Workshop 3: Collective Call to Action: The Importance of Advocacy and Avenues for Engagement in Biomedical Engineering

Although the Society For Biomaterials was chartered to advance the science and safety of biomaterials in medical devices, through the decades we have come to realize that “standardized” testing has come to dominate the regulatory qualification of new or “me too” medical devices. Not only is repetitive standardized testing (and some unvalidated!) now required, but some protocols for standardized tests are even challenged. Most of this pseudo-rigor does not advance safety, is excessively redundant and is conducted in the false name of “risk reduction”.

All this money and energy for show, does not contribute to “biocompatibility” of medical devices, but instead serves to assuage the need to demonstrate false diligence. Presenters at this workshop will offer examples of such non-contributing testing, of overly zealous testing requirements which carry little scientific benefit (if any), and examples of how other biocompatibility issues were overlooked. The Workshop will invite experts recently involved in the significant revision of ISO-10993 which has been rebuked thus far by FDA. Experts on subjects such as material-mediated pyrogenicity,
sensitization and other standardized assays will be invited to reveal the lack of contribution to the science of biomaterials and safety for certain medical devices and materials.

Moderators:

Dr. Dawn Beraud
Executive Director
American Institute for Medical and Biological Engineering (AIMBE)

Jason Marvin
American Institute for Medical and Biological Engineering (AIMBE)