MT Meets IT

An increasing number of factors, including regulatory barriers and less return on investment, are thwarting efforts to bring new medical device technologies to the U.S. market. However, as medical innovation becomes less hardware oriented, new avenues present themselves.
“An evolution is occurring. As venture capitalists shy away from medical devices, a new opportunity unfolds,” says Peter J. Fitzgerald, MD, PhD, co-director of the Center for Research in Cardiovascular Interventions at Stanford University School of Medicine in Stanford, Calif.
The next wave of innovation is MT (medical technology) meets IT, he predicts, specifically driven by the technological opportunity provided by  smartphones and the healthcare-wide push toward prevention.

For example, smartphones are now FDA approved to obtain an ECG through a person’s clothes. Companies like Apple, Qualcomm, Intel and Google are entering this space to manage information for the three Ps: payers, providers and physicians.

“We are going to see an explosion of MT meets IT, not just related to medical records, but related to communication from insurance companies to employees. Employers are going to be the next spokes of innovation,” says Fitzgerald. “Preventive care will be facilitated through early communication and the use of handheld communication devices in a provocative way to prevent hospitalizations, prevent inpatient complications, and most importantly, to decrease the current 26 percent rate of rehospitalization for Medicare patients after 30 days.”

Of course, once a smartphone or rather, an application (app) of that phone becomes a medical device, the FDA is under a mandate to regulate it. “There are some mHealth-related products and issues that meet the definition of a medical device,” says William H. Maisel, MD, MPH, chief scientist and deputy director for science at the FDA’s Center for Devices and Radiological Health. “That being said, we are trying to be very rational and strategic in the areas in which we choose to extend our resources.”

Mobile apps can turn a smartphone into a medical device, such as a glucose meter, says Maisel. The FDA has issued draft guidance, suggesting the agency will only regulate mobile apps that turn smartphones into medical devices, but will not regulate the phone itself. “We recognize how important innovation is in these areas, and we are focusing on those areas that have significant implications for patient safety,” he says.

The market is responding to this growing space, and the mHealth applications market is expected to see revenues grow from $230 million in 2010 to $392 million in 2015, according to market research firm Frost & Sullivan.

“The cost to develop certain MT meets IT solutions is significantly less than a heart valve, for example,” says Fitzgerald. “In the U.S., it’s not going to be plugging holes with devices once you have the disease, it’s going to be averting some of the conditions ahead of time through these IT methods.”
There is “definite overlap” in health IT and medical devices, confirms Fred Khosravi, MS, co-founder and managing partner at Incept, a health sciences and medical development firm. “There are going to be a number of innovations coming out within a few years where health IT overlaps with medical devices that are going to be geared toward reducing the cost of healthcare and maintaining the high quality of care in the U.S.”