Larger medtech companies have traditionally shied away from investing in the pediatric market, but the landscape is changing. In the last year alone, we witnessed the passage of the 21st Century Cures Act and the signing of the FDA Reauthorization Act (FDARA 2017) into law. The industry is ripe for innovation and these legislative advances present new opportunities to connect innovators with the investment community.
What more can be done?
Before a device is cleared for use in adults, it undergoes appropriate testing in its intended population to ultimately receive regulatory clearance. The same is not always true in pediatrics because the age range for pediatric patients is defined as birth to 21 years of age (which includes subpopulations of newborns, infants, children and adolescents). Due to that ambiguity, it’s possible that the tiniest patients, with a low weight, body size and different physiological and neurological development needs, may not be selected to participate in every pediatric study. Which means, that pediatricians still find themselves using adult devices off-label and modifying them on the fly to save children.
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Similarly, parents and patients are desperate for better solutions. While technology to correct scoliosis through the use of a brace has come a long way, parents and patients are urging the industry to catch up by borrowing technology from other fields. And tech-savvy parents are finding ways to hack into their child’s glucose monitor to have continuous access to critical information when the child is away at school or at a friend’s house. These are just some of the many examples. The opportunities for innovation in the pediatric market are limitless.
How to break into the pediatric market?
There are eight FDA Pediatric Device Consortia across the country that work collaboratively with the FDA to help innovators effectively navigate existing laws, regulations and agency guidance to protect the health and safety of children. The consortia provide consultation and some funding for all phases of pediatric device development – from ideation through marketing. Since 2013, through our consortium, NCC-PDI, and our Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System, we have supported 67 devices belonging to over 40 startups and research labs and awarded funding to 26. Four devices, while being supported by NCC-PDI, received market clearance in the form of CE mark of approval, 510(k) approval, and IDE.
If you want to learn how to test a pediatric version of your adult device, or have any questions about getting into pediatrics, contact a consortium.
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How can you get involved now?
Now is your chance to be part of the change. On September 24, 2017, thought leaders in pediatric device space are coming together for the 5th Annual Pediatric Device Innovation Symposium, “Partnering for Breakthroughs in Pediatric Surgery and Care.” It’s a results-driven day that brings together medical device innovators, investors, researchers, clinicians and policy makers to stimulate pediatric device innovation and bring solutions to market faster for the benefit of children. This year, we’re co-locating to San Jose, Calif. in a joint effort with The MedTech Conference powered by AdvaMed.
Our hot-button panel discussions will cover topics from funding to regulations to market dynamics – as they relate to the health of our children. Another highlight is a pitch competition where up to six prizes totaling $250,000 will be awarded to the winning presentations.
Keynote speakers are Daniel Kraft, M.D., faculty chair of Medicine & Neuroscience, Singularity University and executive director, Exponential Medicine; Vasum Peiris, M.D., chief medical officer, Pediatrics and Special Populations, Food and Drug Administration; and Alan Flake, M.D., director of Center for Fetal Research, Children’s Hospital of Philadelphia. Additional details about the agenda and speakers can be found here.
This symposium is your best opportunity to network with fellow professionals across the country who are engaged in pediatric device development and motivated by the mission to innovate for kids.
To register, visit www.pediatric-device-symposium.org, and join the discussion on twitter using #Innovate4Kids.
Kolaleh Eskandanian is the Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System and the National Capital Consortium for Pediatric Device Innovation
