Steps to Market Medical Devices or Diagnostic Tests

23 Sep Steps to Market Medical Devices or Diagnostic Tests

Description

As research coordinators, you work on research studies involving drugs, medical devices, and diagnostics. What are the steps needed to take to get a product into the medical setting? This presentation will provide an overview of the commercialization process, FDA requirements, and the types of expertise needed to take an idea from bench to patient.

Schedule of activities

• 11:30-11:45 – registration and lunch
• 11:45-11:50 – welcome and intro
• 11:50-1:20 – presentation, interactivity, Q&A
• 1:20-1:30 – thank you and feedback survey

Learning objectives

By the end of this session, you will be able to:

• Identify steps to bring a product to market
• Identify expertise needed to bring a product to market
• Identify challenges to bring a product to market

About the speaker

Terri Butler, PhD Director of Research Partnerships, ITHS

Dr. Butler is the primary contact for the Drug and Device Advisory Committee. Over her career, she has worked in nearly every aspect of commercialization, from invention, product development, regulatory management and manufacturing to sales and marketing.  She has been at large companies and small, including 3M, Bioenergy Life Sciences, and multiple university spin-out companies. Products she has commercialized include monoclonal antibodies, cardiac products, pharmaceutical release liner, nutritional formulations, and several non-medical technologies in the high tech materials field.  She is an inventor on 13 patents in coating processes, chemical formulations, and nutritional applications.