of a mold and the life can be maximized for molds that are well cared for.

  • Materials – the life span of an injection mold is significantly impacted by the material of the injection molded products as well as the material of the tooling itself. Molds made of a softer metal, like aluminum, do not generally last as long as harder metal molds such as stainless steel. As for the silicone blend being molded, some formulations contain abrasive or corrosive ingredients, which can wear down the tooling and decrease the life span.
  • Conditions – injection molding manufacturing occurs under a range of operating conditions and some environments are tougher on equipment than others. Additionally, cleanliness and the likelihood for contaminants such as moisture, dust, and debris also impact the life cycle of tooling.
  • Length of Cycles – As a rule of thumb, injection molds tend to last longer when they operate under longer cycle times compared to high-speed production cycles.
  • Proper Maintenance – this is one of the key elements that impact tooling life span yet it is often overlooked. Preventative maintenance and the associated inspections are vital to maximizing the life of injection molds.

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 Medical Device Trends in 2021

Medical devices are constantly evolving in order to identify and treat medical conditions more efficiently and effectively. The trend toward digital, remote technologies was well underway before Covid-19, but the pandemic significantly increased the demand for remote patient monitoring and care. For these reasons, there have been significant advancements in telemedicine and telehealth – and analysts agree this trend is expected to continue. Opportunities abound for growth and innovation within the medical device industry, and below are the top 5 medical device trends in 2021 and beyond.

1. Further Expansion of IoMT

The Internet of Things (IoT) is simply the use of the internet in everyday objects. The IoT is playing a big role in medical devices. Connected, or “smart” medical devices provide a wide range of data such as blood pressure, body temperature, and blood sugar for healthcare providers. This data can be used for various applications ranging from prevention, diagnosis, monitoring, and therapy. In 2021, we will continue to see the IoT evolve into the Internet of Medical Things (IoMT), which will utilize IoT devices, telemedicine, and telehealth technologies – all of which facilitate remote patient care. IoMT apps and devices optimize patient care and improve operational efficiency of medical services. Examples of the IoMT applications include an electrocardiogram monitor that will detect irregular heartbeats or rates that are too low as well as diabetes devices such as smart insulin pens and glucose meters.

2. Continued Demand for Wearables

Examples of wearable devices are a Fitbit to count your steps or a similar device to track your heart rate. There are millions of people worldwide with wearable, connected devices and this figure is growing as the demand increases for wearables, such as smart watches, exercise trackers, oximeters, and heart rate monitors. These devices collect valuable data that enables the patient and healthcare provider to manage health remotely, flagging any potential issues. Wearables are also in high demand for individuals that do not have a given medical condition and simply wish to improve overall wellness. As demand for more personalized wearables increases, tech companies are busy developing new innovations.

Additionally, wearable devices present a huge opportunity to collect data for clinical trials. This type of data is simpler and faster to collect as well as less expensive, allowing researchers to make real-time assessments on the patient’s well-being – rather than wait for data collection via surveys and focus groups. There are already many clinical trials taking advantage of wearable devices and we expect this number to grow significantly in 2021 and beyond.

3. Sensors, Sensors, and More Sensors

One of the biggest booms in medical device technology is sensors. These come in various shapes and sizes and include chemical, optical and pressure sensors that are used in wearable and even ingestible devices. Medical device sensors have the ability to link data collection to real-time decision making, which will allow the healthcare industry to shift more towards individualized patient care. For example, we are seeing the development of an ingestible device with sensors that remain in the stomach for over a month, collecting measurements and administering medicine based on the data-collected.

Biosensors are one of the latest innovations. One example is a bandage or patch with a sensor enclosed to monitor sweat and/or blood to track a patient’s condition and alert the individual or healthcare provider if an intervention is necessary. More medical device technologies like these are expected to be underway in 2021.

4. Increased Utilization of Robots

Artificial intelligence (AI) is becoming more of a presence in healthcare facilities, and one of the fastest growing forms of AI are robots. In many hospitals, robots are already performing repetitive tasks such as restocking supplies or assisting with disinfecting activities. Robots are also assisting doctors with surgeries in the operating room.

Robotics innovations are resulting in robots capable of more complex and intricate tasks. A huge area for research and development is nanomedicine. One advancement underway is the creation of tiny microbots that are capable of entering a patient’s capillaries to assess and repair human tissue. This is an exciting development and, in the future, may result in a treatment for cancer or other diseases that includes a patient swallowing a pill that encapsulates a programmable microbot.

5. Expanded VR Device Usage

Virtual reality (VR) is a computer-generated simulation that can be interacted with in a seemingly real way by an individual wearing special equipment such as goggles or a helmet. In the healthcare community, VR devices are used for medical staff training as well as patient care.

Doctors, nurses, and medical students use VR to practice their skills and simulate “real” medical procedures in what they perceive as a healthcare environment. This hands-on training is invaluable and is believed to translate to higher knowledge retention.

When it comes to patient treatments, VR is used as therapy to treat a variety of conditions such as depression, anxiety, vision problems, and post-traumatic stress disorder (PTSD). For PTSD care, patients are able to explore a simulated environment to determine what triggers a response and how to work through a patient’s emotions and responses to said triggers – all from a safe environment in the presence of a healthcare professional.

VR medical devices are expected continue to play a big role in product development in 2021 and beyond.

ProMed’s 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

ProMed is committed to utilizing advanced technologies, and we are well positioned to partner with OEMs to take advantage of the growth potential within the medical device industry in 2021. Contact us today at 763-331-3800 to discuss your next medical molding project.


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.