Convening Patients and Regulators to Advance Neurotechnology

Jennifer French, founder of the Neurotech Network, a non-profit organization that advocates for greater patient access to devices that treat neurological conditions, as well as chair of ABC’s board of directors, credits Michelle Tarver, M.D., Ph.D.,, director of the CDRH, for bringing the FDA-TAP program to life—and adding neurological and physical medicine devices to the program in 2024.

“It’s not her official title, but [Tarver] is viewed as the mother of patient engagement at FDA,” said French, who lives with a spinal cord injury. “She championed bringing the voice of the patient into development, and it’s all been about changing the conversation so regulators can understand the priorities of people living with the neurological condition these new technologies are trying to address. That’s what will help them weigh the benefits and risks.”

The challenge, however, is getting the right people to the table to facilitate those conversations, said Sale. Many device developers are smaller start-up companies, and they don’t have the connections nor the infrastructure that traditional pharmaceutical companies have to reach out to people living with neurological or psychiatric conditions. Sale said she quickly realized FDA-TAP needed more than just a list of disease-specific associations or patient advocacy groups to get the value they sought. They needed someone to put together a true multi-directional engagement model so device manufacturers and regulatory officials could talk to the right patients and caregivers to ultimately create both effective and useful neural devices.

“The goal is to make sure people with lived experience are being heard as early in the process as possible—and this is especially important for complex conditions like Alzheimer’s or amyotrophic lateral sclerosis,” said Sale. “You don’t want the device company to get so far down the road with a product that they seek regulatory approval and then, suddenly, patients say it won’t work for them and there’s no market for it. These conservations need to happen at the very beginning.”

Acting as a convenor

Sale proposed that ABC, as an umbrella organization for more than 150 brain-related patient organizations, act as a convenor for FDA-TAP, to connect the right voices to the right projects. She and her colleagues applied for the Dana Foundation grant to put together the data and the tools to ensure that a meaningful range of stakeholders were included in TAP’s deliberations and decision-making processes. After receiving the funding, she said ABC got to work on creating detailed profiles of different organizations who might participate.

“We sat down and developed profiles for organizations that described each patient group’s capabilities,” she said. “How big they are; whether they are a membership organization; whether they participate in clinical trials; whether they host educational webinars; how they act with people with lived experiences themselves or with caregivers and the community; whether they interact with neurologists, neurosurgeons, and researchers in the field. We then created a two-page summary for each organization and gave it to the FDA.”

But that was only the beginning, said Sale. It was important to ABC that the conversations kept going, so that any initial meeting between people with lived experience and device developers wasn’t a “one and done.”

“We weren’t just introducing [device companies] to these groups. We also made sure the companies had the resources they needed and knew who they should be meeting with. And it was often more than just one patient organization,” she said.

“It was exciting to see so many of these patient organizations, from small, rare disease advocacy groups that do everything themselves to larger organizations that have their own connections, like clinical trial partners, be so amenable to meeting with these companies and the FDA to help move things forward.”

ABC also used their grant to build a digital patient engagement platform called SHARE, which, French said, offers resources to help patient organizations become more constructive advisors to both the FDA and device companies.

“We have a trained chatbot that can provide the right resources to do patient engagement for product development, and it’s really helping to build capacity on the patient advocacy side,” said French. “It allows us, as the convenor, to get the right information to the right stakeholders in a meaningful way so they can fully participate in this process.”

Continuing the conversation

Since receiving the Dana Foundation grant, ABC has brought together dozens of different patient groups with device developers and the FDA. As of March 2026, the FDA-TAP Pilot had enrolled 115 devices—38 of which are in therapeutic areas relevant to ABC’s member organizations. ABC, to date, has helped convene 24 engagements across 9 innovators. And SHARE went live in early May, helping more patient and caregiving organizations get involved.

When asked what the future holds for supporting neural devices via FDA-TAP, Sale said the FDA is working to bring payer organizations into the conservations to discuss coverage for emerging technologies, which is a critical development to ensure that resulting products will be covered by Medicare and commercial insurance plans. FDA-TAP is also now working with the Department of Veterans Affairs and Centers for Medicare and Medicaid Services to ensure shared innovation priorities moving forward including evaluating the value of new technologies and offering accelerated pathways for device approval.

Ramos said she and her colleagues at the Dana Foundation are thrilled with what ABC has accomplished—and hopes that other groups will scale and replicate their efforts to bring more lived experience to device development and regulatory pathways in the future.

“This project demonstrates the importance of thinking about new ways to connect neuroscience with everyday life,” she said. “They’ve created impactful engagement, providing people living with brain-based conditions a voice at the FDA.”