Embracing Change by Going Back to the Fundamentals in Medtech

Nelson Labs will host a three-day course with a focus on fundamentals that will identify considerations and challenges outlined in regulatory standards to allow for success in an agile environment. The courses will run Aug. 29th through Sept. 1st.

Omar Ford

August 24, 2022

2 Min Read
Image courtesy of GoodIdeas / Alamy Stock Photo

One of the hardest things to manage in any industry is change and the medical device industry has faced a great deal in recent months. The supply chain has been radically altered and there are serious sterilization constraints. 

Experts from Nelson Labs are aiming to help companies navigate these recent “changes” in an upcoming series titled "Focus on Fundamentals."

This 3-day Focus on Fundamentals course will identify considerations and challenges outlined in regulatory standards to allow for success in an agile environment. The topics of focus include navigating Biocompatibility, Packaging, and Sterilization changes and addressing the expectations around managing changes.

Day one will address current challenges in a continually evolving regulation environment using case studies to provide guidance on proper handling and/or product sterilization parameters. Both environmental considerations and product safety will be covered. Additionally, it will cover the unavailability of components and material shortages that can lead to lengthy delays or require product revisions to allow uninterrupted production. Such revisions require careful consideration of product bioburden, terminal sterilization, and potential sterilization residues.

Day two will tackle the supply chain disruptions that have necessitated a shift in how to manage work. While adding diversity and redundancy into your supply chain makes sense from a business perspective, any changes to packaging, devices or sterilization require thoughtful consideration as to impact. This presentation demonstrates how to tackle common packaging-related changes, using case studies to illustrate major points.

On the final day, experts will discuss changes in biocompatibility and biosafety. Many medical device manufacturers find themselves needing to make small changes to the materials and processing of their devices—for example, switching suppliers of an equivalent plastic resin or changing manufacturing location while keeping materials and processing the same. This presentation will give hands-on examples of real changes we have dealt with recently and provide feedback on evaluation of biocompatibility and documentation in the design history file.

Day 1

Title:  Ethylene Oxide & Radiation Sterilization: Evaluating the Impact of a Change

Date: Tuesday, Aug. 30, 2022

Time: 11 a.m. EDT

Day 2

Title:  Packaging: Evaluating the Impact of a Change

Date: Wednesday, Aug. 31, 2022

Time: 11 a.m. EDT

Day 3

Title:  Biocompatibility/Biosafety: Evaluating the Impact of a Change

Date: Thurs., Sept. 01, 2022

Time: 11 a.m. EDT

Click here for registration details.

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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