Polymers in medical device applications
Global demand for medical polymers reached nearly 5 million tons in 2013 and is expected to exceed 7 million tons in 2020. The choice of polymers plays an important role in the development and manufacture of medical devices.Polymer weight, cost, ease of processing , Hardness and biocompatibility, are driving the development of current and next generation implantable products, devices and related packaging technologies.
In view of the nature of the base polymer, it is not generally suitable for direct production or end-use applications, in which case the use of additives can reduce costs, improve performance or increase certain properties of the base polymer for specific medical device applications That is, some specific additives are often added to the base polymer particles during the mixing granulation step.
Typical additives include polymer alloys, plasticizers, radiopaque fillers, heat / light stabilizers, lubricants, antimicrobials, conductive agents, pharmaceuticals and colorants.
These steps are commonly referred to as melt mixing: the base polymer is converted from a solid to a viscous or gel-like substance under the influence of both external and internal heat generated by shearing and mixing, mixing the solid and liquid components into the base polymer During melt mixing, the thermomechanical energy produced by shear and mixing causes the formulation ingredients to diffuse, distribute at the microscopic / molecular level.
Polymer particles that have been widely used in the medical device industry can be divided 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 Polyurethane (TPU), Polyamide 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 properties, and regulatory requirements To ensure the best results when selecting a particle manufacturer, the medical device company and / Or its contractor should consider the following important aspects.
1. How much experience do you work with particle manufacturers?
As with other professional service providers, you'll want to understand the particle maker's track record in the medical device material supply. In addition to years of industry experience and successful experience helping to commercialize medical device products, you need to gain insight into manufacturing Environmental details.
For example, does the particle manufacturer have a fully dedicated production line in a controlled area accessible only to approved personnel and materials? Is the environment in the controlled area clean to minimize dust, fog particles, and chemical vapors Other environmental pollutants?
Their wealth of experience in managing medical production - especially the GMP and GMP standards that focus on cleanliness, traceability, reproducibility, process and change controls, Experience?
To what extent are medical particle manufacturers certified to quality? At least ISO 9001-2015 certified and have a thorough understanding of the requirements for medical devices.
Another key point of manufacturing is the collaboration of various functional departments.Quality testing laboratory, customer service and technical support team, regulatory affairs staff and sales staff must cooperate with each other.The raw material supply chain is another important point to evaluate.Your particle Are the manufacturers working with which suppliers to sign long-term contracts with them, are they able to obtain materials with good biocompatibility, and how do they handle material / supplier emergency changes and verify the backup suppliers?
Not all particle orders are big right from the beginning Can your particle manufacturer meet the needs of small to large size? Can they support different levels of mass?
Ideally, you also want to work with neutral particle manufacturers like Neutral Polymer, who do not recommend the use of a material for their benefit, but are committed to finding the best fit for your medical device application Solutions As a partner to this type of manufacturer, working with custom-made particle manufacturers is the ideal choice Your product may require a polymer solution that meets specific performance needs that require innovation Thinking, so you should look for particle manufacturers that can help you achieve a breakthrough.
2. Product / Business Development Basis
Medical device manufacturers are constantly breaking the reach of physicians and patients, and the population aging and economic growth in developing countries are driving global medical device manufacturers to increase productivity, minimizing secondary processing and overall system costs.
The unique material requirements are often a key part of the new generation of devices, requiring medical particle manufacturers to become true innovators and understand market needs and acquire the technical know-how and expertise needed to gain insight into a wide range of topics including analytics, mechanics, Rheology, Morphology and Infiltration and other disciplines.
In the early stages of product development, medical device OEMs will also benefit if suppliers understand single-tube and multi-layer tubing, film extrusion and injection molding. Another area that may benefit is the possibility that particle manufacturers may be associated with Downstream vertical industry chain manufacturers or some of the relevant partners have a close relationship.
Before building relationships with medical particle manufacturers, it is important to understand their manufacturing capabilities, for example, do they have state-of-the-art technology for pre-drying or post-drying materials? Can they pre-mix materials? What is the form of the material? Do they have a centrifugal loading system for accurate feeding when injecting a solution, adding a filler or aids?
In addition, can they customize the particle size with a flexible screw design to adjust the shear and extrusion times to meet the needs of their customers? Can they provide post-granulation dust removal if needed?
The level of automation is also an important consideration for particle-making technology.Temperature and process control, data acquisition software, ensuring consistency and traceability between batches are important automated deliverables.
3. Medical device manufacturing technology and application of knowledge
Polymers and polymer particles play a key role in manufacturing and developing a wide range of medical devices Understanding your customer's needs, processes, and application areas and translating those requirements into material properties is critical to providing the right synthetic solution It is important that you wish to work with a skilled technical team that assists in the commercialization of a wide range of medical devices including:
Non-invasive (single use) / invasive (implant) / primary or secondary packaging
● Do not touch the human body fluid or tissue fluid equipment
● short-term exposure (less than 30 days) of equipment
● long-term exposure (implanted more than 30 days) equipment
● In vivo contact applications (heart, central nervous system, central circulatory system, skin, blood, mucous membranes, tissues, bones, teeth)
Key product requirements: 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 drug, sterilization techniques (gamma sterilization, ETO sterilization and steam sterilization), chemical resistance and heat resistance, weatherability, humidity, Material compatibility and service life requirements
4. Globalization and laws and regulations support
As more and more medical device companies sell their products worldwide, often in more than one region, it is particularly important to work with a global manufacturer of particle makers in this context.You should investigate your particle manufacturer Are there technical and sales support also available elsewhere? Are they able to purchase the same raw materials and replicate the same particle material elsewhere in the world?
The regulatory requirements for medical devices are also part of the global discussion, with regulatory requirements varying across continents, countries, and sometimes even regions / states, changing and becoming more stringent, so that OEMs and particles with an internal regulatory team It is vital that manufacturers collaborate to not only understand the applicable regulatory requirements worldwide but also to track potential changes at all levels of standards.The team has a responsibility to ensure that the raw materials and finished products meet all the regulatory requirements for a particular application in a particular region or country .
Here are some specific regional or country regulations:
Conclusion
Choosing the right medical device The particle manufacturer is not only important for the commercial success of your product, but it is also critical to the commercialization schedule and associated costs.You must carefully study in advance to be sure that your choice of medical device particle manufacturer has all The required core competencies, which are also key to the success of the product.