Michael Okun, MD: Push for Increased Humanitarian Device Exemptions


The executive director of the Norman Fixel Institute for Neurological Diseases provided his thoughts on changing the perception of humanitarian device exemptions.

"We’ve got to get the players at the table to align or else we’ll continue to sit on technology that we know can help people but remains unavailable. It’s only going to get worse.”

A recently published viewpoint paper by Michael Okun, MD, and James Giordano, PhD, called for a reformation of the process for deep brain stimulation and neurologic device approval in rare diseases. Within the paper, the 2 authors discuss the use of humanitarian device exemptions (HDEs) as a regulatory pathway for device availability.

Despite the fact that HDEs might represent a solution to this problem, they can be underused because they require an industry partner to submit data accompanying the exemption. Industry partners often shy away from dipping their feet in these waters because they perceive HDEs as “unattractive” due to costs required to develop and maintain the HDE, limitations of profit, tax exclusivity, lack of incentives, and legal liability.

Without incentive, industry partners tend to focus on larger disease populations, leaving those with rare diseases to not reap the same benefit from the approval process. Okun, executive director, Norman Fixel Institute for Neurological Diseases, spoke to NeurologyLive about egging on industry leaders to invest in these HDEs, and how readily available funding may incentive those to invest.

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