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).
By following this systematic approach,
which involves literature review, chemical
characterization, and biocompatibility tests, regulatory
requirements for assessing biocompatibility can be
effectively met. In my talk, I will delve into the
interplay between chemical characterization and
biocompatibility, exploring how these two aspects are
interconnected.