Bench to Community Seminar - Series 1 , Session 1: Introduction - Translating New Ideas Into Clinical Practice

This course introduces the multiple factors involved in translating new solutions for unmet needs into clinical practice reality. The session provides an overview of the process of innovation from need identification and solution concept creation, developmental steps, and regulatory influences for commercialization of a finished medical product. VCU medical, academic, and support staff and will receive introductions to VCU resources for innovation and development assistance. This course provides a summary for potential future expansion into a series of sessions focusing on key topic areas. Attendees will gain an understanding of the product development, essential steps in the patent process, funding and commercialization, and medical regulatory and reimbursement elements in order to move their ideas into clinical practice.

Topics

• Overview of Clinical Need to Community Deployment
• Engineering and prototype development
• Patent process: invention disclosure, provisional patent, non-provisional patent, International PCT application
• Avenues for licensing and start-up development and funding
• Regulatory and reimbursement requirements for US medical device classes, 510(k) pathway, PMA pathway, CMS reimbursement

For more information on this seminar, please visit https://iem.vcu.edu/events/bench-to-community/nov-6-20/

To learn more about the Bench to Community Series or to sign up for an upcoming session, please visit https://iem.vcu.edu/events/bench-to-community/