The Perfect Plan

For Pediatric Innovation

Pediatric products are presented with unique challenges in getting market access. Many pediatric products don’t make it through the entire product development and regulatory process, ultimately resulting in a shortage of products intended for this fragile population.

Developing a full-proof regulatory strategy is one of the earliest steps in ensuring your pediatric device reaches patients and providers.

You need a supportive team familiar with the nuances of navigating this regulatory space with a track record of success. Our team works extensively with pediatric medical devices, so we to tap into of wealth knowledge gained through experience and diligent review of regulations to strategically plan your FDA interactions and submissions, whether PMA, 510(k), De Novo, or HDE.

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Proxima & SWPDC: Pioneering 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. The Southwest National Pediatric Device Innovation Consortium is committed to overcoming these obstacles and advancing pediatric innovation.

Our unique partnership with the SWPDC allows us exclusive access to early-stage meetings with FDA senior executives, opening a line of communication that familiarizes the FDA with your product and expediting the clearance process. Proxima and SWPDC give you the advantage needed to get your device to market, offering entry to early and late-stage FDA meetings and providing valuable insight into getting FDA clearance. As a recipient of the FDA’s P50 grant program, SWPDC offers nonconditional funding opportunities that can make a difference in the development of your product.

With the help of the SWPDC, we can work together to make an impact on this vulnerable population.

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Honing In On The Future Of Healing

Clinical trials for pediatric devices present unique challenges. They are costly and costs steadily rise as the duration of the trials are extended due to enrollment changes and the follow-up that comes with a child’s growth and maturation. These challenges not only pose a delay to the clinical trial but also to projected timelines and in receiving FDA approval.

Unexpected delays = wasted investment.

You need a CRO that specializes in pediatric clinical trials and understands and anticipates the challenges that occur. At Proxima, we’ve been there before. We get ahead of obstacles to avoid them, but when they do come up, we know what to do to get you back on track.

Chester J. Koh, MD

Physician

Texas Children's Hospital & SWPDC

Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.

"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."