Medical device chemical characterization testing per ISO 10993-18 is often the leading source of delay, cost overrun, and regulatory questions in a manufacturer’s biocompatibility program. Problematic study outcomes tend to be associated with a few recurring issues, with most difficulties arising not from the analytical chemistry itself, but rather from key decisions made throughout the process.
This 60-minute webinar will discuss real-world case studies that encountered testing challenges. The program will present solutions that highlight the importance of extractable study design, cross-functional integration with toxicologists, clinical use considerations, and regulatory alignment to optimize testing outcomes and reduce the potential need for retesting.
Case study topics include:
- Overly aggressive extractable studies: problematic outcomes from strictly following the ISO standard as well as reasonable alternatives
- Simulated use study considerations: what constitutes a clinically relevant worst case, and how to refine the testing and assessment approach
- Challenges with testing of degradable/resorbable devices and alternative strategies to consider
- Cross functional evaluation planning for an integrated risk narrative
An audience Q&A session will follow the technical presentation.
Speakers:
Robert Mueller, Toxicologist, Nelson Labs
Robert Mueller is a Toxicologist at Nelson Labs, who has eight years of experience working in the medical device industry. He has developed a unique perspective on testing from working for both a contract research organization and a medical device manufacturer. During his time with the medical device manufacturer, Robert planned and managed the execution of biological testing and chemical characterization and wrote toxicological risk assessments for both MDR and 510(k) submissions. He is an ISO 10993-18 subject matter expert, who has designed custom studies for a broad range of medical devices to meet the biocompatibility requirements outlined in ISO 10993. Robert has provided all levels of regulatory support to a wide range of medical device companies. His expertise includes developing and qualifying analytical methods as well as conducting analytical data reviews. Robert has also authored regulatory body submissions and deficiency responses.
Taryn Meade Brow, Sr. Manager, Technical Consulting, Nelson Labs
Taryn Meade Brow serves as the Senior Manager for Technical Consulting at Nelson Labs has over a decade of experience in medical device and pharmaceutical product development, biological safety evaluation, chemical characterization testing, and toxicology, along with a strong track record of collaboration with global regulatory agencies and involvement in the standards development process for the ISO 10993 series of standards. Taryn has degrees in Chemistry and Bioethics, and is an expert in design of testing and evaluation strategies for complex medical devices and combination products.
Moderator:
Amanda Hosey, Editor, SAE Media Group
