December 2014

Pediatric Device Innovation Grows by Baby Steps

Kolaleh EskandanianKolaleh Eskandanian is executive director of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System in Washington, DC. The institute held its second annual Pediatric Surgical Innovation Symposium this past October to discuss the advancement of the field. Follow her at @Eskandanian.

What are the hurdles in developing innovative products for children?

The chief challenge is the small market size, which makes it unattractive for venture funding and large device companies to include pediatric medical devices in their R&D portfolio. That said, less competition means a company can have an edge in this niche market.

Working well in a small market requires creative incentives introduced by legislators and the availability of non-dilutive funding for early- and mid-stage pediatric device development. The U.S. Food and Drug Administration (FDA) has helped with the publication of guidance documents for sponsors of pediatric devices. However, the current regulatory process used in evaluating pediatric devices is the same as that used for adults. An exclusive regulatory path that incorporates data extrapolation and alternative statistics models for safe and effective pediatric medical device development could provide the right incentives.

How can device makers and hospitals help one another?

Our institute, which conducts R&D projects, is located on the sixth floor of Children's National Health System. This arrangement allows developers to interact with pediatric surgeons and nurses.

We have received a grant from the FDA’s Pediatric Device Consortia program, which includes seven other entities. The grant recipients have invited device makers to develop and refine pediatric devices. Device makers thereby gain access to pediatricians, pediatric surgeons and nurses, families and patients, and business professionals and health economists helping with comparative effectiveness research. In return, pediatrician scientists can help device makers better understand the biology and natural history of a disease, as well as the physiological and biological differences of the pediatric population—from newborns to adolescents. The hospitals will, in turn, benefit from products designed uniquely for children, increasing the safety and well-being of our patients and improving cost effectiveness of care.

Where do you see pediatric device innovation in five years?

Michael Harrison, MD, one of the pioneers of pediatric surgical innovation, has said “medical innovation is driven by unmet needs, but also by the market.” Loudon Owen, a venture capitalist and attorney from Toronto-based McLean Watson Capital, said during the symposium that we should take advantage of the “good” in the small market we work in—niche product, less competition, wide range of influencers, and global markets.

Our model for pediatric device innovation should be disruptive strategic innovation. In five years, we would like to see large device companies setting up separate pediatric device units or modifying their existing infrastructure to accommodate testing and validation for both pediatric and adult populations, when applicable. We at the Sheikh Zayed Institute would love to collaborate more closely with device makers, as well as see pediatrics on the agenda of companies’ corporate social responsibility programs.

How can regulators help?

Incentives and regulations have worked in the drug development world. As FDA Commissioner Margaret Hamburg, MD, pointed out during our recent symposium, “there are far fewer incentives available as either carrots or sticks to prod investment in devices” for the pediatric population.

While the incentives applied to pediatric drugs can serve as a model, there are differences between pharmaceutical and device development, as Hamburg explained. For example, there is six-month period of pediatric exclusivity added to patents and existing exclusivity available for drug makers to encourage development of products for children. That incentive won’t necessarily work with medical devices. There are multiple modifications throughout the development lifecycle. This challenge is further complicated by the fact that once a medical device makes it to the market, it may become obsolete and replaced by an improved product in as little as 18 months. Hamburg acknowledged there are startups and small businesses that are specifically focused on pediatric device development, saying that the FDA wants to work with them.