In testimony before the U.S. House of Representatives Energy and Commerce Committee Subcommittee on Communications & Technology, several expert witnesses alluded to “garage entrepreneurs” as the driving force behind the “trajectory of innovation” in the development of mobile health apps. They worry that such “small” enterprises do not have the money or knowledge to deal with FDA regulation, especially when it is uncertain which mobile health apps the FDA will or will not deem to be medical devices subject to regulation.
“The development and availability of mobile health apps has, quite simply, skyrocketed. Approximately 27,000 unique health apps are available for consumers and healthcare professionals,” said Robert Jarrin, Senior Director, Government Affairs, Qualcomm in his testimony. “About 500 new mobile health apps launch every month, which is up from about 400 health apps that launched every month this time last year. Over 7,000 apps are specifically intended for use by medical students, physicians, nurses, clinicians and other healthcare professionals.”
“Unlike other aspects of the healthcare marketplace, there is little to no barrier to entry into the health app market — so
basically anyone with an idea and programming skills can build a mobile health app,” said Ben Chodor, CEO of Happtique in his written testimony. “While this has exposed the healthcare industry to an influx of technologically sophisticated and innovative developers who are eager to make positive transformations, it has simultaneously made the industry vulnerable to a new breed of inventors who are novice to its regulatory landscape. Thus, the easy entry into mHealth offers incredible opportunity for innovation in healthcare; however, the open market comes with certain concerns, namely, ‘how credible are the apps I am (or my patients are) using?'”
The availability of so many mobile health apps and the low economic and technical barriers to entry in this market begs the question: Who is the typical mobile Health App Developer?
The closest I could come to the answer to that question is this graphic in an article (“The Messaging Apps Taking on Facebook, Phone Giants“) published in today’s Wall Street Journal:
It’s a well-known fact that pharma companies and their agencies typical outsource the development of their digital applications and usually the supplier is a lone developer in a garage or unassuming Brooklyn brownstone apartment (see, for example, here).
So, is the typical developer of mobile health apps sponsored by pharma a lone, young man 29 years or less old? Hmmmm… if so, I hope he’s not anti-social, armed and on anti-depression drugs!