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.
Small Medical Device Industry Focus Group:
How do you get information about new FDA regulations and policies about medical devices?
Date: Tuesday, April 29
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.
4:30 pm - 6:00 pm
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
Li Ka Shing Center
Stanford School of Medicine
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
5:00 PM - 7:00 PM Reception to follow
Shuren, Director, FDA's Center for Devices & Radiological
New Directions in U.S. Medical Device Regulation
|Arrillaga Alumni Center - McCaw Hall||Video Available.|
5:00 PM - 7:00 PM
Reception to follow
How will Comparative Effectiveness Impact Medical Device Innovation?
For more information on this topic from Alan Garber see Podcast available of Stanford health-care economist on reform efforts
Dining Room, Schwab
Residential Center, Stanford's Graduate School of Business.
has passed. No recording available.