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James Lyons, PhD, MBA is an industry-recognized toxicologist and biocompatibility expert with over a decade of experience in biomedical research, testing, and the medical device industry. With a strong foundation in global medical device standards and regulatory expectations, James has consistently demonstrated leadership and innovation throughout his career.

James's journey into the medical device field began with his academic pursuits, earning a Ph.D. in Molecular Physiology from the University of Maryland School of Medicine and an MBA from the University of North Carolina's Kenan-Flagler School of Business. His professional path has included key roles at prestigious organizations such as Abbott, Depuy Synthes, WuXi Apptec, and Eurofins Medical Device Testing. At Abbott, James notably served as the Director of Global Biocompatibility, where he led efforts that resulted in significant cost savings and regulatory successes.

In 2024, James announced his departure from Abbott to embark on a new entrepreneurial venture—founding JL Tox Consulting. This move was driven by his passion for guiding startups and small to medium-sized companies through the complex regulatory landscape of medical device biocompatibility. His consulting firm specializes in providing personalized, expert advice on biocompatibility, toxicological risk assessments, and chemical characterization, aiming to expedite product market entry and ensure regulatory compliance.

James is an active member of several professional committees, including several AAMI BE - Biological Evaluation Committee working groups, the AdvaMed Biocompatibility working group, and Society of Toxicology reflecting his commitment to staying at the forefront of industry advancements. His dedication to the field and his clients is evident in his track record of successful regulatory submissions and his strategic approach to biocompatibility challenges.

Through JL Tox Consulting LLC, James continues to make a meaningful impact in the medical device industry, driven by a vision to help companies achieve their goals while maintaining the highest standards of safety and compliance.

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"I consider myself  fortunate to count JL Tox Consulting as a Medical Device Toxicology Colleague for the past 6 years. We have consulted with one another on numerous occasions regarding biocompatibility strategies  within the framework of ISO 10993-1:2018 Evaluation and testing within a risk management process and FDA: 2020 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

I have always been impressed with his in depth knowledge of  the current standards, especially ISO10993-18:2020 Chemical characterization of materials and chemical risk assessment and ISO10993-17:2002 Establishment of allowable limits for leachable substances.  His broad experience with in vitro/in vivo biocompatibility, chemical characterization, and toxicological risk assessment  are demonstrated in his practical approach to biocompatibility strategies and defense.  He applies this expertise while still keeping regulatory acceptability as a primary target.  However, and most importantly, James  never loses site of his primary goal – patient safety.  In my experience with James, his most important decisions have always been based on providing the right data to support patient safety.  He is a true asset for those seeking his consult to minimize regulatory hurdles but maximize patient safety.

Mark Cabonce, MSc, DABT
Medical Device Toxicologist
Dr. James Lyons, Founder/CEO of JL Tox Consulting
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