Robert Greenberg got tired of hearing from senior engineers that it wasn’t possible to build his product idea: a bionic eye that gives sight to the blind.
"A lot of the folks straight out of school didn’t know any better, so I hired them instead," quipped Greenberg, chief executive of Second Sight Medical Products Inc., a Sylmar biotech company. "They didn’t know how hard it was going to be, that it was impossible. And so they tried."
Greenberg can laugh now that he once thought developing the device would take a year and $1 million. Some 20 years and $200 million later, the first bionic eye has helped more than 20 European patients regain some of their sight.
Called the Argus II Retinal Prosthesis System, the device recently was approved by the Food and Drug Administration. Second Sight, which has 100 employees, is allowed to sell the bionic eye system to patients in the U.S. with advanced retinitis pigmentosa, a degenerative eye disease that can cause blindness.
"We are a far cry from restoring 20/20 vision," said Brian V. Mech, Second Sight’s vice president of business development, who holds a doctorate in materials science and an MBA from the UCLA Anderson School of Management.
"We are taking blind people back up to low vision, and that is pretty significant."
Mech likes to show videos of once-sightless patients who, after receiving the retinal prosthesis, are able to follow a person walking down the street and discern a street curb without using their canes.
"Until our product, these patients had no other option to obtain the ability to see," Mech said of the $100,000 device, part of which rests on a pair of Oakley Inc. sunglass frames. The cost to European patients has been paid by insurance companies in most cases.
Palo Alto attorney Dean Lloyd, who lost his vision 17 years ago, got the bionic eye system as part of the U.S. testing process. It allows him to see “boundaries and borders, not images” but has had a profound effect on his life.
Lloyd cites an incident before he received the eye system that still rankles. In the middle of a courtroom trial, an opposing attorney said Lloyd didn’t stand a chance with his case because he couldn’t even keep his socks straight: Lloyd had mixed up his black, courtroom socks with his white athletic ones.
"What did I do after the surgical procedure that I hadn’t been able to do?" Lloyd said. "I went home and sorted all of my socks."
The story of how the bionic eye came to be made in Sylmar underscores the state’s long record of medical device advances and involves top university researchers who were brought to Southern California to work on the project.
Greenberg likened the degree of difficulty to “shrinking a television set to the size of a pea, then throwing it into the ocean and expecting it to work.”
For Greenberg, it began in the early 1990s when he was a doctoral candidate in the Department of Biomedical Engineering at Johns Hopkins University in Baltimore.
Some of the first work was being done there, testing patients who had lost their vision because of retinitis pigmentosa, to see if electrically stimulating their retinas would produce results. It did.
"Using one electrode, the patient saw one spot of light," Greenberg said. "Second electrode, and the patient was seeing two spots of light. During that experiment, I was hooked."
Greenberg said he thought: “This is just engineering. Put more spots and you could make more pixels, like lights on a scoreboard or pixels on your computer monitor. You could see images.”
There was a breakthrough of another sort a few years later, in Washington. There, Greenberg was working as a medical officer and a lead reviewer for the FDA’s Office of Device Evaluation when he met entrepreneur Alfred E. Mann.
Mann had already established himself as a medical device developer through Mannkind Corp. and several other Southern California companies. During the 1980s, the self-made billionaire founded Pacesetter Systems, which made cardiac pacemakers. From there, he moved on to insulin pumps and related equipment.
Another Mann-funded company, Advanced Bionics Corp., took on cochlear implants, which could restore hearing to the deaf. It was the electrode-based cochlear implant that formed the rough basis of Second Sight’s first bionic eye.
In 1998, Second Sight opened with the financial backing of Mann and Sam Williams, another successful entrepreneur whose company, Williams International, designed and built small, efficient turbofan jet engines.
"Sam Williams was blind from retinitis pigmentosa, the disease that we are treating," Mech said. "He had invested along with Al in Advanced Bionics, which restores hearing for deaf people, and they were already on the market in the ’90s. Sam said to Al, ‘Why can’t we do the same for blind people?’"