ProMed Pharma Press Release April 2022

ProMed Pharma announces a preclinical rat study to assess pharmacokinetics of a novel long-acting contraceptive implant

Bioresorbable implant aims to address key unmet needs for
family planning at an affordable price in low and middle
income (LMIC) settings

PLYMOUTH, MINNESOTA, UNITED STATES, April 19, 2022
/EINPresswire.com/ -- ProMed Pharma is pleased to
announce the initiation of preclinical evaluation of a novel
fully resorbable contraceptive implant. The implant,
developed in a project funded by the Bill & Melinda Gates
Foundation, aims to address key unmet needs for family
planning at an affordable price in low and middle income
(LMIC) settings.

Commercially available contraceptive implants, while safe
and highly effective, require removal by trained health care
providers any time the user wants to discontinue the
method, including when pregnancy is desired, or when the
implant reaches the end of its effectiveness. This
requirement imposes a strain on resources in LMIC
settings.

The implant being developed by ProMed is specifically designed to address the needs of LMIC settings.
First, it aims to expand women’s contraceptive options by providing 18 months of contraception by long-term release of levonogestrel. This duration fills the gap between that offered by existing injectables and longer-acting methods such as non-erodible implants.
Second, the implant is fully biodegradable, eliminating the need for women to return to medical clinics for removal at the end of the period of effectiveness.
Finally, the implant, which comprises a levonogestrel-releasing outer sheath surrounding a drug-free polymer core, is designed to retain sufficient mechanical integrity to allow removal if or when desired. Removability is important to respond to women’s needs, such as in cases where pregnancy is desired prior to exhaustion of the contraceptive.

The preclinical evaluation of the implants follows selection of four lead formulations combining levonogestrel with cost-effective, commercially available biopolymers that yield near-linear release without the need of a rate controlling membrane. The preclinical study will evaluate the pharmacokinetics of levonogestrel, establish duration of removability, and track length of biodegradation of the designs. The results will allow further narrowing of formulations for clinical evaluation.

Dr. James Arps, Director of Business Development at ProMed, noted “the implant designs have shown promising mechanical integrity and drug release profiles based on in vitro tests to date and have a form factor which is similar if not superior to other implants on the market.” The study will be carried on for a minimum of 6 months with the option of gathering drug release and polymer degradation data up to 1.5 years.

About ProMed Pharma:

ProMed Pharma specializes in the molding and extrusion of drug-loaded silicones, thermoplastics, and bioresorbable materials, leveraging this expertise to manufacture long-term implants and combination devices under cGMP. Working with both established and early stage companies, we utilize robust manufacturing processes for controlled release of APIs utilizing a variety of materials. From clinical trial materials to commercial products, ProMed supports
pharmaceutical and medical device companies developing controlled release formulations including subcutaneous, orthopedic, cardiovacular, and ophthalmic implants, intravaginal rings, and steroid-eluting combination components. The company has facilities in Plymouth and Maple Grove, Minnesota. Please visit www.promedpharmallc.com for more information.

James Arps
Promed Pharma
+1 763-331-3800
email us here
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DFM Checklist for Medical Manufacturing

Injection molding and other medical manufacturing processes are often complex and peppered with potential pitfalls. Fortunately, nearly all of these potential issues can be resolved with a highly competent design. Achieving the best design the first time around is crucial as there is a lot at stake. If OEMs do not get the design right, product rejection rates will increase, productivity will decline, and a host of other issues will ensue – all negatively impacting the bottom line. Additionally, modifying a product or mold design during the production stage can be very costly – so it is worth the time to get the design phase right.

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

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

How does the DFM Process Add Value?

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

· Save Significant Cost and Time: OEMs are often in a rush to get a new product to market so it is tempting to shorten – or even skip – the DFM process. However, it is important to keep in mind that changes to the design become exponentially more expensive and timely to implement as the product advances through the life cycle. A thorough DFM upfront will allow any optimizations to be made or issues to be resolved before the changes significantly impact the project timeline or budget.

· Optimize Functionality and Aesthetics: tooling for molding projects is often expensive to fabricate and costly to modify; thus, it is imperative to get the tool design right the first time. If the design is off even by a small margin, the product aesthetics and functionality will be altered. The DFM process often includes computer simulations of the design as well as rapid prototyping so the team can fully visualize the product. Oftentimes, these steps yield valuable insights and design optimizations that would have been lost if the DFM process was not performed – resulting in a more functional and aesthetically-pleasing product.

· Confirm Manufacturability: last but certainly not least, the DFM process ensures the part can be manufactured. This may seem obvious but there are many instances of products reaching production only to realize the part cannot actually be manufactured per its current design – costing OEMs valuable time, money, and resources

ProMed’s Approach to DFM

To avoid this situation, OEMS should team up with an experienced medical manufacturing partner, like ProMed, that has DFM expertise. ProMed’s design and manufacturing teams are integrated to allow manufacturability issues to be identified and addressed during the design process instead of after the tooling is fabricated – saving customers significant development time and cost as well as innumerable headaches. At ProMed, we works with our customers throughout the product life cycle, providing a cost-effective solution that meets the customer’s needs.

LSR is a versatile silicone that has a wide range of end-uses from medical devices to consumer goods to electronics to automotive. There are several types of LSR that can be manufactured such as medical, self-lubricating, conductive, flame-retardant, and radio opaque. The type of LSR produced is determined by the additives incorporated during the manufacturing process. Additionally, LSR is available in different grades, namely medical, food, and industrial. Given its versatility, it is not surprising that the worldwide demand for LSR continues to grow.

LSR has excellent properties, such as a low viscosity and low shrink rate, that make it a great choice for silicone injection molding and the manufacturing of complex products and intricate parts. One of the benefits of LSR is that it cures faster than most other rubber materials; additionally, due to the highly automated nature of silicone injection molding and the potential for 24/7 manufacturing, high volumes of LSR products can be produced in a short period of time – adding to its popularity.

A key benefit of LSR’s lower viscosity is that it is easier to mix additives into. Additives that can readily be incorporated into a batch of LSR include colorants, desiccants, barium, and pharmaceuticals such as hormones or steroids. For these reasons, LSR is a great option for medical devices such as combination products. The low viscosity of LSR and the temperatures needed to vulcanize LSR are usually low enough that significant degradation of compounded substances, like Active Pharmaceutical Ingredients (APIs) that are used in combination products, can be avoided.

While LSR has many attractive properties, its biocompatibility is outstanding. LSR has demonstrated superb compatibility with human tissue and body fluids, and is resistant to bacteria growth. Medical grades of LSR are temperature resistance and can easily sterilize, which makes them compatible with various medical devices and accessories such as implantable devices, liquid feeding bottles, dialysis filters, and oxygen mask instruments.

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

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

DFM Checklist for Medical Manufacturing

There are many factors to consider when designing a molded product for the healthcare sector. Below is an example of a DFM checklist that lists key design consideration for an injection molding project. These are topics that OEMs should discuss with their medical manufacturing partner to ensure each of these items is considered in the product design. This is not a comprehensive list but these are some of the most common design parameters that will help ensure a robust design and a successfully molded product. The DFM checklist for your project can be customized to meet the specifics of your application. Visit our website for more medical manufacturing design considerations regarding material selection and part functionality.

· Simplification:

o Can the product size or geometry be simplified or standardized?

o Can complex features such as undercuts or sharp corners be simplified or removed?

o Are all specified tolerances necessary, and which dimensions/tolerances are critical?

· Part thickness:

o Can the part be made to have a uniform thickness throughout?

o Check for thick areas of the part that could result in sinks and voids

o Check for thin areas of the part that could result non-fill

· Part Draft:

o Does sufficient draft exist? Is draft in the right direction and location for a good parting line?

o If texture is being used, is there enough draft to release the part?

· Gate location:

o Can the gate be located in a thick area of the part?

o Will the gate seal at the right time?

o Are multiple gates needed?

· Material considerations:

o Will the material have flow concerns such as excessive shear?

o If the resin does not flow well, are long or thin flow lengths needed?

o Is the fiber orientation correct?

· Operating conditions to consider:

o Maximum pressure during filling and packing

o Clamp force profile

o Fill pattern – is there a potential for material solidification, voids, or hot spots?

o Temperature profile

o Venting temperature - is there a potential for air traps?

· Defects:

o Consider the potential for flash, weld lines, sink marks, short shots, burn marks, shrinkage, warpage, etc.

· Tooling: potential for tool integrity concerns such as thin steel?

About ProMed

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. Over time, we broadened our product offerings to include assembly, micro-molding of highly engineered plastics, and combination products. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

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

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

· Automated Silicone Injection Molding

· Multi-cavity tooling

· Micro molds and micro molding

· Servo-controlled de-molding capabilities

· Insert molds, overmolds, and automation integration

· Transfer molding

· Compression molding

Click here to see why ProMed is your silicone injection molding partner. Contact ProMed today at 763-331-3800 to discuss your next silicone injection molding project.


Common Materials for Silicone Injection Molding

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

Common Silicones for Injection Molding: LSR and HCR

Silicone elastomers have long been a popular material for silicone injection molding due to their highly desirable mechanical and physical properties. Silicones have excellent durability, chemical inertness, high tensile strength, vast range of available durometers, low toxicity, a wide temperature range, and compatibility with many sterilization methods. Furthermore, silicone is compatible with human tissue and body fluids, has a very low tissue response when implanted, and does not support bacteria growth – making it a perfect option for implants due to its excellent biocompatibility.

Silicone elastomers are primarily available in two forms for medical manufacturing: Liquid Silicone Rubber (LSR) and High Consistency Rubber (HCR). LSR and HCR are both used in medical manufacturing. While HCR and LSR have several similarities, viscosity is a key differentiator and often impacts the decision on which material is utilized for a given silicone injection molding project. The following provides an overview of both elastomers and when each should be utilized.

What is Liquid Silicone Rubber (LSR)?

Liquid Silicone Rubber (LSR) is a platinum-cured elastomer. LSR is a newer silicone technology and starts out as a 2-part liquid that cures into a solid form when mixed. LSR generally comes in buckets and has a longer shelf life than HCR.

LSR is a versatile silicone that has a wide range of end-uses from medical devices to consumer goods to electronics to automotive. There are several types of LSR that can be manufactured such as medical, self-lubricating, conductive, flame-retardant, and radio opaque. The type of LSR produced is determined by the additives incorporated during the manufacturing process. Additionally, LSR is available in different grades, namely medical, food, and industrial. Given its versatility, it is not surprising that the worldwide demand for LSR continues to grow.

LSR has excellent properties, such as a low viscosity and low shrink rate, that make it a great choice for silicone injection molding and the manufacturing of complex products and intricate parts. One of the benefits of LSR is that it cures faster than most other rubber materials; additionally, due to the highly automated nature of silicone injection molding and the potential for 24/7 manufacturing, high volumes of LSR products can be produced in a short period of time – adding to its popularity.

A key benefit of LSR’s lower viscosity is that it is easier to mix additives into. Additives that can readily be incorporated into a batch of LSR include colorants, desiccants, barium, and pharmaceuticals such as hormones or steroids. For these reasons, LSR is a great option for medical devices such as combination products. The low viscosity of LSR and the temperatures needed to vulcanize LSR are usually low enough that significant degradation of compounded substances, like Active Pharmaceutical Ingredients (APIs) that are used in combination products, can be avoided.

While LSR has many attractive properties, its biocompatibility is outstanding. LSR has demonstrated superb compatibility with human tissue and body fluids, and is resistant to bacteria growth. Medical grades of LSR are temperature resistance and can easily sterilize, which makes them compatible with various medical devices and accessories such as implantable devices, liquid feeding bottles, dialysis filters, and oxygen mask instruments.

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

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

What is High-Consistency Rubber (HCR)?

Another common elastomer for silicone injection molding is High-Consistency Rubber, or HCR. It should be noted that the terms HCR and HTV, which stands for High Temperature Vulcanization, are often used interchangeably and refer to the same silicone material; for the purpose of this article, we will use the acronym HCR.

HCR is a type of silicone elastomer comprised of long polymer chains with a very high molecular weight. It is cured at high temperatures with a platinum catalyst or peroxides. HCR is known for its gummy consistency that is similar to peanut butter, and mostly comes in partially vulcanized sheets.

HCR has many desirable properties such as excellent aging resistance, thermal stability, electrical properties, mechanical strength, elongation, and hardness. For these reasons, HCR is a good material for a broad range of applications within medical manufacturing. Due to its higher viscosity compared to other elastomers such as LSR, HCR is typically processed using compression and transfer molding methods, but is also utilized for silicone injection molding projects.

HCR takes longer to cure than many other molding materials. A longer cure time results in a longer silicone injection molding cycle time. To improve project economics, HCR molds often have a large number of

cavities in order to accommodate the longer cycles and still achieve the desired production volume for each cycle – resulting in a more cost-effective solution on a per unit basis.

Which Silicone is Best for My Injection Molding Project?

Medical device OEMs often face a tough decision: should we use HCR or LSR for our silicone injection molding project? For companies already using HCR to manufacture medical components, it may make sense to continue using this elastomer especially since the initial capital equipment costs have already been made. For new product development, however, LSR is often the best choice given the lower capital costs and labor associated with processing this silicone. Due to its lower cost and versatility with formulations, companies often prefer LSR over HCR – but the decision should be made on a case-by-case basis. This is why it is important to team up with an experienced partner, such as ProMed, who will guide you through the selection process to ensure the right material is chosen for your silicone injection molding project.

About ProMed

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. Over time, we broadened our product offerings to include assembly, micro-molding of highly engineered plastics, and combination products. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

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

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

· Automated Silicone Injection Molding

· Multi-cavity tooling

· Micro molds and micro molding

· Servo-controlled de-molding capabilities

· Insert molds, overmolds, and automation integration

· Transfer molding

· Compression molding

Click here to see why ProMed is your silicone injection molding partner. Contact ProMed today at 763-331-3800 to discuss your next silicone injection molding project.


injection molded products, silicone manufacturing, molded products

The Science Behind Drug Eluting Combination Products

One of the areas within the medical sector that is rapidly advancing is drug eluting combination products. These medical devices are changing the healthcare industry and offer scientists a myriad of new approaches for treating disease. In time, researchers predict drug eluting combination products will treat patients with a variety of diseases including cancer, heart disease, cerebral palsy, anemia, and diabetes. Scientists expect drug eluting medical devices to continue to evolve and increase in complexity as new innovations and technologies become available over time. The following provides a look into the science behind drug eluting combination products.

It should be noted that not all medical molding companies can successfully and safely manufacture drug eluting combination products. Thus, it is crucial that OEMs work with a proven partner, like ProMed. In fact, ProMed is one of few companies in the world to provide contract manufacturing of drug-eluting products. Our team works with customers to ensure we create a medical device that delivers the desired performance safely and without drug degradation. To learn more, watch our video about combination drug eluting advancements.


What are Drug Eluting Combination Products?

“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 common combination products 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.

Regarding the science behind drug-eluting combination products, these medical devices typically have a polymer film, matrix, tablet, or coating that has a drug compound integrated chemically at an exact potency and concentration. The device gradually releases the medicinal treatment over time at a specific rate. 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 of Drug Eluting Combination Products

Drug eluting combination products provide a great benefit to patients over conventional dosage methods. 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 combination products 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. For these reasons, the trend toward drug eluting combination products is expected to continue as demand grows for patient-centric drug delivery and self-administration of healthcare.

Looking for a proven medical molding partner for your drug eluting combination product?

Contact ProMed

Contact ProMed to learn about our range of medical molding solutions.

ProMed’s Expertise in Drug Eluting Combination Products

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

 

Contact ProMed today at 763-331-3800 to discuss your next biomaterial grade injection molding project.

 


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!