Therapeutic Areas: Pediatrics

Where Tiny Hands
Meet Mighty Solutions.

Navigating the path to market for pediatric innovations can be complex.

Many pediatric products do not make it through the entire product development and regulatory process, resulting in a shortage of groundbreaking solutions that fail to reach the youngest patients who need them the most.

We understand the unique challenges faced by pediatric medical device innovators and developed a full-proof regulatory strategy to help you at your earliest steps.
With extensive pediatric experience, our experts strategically plan every FDA interactions and submissions 
- including PMA, 510(k), De Novo, and HDE.

Proxima & SWPDC: Pioneering Pediatric Innovation

The Southwest National Pediatric Device Innovation Consortium is committed to overcoming obstacles and advancing pediatric innovation.
Due to a lack of funding, limited options for predicate devices, and the high investment risk associated with pediatric products, medical device options for children are in short supply.

Proxima and SWPDC give you the advantage to get your device to market:
Exclusive access to early and late stage meetings with FDA senior executives
Valuable insights into getting FDA clearance
Expedited clearance process
As a recipient of the FDA's P50 grant program, SWPDC offers nonconditional funding opportunities
Learn more At SWPDC.org

WATCH CHESTER KOH, MD'S STORY

Dr. Chester Koh, MD has built a world class consortium helping innovators bring pediatric medical devices to market
With the help of the SWPDC, we can work together to make an impact on this vulnerable population.

Bringing Pediatric Innovations to Life

Unexpected delays = wasted investment
Clinical trials for pediatric devices can be costly, especially as the durations of trials are extended due to enrollment changes paired with follow-ups as a child matures. 
These challenges cause delays to both a clinical trial's projected timeline and FDA approval.

You need a CRO that specializes in pediatric clinical trials. At Proxima, our experts have extensive experience that allows us to understand and anticipate challenges that can occur to ensure you are always on track.
Learn more At SWPDC.org
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."
Position
First & Last Name
Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium that includes Baylor College of Medicine, Texas Children's Hospital, Texas A&M University, Rice University, University of Houston, and Fannin Innovation Studio. SWPDC is supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.
Physician
Chester J. Koh, MD

Frequently Asked Question

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Glossary

21 CFR 812
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Keep your pediatric device on track for approval.
See the difference experience can make.
Engage with A pediatric expert