Stories about: pediatric devices

Meeting an unmet need: A surgical implant that grows with a child

Depiction of a growth-accommodating implant expanding in sync with a child's growing heart.
Artist’s rendering showing how a braided, tubular implant could grow in sync with a child’s heart valve. Credit: Randal McKenzie

Medical implants can save lives by correcting structural defects in the heart and other organs. But until now, the use of medical implants in children has been complicated by the fact that fixed-size implants cannot expand in tune with a child’s natural growth.

To address this unmet surgical need, a team of researchers from Boston Children’s Hospital and Brigham and Women’s Hospital have developed a growth-accommodating implant designed for use in a cardiac surgical procedure called a valve annuloplasty, which repairs leaking mitral and tricuspid valves in the heart. The innovation was reported today in Nature Biomedical Engineering.

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FDA gets serious about improving medical device innovation for kids

FDA entrance-ShutterstockAssisted by a congressional mandate, the FDA has taken a new approach to helping clinical innovators overcome barriers to moving pediatric medical devices from the research stage to commercialization. So says Linda Ulrich, MD, director of the Pediatric Device Consortia Grant Program at the FDA’s Office of Orphan Products Development, who recently spoke at an Innovators’ Forum cosponsored by her office and Boston Children’s Hospital’s Innovation Acceleration Program.

Regulation and reimbursement are the largest barriers to medical device innovation. “The time it takes to develop a medical device and get it to the U.S. market can take a range from 18 months to 10 years,” says Ulrich.

The stages of device development are concept, prototype, preclinical and clinical testing, manufacturing and marketing—only for the device to become obsolete within as little as 18 months after commercialization. Inventors need to consider the return on investment after their products receive regulatory approval, given the time and funding it takes to get them to market, says Ulrich.

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