Dr. Kumaravel is an esteemed Fellow of the UK Royal College of Pathologists, Diplomate of the American Board of Toxicology, and UK/EU Registered Toxicologist. With over 30 years of expertise in Biocompatibility and Toxicology, he has made lasting contributions in both industry and academia. Dr. Kumaravel specializes in Biocompatibility testing of Medical Devices, developing tailored testing strategies and comprehensive Biological Safety Assessments. He is recognized for successfully defending biocompatibility reports with regulatory bodies like the FDA. Beyond his involvement with notified bodies and regulatory agencies, Dr. Kumaravel conducts enlightening biocompatibility training sessions, empowering medical device regulators and manufacturers in ISO10993 compliance.

Dr. Kumaravel obtained MBBS, MD, and PhD degrees from the prestigious Medical University in Chennai. He has conducted impactful toxicology research at Hiroshima University in Japan and worked as a Fogarty Fellow at renowned institutions such as the National Institutes of Health in the USA. Additionally, he served as a National Cancer Institute fellow at Princess Margaret Hospital in Canada. He then transitioned to the industry, where he has worked with leading organizations including Unilever, Covance Laboratories, British American Tobacco, and Huntingdon Life Sciences, consistently delivering exceptional service to international clients.

Dr. Kumaravel has an impressive publication record with over 100 scientific reports on medical device safety assessment, 40+ peer-reviewed toxicology and biocompatibility publications, and has presented over 50 conference papers. He is also a dedicated mentor to PhD students in Toxicology and Biocompatibility, focusing on genetic and molecular toxicology. His research explores the complexities of medical devices, biomaterials, and nanomaterials, while pioneering innovative methodologies for studying human toxicity.

Interlinking Chemical Characterization with Biocompatibility Assessment: A Critical Regulatory Requirement

Dr. T S Kumaravel, Biocompatibility Expert and Chairman, GLR laboratories Pvt Ltd

The field of biocompatibility is a rapidly evolving area with a growing emphasis on conducting thorough assessments to meet regulatory requirements for medical devices. Regulatory bodies such as the FDA, notified bodies, and ISO regularly update their criteria to ensure the safety of medical devices. Previously, compliance efforts focused primarily on completing checklists without considering the broader picture. However, there is a current shift towards a holistic perspective, where regulatory bodies consider all aspects of biocompatibility and their potential impacts.

In this context, it is important to recognize the crucial role of chemical characterization in biocompatibility assessment. The design of chemical characterization should be aligned carefully with biocompatibility endpoints. The Biological Evaluation Plan (BEP) serves as the foundation for chemical characterization, encompassing a review of relevant material information and associated toxicology data from literature sources. It establishes the necessary conditions for conducting chemical characterization, including solvents, extraction methods, and Allowable Exposure Limits (AET).

Upon completion of chemical characterization, the data is subjected to toxicological risk assessment to determine if any biocompatibility endpoints can be waived. The remaining biocompatibility tests are then carried out. The comprehensive results obtained from the literature review, chemical characterization, and biocompatibility tests are subsequently summarized in the Biological Evaluation Report (BER).