A Strategic Roadmap: Assessing Safety & Biocompatibility of Medical Devices

Previously Recorded on November 21, 2019

The regulatory landscape for the safety evaluation, clinical testing and commercial development of medical devices is undergoing considerable changes, including new requirements for material characterization and chemical risk assessment early on in the development process. In this webinar, toxicologist Dr. Joel Cohen (Gradient), and chemists Dr. Mark Jordi (Jordi Labs), and Dr. Jim Rice (Gradient) will discuss strategies for evaluating safety and biocompatibility of a device from the development stage through to market approval.

You will learn about:

  • Regulatory frameworks and guidance to establish that a medical device is safe for use in humans
  • The role of extractables and leachables testing in evaluating potential risks.
  • Non-targeted analytical methods that generate data adequate for toxicological risk assessment including extraction method design, analytical instrument/tool selection, selecting an analytical evaluation threshold (AET), sample manipulation, system suitability, calibration, identification/semi-quantification, and data reporting.
  • Predictive toxicology methods (e.g., computational toxicology programs, read-across, threshold of toxicological concern) for evaluating potential risks from extractable compounds.

Joel M. Cohen, Sc.D., DABT, Senior Toxicologist, Gradient. Dr. Cohen is a senior toxicologist with specialties in computational toxicology and human health risk assessment. At Gradient, his primary responsibilities include chemical hazard and risk assessment, consumer product safety evaluation, and non-clinical safety assessments of medical device and pharmaceutical components. Before joining Gradient, Dr. Cohen earned his doctoral degree at the Harvard School of Public Health, applying in vitro cellular models to study the fate, transport and toxicity of nanoparticles in the lung. He has authored several peer-reviewed articles and one patent, and presented his work to academic and general audiences. Dr. Cohen holds a Visiting Scientist appointment at the Harvard T. H. Chan School of Public Health where he researches the applications and human health implications of nanomaterials across the life cycle of nano-enabled products.


James W. Rice, Ph.D., Senior Environmental Scientist, Gradient. Dr. Rice is an environmental scientist specializing in contaminant transport and source identification, product safety, and new approaches for toxicity testing. He applies his expertise to cost allocation, litigation support, chemical compliance, and medical device assessments. Before joining Gradient, Dr. Rice was a postdoctoral research associate and state agencies liaison in Brown University's Superfund Research Program (SRP), where he served as a knowledge broker between the Brown SRP and its government and business stakeholders. During his doctoral and postdoctoral work, Dr. Rice evaluated the thermodynamics and phase behavior of polycyclic aromatic hydrocarbon (PAH) mixtures.


Mark Jordi, Ph.D., President, Jordi Labs. Dr. Mark Jordi is the President of Jordi Labs, a position he has held since 2006. During his tenure, Jordi labs has experienced 14 years of consecutive growth and has become a leader in the polymer analysis industry. Jordi provides over 2,000 analyses annually and offers more than 60 analytical techniques serving a wide range of industries including the chemical, pharmaceutical, and medical device industries. Dr. Jordi completed his B.S. in chemistry at Olivet Nazarene University and his Ph. D. at the University of Connecticut in the materials science division. His primary interests include development of improved strategies for identification and quantification of Extractables and Leachables as well as chromatographic and mass spectrometric analysis. Dr. Jordi is also an inventor and has developed a number of novel chromatographic stationary phases, some of which are patented. 


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