29 min listen
Biocompatibility Nuances and its Impact on Medical Devices
FromGlobal Medical Device Podcast powered by Greenlight Guru
Biocompatibility Nuances and its Impact on Medical Devices
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
38 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority of medical devices.
Today’s guest is Josh Crist, a biocompatibility expert who used to work for the FDA and is now with Biologics Consulting and he and Jon discuss the nuances of biocompatibility.
Some of the highlights of the show include:
● Best practices for biocompatibility include using the ISO 10993 test matrix for evaluating tissue, duration, and other factors.
● A common misconception about the test matrix is how the FDA determines and considers cumulative contact.
● Are all tests absolutely necessary? Are there other ways to reduce testing requirements? Consider chemical characterization and risk assessments.
● Josh describes challenges he experienced as both a biocompatibility consultant and FDA reviewer.
● What the FDA expects with chemical characterization: Master file, testing on final finished device, and more.
● Start with FDA’s biocompatibility guidance documents, interact early on with FDA during pre-submission process, and conduct quantitative and qualitative tests.
● “I promise…” days are gone. Other options for 510(k) to avoid getting additional information (AI) letter or not substantially equivalent (NSE) decision.
● Most common mistake made by companies when it comes to biocompatibility is not testing.
Today’s guest is Josh Crist, a biocompatibility expert who used to work for the FDA and is now with Biologics Consulting and he and Jon discuss the nuances of biocompatibility.
Some of the highlights of the show include:
● Best practices for biocompatibility include using the ISO 10993 test matrix for evaluating tissue, duration, and other factors.
● A common misconception about the test matrix is how the FDA determines and considers cumulative contact.
● Are all tests absolutely necessary? Are there other ways to reduce testing requirements? Consider chemical characterization and risk assessments.
● Josh describes challenges he experienced as both a biocompatibility consultant and FDA reviewer.
● What the FDA expects with chemical characterization: Master file, testing on final finished device, and more.
● Start with FDA’s biocompatibility guidance documents, interact early on with FDA during pre-submission process, and conduct quantitative and qualitative tests.
● “I promise…” days are gone. Other options for 510(k) to avoid getting additional information (AI) letter or not substantially equivalent (NSE) decision.
● Most common mistake made by companies when it comes to biocompatibility is not testing.
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson: Did you know ISO 13485 has been revised and approved in 2016? And is going to be published later this month. The quality management standard we’ve all grown to know is now being updated, and we’ll explain more on this episode of the Global Medical De... by Global Medical Device Podcast powered by Greenlight Guru