UCSD - University of California - San Diego

01/26/2026 | Press release | Distributed by Public on 01/26/2026 10:12

First-of-its-kind Cleanroom Turns Inventions into Devices Ready for FDA Approval

Published Date

January 26, 2026

Article Content

The first good manufacturing practices facility located on a university campus in the United States opened this fall at the University of California San Diego. The space is dedicated to building devices that can be implanted in the human body - especially for neurological applications.

Located at the UC San Diego Jacobs School of Engineering, the facility meets strict standards and regulations needed for approvals by the Food and Drug Administration for devices implanted in the human body.

"In this laboratory, we're able to take innovations throughout the whole UC San Diego ecosystem, from engineering to medical sciences to neurosciences, and put it all together and get our prototypes toward larger animal testing and clinical trials for FDA approvals," said Shadi Dayeh, a UC San Diego electrical and computer engineering professor. "The full pipeline, from invention and prototyping in the lab to manufacturing of devices ready for FDA approval is taking place in a single facility."

Researchers at the facility, led by Dayeh, work on projects funded by the National Institutes of Health to improve treatments for epilepsy, pain, depression, movement disorders like Parkinson's disease, and spinal cord injuries, as well as for monitoring during surgeries for brain tumors. The research team also works on projects funded by the U.S. Advanced Research Projects Agency for Health, or ARPA-H, to make functional eye transplants a reality.

The facility is important on two fronts: it provides the technology to manufacture devices in fairly large quantities and allows researchers to carefully document the manufacturing process - two critical components for FDA approval.

At 2,200 square feet, the cleanroom provides a clean manufacturing environment that is roughly 5,000 to 10,000 times cleaner than typical indoor or outdoor air with class 100 (ISO 5) and class 1,000 (ISO 6) zones. It houses cutting edge equipment for implantable device manufacturing, as well as the compact integration of chips and electronic modules into implants designed to monitor or modulate neuronal or nerve activity - and more.

The facility will allow researchers led by Dayeh to manufacture a wide range of devices, packaged and ready for sterilization, and to prototype these devices for tests required for submissions and for running small clinical trials.

Grids to record brain activity

The first devices off the new GMP manufacturing line will be platinum nanorod grids for an FDA-approved clinical trial. These grids are ultra-thin, flexible arrays with thousands of sensors that can map brain activity at a resolution far beyond today's standard surgical grids. In 2024, Dayeh received FDA approval for a clinical trial to test the effectiveness of the electronic grid that records brain activity during surgery. The clinical trial requires manufacturing hundreds of identical grids as well as detailed documentation to meet the FDA standards. This will be the first project to benefit from the new facility.

The new brain-sensor array, known as platinum nanorod grid (PtNRGrid) features a densely packed grid of a record-breaking 4,096 embedded electrocorticography (ECoG) sensors and 256 stimulators. The device rests on the surface of the brain and is approximately 6 microns thin-smaller than one-tenth of the human hair - and flexible. As a result, it can both adhere and conform to the surface of the brain, bending as the brain moves while providing high-quality, high-resolution recordings of brain activity. In contrast, the ECoG grids most commonly used in surgeries today typically have between 16 and 64 sensors. These grids are rigid, stiffer and more than 0.5mm in thickness and do not conform to the curved surface of the brain.

The grid's breakthrough resolution could provide better guidance for planning and performing surgeries to remove brain tumors and treat drug-resistant epilepsy. It could improve neurosurgeons' ability to minimize damage to healthy brain tissue. During epilepsy surgery, it could improve the ability to precisely identify the regions of the brain where epileptic seizures originate for safe and effective treatment.

Dayeh also leads a multi-institution effort funded by the NIH to transform epilepsy monitoring with up to 30-day wireless implants. The commissioning of the facility will now enable the manufacture and assembly of the finalized devices to go through regulatory testing and the approval process, leading up to a small clinical trial in the next one to two years. The wireless devices will enable at-home monitoring, which will reduce the load for epilepsy monitoring units and democratize the access for this type of advanced monitoring. It will also permit monitoring of brain activity in natural environments with results that could shed light on human intelligence and adaptivity in the real world.

Professor Shadi Dayeh, right, and researcher Keundong Le, look at a results on a screen in the facility.
Photos: David Baillot/UC San Diego Jacobs School of Engineering

Toward functional eye transplants

Also in 2024, Dayeh became part of a multidisciplinary team working to develop a wireless, multimodal electrode system to wire the optic nerve to the brain with high-end precision after an eye transplant to restore vision. The same GMP facility that manufactures brain-mapping grids will also build the intricate electrode systems needed for functional eye transplants under the ARPA-H Transplantation of Human Eye Allografts (THEA) program led by Stanford University.

The biggest challenge the team faces is moving whole eye transplants from aesthetic to functional by figuring out how to regenerate the optic nerve, which connects the eye to the brain. Dayeh and colleagues aim to use a grid composed of stimulators and thousands of sensors to stimulate the optic nerve and assess functional recovery. The team has already implanted these devices in animals and is studying light encoding and transmission to the brain. In later phases, Dayeh's group will use human-grade, inflatable electrodes they developed to stimulate and help regenerate the optic nerve. The electrodes can generate electrical signals, which would help accelerate the regeneration of axons and direct their growth inside the optic nerve to re-establish connection between the transplanted nerve and the brain.

Researcher Wonjae Jeon works in the GMP facilty.

Translation to Therapy

After enabling high-density brain mapping and epilepsy monitoring, the facility plans to increasingly focus on therapeutic devices such as devices that stimulate the spinal cord and brain to restore movement, ease chronic pain, and treat conditions like depression and Parkinson's disease. Dayeh's team has established safety limits for brain stimulation and will leverage this expertise to engineer devices that can modulate brain activity from the surface or deep inside the brain. Interest in neuromodulation in deep layers of the brain has been fueled by successful clinical trials and successes in the treatment of drug-resistant epilepsy, tremor, Parkinson's Disease, and more recently in pain, depression, obesity, obsessive compulsive disorders.

"We are truly at an inflection point at UC San Diego and in the United States for bringing precision to neuromodulation and neuro-restorative therapies," said Dayeh. "This GMP facility brings us much closer to turning these therapies into reality, and it was made possible by UC San Diego's leadership and by sustained support from the NIH BRAIN Initiative and ARPA-H."

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