Compremium says its noninvasive CPMX-1 system delivers real-time compressibility measurements in less than 30 seconds. [Photo courtesy of Compremium]
But there are important regulatory and strategic reasons why medical device companies shouldn’t pass on pediatrics, says Kolaleh Eskandanian, Compremium’s chief strategy and innovation officer and the head of the Division of Pediatrics and Special Populations.
“Starting in pediatrics can often result in less competitive white space,” she said, “allowing innovators to own the indication and expand upward — scale it up to adults — rather than entering the crowded adult markets from the start.”
Before joining Compremium, Eskandanian was VP and chief innovation officer at Children’s National Hospital in Washington, D.C., executive director of its Sheikh Zayed Institute for Pediatric Surgical Innovation and founding executive of Innovation Ventures.
She’s worked with the FDA and pediatrics experts to improve care for some of the youngest and most vulnerable patients, helping device developers secure financing and partnerships to commercialize innovative technology.
That includes funding and wraparound services available through the FDA Pediatric Device Consortia, which supports five consortia in the U.S.: The Southwest National Pediatric Device Consortium (SWPDC), the External Link DisclaimerUCSF- Stanford Pediatric Device ConsortiumExternal Link Disclaimer, the Consortium for Technology & Innovation in Pediatrics: CTIP 3.0, the External Link DisclaimerAlliance for Pediatric Device InnovationExternal Link Disclaimerand the and the Midwest Pediatric Device Consortium (MPDC).
Compremium Chief Strategy and Innovation Officer Dr. Kolaleh Eskandanian [Photo courtesy of Compremium]
Device developers can secure approval with a lower evidentiary burden through the Humanitarian Device Exemption (HDE) if those devices are intended for rare pediatric conditions. And she said pediatric device developers have shared good experiences with the FDA Breakthrough Devices program.
Though the Breakthrough Devices program is not specifically focused on pediatrics, “the FDA has publicly committed to ensuring that pediatric conditions are included in the breakthrough eligible technologies,” Eskandanian said.
Even for devices ultimately intended to treat adults, starting with the pediatric population can offer advantages.
“Smaller studies may be sufficient to establish safety and early efficacy in pediatric subpopulations,” she said. “Another silver lining is early adoption in children can provide high impact in clinical use cases, particularly in rare diseases or critical care where you can build clinical credibility for adult expansion.”
In our interview, Eskandanian also discussed her company’s noninvasive monitoring technology and offered advice for pediatric device development, including the biggest opportunities in pediatrics, tips for working with doctors and pediatricians specifically, and how to take advantage of public-private partnerships.
“The future of pediatric medtech depends on collaboration across sectors, bold ideas and a commitment to solve real unmet needs,” she said.
The full interview is available in our MDO Min-Vasive Medtech Special Report, a free PDF download which also includes interviews with minimally invasive device engineers and development experts from Edwards Lifesciences, Capstan Medical and Jupiter Endovascular, plus links to on-demand video replays of each interview.
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