Webinars
ON-DEMAND: Solution Development For Engineered Resins
12.04.18
The development of new products always has unknown issues when it comes to performance, compatibility of materials, shelf life and aging. When one is trying specific materials, the final materials selected will be required to fit together into the entire device and function per the device requirements. One would call this "fit for use" per the final application. Not only are the form, fit and functionality important, but the material must be able to pass all regulatory hurdles around the globe.
The list of attributes one must consider will depend upon the final use that may include assembly, special packaging, sterilization, and one item many companies spend more time on - aesthetics. This webinar will help outline many of these attributes and aid in the development of a materials selection process.
The list of attributes one must consider will depend upon the final use that may include assembly, special packaging, sterilization, and one item many companies spend more time on - aesthetics. This webinar will help outline many of these attributes and aid in the development of a materials selection process.
SPEAKERS:
Gaurav Kapoor
CTO - Spectrum Plastics Group
Larry Wallace
Senior Staff Scientist - Spectrum Plastics Group
CTO - Spectrum Plastics Group
Larry Wallace
Senior Staff Scientist - Spectrum Plastics Group
MODERATOR:
Sean Fenske
Editor-In-Chief - MPO / ODT
ON-DEMAND: Irritation Testing Is Becoming Less Irritating
10.24.18
Medical devices around the world are required to be assessed for biocompatibility to determine how the materials and manufacturing processes affect the patient based on contact type and duration. There are three basic tests in this analysis that are applicable for every medical device: cytotoxicity, sensitization, and irritation. We call these the "Big Three". While these tests provide valuable information and protect patients, they also come at a cost in animal lives. Until recently, only cytotoxicity was performed in vitro, meaning "in glass" or not using animals; while sensitization and irritation testing still require the use of animals. Earlier in 2018 a series of articles was published in Toxicology In Vitro reporting data from an international Round Robin study to determine the reliability and predictivity of an in vitro irritation method for assessing medical devices. This data is driving change in irritation testing impacting international testing standards (ISO 10993-10) and seeking regulatory acceptance in the US. In this webinar, we will discuss the history of irritation testing, the innovations that have lead to this change, the incorporation of the method into international acceptance, and where the method is in all of this process.
SPEAKER:
Audrey Turley
Senior Biocompatibility Expert - Nelson Labs
MODERATOR:
Sean Fenske
Editor-In-Chief - MPO / ODT
