FDA Pediatric Medical Device Development Public Meeting Insights

The Food & Drug Administration hosted a public meeting on Pediatric Medical Device Development on August 13-14, 2018, in Silver Spring, Maryland. This meeting was meant to identify strategies that could improve the medical device ecosystem for the development and innovation of devices that will serve the complex needs of children, thus accelerating the medical device innovation for all Americans.

GCMI CEO Tiffany Wilson along with GCMI board member Dr. Kevin Maher attended this event and was a featured speaker at the session Developing a Supportive Marketplace: Medical Device Innovation Models. Here are Tiffany’s top takeaways from the meeting.

Collaboration among diverse disciplines

Many different voices are needed in an effective conversation on pediatric device development because there are so many moving parts involved in the process. Importantly, the audience for this public meeting contained a wide variety of individuals specializing in multiple, distinct areas of the development process.

“The breadth of disciplines at the table spanned clinicians, business, government, and investors – all of them interested in addressing the gap in pediatric innovation,” said Tiffany. “This kind of collaboration amongst varying disciplines is extremely necessary. No one can do it alone.”

Tiffany noted that this meeting was a great opportunity to explore the ways that industry, non-profits, state and federal governments can come together and solve problems in unique ways.

The need for creativity and new business models in pediatric medtech innovation

Tiffany discussed the engaging dialogue that was had at this meeting, focusing on the common themes of creativity in new business models and partnerships to ensure process efficiency.

“There is a big need for creativity and efficiency, especially in pediatrics,” said Tiffany. “The markets are smaller and the resources are even more limited. There are not traditional sources of funding available to get the technologies developed and commercialized.”

Tiffany mentioned new partnerships and business models that are coming into focus may have the potential to provide the additional funding needed for pediatric device development where traditional venture capital may not be a real fit.

In regard to the anticipated announcement of the next round of Pediatric Device Consortium grant awards, Tiffany said, “This will build upon a strong platform of facilitating pediatric innovation to employ best practices and lessons learned, driving more devices to the market.”

If you are a physician innovator, medtech startup or growth stage company seeking an efficient path from concept to commercialization, visit our website, www.gcmiatl.com, contact info@devices.net/info@t3labs.org or fill this form.   

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