On August 14, 2018, GCMI CEO Tiffany Wilson will present before an open public meeting hosted by the U.S. FDA on Pediatric Medical Device Development in Silver Spring, MD.

This meeting provides a discussion about strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations. Specifically, Tiffany will be discussing ways federal, state and private partnerships can develop a supportive marketplace for pediatric medical device innovation at 2:00 p.m.

From the public meeting invitation: meeting attendees will hear from and discuss with experts and stakeholders including patients, industry, health care providers, and academia about regulatory and economic structures to incentivize the development and marketing of medical devices for pediatric populations.

This two-day public meeting will include presentations and interactive discussions about the following topics:
•  Optimizing evidence generation- attendees will hear about the NEST (National Evaluation System for Health Technology) and incorporating Real World Evidence generation strategies into device development for pediatrics.
•  Creating regulatory value and simplicity- attendees will hear about what aspects of the pediatric drug development legislative and regulatory landscape may translate successfully to the device community.
•  Developing a supportive marketplace- attendees will hear about business models for supporting pediatric device development.

You can learn more about the interactive sessions and additional guest speakers by viewing the agenda.

Read more from the FDA website.

Joining Tiffany Wilson, and presenting in a separate part of the program, is GCMI board member Dr. Kevin Maher, MD. Dr. Maher is Co-Director of the Center for Pediatric Innovation, a Pediatric Cardiologist for Sibley Heart Center Cardiology and Professor of Pediatrics with the Emory University School of Medicine.

“Everyone has a different idea of what medical innovation is or should look like,” Tiffany says. “Pediatric medical device innovation has a unique set of challenges for all concerned including innovators and regulatory bodies compared to devices created for the much larger, adult population. If the goal is progress and bettering patient outcomes we must focus on the problem that needs to be addressed and develop technology based solutions- which takes a village. Healthcare is a multidisciplinary industry. And because the industry is layered with expertise, we must engage a wide range of stakeholders during every step of the innovation process. We thank the FDA for their leadership and the opportunity to advance pediatric innovation in an open, collaborative way.”

To learn more about GCMI, our medtech accelerator, design & development capabilities or preclinical testing and bioskills training service lines, contact info@devices.net, info@t3labs.org or visit our website www.gcmiatl.com

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