We first covered ResApp more than three years ago. The company has developed a smartphone app that can diagnose the different types of childhood coughs, simply by analyzing a sound sample recorded by a phone. It can distinguish between lower respiratory tract disease, croup, pneumonia, asthma, and bronchiolitis. At the time, we saw it as a bellwether for smartphone health apps and for digital health in general.

Now comes the news that the company has received CE Mark certification for its ResAppDx-EU version of the program. According to the company, this is ” the world’s first smartphone-based diagnostic test for acute paediatric respiratory disease.” It also marks the launch of its first commercial product now that it meets the European regulations for medical devices.

There are many important take-aways from this story, beyond the obvious news that a new tool is available to diagnose coughs for infants and children. It is also important to realize that this has been a lengthy development process with extensive clinical trials to prove its effectiveness (including some studies that had to be thrown out and started over again.) The most recent study involved 585 patients in a double-blind, prospective study. Such research takes time and money, but is essential to demonstrate that the product actually does what it is designed to do.

Another point is that this is not an arrival, but rather just a milestone. The product cannot be sold in the U.S. yet; FDA clearance has been requested and the application is still under review. CE and FDA approvals will help smooth the way for other markets. But all of this takes time and money and further delays the start of sales revenues.

Ralph Waldo Emerson once wrote “If a man can write a better book, preach a better sermon, or make a better mousetrap than his neighbor, though he build his house in the woods, the world will make a beaten path to his door.” The hard truth is that it is no longer sufficient to build a better mousetrap, especially in the realm of health technology. Instead, a company must be prepared for a long haul, refining the innovation and proving its value. And then comes the challenge of making that news known to the potential market.

ResApp was a bellwether for digital health innovation, and remains an example of what it takes to be successful in this field.