“How to fulfill biocompatibility in today’s rapidly changing regulatory and scientific scenario?”

It is the management responsibility to assure the safety of medical devices that they placed in the market. One of the safety requirements is to fulfill the biocompatibility of the medical device.

Biocompatibility testing provided confidence to the manufacturer, regulators and the patients that the device is safe for the intended use.

General guidance for biocompatibility testing is provided by ISO10993, Part 1. The other parts of ISO 10993, Parts 2-20 give guidance on how to perform these tests. There are also other guidance that are device specific. These device specific guidance
are issued by ISO, regulatory bodies and sometimes scientific committees can issue recommendations.

Biocompatibility testing and guidance came into use in mid 1990s, when ISO started developing guidelines. Initially the regulators and notified bodies looked at biocompatibility as a mere box ticking exercise. At that time, certificate that biocompatibility was fulfilled was considered sufficient. With further developments and revisions in ISO standards, and further experiences in biocompatibility testing over the last 10 years, the expectation from biocompatibility testing has massively increased. The regulators and the notified bodies have started looking at the biocompatibility reports in greater details for scientific and regulatory fulfilments. They are employing biocompatibility experts to review the files submitted to them for CE marking or 510K/PMA.

Under these circumstances, it is important for the manufacturers to understand these changing requirements and prepare their biocompatibility files accordingly. There is also more emphasis on literature review and risk management approached to fulfil
biocompatibility requirement, without the need for unnecessary animal testing.

In this talk, I will briefly introduce you to these changing regulatory requirements in biocompatibility testing.

“Novel Styrenic Block Copolymers and Polyisoprene Rubber for Medical Devices.”

Styrenic Block Copolymers (SBCs) and polyisoprene rubber are suitable for a variety of applications. This paper describes Kraton® polymers, especially Kraton Enhanced Rubber Segment SEBS (Kraton®ERS SEBS) in transparent medical applications. Due to their cleanness, softness, good processability and excellent compatibility with polypropylene, Kraton ERS SEBS polymers have been widely used, as a toughness modifier for polypropylene, in transparent medical application such as IV bag ilms, medical tubing and consumer goods application such as containers, etc. Cariflex®Polyisoprene Products are designed to replace natural rubber for producing medical products ranging from surgical gloves and tube connectors to IV bag and medical stoppers, balloon catheters, needle shields, dental dams and cohesive bandages.

Thermoplastics Polyurethanes: Enabling Innovative Competitive Technologies through Advanced Materials

Thermoplastic Polyurethanes (TPUs) are a class of polymers with unique physicochemical properties. They are inherently strong like thermoplastics yet flexible like elastomers, making them the most versatile class of polymers. TPUs are composed of soft and hard building blocks and the phase segregated morphology of these building blocks imparts physical properties that cover the entire range of polymers from soft, flexible elastomers to rigid engineered polymers and everything in between. Additionally, the soft and hard blocks can be chemically chosen such that they are biocompatible and biostable, suitable for medical applications. Medical Device industry has grown exponentially in the last decade with an evolving regulatory landscape. Device design engineers are constantly looking to create the next-generation device with advanced polymers and materials that offer an edge over existing materials. The versatility and tailor ability of thermoplastic polyurethanes has become an essential tool in the design engineer’s toolbox. TPUs have successfully replaced PVC for certain device applications where regulations prohibit the use of plasticizers. In some other instances, TPUs are being used instead of silicones in next generation devices, thereby providing a competitive edge in the marketplace.

Lubrizol’s medical grade TPU offer a wide range of chemistries to choose from depending on the application. Ease of process ability is key for efficient manufacturing, Lubrizol’s TPUs can be processed by standard methods such as extrusion, injection molding, and solvent casting. With the addition of Vesta, Lubrizol has gained additional capabilities more towards device manufacturing and assembly. Lubrizol is no longer just a resin supplier; it is a complete Device Solution provider.

"Process oriented approach for building safer and secure medical devices"

For medical device developers, increased government scrutiny and new international standards create a compliance burden that challenges time-to-market goals and threatens to explode development costs. Along with Safety, now Security is also a serious concern for all and without global safety certifications, today our innovations cannot reach global markets. We would discuss international safety standards like IEC 62304 and secure software development approaches that could help in accelerating your go to market strategy, while keeping the costs under check.

“Coloration & Modification of Medical Plastics – Managing Risk & New Opportunities.”

Designers and manufacturers of medical devices and pharmaceutical packaging invest significant time and money in meeting performance and regulatory standards to fulfil the increasingly stringent demands of these global markets. Materials that can help minimize the risks and costs of non-compliance in a product’s development and lifecycle are vital to this process. Clariant’s package of dedicated service and expertise, product reliability and innovative material performance gives the industry the confidence it needs to address risk potential.