Mohan Sancheti
Sr. Vice President,Manufacturing, VNUS Medical Technologies
Mohan F. Sancheti, Sr. Vice President, Manufacturing, joined VNUS in 2006 from W. L. Gore and Associates, a medical device company, where he held various senior engineering and manufacturing management positions and helped drive the commercial launch process for Stent-Graft products. Mr. Sancheti previously held several engineering positions at Raychem Corporation. He holds an MS in manufacturing engineering from the University of Massachusetts and a BSME from Birla Institute of Technology and Science in India.

Hugh Sharkey
President & CEO, AEGEA Medical Inc.
Mr. Sharkey is an experienced executive and inventor with over 110 issued patents and 50 pending applications. He has been involved in raising over $100 M in institutional financing over the years. He was a founder of several successful start-ups to include Oratec Interventions Inc., (now Smith & Nephew), VidaMed (now Medtronic), Danforth BioMedical Inc. (ACT Medical), RITA Medical (now Angiodynamics), and CardioKinetix; and he was General Manager of EP Technologies (now Boston Sceintific) when it was a start-up. He was the chair of the Device Screening Committee for the Life Science Angels for two years and sits on the Board of Directors of several medical device companies.

Randall J. Sword MBA
Design Services, Creganna Medical Devices
Randall has over 20 years experience consulting to medical device companies. His work includes a broad range of technology based assignments including defining technology strategy, portfolio management, due diligence, business acquisition, product development management and product design. Randall’s clients range from large device manufactures to start-up organizations involved in a wide variety of markets from minimally invasive devices to highly automated critical care instrumentation. His experience and education provides unique insights at the intersection of technology and business. He authored a number of articles and has spoken to conferences on best practices to define successful products, the product creation process, product portfolio management and the business of product development. He holds seven patents. At Creganna, Randall works with clients to create successful partnerships and create the conditions for successful new product development. Prior experience includes senior positions with Integrated Development Enterprise, MedSource Technologies, Applied Marketing Science, and Arthur D. Little. Randall earned a Bachelor in Industrial Design from the Rhode Island School of Design and a Masters in Business Administration from Boston University. Sword has been a member of the Product Development and Management Association and was certified as a New Product Development Professional in 2000.

Shelley Trimm
President, RCQ Consulting
Shelley has 17 years experience as a regulatory strategist and design control expert focusing on medical device start-up companies. Shelley is an expert in design control and quality system implementation for virtual, on-site, and hybrid companies. Shelley’s recent FDA/EU/ISO clearances include Class II, Class IIa, and Class III devices, with and without software, in spine orthopedics, neurology, ob/gyn, and cardiology products. She has planned and managed FDA panel meetings packets; developed and obtained clearance/approval for numerous submission types including premarket notifications, IDE applications, , IDE supplements, PMA applications, annual reports, CE Mark technical files, and Japanese Shonin. Shelley earned a B.S. in Anatomy/Physiology with a Minor in Chemistry, from California State University, Sacramento.