Safer Medical Devices – In Vitro Assays As Part of a Biological Evaluation

In this webinar, the speakers will discuss the uses of in vitro assays as a part of the risk assessment and biological evaluation for the following endpoints: cytotoxicity, skin irritation and skin sensitization.

The presentation will introduce biological evaluation and biocompatibility testing of medical devices, with focus on in vitro assays for skin irritation and skin sensitization now implemented in the ISO 10993-23:2021 and ISO/FDIS 10993-10:2021. For assessment of skin sensitization, the GARD™-technology will be introduced and the speakers will discuss how it can be used as a part of a biological evaluation.

The webinar will conclude with customer cases where in vitro assays, including GARDskin Medical Device assay and GARDskin Dose-Response, have been successfully utilized for risk assessment as part of the biological evaluation and for risk-based decision-making in compliance with the principles of the 3Rs throughout the product life cycle.

A highly accurate and ethical alternative

An exciting evolution is ongoing in the medical device toxicology field, transitioning from a process that largely relied on the results of animal testing to one which is increasingly focused on the use of in vitro methods for the safety assessment of medical device materials. A big step towards replacing animal testing for medical devices was taken when in vitro skin irritation testing using Reconstructed human Epidermis (RhE) tissue was implemented in the ISO 10993-23 standard published earlier this year. Moreover, in vitro assays for skin sensitization have been included in the updated ISO 10993-10.

In vitro biocompatibility package

The in vitro biocompatibility package includes testing of the three endpoints that need to be evaluated for all medical device products: cytotoxicity, skin irritation and skin sensitization, offering a solution for customers looking for a highly accurate and ethical alternative for testing of materials and medical devices.

Cytotoxicity

The endpoint cytotoxicity can be tested in vitro using qualitative and quantitative test methods as described in ISO 10993-5:2009 and have a history of use both for regulatory purposes and as a screening tool early in the product development phase.

Skin irritation

The endpoint skin irritation using RhE-tissue according to ISO 10993-23:2021 provides human relevant results with higher accuracy and less false positive results compared to the rabbit model.

Skin sensitization with GARD™

The endpoint skin sensitization can be assessed in vitro using the GARDskin Medical Device assay, based on a state-of-the-art technology GARD; including human immunological cells, a specific genomic biomarker signature and a machine learning-assisted classification-model. The GARDskin Medical Device assay enables the medical device industry to perform in vitro skin sensitization testing of both saline and oil extracts from devices or materials as described in ISO 10993-12 and FDIS/ISO 10993-10:2021, thus mimicking the intended use of the device when in contact with skin.

Speakers

Rose-Marie Jenvert, PhD, Product Manager, SenzaGen AB

As a Product Manager at SenzaGen, Dr. Rose-Marie Jenvert is responsible for managing new GARD applications, being the link between the market and the internal organization. She also acts a medical device expert, contributing with her extensive knowledge from the medical device industry, previously working at Gambro/Baxter as study director for biocompatibility studies and currently as an expert in ISO/TC194 updating the standards for skin sensitization and skin irritation (ISO 10993-10 and -23). She also brings many years of experience working with R&D, method development and QA at AstraZeneca and Johnson & Johnson. Dr. Rose-Marie Jenvert holds a Master of Science in Molecular Biology from Lund University and a PhD in Cell Biology from Stockholm University.

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Tim Lindberg, PhD, Key Account Manager, SenzaGen AB

As an experienced scientist in the in vitro assay development field, Dr. Tim Lindberg brings knowledge on both mechanistic and technical aspects. Coming from a commercial sales role in the biotech industry, after having obtained a Master of Science in molecular biotechnology and a Doctor of Philosophy in Immunotechnology from Lund University, he has a vast understanding of immunology and genomics and how they serve the needs of the industry. In addition, Dr Lindberg is a co-developer of the GARD platform and holds a patent related to the technology. He currently serves as a Key Account Manager at SenzaGen.

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