Device Development, The FDA, and the University-Michael Harrison, MD -11/08/2011 - 6:00pm

Event Information
Event Topic: 
Device Development, The FDA, and the University
Event Date: 
11/08/2011 - 6:00pm
Event Location: 
Wilson Sonsini Goodrich & Rosati, 650 Page Mill Road, Palo Alto CA
Speaker Information
Event Speaker: 
Michael Harrison, MD
Event Speaker Title: 
Professor of Surgery, Pediatrics, Ob-Gyn and Reproductive Sciences, Emeritus
Event Speaker Company: 
University of California San Francisco
Event Speaker Bio: 

Dr. Michael Harrison is Professor of Surgery, Pediatrics, Ob-Gyn and Reproductive Sciences, Emeritus at UCSF. He received his undergraduate degree at Yale, his medical training at Harvard Medical trained Massachusetts General Hospital, Rikshospitalet, and Children’s Hospital of Los Angeles before beginning a successful career at UCSF where his concentration centered on surgery, OB/GYN, and Pedicatrics. He then was then Surgeon-in-Chief at Lucile Packard Children's Health Services.

Dr. Harrison is Co-Founder and Director of Research and Development at Magnets-in-Me, Inc.

Dr. Harrison has been the Recipient of the Julius H. Jacobson III Innovation Award from the American College of Surgeons, Recipient of the Michaël van Vloten Award, Congress of the Association of Surgeons of The Netherlands in Amsterdam, and Recipient, Arnold M. Salzberg Mentorship Award, 2006 American Academy of Pediatrics. He is a past-president of the International Fetal Medicine and Surgery Society, and the American Pediatric Surgical Association.

He has published widely and has been Keynote/Invited Lecturer at numerous Surgery and Pediatric Symposia.

Event Details
$6 - Students/In-transition - Members only
$11 - Early-bird Registration - Members only
$20 - Late Registration and Non-Members
$25 - Walk-ins
Event Details: 

Magnamosis is a system that creates an anastomosis through magnetic compression. In prior studies, we demonstrated safety and efficacy in pigs by creating gastrojejunostomies, jejunojejunostomies, duodenocolostomies, and colocolostomies using minimally invasive endoscopic and laparoscopic techniques. The purpose of this study is to review the arduous process of design development and regulatory review.

The design development process under the FDA funded Pediatric Device Consortium proved efficient and productive, yielding a device that can create a secure compression anastomosis using minimally invasive endoscopic and/or laparoscopic techniques. Innovative surgeons will find many ways to use the magnamosis strategy to solve a variety of clinical problems. However, approval to use the device has proven extremely difficult due to the complexity and cost of navigating the regulatory process.