You would think that something as vital as a cardiac catheter designed specifically for children would have been on the market years ago. Sad truth is, a lack of financial incentives previously prevented such a device from being produced.
"There aren't many players in the pediatric medical device space because there isn't huge cash-out potential," explains Tim Moran, founder of Cleveland-based nonprofit PediaWorks. The issue, he notes, is simply a matter of market share. Whereas the adult medical device market caters to patients aged 18 to, well, death, the pediatric market stretches only from birth to 18. "And people in that younger age group are, thankfully, relatively healthy."
The out-and-out lack of medical devices designed for young patients often leaves practitioners scrambling for suitable off-label replacements. In fact, there are relatively few devices that are FDA-approved for pediatrics. The associated problems can range from pain and discomfort, as in the case of an ill-fitting airway mask, to matters of life and death, illustrated by the absence of pediatric pacemakers.
Thanks to a new joint venture between PediaWorks and Medikit, a manufacturer of interventional cardiology products headquartered in Japan, Cleveland will serve as new headquarters for PediaCath, the first developer of pediatric catheters.
In addition to the use of its rapid prototyping facilities and top-notch R&D engineers, Medikit is kicking in $500,000 in seed funding. PediaWorks will be providing executive management services and access to a network of pediatric clinical advisors and research partners. The Cleveland Clinic is also involved in the project.
PediaWorks was formed in 2009 as a nonprofit organization to help children through the development of medical devices.
SOURCE: PediaWorks
WRITER: Diane DiPiero
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