In the back of the El Camino Hospital campus, clinical specialist Will Johnsen slapped on a pair of 3-D glasses and began picking apart a virtual human body, pulling out neck vertebrae and arteries, rotating and manipulating each part as it's projected about 6 inches in front of a computer monitor.
It may sound like science fiction, but it's one of several new products that medical technology innovators are developing at the Fogarty Institute for Innovation, which operates out of the hospital. The institute has proven to be a powerhouse for fledgling startup companies trying to get through a labyrinth of financial and regulatory hurdles. EchoPixel, a three-year member of the institute, certainly has one of the flashier products deep in development, allowing physicians to transform MRI and CT scan data into 3-D holograms with a clear sense of depth perception.
Silicon Valley is the well-established home of tech innovation and startup culture, with new software, high-tech and information technology firms cropping up all over the Bay Area. It would seem that companies like EchoPixel would fit right in, but it turns out that launching a new company and putting medical technology on the market is a dreadfully slow process when compared to developing a new app, and finding investors willing to put money down on med-tech companies can be next to impossible.
That's where the Fogarty Institute for Innovation comes in. For years, Fogarty has been a breeding ground for new companies creating medical technology, but that don't have the office space, the investor money or the regulatory approvals needed to move forward. Some eight companies operate out of the Melchor Pavilion at El Camino Hospital, as well as the kitchen area of the old main hospital building, which looks suspiciously like a morgue.
Along with office space and limited research and development tools, Fogarty also provides a "modest infusion" of staring capital as well as access to a circle of investors, according to Kerry Pope, the executive director of mentoring at the institute. Companies "graduate" and move out of Fogarty once they finally secure the funding they need -- which can take years.
One of the companies deep in the development phase is EchoPixel, which calls its three-dimensional imaging technology "True 3D." Using a tool similar to a stylus pen, True 3D allows physicians equipped with a pair of 3-D glasses to examine the patient's body on a virtual plane, vastly reducing the time it takes to make a diagnosis and increasing the chance of catching any health defects, according to CEO Ron Schilling. The technology has been used to spot congenital heart defects in newborn children, and can enable physicians to do a "virtual colonoscopy" and locate flat lesions that may be tough to spot.
With any luck, Schilling said they will be able to replace the flat, gray 2-D images that physicians normally rely on, which only provide a glimpse of what's going on in a patient. He said physicians have critiqued the status quo, pointing out that they've never opened a patient and seen them in 2-D.
"The idea of radiology and surgeons working together is very important to us," Schilling said. "(True 3D) gives them a common language."
Another company at Fogarty, Marz Medical, has developed a new product called "Blossom," a device that expands tissue for breast reconstruction following a mastectomy. Josh Korman, a plastic surgeon who practices at El Camino Hospital, joined Fogarty about a year ago and received two patents for Blossom, which aims to shorten the recovery time for women undergoing breast reconstruction.
Normally, women who undergo a mastectomy have to go through a lengthy tissue expansion process using an "expander," that takes anywhere from two to six months, and requires weekly visits to a physician. Korman said he could never really understand why there wasn't a faster way to finish tissue expansion before scar tissue and contraction sets in, so he began work on a device that would automatically pump a saline solution into the expanders.
The first round of clinical trials showed women were able to complete tissue expansion between seven and 10 days with a 100 percent rate of success.
"The patients don't have to have a prolonged process hanging over their heads," Korman said.
Brenda Mijares, one of Korman's patients, said she wanted to get better right away when she learned about her cancer diagnosis. Her surgeon recommended the alternative path for breast reconstruction using Blossom, and she went for it. In about two weeks, she was ready for breast implants.
"It was a big relief," Mijares said. "I didn't have to come in every few weeks."
Pope, who works closely with Marz Medical and the rest of the startups at Fogarty, said he is confident that Korman has created a product that will improve the lives of patients once he's able to put it on the market for widespread use.
"He's absolutely hit a winner," Pipe said. "We just need to get him funding."
Securing that funding, however, is no easy task. Medical technology startups have to compete with information technology and high-tech firms that are generally seen as a safer investment, making it difficult to graduate from Fogarty. These are products that can save lives, but there's a chance some of them won't be able to make it to the market with the dearth of investor money, said Fogarty Institute spokeswoman Birgit Johnson.
"The funding for med-tech companies has really dried up," Johnson said. "There's been a cold freeze on VC money because it takes so long to get to the market and there's a higher risk."
Companies like EchoPixel and Marz Medical have to tread a difficult path in order to put a new medical device on the market. Unlike other startup companies, med-tech companies need to seek regulatory approval with the U.S. Food & Drug Administration, which can be a huge pain. Pope said that companies have to submit what's called a 510(k) application with the FDA, which demonstrates that the device is safe and effective and can legally be placed on the market.
The process sounds simple enough, but completing this regulatory hurdle can be a lengthy endeavor because of slow and cumbersome communication between regulators and startups, Pope said. Often times, the startup will make a submission and be forced to wait 90 days for the FDA to respond with follow-up questions about the product. Then the 90-day clock starts again for another round of responses from the FDA. Sometimes regulators ask nuanced questions that are so hard to answer in such a disconnected way that companies at Fogarty are forced to elevate their request to senior management at FDA.
Pope's perspective has been on the startup side of things, but he said the relationship between the FDA and Fogarty has helped him see things from both sides. FDA officials are often faced with going through 10 to 15 different applications at a time, each one hundreds of pages long, and essential information on how the product will be used is omitted -- sometimes intentionally -- from the applications.
"As a CEO for two medical devices, the FDA was the enemy," Pope said. "We saw them as putting up obstacles."
Rather than accept this adversarial relationship, Pope said the Fogarty Institute is hoping to turn things around. Starting last year, Fogarty forged a new partnership with the FDA so regulators can better understand what startups have to go through in order to put a new medical product on the market. Four teams of two FDA officials, including high-ranking branch chiefs, have spent time at the institute, essentially embedding themselves in the startup teams, learning about the trials and tribulations that are potentially hindering innovation.
Large, well-established medical technology companies don't really have the same problem as small, ambitious startups, and can get products' regulatory clearance without too much trouble, Pope said. But it's the companies at Fogarty on shoestring budgets that make the real breakthroughs in the medical world.