What are the capabilities of an ideal medical polymer particle partner?

What are the capabilities of an ideal medical polymer particle partner?

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Polymers in medical device applications

In 2013, the global demand for medical polymers reached nearly 5 million tons, and by 2020 it is expected to exceed 7 million tons. The choice of polymers plays an important role in the development and manufacture of medical devices. The weight, cost, ease of processing, softness and biocompatibility of polymers are driving the development of current and next-generation implant-grade products, devices and related packaging technologies.

Due to the nature of the base polymer, it is generally not suitable for direct production or end use. In this case, the use of additives can reduce costs, improve performance, or improve certain properties of the base polymer for use in specific medical device applications. That is, in the step of mixed granulation, certain specific additives are often added to the base polymer particles.

Typical additives include polymer alloys, plasticizers, radiopaque fillers, heat/light stabilizers, lubricants, antibacterial agents, conductive agents, drugs, and colorants.

These steps are often referred to as melt mixing: under the influence of external and internal heat generated by shearing and mixing, the base polymer is converted from a solid to a viscous or gelatinous substance, and the solid and liquid components are mixed into the base polymer. . During melt mixing, the thermomechanical energy produced by shearing and mixing causes the formulation components to diffuse and distribute at the micro/molecular level.

Polymer particles that have been widely used in the medical device industry can be classified into the following categories:

Thermoplastics: Polyvinyl chloride (PVC), polyolefin and styrene particles

Elastomers: Thermoplastic polyolefin (TPO), styrenic thermoplastic elastomer (TPE-S) and thermoplastic vulcanizate (TPV) particles

Engineering Thermoplastic Elastomers (TPEs): Thermoplastic Polyester Elastomers (COPE), Polyether Block Amide Thermoplastic Elastomers (COPA), Thermoplastic Polyurethanes (TPU), Polyamides and Polyester Particles

High performance polymers: fluoropolymers and high temperature materials such as polycarbonate, polyetheretherketone and polysulfone resins

Polymer particles suitable for a particular medical device should be selected based on the application of the polymer particles and their physical, chemical, biological, and regulatory requirements. When choosing a particle manufacturer, medical device companies and/or their contractors should consider the following important aspects in order to ensure optimal results.

1. How much experience do you have with the particle manufacturer?

As with other professional service providers, you'll want to know how particle manufacturers are documenting the supply of medical device materials. In addition to years of industry experience and successful experience in helping to commercialize medical device products, you need to understand the details of the manufacturing environment.

For example, does the particle manufacturer have a fully dedicated production line, is it in a controlled area where only approved personnel and materials can enter? Is the environment in the controlled area clean to minimize dust, fog particles and chemical vapors? And other environmental pollutants?

Their experience in managing medical production is rich – especially the Good Manufacturing Practice (GMP) and the Quality Control Practice for Drug Clinical Trials, which focus on cleanliness, traceability, reproducibility, process and change control. Experience?

What level of quality certification does the medical particle manufacturer have? At least ISO 9001-2015 certification and a deep understanding of the requirements for medical devices.

Another key point of manufacturing is the collaboration of various functional departments. Quality inspection laboratories, customer service and technical support teams, regulatory affairs staff and sales personnel must coordinate and cooperate. The raw material supply chain is another focus that needs to be assessed. With which suppliers does your particle manufacturer work with, have they signed long-term contracts with them, can they get materials with good biocompatibility, how do they handle material/supplier emergency changes, and whether they are working with alternate suppliers? Verified?

Not all particle orders are large from the start. Can your particle manufacturers meet the needs of different sizes from small to large? Can they support different volume levels?

Ideally, you also want to work with a neutral particle manufacturer like the “neutral polymer”. Instead of recommending a material for their benefit, they are committed to finding the best solution for your medical device application. As a partner of this type of manufacturer, working with particle manufacturers with customized service capabilities is the ideal choice. Your product may need a polymer solution that meets specific performance needs, and this requires innovative thinking, so you should look for particle manufacturers that can help you achieve breakthroughs.

2. The basis of product / business development

Medical device manufacturers are constantly breaking through the supply of products to physicians and patients. Population ageing and economic growth in developing countries are driving global medical device manufacturers to increase productivity and minimize secondary processing and overall system costs.

Unique material requirements are often a key component of a new generation of devices. This requires medical particle manufacturers to become true innovators and understand market needs, technical knowledge and expertise. These capabilities require in-depth disciplines including analysis, mechanics, rheology, morphology, and penetration.

In the early stages of product development, medical device OEMs will also benefit if suppliers understand single- and multi-layer tubing, film extrusion, and injection molding. Another area that may benefit is that particle manufacturers may have a close relationship with downstream manufacturers or certain related partners located in the vertical industry chain.

Before building a relationship with a medical particle manufacturer, it is important to understand its manufacturing technology capabilities. For example, do they have the most advanced technology to pre-dry or post-dry materials? Can they pre-mix materials? What is their loading form? When injecting solutions, adding fillers or additives, Do they have a centrifugal feed system to provide accurate feed?

In addition, can they tailor the shear force and extrusion time to customize the particle size to meet the customer's needs, and if they need to provide you with a post-granulation dust removal function?

For particle manufacturing technology, the level of automation is also an important consideration. Temperature and process control, data acquisition software, ensuring batch-to-batch consistency and traceability are important automation deliverables.

3. Medical device manufacturing process and application knowledge

Polymers and polymer particles play a key role in the manufacture and development of various medical devices. Understanding your customers' needs, processes and application areas and turning those requirements into material properties is critical to providing the right synthesis solution. You want to work with a technical team with extensive expertise/experience to help commercialize a variety of medical devices, including:

● Non-invasive (single use) / invasive (implantation) / primary or secondary packaging

● Devices that do not touch human body fluids or tissue fluids

● Devices with short-term exposure (less than 30 days)

● Long-term exposure (implanted for more than 30 days)

● In vivo contact applications (heart, central nervous system, central circulatory system, skin, blood, mucous membrane, tissue, bones, teeth)

Key requirements for the product: hardness, appearance, color, thermodynamics, rheology and electrical properties

General Process: Extrusion (pipe), film, blow molding or injection molding

Secondary process: solvent bonding, gluing, product testing, printing / labeling

Environmental challenges: Biocompatibility with tissue or drugs, sterilization techniques (gamma sterilization, ethylene oxide (ETO) sterilization and steam sterilization), chemical and heat resistance, weatherability, humidity, Material compatibility and service life requirements

4. Globalization and legal and regulatory support

More and more medical device companies sell their products globally, often in more than one area. In this context, it is especially important to work with particle manufacturers with a global layout. You should investigate whether your particle manufacturer also provides technical and sales support in other regions. Do they have the ability to purchase the same raw materials and replicate the same particulate materials in other parts of the world?

The regulatory requirements for medical devices are also part of the global discussion topic. Different intercontinental, national, and sometimes regional/state regulatory requirements are constantly changing and becoming more stringent. Therefore, it is critical that OEMs work with particle manufacturers with internal regulatory teams to understand not only the applicable regulatory requirements worldwide, but also to track potential changes in standards at all levels. It is the responsibility of the team to ensure that the raw materials and finished products used meet all regulatory requirements for specific applications in a particular region or country.

The following are the regulations for certain regions or countries:

Conclusion

Choosing the right medical device particle manufacturer is important not only for the commercial success of the product, but also for the commercialization schedule and associated costs. Research must be done in advance to be sure that the medical device particle manufacturer you choose has all the core competencies you need, which is a key factor in the success of your product.

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