Q: What is the greatest design challenge when it comes to developing mobile medical device technology?

With predictions that the global mHealth market will reach $18B next year and reach a compounded, annual growth rate of 33%, it is clear that a plethora of ever-changing challenges will come with it. I find two particularly interesting.

The first is trying to understand which side of the regulatory fence a system falls on. The FDA’s Mobile Medical Applications Guidance Document released in February of this year aims to define what is and is not a regulated medical system. While this is a great step in helping developers understand what their regulatory pathway will be, the problem is that it is still a new guidance and will surely evolve in the years to come. I find it very interesting that the term “Contains Nonbinding Recommendations” is the header on every page. I expect that will change very soon.

The second challenge is trying to understand the needs of lower income and developing country users. These users are key components in the significant growth of mHealth. Extensive research needs to be performed to understand and characterize the needs of these groups to promote adoption and minimize abandonment rates.