by
Brendon Nafziger, DOTmed News Associate Editor | July 22, 2010
An authority on medical device law, Thompson literally wrote the book on the subject, "FDA Regulation of Medical Devices," published by Interpharm Press in 1995. He has also testified before Congress on FDA rulemaking.
Planning ahead
Nonetheless, the FDA is taking a closer look at the industry, Thompson said. But even with tougher scrutiny, he thinks the field will remain extremely attractive to companies. Simply put, health care is a good place to be, even with - or in some cases due to - regulatory hassles.
Merge Healthcare eFilm Mobile
In one of a series of articles published in MobiHealthNews about FDA regulations of smartphone apps, Thompson cited a Thomson Reuters study that showed medical device makers enjoying an average of five-year gross margins of 59 percent, compared with about 46 percent for the Standard & Poor 500. And a Deloitte Center for the Edge study also cited by Thompson found that unlike most of the economy, which only provides one quarter of the return on assets (ROA) it did 40 years ago, the ROA for health care nearly doubled over the same period.
But to prosper with medical apps, the software makers need to do their homework - and maybe even change their culture.
Weight management vs. management of obesity
Not all medical-themed apps will fall under the FDA's purview. While a product marketed to help people lose weight might seem the same as a one designed to help treat obesity, to the FDA, it could mean the difference between giving the product a free pass and requiring extensive pre-release research.
As Thompson explained, an app advertised as helping people lose weight would probably count as a mere "wellness" program. It would therefore stay well outside the agency's remit. But if the product were marketed as a way to treat obesity - a disease - then it would be making a clinical claim and could fall under the agency's scrutiny.
"That's one of the things I'm preaching: these companies need to be aware of the rules, so when they make their claims, when they put their advertising together and other information that describes the use, they can make intelligent decisions about how they want to manage them," Thompson said.
