New regulations and Corporate Finances-Patrick Lee-05/30/2017 - 8:30am

Event Information
Event Topic: 
New regulations and Corporate Finances
Event Date: 
05/30/2017 - 8:30am
Event Location: 
Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale
Speaker Information
Event Speaker: 
Patrick Lee
Event Speaker Title: 
Senior Director of RA/QA
Event Speaker Company: 
Vascular Dynamics
Event Speaker Bio: 

PATRICK LEE, M.B.A., M.S., PE, RAC, is a regulatory affairs / QA professional with many years of experience in FDA–regulated industries including health-care, medical device, and nutritional products. He currently serves as the Senior Director of Regulatory Affairs and Quality Assurance at Vascular Dynamics, Inc. (VDI), where he is involved in regulatory, quality, and clinical activities worldwide in supporting VDI’s primary product. Prior to Vascular Dynamics, Patrick served in various regulatory affairs positions for Bay Area medical device companies. The product categories that he has worked in include neuro-implants, cardiovascular devices, laser devices, blood processing and stem cell harvesting devices, cell therapy biologics, and other innovative products.
He received his BS in chemical engineering from Cornell, MS in engineering from Columbia, and MBA from the Anderson School at UCLA. He is a licensed professional engineer in the states of New Jersey and California and holds several patents. Mr. Lee holds the US Regulatory Affairs RAC (US) designation and is a certified quality auditor (CQA).

Event Details
Event Details: 

A number of upcoming regulatory changes will impact medical device companies directly. For those based in the US, some of these changes could mean a faster regulatory path and therefore higher profitability. Or will it? The changes at FDA (administratively and procedurally) and impact competition and time to market.

Other changes are coming too in Europe, including Brexit and the new Medical Device Regulations. Brexit could add to the burden of regulatory and marketing requirements of medical products in the UK. How will Brexit impact the launching and marketing of new medical devices in the UK?

The new MDR is a replacement for the Medical Device Directives. MDR has tighter reporting requirements, greater design control measures, more clinical data, more clinical reporting using Eudamed. How will MDR affect you?

An economic analysis will help us understand the economic impact for medical device companies.