MEDICAL TUBING EXTRUDER B I O P H A R M A C E U T I C A L T U B I N G • Low leachables & extractables • Great tensile performance and kink resistance • Good thermal weldability • Excellent clarity and medical blue tint • ISO 10993-4 & 5, USP Class VI & Animal Derivative Free (ADF) • Supplied drop-in material replacement to overcome supply constraints of incumbent TPE • Offered a lower extractable profile than comparable materials in the market • Enabled easy material transition without changes in tooling or thermal welding machine settings • Formulated solution with proprietary additives to provide clarity and prevent yellowing after sterilization Versaflex™ HC BT218 Thermoplastic Elastomer KEY REQUIREMENTS WHY AVIENT?

MEDICAL DEVICE MANUFACTURER S T E T H O S C O P E S • Provide a silicone paste colorant dispersion for liquid silicone rubber (LSR) to use in stethoscope ear tips • Create a custom-colored vinyl plastisol formulation for stethoscope tubing • Harmonize color across materials to meet specific process and performance requirements • Deliver effective communication and cross-functional collaboration • Offered dependable silicone paste colorants that allowed for comfort and easy sterilization • Provided a colored vinyl plastisol to reduce tackiness and support product longevity • Collaborated internally to align all materials and provide color consistency across components • Supported fast color changes and met quality specifications through constant communication and technical expertise Silcopas Silicone Paste Colorants and CORE Vinyl Plastisols for Healthcare KEY REQUIREMENTS WHY AVIENT? https://www.avient.com/products/vinyl-formulations/vinyl-plastisols-organosols/core-vinyl-plastisols-healthcare https://www.avient.com/products/polymer-colorants/colorant-dispersions/colorants-liquid-silicone-rubber Slide 1: Medical device manufacturer

240625-2017-AQ-RGC-NA-PS Initial certification date: 14 September 2017 Valid: 08 February 2025 – 07 February 2028 This is to certify that the management system of PolyOne-Shanghai, China 88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode: 91310000607342402D) has been found to conform to the Quality Management System standard: ISO 13485:2016 This certificate is valid for the following scope: Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates Used for the Plastic Parts of Medical Devices http://www.dnv.com

Fast, accurate and reliable results aid medical professionals to understand the illness and develop the strategy for an effective treatment. It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

FOUR MAIN PLASTIC VARIABLES Flow Rate Plastics are a non-Newtonian fluid, therefore, with a higher shear rate, the viscosity of the material is reduced. This will FIGURE 43 - Non-Newtonian Fluid Flow Low Level of Orientation Frozen Layer Highly Oriented Laminates Gate Transducer A Transducer B Hydraulic x 10 Filling Hold Start of mold shrinkage Time Pack P ss A B FIGURE 45 - Non-Newtonian fluid flow Relative Viscosity = Transfer Position * Fill Time Shear Rate = 1 Fill time FIGURE 46 - Pressure vs. Reduce the clamp tonnage until flash is seen around the parting line, then increase the clamp tonnage by 5-10% Minimize Cycle Time • Mold Open/Close – Should be as fast as possible, without slamming, and still produce a nice fluid motion • Ejector Speed – As fast as possible, without influencing part quality • Ejector Stroke – Only stroke the ejectors as many times as needed to separate the part from the core - i.e.

MEDICAL DEVICE DISINFECTION—HOW TO PREVENT CRACKING AND CRAZING Understanding polymer performance is key to minimizing disinfectant-related failures DISINFECTANT-RELATED DAMAGE ON POLYMER HOUSINGS Strong chemicals used to reduce hospital- acquired infections can damage equipment and result in material failures, such as: • Stress cracking • Crazing • Discoloration CHEMICAL RESISTANCE REQUIREMENTS VARY BY ENVIRONMENT • Patient/exam rooms • Operating and radiology rooms • Reception areas • Home (patient equipment & devices) Healthcare devices must perform flawlessly in a myriad of challenging environments and engineers must be certain their devices can withstand increasingly potent disinfectants, which have begun to outstrip the performance of traditional polymers. Additionally, the wide variability of environments that medical devices might see, which can range from home to hospital, mean devices must be able to withstand varying disinfectant strengths, exposure levels and frequencies. Whether you are designing for a medical device housing or a surgical device in the operating room, we offer solutions to meet a wide variety of performance specifications and application needs.

It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

gate location, fill/pack/warp/cool) & material solution • Evaluates component design viability with preferred Avient material solution • Fiber analysis determines fiber orientation and length • Predicts part quality and manufacturability (shrink, warp, weld line location) FILLING PART QUALITYFIBER ORIENTATION Finite Element Analysis (FEA) • Virtually simulates how an application will perform in real-world conditions with a high level of precision • Able to represent a variety of problems, test methods, models and outputs to evaluate the design, process and material combination for validation or optimization • Dynamic - Acceleration - Impact - Break/no break - Transmitted force - Energy absorption • Thermal Mechanical - Temperature Computational Fluid Dynamics (CFD) - Heat path - Dominant heat transfer - Temperature mapping - Coupling with mechanical simulations FEA Simulation Capabilities • Static - Displacement/rotations - Stress and strains - Contact pressure - Reaction forces/moments - Factors of safety • Vibration - Eigen frequencies - Harmonic response ○ Harmonic displacement, acceleration and stress Software Used • Autodesk Moldflow • Digimat • Simulia/Abaqus • MSC Cradle • CAD/CAE - MSC Apex - SolidWorks Failure Mode Effect Analysis (FMEA) Support By leveraging mold filling simulation, multiphysics simulation, and the understanding of the link between design, process and material, we can help inform your decision-making process for product development.