Why is cytotoxicity testing critical in medical device development?
Cytotoxicity testing is a critical step in medical device evaluation, but it comes with many challenges. Factors like device composition, sample preparation and contamination can impact biocompatibility results. With so much riding on accurate safety data, it is essential to understand the challenges and considerations for skillful navigation.
What are the challenges in cytotoxicity testing?
Cytotoxicity testing determines if a device damages cells, indicating potential toxicity. Devices must be tested to verify biocompatibility in order to satisfy regulatory requirements before they can be brought to market. While testing for cytotoxicity generally follows a routine procedure, it is not unusual to experience unexpected drawbacks during testing. The test method, device size and shape, extraction medium and lab procedures can all influence outcomes. With so much complexity surrounding cytotoxicity testing, it is crucial to have an experienced laboratory testing partner.
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How does Labcorp provide quality results?
Overcoming testing obstacles
Cytotoxicity testing can face real-world complications that deviate considerably from theory. At Labcorp, we mitigate issues from factors like sample size, shape and composition by leveraging extensive experience with different assays and diverse medical devices. Our team prioritizes identifying problems early and determines solutions to deliver reliable data.
Advancing alternative methods
Given the growing interest in replacing animal testing with new in vitro alternative approaches, we stay current on the latest research and regulatory guidance. Consider the In Vitro Skin Irritation assay: upon acceptance by regulatory authorities, this alternative to In Vivo Irritation is expected to improve animal welfare in the preclinical device testing realm. The In Vitro Skin Irritation assay is just one of many alternative assays our team continues to research and develop, demonstrating our commitment to refining, reducing and replacing animal studies.
Interpreting results accurately
Detecting cytotoxicity requires nuanced morphological grading. Our consultants are well versed in rating cellular changes from none to severe per ISO 10993-5 criteria. We provide clients clear analysis on their device’s biocompatibility.
Labcorp’s dedicated specialists help you successfully navigate the unexpected challenges of cytotoxicity assessments. With more than 40 years of experience in preclinical medical device testing and consulting, we deliver reliable and comprehensive safety assessments to advance your device development program.