Elon Musk’s brain-computer interface company Neuralink is on the hunt for a clinical trial director as it moves closer to testing its implantable brain chip in humans, according to the company’s website.
The ideal candidate for the position, based in Fremont, Calif., is expected to have an “understanding of the clinical trial process from beginning to end” and “experience with implantable Class II or Class III medical devices,” among other qualifications.
Preferred qualifications include “a minimum three years of U.S. medical device regulatory experience” and experience in designing and leading studies to qualify the FDA’s Investigational Device Exemption (IDE) studies.
The FDA evaluates BCI devices based on their degree of risk (categorized by “Class”). The kind of implantable chips made by Neuralink would fall under the FDA’s higher-risk Class II and Class III designations.
For the same team, Neuralink is also hiring a Fremont-based clinical trial coordinator. The position requires “thorough knowledge” of applicable regulations, understanding of implantable medical devices, and other similar skills as the director role.
Neuralink has two main products: a wireless coin-sized computer chip called “Link” and a surgical robot that can automatically implant the device into a human or animal brain, essentially performing the job of a neurosurgeon.
The technology has been tested in animals with success. In August 2020, Neuralink presented that its robot surgeon had successfully implanted “Link” chips in three pigs. In April 2021, the company demonstrated a macaque monkey who had two “Link” devices implanted in his brain playing a simple video game solely with his mind.
Last month, Musk said at an event that Neuralink hoped to begin human experiments sometime in 2022. But, instead of playing video games, a human trial will aim for therapeutic uses, such as helping paralyzed patients restore certain physical functionalities.
“We have a chance with Neuralink to restore full-body functionality to someone who has a spinal cord injury,” Musk said on Twitter last month.
To implant a chip in a human, Neuralink will first need to go through a feasibility test with the FDA and then obtain the agency’s approval for a pivotal device test. Musk is confident that the FDA will issue those green lights.
“Our standards for implanting the device are higher than what the FDA requires,” he said at December’s event, although he later explained on Twitter, “I am definitely not saying that we can for sure do this, but I am increasingly confident that it is possible.”