Clot-Busting Inventor Breaks Barriers for Medtech Entrepreneurs

Xconomy San Francisco — 

A typical entrepreneur accepted into the competitive startup incubator at the Fogarty Institute for Innovation in Mountain View, CA might be an engineer from the Stanford Biodesign Program, a formal academic program that trains students to invent medical devices. But Dr. Thomas J. Fogarty, who founded the Fogarty Institute in 2007, says he’d be equally open to a great idea that came from a hospital nurse, or even an orderly.

“It could be anybody,” says Fogarty, the cardiovascular surgeon who invented the groundbreaking balloon catheter for clot removal in 1960. “Great ideas do not reside within any given institution—it resides within the person,” he says.

Over the past five years, the Fogarty Institute has nurtured more than a dozen fledgling companies with ideas for cardiovascular diagnostics, blood clot treatments, ear care tools, a miniature sewing machine for surgical stitching, baby monitoring devices during childbirth, and other innovations. One of the current entrepreneurs in residence is Peter Coelho, a family practitioner from Hollister, CA who felt he didn’t have the tools he needed during tricky home births.

The institute’s resident innovators are all kept in close touch with nurses, doctors and other hospital staffers who deal with unsolved medical problems every day.

“It’s very important that we pay attention to those people,” Fogarty says.

The program is based at El Camino Hospital, a non-profit community medical center founded more than 50 years ago. Each inventor is assigned to work with a physician who provides guidance and feedback, says Anne Fyfe, CEO of the institute.

Fogarty, 79, holds that inspiration comes from close observation of a practical problem. It’s not a surprising belief, given his biography. The veteran of many humble jobs before he was out of his teens—grocery store clerk, machine shop assistant, and hospital scrub technician at 5 cents an hour—Fogarty started on the path toward his seminal invention when he witnessed the invasive and often unsuccessful clot removal surgeries performed by the experienced physicians of the time.

As a 26-year old medical student, he faced an initial backlash from traditional surgeons in 1960, when he offered an alternative—an invention now known as the Fogarty balloon embolectomy catheter. As he recalls in a video on the institute’s website, the device was inspired by his observation that a balloon will conform to the varying shape of a soda bottle’s neck when the balloon is pushed into the bottle. The same thing would happen, he concluded, if a balloon were pushed through an artery to clear out a clot. He made the first conceptual model with a balloon made of a surgical glove fingertip, tied to a hollow tube with fishing line.

In the final version used in patients, a tiny deflated balloon is enclosed in a catheter. The catheter is threaded into a blood vessel until it has passed the location of a clot. Then the balloon is inflated, using air that flows from the hollow core of the catheter. As the catheter is then pulled back out, the inflated balloon pushes the deposits in the clot out with it.

The invention, later widely adopted and commercialized by Edwards Lifesciences of Irvine, CA, launched Fogarty’s long career as an entrepreneurial surgeon, device company founder, venture capital firm executive, and co-founder of a winery.

Fogarty sees a host of obstacles for the US innovators of today—regulatory hurdles, academic inertia, funding bottlenecks, and high startup costs that are driving entrepreneurship to other countries. But innovative individuals and industry also need to aim higher, he says, and try to create significant improvements that also save money for the health care system.

“Small improvements can cost an awful lot of money,” Fogarty says. Applicants to the Fogarty Institute must demonstrate that their inventions could cut costs.

One of the institute’s earliest portfolio companies, HeartFlow of Redwood City, could save the US health care system billions of dollars on unnecessary diagnostic tests, says Fyfe.

HeartFlow, founded by a vascular surgeon and an engineer from Stanford University, is developing a non-invasive test to improve the diagnostic power of a standard imaging test, the coronary CT scan or coronary computed tomography. This Xray scan collects data that is assembled into a 3-D image of the heart and coronary arteries. HeartFlow’s test uses computer algorithms on the CT data to calculate the flow of blood through each vessel and identify patients who may have a significant obstruction that requires further testing or treatment. It can also rule out patients who don’t need further invasive procedures, the company says.

Among the other alumni of the Fogarty Institute is PQ Bypass of Sunnyvale, CA, which is testing a less invasive form of surgery to improve blood flow in the limbs.

The incubator program has a rolling admissions policy. New startups are invited … Next Page »

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