Making pregnancy safer, one medtech start-up at a time

Surgeon-cum-winery owner Thomas Fogarty is the founder of an incubator for cutting-edge childbirth technologies

Published August 9, 2013 7:35PM (EDT)

    (<a href='http://www.shutterstock.com/gallery-92898p1.html'>kaarsten</a> via <a href='http://www.shutterstock.com/'>Shutterstock</a>)
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Not every 79-year-old surgeon happens to run a tech incubator. Not every 79-year-old surgeon who runs a tech incubator happens to have a winery either. But Thomas Fogarty does. The doctor-entrepreneur-vintner, best known for inventing the angioplasty balloon, runs the Thomas Fogarty Winery just a few miles uphill from his medtech incubator at El Camino Hospital in Mountain View.

The non-profit Fogarty Institute for Innovation is based around a simple concept: Making life easier for small or early stage medtech firms developing cutting-edge products or tools. In an interview with Fast Company, Fogarty decried what he saw as the increasing cost of American medical innovation, and said that small medical companies need a safe environment for growth similar to those of lower-overhead conventional tech startups.

Since its founding in 2007, the Institute has helped about a dozen small medical companies launch. Back in June, the Institute announced its latest crop of participants. The five new companies are primarily centered around providing services for expectant parents or newborn children. Among them are a non-invasive sensor that records fetal vital signs, a device that prevents vaginal tearing during childbirth, and a sensor set for clinicians giving urgent care to newborns.

An Incubator for Incubators

Here are the five companies the Fogarty Institute started incubating in June. These technologies are still in their early stages and have not received FDA approval to hit the mass market yet:

First Pulse Medical: First Pulse manufactures one of the first attempts at a heart rate monitor for fetuses during labor and delivery. The monitor uses proprietary light sensors to track a fetus's heart rate and oxygenation.

InPress Technologies: InPress is testing a single-use medical device which quickly and effectively treats postpartum hemorrhaging (PPH) as it happens by stimulating vaginal contractions. One woman dies from PPH every four minutes.

Materna Medical: Materna is conducting tests in Australia on an anti-vaginal tearing device for women giving birth. The mechanical dilator is inserted during the first stage of labor and is designed to prevent vaginal tearing or pelvic damage during childbirth.

Medical Cue: Medical Cue's NeoCue system is a combination sensor set/workflow organizing tool for childbirth. The system automatically gives medical professionals key physiologic data and real-time decision guidance.

Prescient Surgical: Prescient Surgical's Cleancision device prevents dangerous surgical wound infections. This Stanford University spin-off is targeting a very specific market--obese patients undergoing colorectal surgery.

How It Works

During our conversation, which jumped from Fogarty's anger at the press for publishing (in his opinion) to many scare stories about medical innovation to the interaction between his institute and the larger Silicon Valley tech scene, he said something interesting. “The venture capital community has largely avoided medical companies because of the expenses associated with it. There are also many other problems, but primarily they're regulatory. We need more clinical research [for products] in addition to basic research... What we're doing at the Institute is trying to solve these issues." Fogarty also added that the institute works with entrepreneurs in other highly regulated industries to trade best practices on navigating bureaucracy, which is a common hurdle for health startups.

There are fewer industries more highly regulated than the medical profession. While transport apps like Uber have to deal with byzantine local taxi bureaucracies, medical startups face the FDA--an organization that is both costly and inefficient to deal with. Fogarty, along with many other biotech innovators I've spoken to, complains that the FDA is inefficient when it comes to evaluating new technology. It's not that the FDA is hostile to innovation; rather, it's that agency bureaucrats don't keep up with new research.

What the Fogarty Institute tries to do is to make the regulatory and fundraising parts of getting off the ground easier for young medtech firms. Participating companies in the Innovation Cultivation incubator base themselves at the Institute and are given assistance with research and development costs, staffing, mentorship, and securing financing. Participants are steered toward securing venture capital and angel investors alongside the standard government grants and private donations from charitable foundations, which is unusual for a medical incubator but falls in line with the Institute's venture capital-friendly approach.

Since the Fogarty Institute is a nonprofit, things work a bit differently than in a traditional tech incubator. Most importantly, their program is designed to connect medical firms with investors quickly. After grants are given to participating companies to cover expenses, the immediate goal is connecting companies with investors or government funding. Companies which have previously received A-round funding are generally barred as well.

Other health tech incubators and accelerators work on a similar model. Fellow nonprofit Rock Health offers similar startup assistance, as does the more informal Prebacked. In the end, for Fogarty and others, the challenge is simple: Successfully tweaking working funding models from the tech world in order to save lives in the real one.


By Neal Ungerleider

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Childbirth Fast Company Medical Technology Medicine Pregnancy Start-ups