Biocompatibility is often treated as a milestone, a box to check on the path to regulatory approval. In reality, it is the cumulative outcome of hundreds of decisions made long before a device ever reaches a test lab. Every choice in materials, manufacturing processes, geometry, packaging, and sterilization shapes the biocompatibility profile of a medical device. When viewed through this lens, biocompatibility is not a test, but a design philosophy. Because all roads, no matter where they begin, eventually lead to biocompatibility, it is essential to consider biological safety throughout the design and development process. Read the full article to learn how a proactive approach to biocompatibility can help support regulatory success and patient safety.
Design and Development Roads Converge at Biocompatibility
Published In: Medical Product Outsourcing (MPO) Magazine
July 9, 2026
Audrey Turley
RM (NRCM), CBA (ASQ)
Biocompatibility Expert
Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert, having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...
Logan Luke
Packaging Expert
Logan has worked at Nelson Labs since 2018. He has worked in the sterilization, microbial IDs, and packaging departments. He has extensive knowledge in the packaging section and has aided many customers with their package-testing needs, from the benchtop to troubleshooting and validation design. He is well versed in a broad spectrum of packaging tests,...
Robert Dieker
Expert Consultant
Robert Dieker has over a decade of experience in the medical device testing industry, with extensive expertise in supporting the biological safety evaluation of medical devices through technical consulting, laboratory coordination, and regulatory risk assessment activities. His expertise includes the development of Biological Evaluation Plans (BEPs) and Reports (BERs), material characterization evaluations, and interpretation of biocompatibility data in accordance with the ISO 10993 series and ISO 14971. Prior to his consulting work, Robert served as a Study Director, where he designed and executed studies related to sterilization validation, dose audits, and routine bioburden testing. His hands-on laboratory background strengthens his ability to provide practical testing strategies, develop clear technical documentation, and support regulatory submissions for global markets, including FDA and MDR. Robert also contributes to industry initiatives through standards working groups, cross-functional collaboration, and internal training and mentorship activities.
