News on Pediatric Medical Devices

Some pediatric medical devices are designed specifically for children, while others are borrowed from adult applications or produced for more general use. Designing medical devices for children can be challenging since children are often smaller and more active than adults. In addition, body structures and functions change throughout childhood, and children may require the device long term which can bring a life time of exposure to implanted materials.

FDA has awarded funding to support pediatric device innovators. For example, the Southwest National Pediatric Device Consortium (SWPDC) https://swpdc.org anchored by Texas Children’s Hospital https://texaschildrens.org, Baylor College of Medicine https://www.bcm.edu, and Texas A&M University https://www.tamu.edu received a five year $6.75 million P50 grant.

The SWPDC members also includes, Rice University, University of Houston, and Fannin Innovation Studies, along with Biotex Inc., Children’s Hospital of San Antonio, Children’s Health in Dallas, and Phoenix Children’s Hospital.

The FDA-funded SWPDC will provide services to further develop pediatric devices by doing assessments, developing prototypes, and by providing product technology acceleration and business services.

Also SWPDC members will evaluate and support projects as well as advise innovators throughout the total product life cycle. Based on project needs, the consortium will direct investigators to specific resources, collaborators, and industry experts, and coordinate the services offered by its member programs.

Also, FDA just awarded five grants totaling up to $6 million per year over five years to the Pediatric Device Consortia (PDC) to advise and support services to help innovators of children’s medical devices.

One the PDC grant recipients for 2018 are the Philadelphia Pediatric Medical Device Consortium (PDMDC) https://www.phillypediatricmeddevice.org based at the Children’s Hospital of Philadelphia (CHOP) supports projects addressing cystic fibrosis, urinary flow disorders, kidney reflux, brain injury, skeletal defects, and vision impairment.

The PPMDC recently announced their latest round of seed grants to companies developing medical devices for children. The Consortium chose six companies from among ten finalists to receive seed grants for up to $50,000.

The awards went to:

  • Dymedso Inc., for developing a devices to be used as an airway clearance system
  • Jason Van Batavia, MD of CHOP for a urological biofeedback monitor
  • Kite Medical to develop a device to detect vesicoureteral reflux in children
  • Oculogica Inc., to develop an eye-tracking test for TBI patients
  • Ostiio LLC to develop a device for distraction osteogenesis within the cranio maxillofacial skeleton
  • Vifant LLC to develop a vision acuity test for preverbal children

 

To move pediatric device development forward, a specialized competition calling for the development of pediatric cardiovascular devices is currently being conducted by Children’s National Health System https://childrensnational.org based in Washington D.C., Proposals are now being accepted for their annual “Make Your Medical Device Pitch for Kids” competition.

The competition in Philadelphia http://www.pediatric-device-symposium.org will be held September 23, 2018. However, the deadline to apply for the competition and prize funding was September 10, 2018. The program will be a one day symposium co-located with the MedTech Conference https://www.themedtechconference.com.

Children’s National is inviting proposals from innovators with pediatric cardiovascular medical devices that have the potential for commercialization. Competition finalists will pitch their device to a panel of judges and as many as four innovations will be awarded $25,000 each.

In addition, the winners will receive consultation services from Children’s National Sheikh Zayed Institute for Pediatric Surgical Innovation and from the University of Maryland’s James Clark School of Engineering.

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