Carson Thomas, PhD

Vice President of Strategy & Development at Konica Minolta Healthcare Americas, Inc.

PhD in Biomedical Engineering from Northwestern University

"Medical Device Innovation and Development: What it Means to be part of a Regulated Industry"

This session is an overview of the Medical Device product development process and the cross-functional teamwork needed to progress through this complex environment. All Medical Device companies, as part of a regulated industry, are required to follow a process outlined by the FDA (or other global regulatory organization) that is dependent on the type of innovation or product scope. Additionally, all companies have a business review process to evaluate opportunity, resources, risk and many other project aspects. We will discuss the regulatory process, the business review process, different team functions (Engineering, Marketing, Quality, Regulatory, Manufacturing, etc.), and the various stages or milestones in the product lifecycle (Concept Development, Feasibility, Development, Verification, Regulatory Clearance, Design Transfer, and Post-Market Activities). All of these aspects are intertwined and critical components in the product development and lifecycle process, and understanding the teamwork needed enables one to better navigate the complex Medical Device development environment.

Host: Professor Suzanne Olds