Addressing regulators, members of industry, and other stakeholders, Jennifer French delivered a powerful message about those requiring brain–computer interface (BCI) devices to treat paralysis and other neurological conditions: “We are not patients; we are consumers, end users.”
French, who is quadriplegic, spoke at a U.S. Food and Drug Administration (FDA) workshop, held Nov. 21 at the agency’s White Oak campus in Maryland to gather feedback on scientific, clinical, and regulatory considerations associated with BCI devices. The agency said it may use the findings and discussions from the workshop to create draft guidance on the content of premarket submissions for BCI technologies.
“We’re real people; we’re real people with real stories,” added French, who was paralyzed in a snowboarding accident in 1998. The following year, she became the first woman to receive an implanted system that allowed her to stand again. She also won the silver medal in competitive sailing at the 2012 Paralympics Games in London.
French said that as consumers, people with BCI devices should have their concerns addressed by clinicians, regulators, and medical device manufacturers. For example, there is a perception that walking again is the top priority for quadriplegics; however, she said that surveys have shown that having use of their arms and hands is the number one wish for these patients.
These findings suggest that manufacturers should engage these consumers early in the development process to determine their needs. “We don’t bite. We want to be able to help you,” she said.
Tiffany Ryan, national director of therapeutic services at Advanced Arm Dynamics, echoed this sentiment. “We have to meet [patients] where they are and help them get where they want to be.” She showed slides of patients, saying that different people want different things from their prostheses—some may want only basic function, others have specific needs.
A Growing Initiative
In April 2013, President Obama announced the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, which was developed to answer questions about major brain disorders, including Alzheimer’s and Parkinson’s diseases, depression, and traumatic brain injury.
The FDA, Intelligence Advanced Research Projects Activity, National Institutes of Health, National Science Foundation, and Defense Advanced Research Projects Agency (DARPA) are taking part in this project, with support from GE, Google, GlaxoSmithKline, and Inscopix.
During the workshop, Douglas Weber, a program manager within DARPA’s biotechnology office, highlighted other BCI projects the agency has undertaken, including the Electrical Prescriptions (ElectRx) program, which involves the modulation of the peripheral nervous system to treat inflammatory diseases and depression.
DARPA is holding an event Dec. 16, which is intended to inform the science and technology community about the ElectRx program, as well as encourage collaboration among different parties.
Although the federal government seemingly has taken great interest in the area of BCI devices, challenges remain, such as the small market size.
Hunter Peckham, the Donnell Institute professor of biomedical engineering at Case Western Reserve University and director of the Cleveland Functional Electrical Stimulation Center, noted that French with her device is still in an investigational device program, and long-term support for patients represents a major hurdle.
He recounted the experience of the NeuroControl Corporation, which developed a FreehandSystem, an implanted device that restores hand function in people with quadriplegia. The FDA approved the system in 1997; however, the company stopped marketing Freehand in the early 2000s due to low sales.
Peckham said he views the discontinuation of Freehand as a business failure, not a failure of the device. BCI devices will be “expensive to develop and support,” he said, and an innovation pathway is needed. This market “is not going to be small and investigational forever.”