Strategies for a Biomaterial World: A Regulatory and Clinical Affairs Perspective

We live in a “biomaterial world” and we’re dependent upon biomaterials for the delivery of therapeutics as diverse as artificial hearts, vascular grafts, orthopedic implants and sterile disposable products.  A decade ago “combination products” were considered a new frontier in medical devices, but now the need to engineer biologics and drugs with compatible biomaterials is commonplace.  Tissue engineering and nanotechnology are today’s fertile ground for innovative medical devices, stretching our understanding of how biomaterials are safe and functional.  As we develop the new products requiring more than a decade of R and D, how do we anticipate the future user needs, translate these needs into specifications, plan and conduct pre-clinical and clinical evaluations, and deliver the evidence of safety and effectiveness required for regulatory approval?  And, how do we do this while the goalpost is moving ever outward, with escalating requirements for biocompatibility testing, expectations for perpetual reliability and infinitesimal risk, plus demands for lower and lower costs?  And, how will we do all this with a receding US chemical industry, raw material scarcity, pressure to reduce the hydrocarbon footprint that brings us the feedstock for current biomaterials, with older and older Americans needing expert medical care?  This presentation will challenge the audience to contemplate the evolutionary trends shaping the medical device industry, new medical product development strategies and regulatory constraints.