Fogarty Innovation’s Lunch & Learn sessions provide a unique opportunity for knowledge sharing amongentrepreneurs and members of the industry as a key part of the organization’s mission to empower innovators in their quest to transform healthcare and improve lives. An integral—and often complex—component of the medtech lifecycle is working with the FDA. A recent session, titled “Breakthrough Device Designation and the Total Product Life Cycle Advisory Program (TAP)” covered perspectives from both the FDA and two companies who are have already received breakthrough designation and are part of the TAP program.
Speakers included Laura Gottschalk, Ph.D., FDA Total Product Life Cycle Advisory Program (TAP) advisor; Jane Noble, Ph.D., FDA acting team lead; Alexis Dineen, VP of regulatory affairs, SetPoint Medical, Ankit Shah, VP of marketing, SetPoint Medical; and Marc Powell, Ph.D., CEO and president, Reach Neuro. The discussion was moderated by Peggy McLaughlin, Fogarty Innovation’s strategic clinical and regulatory advisor.
Shedding light on these game changing programs
The session featured FDA representatives Noble and Gottschalk discussing the Breakthrough Devices and TAP programs respectively.
Noble shared that the Breakthrough Devices program is designed to provide patients and healthcare providers with timely access to devices that provide more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition than solutions currently on the market. Devices that meet the program eligibility criteria will receive expedited development assessment and review.
In addition, the program offers the opportunity for interactive and timely communication from the FDA, which allows companies to move forward with their device development decisions more quickly.
Next, Gottschalk shared an overview of TAP and how it helps prevent many of the uncertainties that often arise later in the development pathway, which can unfortunately result in the failure of what may very well be a safe and effective device.
The goal is to de-risk the process for device developers through early, frequent coordinated stakeholder interaction—and not just with the FDA, but with other stakeholders, such as patients, payers and providers and professional organizations, which can help innovators optimize their evidence-generation strategy for faster commercialization.
“TAP offers a concierge service to help companies think not just about their regulatory strategy, but about their bigger business strategy,” Gottschalk explained. “The long-term vision for TAP is to spur more rapid development and widespread patient access to safe, effective, high-quality medical devices of public health importance.”
In addition to answering immediate questions, the TAP advisor will nurture sustained relationships and further inform aspects of device development, with the hope that by facilitating these strategic interactions sooner, innovators will be better positioned to achieve faster and more successful results.
“So far, I have gotten positive responses from participating companies that have received feedback much faster and more efficiently, allowing them to make key strategic decisions sooner,” Gottschalk said.
Currently TAP is enrolling devices that have already received breakthrough device designation from just two offices, cardiovascular (OHT2) and neurological and physical medicine devices (OHT5). Each candidate will go through an assessment process to ensure they are early enough in development, given that TAP is designed to bolster companies in the early stages. Over time the program will increase the number and type of devices considered. After the session, the FDA announced that the TAP program will add devices reviewed in the Office of Radiological Health (OHT8) and the Division of Ophthalmic Devices (DHT1A) this fall and the Office of Orthopedic Devices (OHT6) in 2025.
Positive feedback from program participants
As CEO and co-founder of Reach Neuro, Powell described the device they’re creating to help people who have had a stroke recover motor function. The device resembles spinal cord stimulators currently used to treat other indications like chronic pain. While it leverages familiar hardware, it’s unique in that they are using it to directly restore motor function by precisely stimulating the neural circuits responsible for motor control. A proprietary programming algorithm enables the technology to adapt to the needs of each patient, targeting the specific muscles they have difficulty controlling.
Founded in late 2021, the company received breakthrough designation in March 2023, and applied for the TAP program a few months later. Although new to the program, Powell reports it has changed the way they communicate with the FDA, enabling more open and frequent discussions about their product and its development.
The second program participant to present, SetPoint Medical, is developing a neuroimmune modulation platform to treat autoimmune conditions. It uses a differentiated mechanism of action, electrical stimulation of the vagus nerve, to activate a downstream chemical cascade that changes the inflammatory homeostasis—or setpoint of the body.
The company has received two breakthrough device designations, one in rheumatoid arthritis in 2020, for which they recently announced positive topline results in their pivotal study. The second breakthrough device designation and subsequent TAP acceptance is for the use of their platform for treatment of remyelinating relapsing multiple sclerosis. Dineen and Shah shared that they have appreciated their enrollment in TAP and encourage others to look into the possibility. They described the streamlined TAP approval process, sharing that “It literally took about five minutes from receiving our breakthrough designation to being invited to apply [for the TAP Pilot], and it was a very quick turnaround from there with a simple application. Now we have access to this combined wisdom that will make our device better and our path smoother.”