How to Manage Mobile Medical App Development Under FDA Regulation
San Diego, Calif., January 9, 2014 -- A consortium of six leading universities, more than a dozen industry trade associations and professional societies, and the U.S. Food & Drug Administration announced their unprecedented collaboration to develop a series of educational programs designed to help mobile app developers learn about FDA requirements for producing higher risk medical apps as well as the business issues associated with entering this space.
Called the “MMA Roadshow: Managing App Development under FDA Regulation,” the four-hour workshops are scheduled over several months across the country, including Jan. 27 at the University of California, San Diego. The UC San Diego workshop is sponsored by the von Liebig Entrepreneurism Center at the Jacobs School of Engineering and the Institute of Engineering in Medicine. Registration and program information for the Jan. 27 event at UC San Diego is online here.
1/16/14: University of Illinois, Chicago 1/23/14: Johns Hopkins University
1/27/14: University of California, San Diego 1/28/14: Stanford University
1/31/14: University of Texas, Austin 3/20/14: Massachusetts Institute of Technology
5/6-8/14: mHealth Europe Summit 6/12-13/14: HIMSS Innovation Center
The Need for Regulatory Clarity on Mobile Medical Apps
On September 25 of this year, FDA published its final guidance on mobile medical apps, or MMA. While long anticipated, the final guidance clarified that FDA regulates the higher risk portion of mobile apps, those intended for use in the diagnosis or treatment of diseases or other conditions. Since that time, companies have been examining the final guidance, trying to figure out how it impacts their particular apps and business plans.
The goal of the MMA Roadshow, according to Bradley Merrill Thompson, the chairman of the steering committee for the program, is to advance patient care by encouraging the development of apps at the higher benefit/higher risk end of the spectrum. “Mobile apps offer incredible opportunities to improve the quality of care, as well as its effectiveness and efficiency, and so far developers have barely scratched the surface. We hope to help more companies enter this space.”
Many of the medical-related apps developed so far address low-risk needs such as basic tracking and trending of health data, but there are huge opportunities to use apps for more serious purposes such as managing cardiovascular disease. However, with these greater opportunities come greater risk and the likelihood of FDA regulation. The consortium wants to help traditional medical device companies and IT companies looking to bring their technology to healthcare understand the process for innovating in this regulated space. The MMA Roadshow will help demystify the FDA requirements for new entrants, and identify best practices among those already producing regulated apps. At the same time, the consortium hopes to spur economic development in an area where the United States has a clear advantage globally.
Program Features Lessons Learned from Pioneers in the Field
The thrust of the program will be panel discussions with people who have successfully navigated the FDA process with a mobile app. There are over 100 companies that have obtained clearance from the agency to market their app. The MMA Roadshow will draw speakers from that pool of companies to address both what they learned from a regulatory strategy perspective, but also what they encountered from a business perspective. By comparing notes, these entrepreneurs and innovators will seek to identify strategies that work the best, and pitfalls they would recommend avoiding. Speakers will discuss the business realities behind their decision to seek FDA clearance, and the marketing impact that FDA clearance has had. The program also will feature select experts in both U.S. and EU regulatory requirements. The FDA will be an active participant in the program, both helping to explain its requirements and fielding difficult questions.
In recent years, members of the IT industry have implored FDA to use new strategies to explain the agency’s requirements when the complex statutes and regulations are not clear. Over the summer, a federal advisory committee organized under section 618 of the FDA Innovation and Safety Act of 2012 specifically recommended that FDA look for avenues to accelerate the learning of the IT industry with regard to agency requirements. Because the MMA Roadshow is a coordinated effort of the major industry associations with an interest in mobile health, it reflects a very effective and efficient means for the agency to educate potential innovators.
According to Thompson, “the universities were a natural partner in this initiative. With their engineering schools, these universities all act as hubs for innovation, training the next generation of developers and indeed themselves generating potentially life-saving technology that can be transferred to industry for commercialization. Further, these universities all have outstanding business schools interested in developing new business models to support innovation in these higher risk applications. We selected not just leading universities, but those geographically well-positioned to serve as focal points for industry gatherings.”
The consortium members, industry trade groups and professional societies all volunteered to do their part to connect these educational opportunities with budding entrepreneurs. There is strength in numbers – the consortium members have hundreds of thousands of members many of which are interested in mobile health. They span such areas as consumer electronics that are increasingly being used for managing health; wireless connectivity, which is the backbone of mobile health; telemedicine technology that is driving the availability of health care to previously underserved populations; health information technology developers; traditional medical device manufacturers; venture capital and professional societies focused on FDA regulatory education. Collectively they represent the vast majority of technology developers in this mobile space.
The MMA Roadshow is being organized by the mHealth Regulatory Coalition, a group specifically focused on enhancing the FDA regulatory environment for new mobile technology. The group is providing expert speakers as well as representatives of the companies that have waded into these regulatory waters.