https://www.avient.com/news/polyone-develops-new-silicone-alternative-tpe-medical-tubing
Throughout 2019, the FDA issued multiple alerts regarding medical tubing and potential medical device shortages due to reduced supplies of siloxane, a key ingredient in silicone, and the closure of multiple ethylene oxide (EtO) sterilization facilities.
We are committed to leveraging our material science expertise to formulate alternative and customized solutions that meet regulatory demands and functional necessity for life-saving medical devices, especially in the face of market uncertainties.”
To learn more about solving your medical device and healthcare application challenges, visit the PolyOne team at MD&M West in Anaheim Feb. 11-13 in Booth #2201.
https://www.avient.com/knowledge-base/article/quality-design?ind[]=6598
Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals).
Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).
https://www.avient.com/knowledge-base/article/quality-design?rtype[]=1164
Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals).
Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).
https://www.avient.com/investor-center/news/polyone-announces-fourth-quarter-and-full-year-2016-results
Liquidity is calculated as follows:
Below is a reconciliation of Adjusted EBITDA to the most directly comparable financial measure calculated and presented in accordance with GAAP.
Below is a reconciliation of Net Debt to the most directly comparable financial measures calculated and presented in accordance with GAAP.
https://www.avient.com/products/thermoplastic-elastomers/versaflex-hc-thermoplastic-elastomers
Learn about design considerations that improve device interaction and performance.
TPE in Medical Device Saves Costs
Medical devices
https://www.avient.com/sites/default/files/2021-11/eccoh-5565-antenna-power-cable.pdf
https://www.avient.com/resource-center?document_subtype=216&document_type=59&page=1
Thermoplastic Elastomers in Medical Devices - White Paper
Safety factors, barrier properties and applications of TPEs in medical devices
https://www.avient.com/news/archives?page=58
– To help medical device manufacturers develop ways to address healthcare-associated infections (HAIs), PolyOne is launching two new
ANAHEIM, Calif. – PolyOne Corporation is highlighting materials, colorants, and expert resources for medical device housing and component applicatio
https://www.avient.com/sites/default/files/2021-04/edgetek-nylon-power-tool-case-study-one-pager.pdf
POWER TOOL
MANUFACTURER
P I S T O N R I N G A N D
C O N N E C T I N G R O D F O R
P O W E R T O O L
• Exceptional mechanical properties
• Good wear and abrasion resistance
• High purity and light weight
• Worked directly with the manufacturer from
design to molding to better understand and
satisfy key requirements
• Improved strength, stiffness and stability
with one-stop technology service to best
meet customer’s needs
• Provided lightweighting solution to help
customer achieve its sustainability goal
Edgetek™ PK PEEK Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/sites/default/files/2021-04/trilliant-hc8900-medical-device-housing-case-study.pdf
DEVICE
MANUFACTURER
M E D I C A L D E V I C E H O U S I N G
• Improved chemical resistance compared to PC/ABS,
PC/PET & COPE
• Flame retardant (FR) rating of V-1 at 0.75 mm
• Zero BPA & non-halogenated FR material
• Available in standard hospital grade pre-colors
• Provided a cost-effective material with superior
chemical resistance to traditional materials
• Formulated a medical-grade, semi-crystalline
blend to support regulatory testing and
approvals
• Demonstrated superior property retention and
crack resistance after exposure to hospital-
grade disinfectants, including Virex® Tb,
helping to extend the device life
Trilliant™ HC8900 Thermoplastics
KEY REQUIREMENTS
WHY AVIENT?