Medical Polymers : Emerging Trends & Opportunities

About Importance of ISO 13485 for Medical Plastic Materials & Components Suppliers

Regulatory requirements demand making sure that Medical Device Manufacturers take responsibility for every supply-chain link to meet Good Manufacturing Practices.

Medical Polymers and Components : Quality Requirements

Plastics Materials & Components used for medical applications need consistent performance, including resistance to sterilization, chemicals and lipids. They often must also meet standards for biocompatibility and toxicity, where even slight changes in the ingredients in the plastics used could affect the acceptability of the finished device. Regulatory authorities require that the plastics are “well-characterized” with detailed information on the material ingredients and for mulation, manufacturing processes, and extensive supporting data with respect to physical and mechanical properties, biocompatibility and toxicity.

Any material or formulation change over the lifetime of the product, and at any point in a sometimes highly complex supply chain, can invalidate previous approvals.

Importance of ISO 13485

This is why ISO 13485 certification is becoming more and more important. ISO 13485-2016 is the standard governing organizations involved in the design, production, and installation and servicing of medical devices. If upstream suppliers, like plastics processors, are also certified to the standard, they provide their customers with the assurance that they have invested in and understand the medical-device risk-management principles that are core to the standard. Also, that quality control and testing procedures have been applied to the raw materials they use in the components they provide and that they have the documentation to prove it.

Plastic Materials for medical applications need consistent performance including resistance to sterilization, biocompatibility and toxicity.

Materials & Components suppliers should have a thorough understanding of the end-use application requirements, medical-device regulations that OEMs must meet, risk-management practices, and they will have put change-control measures in place. Usually this involves enhanced GMP and probably certification to an advanced quality standard such as ISO 13485-2016.

Colorants and additives must also be just as tightly controlled as the polymer. They are often subject to frequent changes, both major and minor ingredients such as  pigments, stabilizers, plasticizers, lubricants etc. Careful sourcing procedures at each level of the supply chain are increasingly necessary to ensure that materials come with the necessary assurances, and that controls are in place.

The regulatory compliance and quality of a medical device is only as good as its weakest link.

In medical plastics processing, it’s all about minimizing risk.

Suppliers need to make sure there’s no chance a patient might have an adverse experience caused by some defect or oversight. Therefore, the companies supplying materials / components need to be vigilant to make sure actions they take don’t compromise the performance or safety of the final product.

Medical Polymer Tubing : Applications & Extrusion Technology Highlights

Critical Applications, Medical Tubing Configurations, Material & Process Requirements For High-Quality Extruded Tubing, About Catheter Tubing, Methods To Assess Tubing Quality, The Economics Of Extrusion

The medical tubing segment comprises the most dynamic area in the medical device landscape. The market for Plastic Medical Tubing is expecting significant growth due to changing global demographics and the growth of medical procedures such as minimally invasive surgeries.

As per a recent study by “Markets AndMarekets”, the global medical tubing market size is projected to grow from USD 4.9 billion in 2021 to USD 7.9 billion by 2026, at a CAGR of 10.0% between 2021 and 2026.

Primary drivers of the global market for medical tubing are the increasing demand for medical devices that incorporate tubing, the growing access to health care around the globe, which carries with it a market for medical devices and the tubing associated with those devices and minimally invasive surgeries.

A technical article on analysing use of various polymeric materials in one of our previous issues (MPDS - May-June 2018) by Mr Dan Lazas , Senior Director, Tekniplex covered critical applications like Blood Management, Therapeutic Delivery, Cardiac Intervention etc. For the benefit of the Medical Plastics Processing Industry, we give below highlights for some of the important facts related to Medical Tubing & Extrusion Process.

Critical Applications

Applications that rely heavily on medical tubings / extrusion technology include the following:

• Neurovascular (e.g., treatment of stroke).
• Cardiovascular (e.g., angioplasty, stenting, cardiac ablation, and mitral valve repair).
• Peripheral interventions (e.g., stent grafts, venous therapy).
• Endoscopic and renal denervation applications
• Implants (e.g, inferior vena cava filter, and prosthetics valves).

Medical Tubing Configurations

Medical Tubes are categorized mainly by following types according to Different Configurations:

a. According to the structure : Single-Lumen, Double-Lumen, Multi-Lumen, Two-Row, Multi-Row etc.

b. According to the performance : High-Pressure Tube, UV Protection Tube, Flame Retardant Tube Antimicrobial Tube, Gamma Ray Protection Tube.

c. According to the usage : High-Transparent Tube, Tube With Color Line (One Or Multi-Lines), Radiopaque Tube (One Of Multi-Lines Or Whole ), Micro - Flow Tube, Intravascular Tube, Balloon Tube, High-Pressure Tube.

Material & Process Requirements For High-Quality Extruded Tubing

A good understanding of polymer science and the behavior of polymer materials is extremely important for achieving high quality extruded tubing. Polymer material suitable for medical tubing should have: Inertness to body tissues and fluids, Flexibility, Resistance to sterilization conditions, Low extraction, Clarity and Low cost for high volume applications.

Tubing quality is affected by a number of factors, including raw material selection, material handling, and the many parameters of the tubing extrusion process.

Advances in extrusion technology are aiding the evolution of plastic tubing with the latest developments that include special formulations offering unique combinations of desired properties such as strength, flexibility, a high gas-barrier rating and lubricity. The extrusion process is only as good as the manufacturer’s ability to control it.

A tube’s dimensions can affect the performance characteristics of extruded medical tubing. However, process parameters, equipment, and material characteristics also play an important role in determining the end properties of an extruded tube. Tubes have also shrunk dramatically in recent years, to the point where a human hair is thick compared with some tube walls. Manufacturing such products poses considerable challenges, requiring special extrusion equipment, precise process control, and painstaking inspections.

Designing and developing complex multiplelumen tubing can spur innovation, provided that the designer understands the latest technology and how best to work with a tubing manufacturer. The extrusion process is only as good as the manufacturer’s ability to control it.