Trends, Best Practices, and Analytical Challenges in Chemical Characterization of Medical Devices—a Roundtable Discussion

Event Overview:

Chemical characterization (or assessment of extractables and leachables [E&L]) of medical devices, including drug-device combination products, is an essential aspect of the regulatory review and approval of these devices globally to ensure safety for their intended use. It is an analytical process that identifies and quantifies the constituent chemicals of medical devices that may be released during their use. Chemical characterization involves a broad range of studies, designed specifically for each device based on the type of tissue contact and duration, with analytical outputs for toxicological risk assessments. This roundtable discussion will provide an open forum for discussing the current trends, best practices, and the associated analytical challenges in characterizing medical devices. The panelists will also discuss the regulatory trends they see for medical device chemical characterization (E&L studies) in the future.

Key Learning Objectives:

Understand key considerations for medical device chemical characterization (E&L assessment)
Assess recent regulatory expectations, including the recently released US FDA Chemicals List for Analytical Performance (CLAP) and changes in the field of medical device chemical testing over the last few years
Discuss the chemical characterization process and the associated critical analytical challenges to comply with regulatory and ISO expectations

Who Should Attend:

Researchers interested in medical device characterization
E&L analysts and lab managers
Quality assurance experts in the medical device industries
Regulatory affairs professionals
Medical device development professionals

Featured Speakers:

Dujuan Lu, PhD

Global Lead, E&L

SGS Health Science

Dujuan Lu, PhD, serves as the head of the E&L team at SGS Health Science. She has extensive contract research organization (CRO) and pharmaceutical/medical device industry experience with more than 800 E&L projects on a broad range of packaging systems, including process materials, pharmaceutical finished packaging, and medical devices. As a subject-matter expert in the E&L field, she frequently presents at various conferences as an invited speaker and technical session chair. She was named one of the top 60 most influential people working in the pharmaceutical industry in The Medicine Maker’s 2020 Power List. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and BS in chemistry from Nanjing University in China.

Jianwei LI, PhD

Principal Consultant and Technical Writer

Chemical Characterization Solutions, LLC

Jianwei Li, PhD, is the principal E&L and chemical characterization consultant and technical writer at Chemical Characterization Solutions, LLC. He worked at Medtronic for nearly 17 years as a technical fellow and subject-matter expert in chemical characterization of medical devices. Jianwei has run nearly 200 projects on implantable and drug-device combination medical devices. Over the course of his nearly 30-year academic and industry career, his works on analytical chemistry have been published extensively, with nearly 50 publications, 10 of which were devoted to the chemical characterization of medical devices during the last 3 years. He received his PhD in analytical chemistry from Purdue University and did his postdoctoral research at the University of Minnesota.

Steve Zdravkovic, BS

Research Scientist

Baxter International

Steve Zdravkovic, BS, is a research scientist II at Baxter International, which he joined in February 2021. Previously, he worked for 16 years in the E&L team at PPD. In these roles, Zdravkovic has been responsible for all aspects of E&L studies with a focus on the design and execution of screening studies using mass spectrometry-based techniques. Zdravkovic has published 9 peer-reviewed journal articles that pertain to various areas of research within the E&L field. He is a member of the editorial board of the PDA Journal of Pharmaceutical Science and Technology. Zdravkovic holds a bachelor of science degree in chemistry and mathematics from the University of Wisconsin-Whitewater.

For any technical questions please contact Jordan Ramesh: jramesh@mjhlifesciences.com

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Trends, Best Practices, and Analytical Challenges in Chemical Characterization of Medical Devices—a Roundtable Discussion

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