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:

• Can the product size or geometry be simplified or standardized?
• Can complex features such as undercuts or sharp corners be simplified or removed?
• Are all specified tolerances necessary, and which dimensions/tolerances are critical?

· Part thickness:

• Can the part be made to have a uniform thickness throughout?
• Check for thick areas of the part that could result in sinks and voids
• Check for thin areas of the part that could result non-fill

· Part Draft:

• Does sufficient draft exist? Is draft in the right direction and location for a good parting line?
• If texture is being used, is there enough draft to release the part?

· Gate location:

• Can the gate be located in a thick area of the part?
• Will the gate seal at the right time?
• Are multiple gates needed?

· Material considerations:

• Will the material have flow concerns such as excessive shear?
• If the resin does not flow well, are long or thin flow lengths needed?
• Is the fiber orientation correct?

· Operating conditions to consider:

• Maximum pressure during filling and packing
• Clamp force profile
• Fill pattern – is there a potential for material solidification, voids, or hot spots?
• Temperature profile
• Venting temperature – is there a potential for air traps?

· Defects:

• 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.

5 Benefits of Complete Prototyping Services in Medical Manufacturing

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

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

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

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

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

1. Lowers Manufacturing Risk: there is some degree of risk associated with every manufacturing project and rapid prototyping lowers the risk level. Prototypes enable designers to quickly discard ideas that will not result in a successful manufacturing project – and focus on the designs that will. A thorough Design for Manufacturing process (DFM) upfront allows optimizations to be made or issues to be resolved before the changes significantly impact the project timeline and budget – reducing the project risk.
2. Reduces Cost: tooling for injection molds is often expensive to fabricate and costly to modify; thus, it is imperative to get the tool design right the first time. If the design is off even by a small margin, the product aesthetics and functionality will be altered. Rapid prototyping gets the tool design right and ensures product manufacturability. These steps result in higher quality production, less rework, and lower waste generation – leading to significantly lower costs.

ProMed Prototyping Expertise

ProMed Prototypes fills a market void by offering customers real molded parts, made from a wide variety of materials. Our team of rapid prototyping experts offers complete in-house mold design, mold build, and prototype component manufacturing. Allowing ProMed to serve its customers throughout a product’s lifecycle decreases production development time, development cost, and production piece part price due to critical manufacturing information learned through prototyping. Click here for a comparison of the speed, cost, and likeness to production for different prototype materials.

ProMed Prototypes offers rapid prototypes that include tool design, tool manufacturing, prototype manufacturing, cleaning, packaging, and shipment. ProMed provides customers a distinct advantage because, in the world of product development, time is money, and getting a product to market before the competition is a key to the success of the long-term business strategy. When your device is ready for full scale production, ProMed Prototypes’ manufacturing knowledge will be transferred to the New Product Development department of ProMed Molded Products for pre-production runs, validation, and ongoing production runs. We focus on prototypes for the following industries:

• Medical: Dedicated quality system, facilities and personnel support the activities necessary to develop and manufacture these drug eluting components. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust manufacturing processes and platforms for the controlled release of drugs from a variety of materials. Our medical prototypes are offered in a variety of materials including LSR, HCR, and RTV.
• Aerospace and Defense: ProMed also has more than ten years of experience in serving the aerospace and defense markets. We offer rapid prototypes of nearly any geometry and material type, along with complex assembly and over-molding prototypes for the aerospace market. ProMed Prototypes has leveraged its experience to become a leader in providing precision rapid prototypes to the aerospace and defense markets, along with ProMed Molded Products taking many aerospace and defense products into full production.
• Pharmaceuticals: ProMed Pharma, offers rapid prototypes for drug eluting and drug delivery components, among other pharmaceutical, medical device, and combination products. ProMed Pharma focuses on silicone and plastic pharmaceutical prototypes but has extensive experience in final product assembly and packaging as well.

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

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

What is a Clean Room in Medical Manufacturing?

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

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

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

What is a Class 10,000 Clean Room?

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

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

At ProMed, our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites: all are certified class 10,000 / ISO Class 7 clean rooms. Our facilities support silicone injection molding of various medical devices and components including:

About ProMed Pharma

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

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

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

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

4 Surprising QMS Statistics about Medical Manufacturing Companies

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

What is a QMS for Medical Manufacturing Companies?

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

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

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

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

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

QMS Statistics about Medical Manufacturing Companies

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

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

ProMed’s Commitment to Quality

At ProMed, quality is not just a department, it is a cultural commitment. We understand the importance of quality to your success. That is why quality is embraced every step of the way to create a product that will assure confidence in your products.

Partnering with an experienced injection molder like ProMed allows for the necessary production planning needed to meet all of the necessary regulatory, quality, and commercial standards. Our work force is highly specialized in the manufacturing and quality requirements of medical products, much of which go into the long-term implantable market space. Every employee at ProMed is trained with the idea that quality is their most important responsibility.

Our equipment utilizes cost-effective, high-end molding technology to keep operating expenses down while producing parts with an extremely high level of precision and repeatability. Our tools are designed and manufactured to exacting tolerances. Expert toolmakers use high-tech design software and machining centers to produce molds that are durable and dimensionally repeatable from cavity-to-cavity, part-to-part!

We are an approved, certified supplier to many of the top medical device manufacturers in the world. All ProMed facilities go through routine audits by our ISO registrars and customers. Below is a sample of the standards we meet. Additionally, our products are wholly synthetic, not animal derived, and do not contain substances of very high concern or materials sourced from conflict regions.

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

The Future of Liquid Silicone Rubber in Medical Manufacturing

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

What is LSR?

Liquid Silicone Rubber (LSR) is a very-pure, platinum-cured elastomer. LSR starts out as a 2-part liquid that is heated in order to accelerate the reaction of the two parts to form solid rubber that can be injected into a mold cavity to manufacture a part. LSR has excellent properties, such as a low viscosity and low shrink rate, that make it a great choice for injection molding and the manufacturing of complex products and intricate parts. One of the advantages of LSR is that it cures faster than most other rubber materials; additionally, due to the highly automated nature of injection molding and the potential for 24/7 manufacturing, high volumes of LSR products can be produced in a short period of time – adding to its popularity. LSR is a versatile rubber in the elastomer industry and has a wide range of end-uses including medical devices such as stents and catheters. Click here to learn why the medical industry uses silicones.

Benefits of LSR in Medical Manufacturing

In medical manufacturing, LSR has many attractive properties such as durability, low viscosity, chemical and temperature resistance, and flexibility, but its biocompatibility is outstanding. LSR has demonstrated superb compatibility with human tissue and body fluids, and is resistant to bacteria growth. Medical grades of LSR are temperature resistant and can easily sterilize, which makes them compatible with various medical devices and accessories such as implantable devices, liquid feeding bottles, dialysis filters, and oxygen mask instruments. Additionally, demand continues to grow for wearable medical devices, leading to even higher LSR demand.

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

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

Continued LSR Market Growth

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

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

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

ProMed Pharma’s Capabilities

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

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

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

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

5 Advantages of Additive Manufacturing

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

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

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

5 Advantages of Additive Manufacturing

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

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

About ProMed

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

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

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