Experience Helped San Diego’s EHS Get First FDA-Approved Wireless Blood Glucose Meter
“I describe Entra Health Systems mainly as a medical device company,” CEO Richard Strobridge said when we met recently at his company’s San Diego headquarters. “We’re under the jurisdiction of the FDA, and we have to have all kinds of certifications and qualifications [as a medical device company.] But a lot of our expertise, and my personal experience is in integrating telecommunications.”
Strobridge spent a decade at SAIC, the Virginia defense contractor that was founded in San Diego. There, he integrated teleconferencing systems with communications networks so the fast-growing company could communicate more efficiently with its offices around the country and the world. He claims several firsts in video networking, including technology that enabled a surgical team in a hospital operating room to provide training to surgeons in another operating room.
At Entra Health, Strobridge and co-founders John Hendel and Larry Mahar decided to focus on a different sort of technology integration—by combining an electronic blood glucose meter with a cell phone. The company created a Bluetooth-enabled blood glucose meter, which the company says is the first such device cleared by the Food and Drug Administration.
After starting the company in April, 2007, they spent most of the next year engineering a prototype and developing software. By the fall of 2008, Entra Health won approval to market their wireless medical technology in Europe. The FDA issued its approval for Entra Health’s technology in the United States in April 2009.
“It’s not our first rodeo,” says Bruce Ahern, the company’s chief marketing officer.
The consultant who managed the company’s FDA application had worked closely with Strobridge at Stryker (NYSE: SYK) the Michigan-based medical technology company that acquired one of his first startups, San Diego-based Infomedix Communications, in 1999.
“It took about nine months to get it through the FDA,” Ahern says. “He had done about 100 devices before that.”
Beyond the device itself, Entra Health also offers a comprehensive, Web-based diabetes management platform that automates the process of plotting individual blood-glucose levels, giving patients more direct control of their own care. Because doctors, relatives, and caregivers also can access the online data, Entra Health says it helps clinicians stay up-to-date on patients and enhances their communications.
The startup’s rapid progress reflects some decisions that proved to be fortuitous.
Strobridge said the founders initially envisioned a device that combined a cell phone and blood glucose monitor. But they quickly realized that the cell phone business was moving so fast that the phone would be outdated by the time they could bring their product to market.
So they decided instead to develop a blood glucose meter that could plug into a mobile phone. Patients insert a test strip with a 0.3 microliter sample of their blood into the meter, which uses Bluetooth technology to transmit test results to the phone. The device then transmits the data to a Web portal at myglucohealth.net.
As it turns out, the company had a much easier time winning FDA approval because regulators only had to validate that the meter was the same as existing technology.If the company had integrated the meter in the phone, Strobridge says regulators would have gotten bogged down in the process of evaluating the entire phone.
Deciding to first apply for regulatory approval in Europe also made it easier to win FDA approval in the U.S. “It wasn’t a conscious decision,” Strobridge said, “but it ended up being easier.”
The expertise and experience of Entra Health’s co-founders also helped. Hendel, who had previously worked in Europe for two years with a telephone communications services company, had contacts with UK Trade & Investment that led to a major consulting project in England for Entra Health’s founders. The work generated early revenue for the startup, and enabled the company to begin working immediately with European regulators.
Entra Health also serves as an example of the type of wireless health startups that are taking root in San Diego, and helps to explain why San Diego is emerging as an innovation hub for mobile health.
The three co-founders have self-funded the company, as Strobridge put it, “to not give up a lot of equity and get as far down the road as we can with regulatory clearances and worldwide distribution.”
In the past year or so, Entra Health also introduced its “MyGlucoHealth Wireless” technology in Australia, Hong Kong, and South Korea. The company now has a global workforce of about 20 employees, prompting Strobridge to quip, “We’re the smallest multi-national company that I know.”
Strobridge adds, “Our strategy is to stay out front with our product road map [for MyGlucoHealth] and with the development of other products that help manage chronic diseases.”
For example, Entra Health has developed a wireless hub device for its MyGlucoHealth Wireless technology that can support several blood glucose meters simultaneously. The company also created TouchTrak, a patient management system for hospitals and healthcare practices that enables patients to check-in at a free-standing touch-screen computer display that asks a series of questions about the patient.
Strobridge says the company also has been doing a lot of work to identify potential strategic partners, and has been in discussions with others.
“A lot of non-traditional healthcare providers are quite interested in [MyGlucoHealth], and in seeing how it will play out,” he says.