Innovations in healthcare technology, especially when it comes to mobile health, are well outpacing an ability to wait for a regulatory strategy. These solutions are not being developed by large enterprise vendors but entrepreneurial developers that have a passion for making our healthcare industry better. The venture community agrees. With a predicted investment of more than $3 billion in mobile health solutions, money is flowing to organizations that can harness the power of mobile technology to solve the most complex health problems. We cannot stifle this energy for advancing healthcare diagnosis and new methods of treatment, which could happen without a clear policy on how to regulate the health information technology sector.
The Mobile Medical Application (MMA) market is saturated with a lack of clarity regarding the potential costs and barriers to FDA approval. The cause of this confusion is not entirely one of willful blindness, but instead rests mostly on the lack of information being supplied to developers. For many start-up developers, the immediate concerns about creating a profitable product are at the forefront while the thought of regulatory problems are pushed to the back.
Even though regulation is important, early resources and funding rounds tend to be dedicated to product development and business goals, not regulation research. While it might make sense, this myopic thinking is extremely dangerous for start-up developers. By not preparing for the cost of approval and the added time for product deployment, these start-ups are ignoring a barrier that could ultimately cost them their company.
What can start-ups do?
I'm not saying that these companies need to secure millions in funding immediately to focus on regulation costs. They need to understand the costs and build that information into their business model. Not only will this allow them to not be blind-sided by regulation, but they will become more appealing to venture capitalists who will be more than pleased to know their investments won't whittle away under the weight of the FDA.
Enterprising developers can implement the FDA mandated current good manufacturing practices (CGMP's) so they don't have to retrace their steps in the future to be in compliance, thus helping speed up the approval process. FDA regulations will be a barrier to entering the MMA market and taking the proactive steps of information gathering and preparation will increase the chance of being one of the first to be approved to market.
What can policy do?
We need to have clear processes from the FDA that make the classification procedures less burdensome and streamlined. We need to have better programs for educating these entrepreneurs on the FDA so they can make informed business decisions. We need these guidelines to match innovative tools for mobile and tablet devices as well as the use of nano scale development. We cannot be indecisive on these actions. That alone will, and has, stifled innovation.
The increased focus on funding MMA start-ups, accelerators, and mentor programs has become more abundant with the advent of technology challenges sponsored by notable organizations like Nokia, Robert Wood Johnson Foundation, and Qualcomm. We cannot lead these new and innovative companies down a black hole that means their unique solution - that can detect cancer or monitor patients via physiological nano sensors for example - will never see the light of day in the US healthcare market.
Instead we need to show them a roadmap to enter the market and more importantly become the disruptive change that they can be. It will take a combination of innovation and regulation to ensure breakthroughs are safe for patients. This is how we can create a foundation based on new ways of treating patients that will lead to better quality of healthcare, saving lives and managing costs.
This post is part of a series produced by The Huffington Post, the mHealth Alliance and HIMSS Media in conjunction with the mHealth Summit, which will take place in the Washington, DC, area on December 8-11, 2013. The Summit brings together leaders across sectors to advance the use of wireless technology to improve health outcomes, both in the United States and globally. For more information about the mHealth Summit, click here.