The FDA classifies a medical device as “…an implementation, product, apparatus or other component or accessory, which is used in the diagnosis, cure, mitigation, treatment, prevention of disease or effects any structure of the body–that could actually include some information technologies and performance technologies–but usually something that is performed on the patient, touches the patient or is performed between physician and patient.”
By this definition, an iPhone or Blackberry loaded with the proper apps or enabling a key medical service becomes a FDA-regulated device. That is an industry with over 5 billion previously unregulated potential medical devices waiting to be enabled by the 17,000 plus increasingly sophisticated wireless health applications in the market and thousands applications more in active development. Wireless and mobile health researchers at strategy consulting firm CSMG estimate industry revenues to top $4.6 billion by 2014, a stunning figure for an industry that didn’t exist just 5 years ago.
Recognizing the potential regulatory bombshell, the FDA and the FCC convened last July for a meeting on “Converged Communications and Healthcare Devices Impact on Regulation to address the current state of wireless health, innovator perspective, and investor perspective. The agencies’ stated motivation for the meeting was to “clarify and delineate the respective areas of expertise and jurisdiction between the agencies” given the increasing convergence of communications and wireless technologies and medical devices. Emerging from the meeting was a joint FDA-FCC memorandum of understanding to promote collaboration and eventually refine and improve the regulatory processes applicable to wireless-enabled medical devices (and conversely wireless devices with medical applications). While an admirable step towards normalizing government oversight over the mHealth market, neither agency has issued concrete guidance or a path to regulatory approval to date.
The FDA’s lack of clarity is causing uncertainty amongst entrepreneurs and investors. Just last month, the agency finally announced it would issue guidance on mobile medical applications later this year, settling an issue that has had many industry investors cautiously observing from the sidelines and developers nervously eying their own business plans.
Given the day’s current political environment of overregulation, it’s possible that the decision could have severe ramifications on growth in an industry in the midst of considerable upswing.
With the number of mobile subscribers worldwide passing the 5.3 billion mark at the end of the year, over 75% of the global population has a mobile device, and that number is expected to grow thanks to increasing penetration in developing countries and the growing presence of tablet computing.
We are optimistic that the FDA will adjust its need for regulation in harmony with the industry’s need for innovation, creating a set of guidelines that will attract investors and entrepreneurs while protecting the security of consumers and medical data.
Have a great week!