Learnings from the Investigational Device Exemption (IDE) Workshop

A perfect example of the ecosystem for medical device innovation on campus

On Wednesday, January, 24, 2018, the Georgia Tech Petit Institute for Bioengineering and Bioscience and VentureLab principal, Harold Solomon hosted Kelly Lindblom, Ph.D., R.A.C. for an Investigational Device Exemption (IDE) workshop. 

The workshop was designed to give Georgia Tech's medical device researchers an overview of the FDA process for both the 510k pathway and the Investigational Device Exemption. Thirty faculty and graduate students from several research institutions and members of the medical device community in great Atlanta attended this two hour session. Questions focused on the nature of the communications at the pre-IDE stage. It was clear that the researchers were interested in the topics covered and that they had much to learn about the leadership role they must take in this important dialog with the agency. This was one of two FDA related workshops, the other covering Investigational New Drugs.

Learn more about the latest medical device innovation and IDE by downloading the January 24th presentation.

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BLUEJEANS Presentation

 

VentureLab is part of Georgia Tech's Enterprise Innovation Institute. It launched in 2001 to collaborate with researchers who want to create startups based on their Georgia Tech research.

Staffed by five serial enterpreneurs, two graduate research assistants, and four National Science Foundation (NSF) sponsored entrepreneurial teaching team members, VentureLab provides a structured approach to moving research out of the lab and into the marketplace. Startup processes include extensive customer discovery, frequently using I-Corps grants. Seed funding is provided to startup teams using a state resource, Georgia Research Alliance (GRA) and local angels, private equity and the venture capital community nationally. GRA funding is milestone based and starts before company formation. We actively recruit volunteer enterpreneur mentors who provide teams assistance with finding a fundable busines model and occasionally take an active role in or leading the startup. VentureLab exists to serve the Georgia Tech research community.

Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Tech
315 Ferst Dr. NW
Atlanta, GA 30332-0363
Phone: 404-894-6228
Fax: 404-894-2291