Incentivizing Industry to Advance Pediatric Medical Device DevelopmentPariya Ghayyem
Abstract: The limited profits afforded to pediatric device manufacturers do not incentivize the industry to develop treatments for these populations. Existing incentives, in the form of patent protections, marketing thresholds, and development grants indicate modest potential for future development of these devices.
Published: 10 January 2013 Cite as: Ghayyem P. Incentivizing Industry to Advance Pediatric Medical Device Development. Bull Health L Policy. 2012;1(2).
Introduction
Pediatric medical devices have crucial life extending impacts. However, as children are generally a healthy subpopulation, the market for such devices is limited.1 The small market size weighed against the high costs of research and development do not justify sufficient commercial profit for industry investment.2 As a result, existing pediatric medical devices, such as surgical tools, have remained largely unaltered for the last 40 years.3
In an effort to stimulate the development of medical devices for neglected pediatric populations, Congress authorized the Humanitarian Device Exemption (HDE) in 1990.4 This exemption established a marketing approval requirement that required manufacturers to demonstrate evidence that the probable benefits of the device outweighed the risks involved.5 At the time the HDE was authorized, pediatric manufacturers were not allowed to make a profit off these devices, known as Humanitarian Use Devices (HUDs), intended to treat rare diseases affecting less than 4,000 individuals a year.6
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