Meet Zoe.

Zoe Lalji is the daughter of Dr. Ayeez Lalji, who she described as an avid runner, loving father and self-made entrepreneur. In September 2017, her dad woke up with twitches all over his body and three months later he was diagnosed with amyotrophic lateral sclerosis or ALS. From that day on he could no longer run or operate his dental practices, and now he is no longer able to speak or move on his own. Zoe is hopeful that there will one day be a cure for ALS, but believes strongly in the words of Steve Gleason, former NFL player and ALS patient, that “until there is a cure, technology is the cure.” Zoe believes that brain-computer interface (BCI) technology provides hope for the millions that suffer from severe speech and motor impairment, and the possibility to improve connection between family members and caregivers, resulting in better patient care. 

‍ALS Heroes, a Lalji family foundation inspired by Dr. Ayeez Lalji, is a founding member of the Implantable Brain-Computer Interface Collaborative Community (or iBCI-CC). This community was formed by a group of diverse stakeholders with a wealth of experience in the fields of neuroscience, medicine, technology and patient advocacy to advance the development of implantable brain-computer interfaces in a thoughtful, impactful, and results-driven approach.

“Our goal is to foster collaboration among diverse stakeholders, including researchers, clinicians, medical device manufacturers, patient advocacy groups, and people with lived experience, to accelerate the development, safety and efficacy evaluation, and access to iBCI technologies.”

Collaborative communities are central to the advancement of brain-computer interfaces and foster interdisciplinary dialogue and cooperation that is essential for tackling the multifaceted challenges of BCI development:

• Research and innovation: Collaborative efforts bring together diverse expertise, from neuroscience to robotics, enabling rapid progress in understanding brain function and developing more sophisticated interface technologies.
• User-centered design: BCIs must serve the practical needs and preferences of their users so individuals with disabilities, and their caregivers, are actively involved to ensure technology is intuitive, functional, and genuinely empowering.
• Ethical considerations: BCIs raise profound ethical questions regarding privacy, autonomy, and the potential for misuse. Ethicists and social scientists are integral to addressing these issues and promoting responsible innovation.
• Clinical trials and validation: Medical device development requires rigorous testing and validation through clinical trials to ensure the safety and efficacy of BCIs. Central to this ecosystem is the U.S. Food and Drug Administration (FDA), which is instrumental in balancing innovation with patient safety and promoting advancements that benefit patients.

For collaborative communities developing new medical technologies, the FDA serves as a critical partner to provide regulatory guidance throughout the product development and submission process. The FDA also encourages dialogue among stakeholders within collaborative communities, promotes best practices in medical product development, and, through medical technology accelerator programs, ultimately lays the foundation for “more rapid development and more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance.”

The goal of the FDA and other contingents of the iBCI-CC is to cultivate a meaningful, needs-driven brain-computer interface field. The group is intentionally limited in scope to include implants under the scalp or intracranial space that sense and interpret signals from the brain via intravascular, epicortical, and/or intraparenchymal electrodes with the intent to facilitate restoration or rehabilitation of users’ function. By maintaining a narrow focus, the group is positioned to efficiently and effectively answer the multitude of questions that must be answered before clinical use is possible; including how iBCIs will be categorized for reimbursements, whether any iBCI components should be standardized, and best practices for handling neural data. 

By fostering inclusive, ethical collaboration and uniting diverse expertise and perspectives, these and many other considerations are being addressed thoughtfully by the iBCI-CC and are paving the way for a future where individuals with disabilities can reclaim autonomy and enhance their quality of life through direct brain-computer communication.

Paradromics is a proud founding member of the iBCI-CC. We look forward to the many clinical advancements that this group will bring to the implantable Brain Computer Interface field.

Learn more in The Role of FDA in the BCI Journey.

Learn more about Zoe’s story and ALS Heroes. You can also watch her TEDx Talk here.