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| Bivona FlexTend TTS tracheostomy tubes--Courtesy of Smiths Medical |
As the FDA keeps pushing for more pediatric-friendly devices, Smiths Medical has taking a small but crucial step that helps answer that call.
The Minnesota-based healthcare arm of British conglomerate Smiths Group said it has added tracheostomy tubes for newborns and pediatric patients to its standard product line. Smiths had previously made these devices, which help patients breathe through an incision in the windpipe, only as customized products for specific clinician orders. It's available now in the U.S. and slated for launch in other markets later in 2014.
Smiths Medical said it will still offer its Bivona FlexTend TTS tracheostomy tubes as a customized product, allowing production of the devices to meet the specific contours and dimensions of a patient's neck and trachea. But providing a standardized option helps expand the availability of a product line whose mass produced version also counts because it uniquely targets infants and smaller children.
While a pediatric market may have its limits in size or revenue generation, the move allows Smiths to expand its offerings in a way that providers and clinicians will remember, generating good will and possibly more customers down the line. Smiths could use it after pricing pressures and the medical device tax helped erode its fiscal 2013 sales. Rumors erupted that Smiths Group may want to sell its medical division, but CEO Philip Bowman has previously denied this.
Smiths could not be reached for comment on deadline. Its pediatric product advance comes during the FDA's ongoing push for more medical devices designed for kids. Adding to its effort, the agency last fall gave out $3.5 million in grants to 7 research consortia around the country to spark a greater development effort.
Companies and researchers are addressing this need to some extent. DexCom ($DXCM), for example, recently won FDA approval for a continuous glucose monitor designed for toddlers, the first of its kind to reach the U.S. market. Denmark's Novo Nordisk ($NVO) will be rolling out its child-friendly insulin pen in the U.S. market this year. And researchers at Cincinnati Children's Hospital Medical Center and Ben-Gurion University in Israel are developing new pediatric medical devices. Smith's effort counts here, too.
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