Over 40 years of product development and management experience in the medical device industry, including the development of bioactive glass products, orthopedic and dental bone graft materials, nano materials for drug delivery and other applications, and allograft and xenograft products. I have held positions with medium and large orthopedic companies (Howmedica, Tutogen Medical/RTI Biologics) and a number of start-ups, including USBiomaterials, Pulse Therapeutics and NovaMin Technologies. I started Spinode Consulting 14 years ago and I have served clients large and small. My services have included product development, quality assurance with an emphasis on Design Control, and regulatory matters in the medical device space. I have served on the editorial boards of a number of biomaterials and materials science journals and have been adjunct faculty in Materials Science at the University of Florida and Clemson University. I have been a grants reviewer for NIH on the SBIR program for 12 years. I also serve on ASTM F04, Medical Devices, specifically F 04.13 - Ceramics and Glass, and I am a member of the U.S. delegation for ISO TC150 and TC 192. I have been responsible for the creation of standards related to bioactive glasses.Specialties: product development, implantable biomaterials, quality assurance, intellectual property, materials analysis