The Neurotech Revolution goes (back) to Washington!

AUSTIN, TX - The 2018 Export Control Reform Act (ECRA) gave the Bureau of Industry and Security (BIS) the responsibility to review and control emerging technologies. Soon after, brain-computer interfaces (BCI) were identified as a category of technologies to be reviewed. After a chance meeting at last year’s White House Summit on Biotechnology, Dr. Betty Lee from BIS asked Paradromics founder and CEO Matt Angle to help organize a conference to bring the Department of Commerce up to speed on BCI technologies. This conference was held February 16 and 17 at the Commerce Library in Washington, D.C.

The Paradromics team helped build an agenda to ensure industry, patients, ethicists, and regulators were represented to paint a full picture of the brain computer interface ecosystem. In the spirit of industry-wide cooperation, leaders from across the BCI industry attended or presented at the forum. In addition to Paradromics, companies included AE Studio, Blackrock Neurotech, Cognixion, INBRIAN Neuroelectronics, Motif Neurotech. Neurable, Neuralink, Neuropace, ONWARD, Precision Neuroscience, and Synchron.

Powerful presentations from patients, caregivers, and advocates kicked off both days of the conference, and their message was loud and clear: Technologies to enable communication and autonomy are needed by motor-impaired people immediately. Jennifer French and Ian Burkhart provided first-hand accounts of their experience as BCI pioneers. Zoe Lalji shared the personal story of her father’s journey with ALS, focusing on the severe impact losing communication has on the patient and their family, while mom Dr. Shelena Lalji took the mic near the end of the conference to bring the focus back to patients and the desperate, immediate need for these technologies. Blair Casey provided an excellent overview of the work of the Team Gleason Foundation to help ALS patients with existing technologies. He delivered an important reminder that patients’ needs must be considered throughout the development process.

Speaking on neuroethics, dual use, and mitigation strategies were Dr. Karen Rommelfanger, Dr. Arleen Salles, and Lucy Tournas of the Institute of Neuroethics, and Amanda Pustilnik of University of Maryland School of Law. They were also invaluable in moderating the sessions, organizing a well-rounded agenda, and bringing bigger-picture thinking to the conference.

Because BCI is a new and growing industry, regulators had much to learn about our technology and its applications. And, likely, many in the industry were not well-versed on export controls. We came away from the conference confident that BIS is supportive of BCI development and will act reasonably to ensure export control measures do not impede the market for these much-needed medical devices.

As a medical device company bringing a Class III device to market, Paradromics is accustomed to working in a regulated environment. Our view is that early collaboration is the best way to engage with regulators, whether the FDA or the Commerce Department, as this helps reduce uncertainty in the path the market. Further,  as a young company in a nascent industry, we see collaborating with our peers to engage regulators as positive for all. The Paradromics team looks forward to helping advance future cooperative BCI initiatives.