biocompchatibility

Lisa Olson, NAMSA’s Global Director of Analytical Services joins Sheri and Don on this special episode.  As Lisa is a recent addition to the NAMSA team, our hosts ask about her background, her thoughts on the future and present state of biocompatibility, and most specifically the use of chemical characterization in the biological evaluation strategy.  The hosts also introduce a new game of 2 truths and a lie, for biocompatibility.

“Biological testing and chemical testing have traditionally been separated out from one another .….I’m excited to join in on the analytical chemistry side to be able to create that blending of the thought process.” – Lisa Olson

“Chemical characterization plans require a variety of scientific disciplines.” – Lisa Olson

“Wolverine is a mutant.” – Don Pohl

Key Discussion Points Include:

  • The “and” vs “or” of chemical characterization in 10993-1
  • The importance of linking biocompatibility testing and chemical testing to aid the evaluation process
  • The risk of assuming all materials are good without knowing what is exactly leaching out of them
  • The future challenges of knowing more and how to use that data

To connect with Lisa, you can find her here at: https://www.linkedin.com/in/lisa-olson-09659511/.

Also be sure to check out our Biocompatibility Strategy Navigator.

Host Information

 

Lisa M. Olson, MBA

Global Director of Analytical Services, NAMSA

Lisa has over 20 years’ medical device industry experience, including laboratory operations, research and development, service development, market development and executive leadership, as well as international standards development. Lisa brings a multifaceted view to strategic growth and organizational transformation within highly regulated businesses. Lisa received her undergraduate degree in Microbiology from the University of Minnesota and her Masters of Business Administration from the University of St. Thomas.

 

Sheri Krajewski-Bibins

Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl

Principal Product Development Strategist, NAMSA

Don holds a Bachelor’s degree from Ohio State University. He has over 25 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.