Digital Preanalytics - a US perspective

This conversation from mid‑2025 captures Christa Cobbaert at a pivotal moment in IVDR evolution. She reflects on the regulation’s origins, unexpected consequences for laboratories and industry, and the missing pathways needed to protect innovation and rare disease diagnostics. She also reveals how BioMed Alliance, MedTech Europe, and EFLM worked behind the scenes to push for change, which led to the EU’s IVDR amendment proposal published in late 2025. This proposal is currently open for feedback, where stakeholder influence continues. After the feedback phase, the proposal will move through the legislative processes of European Parliament and Council.

In this episode of Greiner Bio-One Talks, Prof. Ana-Maria Šimundić welcomes Timo Kouri, lead author of the 2023 EFLM Urinalysis Guideline and professor emeritus at the Department of Clinical Chemistry, University of Helsinki. Together, they discuss the significant updates in urinalysis, including advancements in automation, new accreditation standards, and best practices for preanalytical processes. Listeners will gain valuable insights into minimizing errors, improving sample collection, and ensuring proper urine preservation. The conversation also covers the evolving landscape of urine biomarkers and memorable moments from Dr. Kouri’s distinguished career, providing practical tips for medical professionals and laboratory staff.

Listen in as Dr. Cradic and Prof. Simundic explore the challenges of hemolysis detection in clinical labs, discussing automation, standardization, and the importance of quality assessment.

This podcast explores in depth the topic of in vitro hemolysis. Join us as Professor Gian Luca Salvagno discusses his experience and thoughts with Greiner Bio-One's global director of clinical and medical affairs, Ana-Maria Simundic. Gian Luca Salvagno brings many years of experience in the field of preanalytics, both from the practical side as a medical doctor and currently as director of a clinical laboratory as well as in the academic research in his position as professor of clinical biochemistry at the University of Verona. Find out more about the challenges hemolysis brings to the laboratory, as well as risks and possible mitigation measures for accurate analysis results.

Join our insightful discussion with Jaffar Khiariy, Head of the Department of Pathology & Laboratory Medicine at the renowned King Faisal Specialist Hospital and Research Centre in Jeddah, Saudi Arabia on evolving digital workflows and monitoring capabilities in the preanalytical phase. King Faisal Specialist Hospital & Research Centre: https://www.kfshrc.edu.sa/en/home CBAHI - Saudi Central Board for Accreditation of Healthcare Institutions: https://portal.cbahi.gov.sa/english/home

Join us as we host Dr. Jaime Noguez, section head of clinical chemistry at UH Cleveland, discussing digital solutions, automation, and AI in preanalytics. Discover what makes a great phlebotomist from her professional and personal experience in this insightful episode.

Professor Dr. Waleed Al Tamimi, head consultant of the clinical biochemistry lab at the King Abdulaziz Medical City in Saudi Arabia, shares his expertise and experience in converting to using safety products to promote healthcare worker safety and risk management.

Mads Nybo, chief physician at the Clinical Biochemistry department of the Odense University Hospital shares his views on and experience with sustainability in the medical sector.

Dr. David Grenache, now retired, former Chief Scientific Officer at TriCore Reference Labs in Alberquerque, New Mexico, shares his views on glucose stabilization methods with our host Ana-Maria Šimundić.

Henk Ruven, clinical chemist at St. Antonius Hospital, Netherlands and our host Ana-Maria Šimundić discuss the role of digital solutions, AI and automation in the field of preanalytics.