Dr. Schmidt combines development and regulatory expertise spending more than 25 years developing medical devices for large corporations and small start-ups as well as more than 5 years as a regulator analyzing Class III devices to issue regulatory approvals for new products.
Most recently, Dr. Schmidt spent 11 years with K2M leading developmental research on spine pathology to improve surgeon planning prior to spine surgery. Prior to K2M, Dr. Schmidt’s experience includes Intermedics, Quetzal Biomedical, and BSI (Notified Body). At BSI, Dr. Schmidt focused on evaluating Class III medical devices under the MDD and the AIMD, issuing regulatory approvals to companies such as Johnson & Johnson, CR Bard, and Becton Dickinson. In 2018, Dr. Schmidt filed 7 patents on technology in the spine field alone.
Dr. Schmidt received a BS in Physical Metallurgy from Washington State University and MS and PhD in Bioengineering from Clemson University.