Biodesign Roundtable - Let's TALK about this

Biodesign in partnership with the Center for Primary Care and Outcomes Research (PCOR) and SPECTRUM seeks to discuss topics of special interest to the medical device community in a timely way. We created a series in 2010 called the Biodesign Roundtables for this purpose. We invite the medtech community to join us in discussing important issues in an open forum. These events are free and open to the public.

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2014 Roundtables

Small Medical Device Industry Focus Group:
How do you get information about new FDA regulations and policies about medical devices?

Date: Tuesday, April 29
Time: 6:30-8:00pm
Location: S360

Background
For new and/or small medical device businesses, it is a daunting task to understand all of the basic FDA policies and laws that regulate medical devices.  It’s even harder to keep up with the changes that occur even after an initial policy is established. The FDA has a dedicated in-house group (DSMICA or Division of Small Manufacturers, International, and Consumer Assistance) whose mission is to educate the medical device industry on the FDA device regulations and policies.The division has historically done this by answering emails and phone calls.  However, that may not be the most efficient way to get information out the vast medical device industry.

Purpose of Feedback Session
DSMICA is interested in improving how it can help the medical device industry understand FDA regulations and policies.  In order to do this, we would like to get some some insights such as:

• How do you get information about FDA policies and regulations?  Where do you start?

• Do you keep up with new policies?  If so, how do you do this?  What FDA resources do you currently use?  Do you think there is a better way?

• Technology continues to evolve and provides more options for how to learn about topics.  Some recent examples of tools FDA has used includes:
  • audio webinars that include a Q+A session, soon after a new policy has been rolled out;
  • development of teaching modules (CDRH Learn) that feature a power point presentation delivered by the subject matter expert;
  • text-based education materials on the FDA webpage (Device Advice)
  • teaching modules that use advance software learning module technology to walk though databases and screen shots

This feedback will help DSMICA to understand what learning tools would be useful for which topics so that we can efficiently meet the educational needs of the medical device industry.

Rountable on Mobile Medical Apps
Date: January 28, 2014
Time: 8:15 AM - 12:30 PM 
Location: Clark Center Auditorium

In conjunction with the FDA, the mHealth Regulatory Coalition and Stanford, we're presenting the Mobile Medical App Roadshow. Further information on the MMA Roadshow webpage.

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Previous Years

2011 Roundtable

DATE	TOPIC	LOCATION	RECORDINGS
April 13, 2011 4:30 pm - 6:00 pm	Intellectual Property and Entrepreneurship in Medical Devices: A Joint Conference between USPTO and Stanford University featuring David Kappos, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO) and USPTO's Chief Economist Stuart Graham	Paul Berg Hall Li Ka Shing Center Stanford School of Medicine	Audio Capture Private Session 1 - University Private Session 1 Private Session 2 - Investors Private Session 2 Private Session 3 - Late Stage Start-Up Companies Private Session 3 Private Session 4 - USPTO Direction Private Session 4 Public Session - Recap Public Program
2010 Roundtable
DATE	TOPIC	LOCATION	RECORDINGS
September 27, 2010 5:00 PM - 7:00 PM Reception to follow	Jeffrey Shuren, Director, FDA's Center for Devices & Radiological Health (CDRH) on New Directions in U.S. Medical Device Regulation	Arrillaga Alumni Center - McCaw Hall	Video Available.
February 23, 2010 5:00 PM - 7:00 PM Reception to follow	How will Comparative Effectiveness Impact Medical Device Innovation? Overview by: Alan Garber, MD, PhD Panel Discussion Moderated by Ross Jaffe, MD Panelists: Chip Hance, MBA Dana Mead, MBA Rodney Perkins, MD Robbie Pearl, MD Lew Sandy, MD, MBA Amit Sinha, MBA For more information on this topic from Alan Garber see Podcast available of Stanford health-care economist on reform efforts	Vidalakis Dining Room, Schwab Residential Center, Stanford's Graduate School of Business.	Event has passed. No recording available.

Thanks to Versant Ventures and Kleiner Perkins Caufield & Byers for their support of the Roundtable series.

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Location of Clark S-360