The world of physics has a foundation built on beautiful universal constants, which work their way steadfastly into the equations governing electrodynamics, and then further extend themselves into our very hands in the design of smart interconnected electrical devices that are commonplace to modern life. Ironically, universal constants form the foundation of life for which it is popularly said that the only constant is change. This constancy of change is also very well proven in the world of medical device regulation, perhaps especially with respect to biocompatibility and how chemical information fits into that puzzle. Over the past 5 years, the medical device community has swung from nearly full ignorance of the potential power of chemistry testing, to full adoration and acceptance, and now back – in a sense – to a state of scrutiny and skepticism. Regulators, in response to an influx of medical device submissions centered on supporting chemistry data, have increased their knowledge and finesse with the science and have been asking tough questions. Widely circulated studies have been critical of chemistry testing for toxicological evaluation of medical devices. Therefore, in response to this feedback, as medical device chemistry for toxicology (ChemTox) has matured, the overall strategy has changed dramatically on some points…
Medical Device Extractable and Leachables Testing in 2020
Chemical Characterization of Medical Devices and Compendial Testing Expert
Annelies Vertommen started her career at Nelson Labs as a Study Director for extractables and leachables projects for the pharmaceutical industry. In recent years, her focus changed to chemical characterization studies for the medical device industry. She closely follows all changes in this field by actively participating in the ISO10993-18 committee and following the discussions in the ISO 10993-17 committee.
Matthew R Jorgensen, Ph.D.
Chemistry and Materials Scientist
Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. To characterize materials, Dr. Jorgensen has extensively used a wide variety of techniques including GC/MS, LC/MS, FTIR, UV/VIS, SEM, NMR, and several types of advanced spectroscopic techniques. His Ph.D. in Physical Chemistry from the University of Utah was based on the fabrication and analysis of titanium dioxide and silicon dioxide photonic crystals templated from the three-dimensional structure found in the exoskeleton of exotic weevils. During his time at the University of Utah, he received the Henry Eyring Research Fellowship, the DOW Chemical First Year Scholarship, and additional grants to travel and present his research at national and international conferences. His research has resulted in over 30 peer-reviewed publications.