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The Current Regulatory Acceptance of In Vitro Alternatives for Biocompatibility

Published Date: May 17, 2022

In 2018 ISO 10993-1 was released. This new revision of the main biocompatibility standard focused on a risk-based approach for evaluating biocompatibility. It placed an emphasis on the 3Rs of animal testing: reduction, replacement, and refinement.

In 2021 the revolutionary 10993-23 was released, emphasizing the use of an in vitro irritation test over the traditional rabbit irritation test.

In this webinar Thor Rollins, Ron Brown, and Kelly Coleman, Ph.D., will discuss the current status of in vitro testing in the medical device industry, the FDA’s current stance on the testing, the benefits of in vitro alternatives, and the prospect of animal testing in the future.

Thor Rollins

Thor Rollins

Biocompatibility Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...


Ron Brown

Owner and Principal Toxicologist, Risk Science Consortium, LLC

Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. While at the FDA, he served in a number of leadership roles in standards development organizations. At the international level, he served for many years as convener of ISO TC194 WG11, which is responsible for the development and revision of the ISO 10993-17 standard, Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances. At the national level, he represented the United States as an expert on ISO TC194 WG11 and served as co-chair of the AAMI Biological Evaluation Committee. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.


Kelly Coleman, PhD

Distinguished Toxicologist

Kelly Coleman is a distinguished toxicologist and technical fellow at Medtronic, where he provides preclinical product-development support across the company. He is also a U.S. expert on ISO Technical Committee 194’s Working Group 11, which is responsible for the medical-device toxicological-risk-assessment standard (ISO 10993-17) and a U.S. Expert on Working Group 8, which is responsible for the skin-irritation and sensitization testing standards (ISO 10993-10 and ISO 10993-23). In this role, he co-directed a successful international round-robin study, which proved that 3D human-skin models are suitable replacements for the rabbit skin irritation test. Kelly earned his Ph.D. in Toxicology from the University of Minnesota. He is a diplomate of the American Board of Toxicology, a European-registered toxicologist, a fellow of the Academy of Toxicological Sciences, and is certified in regulatory affairs. He is a past president of the Society of Toxicology’s In Vitro and Alternative Methods Specialty Section and the Medical Device and Combination Product Specialty Section. He also recently served on the National Institute of Health’s Scientific Advisory Committee on Alternative Toxicological Methods. In 2017 Kelly was inducted into Medtronic’s Bakken Society, which is the company’s highest technical honor.

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