Stanford Alumni, Doctor Revolutionizing Cancer Therapy

Once they've been cured, the last thing endometrial cancer (cancer of the uterus) survivors want to do is receive more radiation therapy. But at medical device company VivaRay, Inc., Stanford alumni are changing the out-dated process with their bare hands.

"The current method is so bad, most women abandon treatment," recent graduate Hanna Michelsen said. "Once nurses used it on patients, nurses would swear never to use those devices on women, the screams of agony were so bad."

The flash of invention came to VivaRay founder, George Hermann, '82, when a physicist approached him at a conference and pleaded '"Please design a better applicator!' he explained.

Hermann teamed up with Stanford Hospital surgeon and American Society of Breast Disease President Gail Lebovic and another product developer, Doug Sutton, to change the status quo of radiation therapy.

"The old technology was this barbaric, rigid cylinder that clamped onto women," Hermann said. "Literally something that looked like it was from World War II. In fact, it was designed about 60 years ago."

Yet many women are still willing to endure the treatment. Endometrial cancer is the most common gynecological cancer and affects approximately 42,000 women in the United States every year.

Though the likelihood of a local recurrence of medium risk cancer is low, around 15 percent, should the disease recur, the five-year survival rate is around 50 percent, Hermann and Michelsen said. Brachytherapy has been shown to reduce the likelihood of recurrence to one to two percent.

The Food and Drug Administration recently approved the product and now VivaRay is in stealth mode. To avoid inspiring other competitors to develop similar technology, all five employees cannot publicly explain the exact mechanics of the product.

But, Michelsen promises that the new machine is superior to the old technology because it has fewer side effects and is much more comfortable.

And the Stanford grad knows the process from start to finish. She and the team build an average of three machines a day with their bare hands.

"I can't mess up," she said. "These machines are literally being applied to human beings. In school, if something went wrong, you would never get caught. But now, I could directly hurt people with the tiniest mistake."

While most engineers are "sitting in windowless cubes building the product away from the clinics," Hermann said, Michelsen assumes many roles at the company, typical of a start-up.

She travels around the country to attend medical device manufacturing conferences. There, she must select all the materials to use from the plastic to the glue used to weld parts together.

Hermann also deploys his team out into the field to get real-time reactions and feedback from patients.

"Hanna is in the room, often times with the patient," Hermann said. "She's got great social skills and it definitely helps that she's a woman. The last thing they want is a guy in the operating room with them!"

Yet Hermann is no stranger to the biomedical sphere. VivaRay is his fifteenth biomedical device company. After graduating in 1982, Hermann said he was "sick of school" and discovered his knack for developing products to improve the current medical treatment.

In 2007, he founded Cianna Medical, Inc.—which developed a less invasive radiation therapy for breast cancer—and Biolucent, Inc. with Lebovic in 2001, which created soft, warm disposal pads that doctors can place on the shockingly cold x-rays during mammograms.

One nurse confided in Hermann that a patient refused to get mammograms until she heard about this new technology. When the patient did go in, doctors detected an early stage of cancer and saved her life.

"It's the best job in the world," he said. "You're solving a clinical problem where millions of women benefit. I can impact more people than I could if I were a doctor."

Hermann explained that surgeons don't often have the creative license to design new, improved technology.

"Because surgeons are always trying to amass the most current knowledge, they're rarely thinking 'what if I had a better product?'" he said.

And that's where engineers like Michelsen and Hermann enter. Though they graduated 28 years apart, the two represent the trans-generational desire to change medicine's status quo.

"I can mentor Hanna in the same way [my mentor], Tom Fogarty, exposed me to this innovative environment," he said. "I was fortunate that he was so forward-thinking."

Known as the "Godfather of Biomedicine" by many colleagues, Fogarty is currently a professor of surgery at the Stanford Medical School and was president of the hospital from 1977 to 1979. He co-founded over 33 companies in the medical field and is an inductee in the National Inventors Hall of Fame.

"Mentorship is absolutely critical," Fogarty said. "You're learning stuff you can't learn in a classroom. You go out and experience the actual process."

The tight-knit nature of the company is what spurs along the productivity, said co-founder and Director Doug Sutton.

"It's like being in a band," Sutton said. "Everyone has to get along really, really well to create the chemistry and atmosphere. There's nowhere to hide and you have to work incredibly hard."

Up until this point, VivaRay's hard work has earned the approval of biomedical professionals like Fogarty.

"[VivaRay] will be a smashing success because it puts the patient first and then everything else falls into place," Fogarty said. "It's going to radically alter the existing paradigm and shift the landscape of brachytherapy."