By Bill Hanlon, Covance, and Scott Thiel, Navigant Consulting, Inc.
Mobile health applications have the potential to significantly change drug development, clinical trials and the administration of health care. The industry has grown rapidly, with roughly 45,000 identified mobile health publishers and more than 3 billion app downloads in 2015. By some projections the global market will reach $10.2 to $11.8 billion by 2018 with a compound annual growth rate of 39-41%. Currently, less than one-fifth of health care providers currently use mobile health apps with their patients, but nearly half say they will start in the next five years.
This expanding industry has created new opportunities for developers ranging from small start-ups to established companies. But many of these firms will face similar challenges entering this evolving field. Regulations are still emerging, and the US Food and Drug Administration (FDA) has not yet provided definitive guidance on some types of products. Expectations for precision and accuracy can be as high as those for traditional medical devices, and users are starting to demand more reliable performance. While mobile health apps hold promise for reducing the cost of clinical trials, concerns about issues such as validation, logistics and data security must be addressed.
To succeed, companies will need to keep pace with changing guidelines, make informed design decisions and develop quality systems that ensure patient safety.