Mike Winegar, Vice President of Regulatory Affairs for Medpace Medical Device presented at the Medtech Investing conference in May 2012.
His session was titled: Obtaining Regulatory Approvals for Medical Devices in a Global Market. Here is a brief outline of his talk.
For the emerging or start-up medical device company, corporate objectives and budgets often revolve around clinical trials. Very often, the success or failure of the company mirrors the success or failure of those early clinical trials. In this session, Mike Winegar will be discussing:
• How the strategic design, geography, and execution of early-stage clinical trials can have a tremendous impact - positive or negative - on future product and company success
• Designing a trial to meet financing, regulatory, and/or marketing objectives
• The advantages and pitfalls of various global medical device clinical trial scenarios