Michael Okun, MD: Long-Term Plan for Modifying Neurologic Device Approval System

January 12, 2021
Michael Okun, MD

The executive director of the Norman Fixel Institute for Neurological Diseases gave his call-to-action on how to change the approval system for neurologic devices for rare diseases.

"We have the technology to modulate circuits, we just need to wake up and realize that this is exciting and can save the healthcare system in the long run. We need to put a system into place and it’s going to take the whole kitchen table.”

In an effort to raise awareness, Michael Okun, MD, and James Giordano, PhD, recently published an editorial in JAMA Neurology calling for the reformation of the process for deep brain stimulation and neurologic device approval in rare diseases. Patients with rare diseases often do not benefit from the same process that traditional pipeline drugs receive because they represent a small population that is deemed unattractive to invest money into by private companies or industry leaders, they noted.

If these corporations are not incentivized, they will not come to the table even if the device or treatment could satisfy a great unmet need in the disease treatment landscape. Okun, the executive director of the Norman Fixel Institute for Neurological Diseases, and Adelaid Lackner Professor and chair of neurology at the University of Florida, also works for the Tourette Association of America. He has been at the forefront of trying to raise more discussions about the outdated system to spark a change for the future.

Okun sat down with NeurologyLive to discuss how the process for changing the system must begin, which leaders are necessary to the discussion, and why the patient needs to be the center focus when thinking about approving devices.